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motivated [35:<75 lb) 0.1 mg/kg SC daily Treatment with Serostim 0.1 mg/kg every other day was associated with fewer side effects, and resulted in a similar improvement in work output, as compared with Serostim 0.1 mg/kg daily. Therefore, a starting dose of Serostim 0.1 mg/kg every other day should be considered in patients at increased risk for adverse effects related to recombinant human growth hormone therapy (i.e., glucose intolerance). In general, dose reductions (i.e., reducing the total daily dose or the number of doses per week) should be considered for side effects potentially related to recombinant human growth hormone therapy. Most of the effect of Serostim on work output and lean body mass was apparent after 12 weeks of treatment. The effect was maintained during an additional 12 weeks of therapy. There are no safety or efficacy data available from controlled studies in which patients were treated with Serostim continuously for more than 48 weeks. There are no safety or efficacy data available from trials in which patients with HIV wasting or cachexia were treated intermittently with Serostim. Preparation and Administration Each vial of Serostim 5 mg or 6 mg is reconstituted with 0.5 to 1 mL Sterile Water for Injection, USP. Each vial of Serostim 4 mg is reconstituted in 0.5 to 1 mL of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved). For patients sensitive to Benzyl Alcohol, Serostim may be reconstituted with Sterile Water for Injection, USP [see Pediatric Use (8.4) ]. When Serostim is reconstituted with Sterile Water for Injection, USP, the reconstituted solution should be used immediately and any unused portion should be discarded. When Serostim is reconstituted with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved) the reconstituted solution may be refrigerated (2-8 C/36-46 F) for up to 14 days. Approximately 10% mechanical loss can be associated with reconstitution and administration from multidose vials. To reconstitute Serostim, inject the diluent into the vial of Serostim aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. DO NOT SHAKE. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Serostim MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless. Serostim can be administered using (1) a standard sterile, disposable syringe and needle, (2) a compatible Serostim needle-free injection device or (3) a compatible Serostim needle injection device. For proper use, refer to the Instructions for Use provided with the administration device. Injection sites, which may be located on the thigh, upper arm, abdomen or buttock, should be rotated to avoid local irritation. Dosage Forms and Strengths Single-use administration (to be reconstituted with Sterile Water for Injection): Serostim 5 mg per vial Serostim 6 mg per vial Multi-use administration (to be reconstituted with Bacteriostatic Water for Injection): Serostim 4 mg per vial Contraindications Acute Critical Illness Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure [see Warnings and Precautions (5.1) ]. Active Malignancy In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity [see Warnings and Precautions (5.3) ] . Hypersensitivity Serostim is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products [see Warnings and Precautions (5.6) ]. Diabetic Retinopathy Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. Warnings and Precautions Acute Critical Illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo [see Contraindications (4) ] . Concomitant Antiretroviral Therapy In some experimental systems, somatropin has been shown to potentiate HIV replication in vitro at concentrations ranging from 50-250 ng/mL. There was no increase in virus production when the antiretroviral agents, zidovudine, didanosine or lamivudine were added to the culture medium. Additional in vitro studies have shown that somatropin does not interfere with the antiviral activity of zalcitabine or stavudine. In the controlled clinical trials, no significant somatropin-associated increase in viral burden was observed. However, the protocol required all participants to be on concomitant antiretroviral therapy for the duration of the study. In view of the potential for acceleration of virus replication, it is recommended that HIV patients be maintained on antiretroviral therapy for the duration of Serostim treatment. Neoplasms Because malignancies are more common in HIV positive individuals, the risks and benefits of starting somatropin in HIV positive patients should be carefully considered before initiating Serostim treatment and patients should be monitored carefully for the development of neoplasms if treatment with somatropin is initiated. Monitor all patients with a history of any neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor [see Contraindications (4) ]. Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes of preexisting nevi. Impaired Glucose Tolerance/Diabetes Hyperglycemia may occur in HIV infected individuals due to a variety of reasons. In wasting patients, treatment with Serostim 0.1 mg/kg daily and 0.1 mg/kg every other day for 12 weeks was associated with approximately 10 mg/dL and 6 mg/dL increases in mean fasting blood glucose concentrations, respectively. The increases occurred early in treatment. Patients with other risk factors for glucose intolerance should be monitored closely during Serostim therapy. During safety surveillance of patients with HIV-associated wasting, cases of new onset impaired glucose tolerance, new onset type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus have been reported in patients receiving Serostim. Some patients developed diabetic ketoacidosis and diabetic coma. In some patients, these conditions improved when Serostim was discontinued, while in others, the glucose intolerance persisted. Some of these patients required initiation or adjustment of antidiabetic treatment while on Serostim. In clinical trials of Serostim conducted in HIV patients with lipodystrophy (an unapproved indication), evidence of dose-dependent glucose intolerance and related adverse reaction was observed at doses of 4 mg Serostim daily and 4 mg Serostim every other day for 12 weeks [see Adverse Reactions (6.1) ] . Intracranial Hypertension Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropin products. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Funduscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Severe Hypersensitivity Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications (4) ]. Fluid Retention/Carpal Tunnel Syndrome Increased tissue turgor (swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness) may occur during treatment with Serostim, but may resolve spontaneously, with analgesic therapy, or after reducing the frequency of dosing [see Dosage and Administration (2.1) ]. Carpal tunnel syndrome may occur during treatment with Serostim. If the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Serostim, it is recommended that treatment be discontinued. Lipoatrophy When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site [see Dosage and Administration (2.2) ] . Pancreatitis Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin-treated patient, especially a child who develops abdominal pain. Adverse Reactions The following important adverse reactions are also described elsewhere in the labeling: Acute Critical Illness [see Warnings and Precautions (5.1) ] Neoplasms [see Warnings and Precautions (5.3) ] Impaired glucose tolerance and diabetes mellitus [see Warnings and Precautions (5.4) ] Intracranial hypertension [see Warnings and Precautions (5.5) ] Severe hypersensitivity [see Warnings and Precautions (5.6) ] Fluid retention/Carpal tunnel syndrome [see Warnings and Precautions (5.7) ] Lipoatrophy [see Warnings and Precautions (5.8) ] Pancreatitis [see Warnings and Precautions (5.9) ] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical trials in HIV-associated wasting or cachexia: In the 12-week, placebo-controlled Clinical Trial 2, 510 patients were treated with Serostim. The most common adverse reactions judged to be associated with Serostim were musculoskeletal discomfort and increased tissue turgor (swelling, particularly of the hands or feet), and were more frequently observed when Serostim 0.1 mg/kg was administered on a daily basis [Table 1 and Warnings and Precautions (5)]. These symptoms often subsided with continued treatment or dose reduction. Approximately 23% of patients receiving Serostim 0.1 mg/kg daily and 11% of patients receiving 0.1 mg/kg every other day required dose reductions. Discontinuations as a result of adverse reactions occurred in 10.3% of patients receiving Serostim 0.1 mg/kg daily and 6.6% of patients receiving 0.1 mg/kg every other day. The most common reasons for dose reduction and/or drug discontinuation were arthralgia, myalgia, edema, carpal tunnel syndrome, elevated glucose levels, and elevated triglyceride levels. Clinical adverse reactions which occurred during the first 12 weeks of study in at least 5% of the patients in either active treatment group and at an incidence greater than placebo are listed below, without regard to causality assessment. Table 1: Controlled Clinical Trial 2 Adverse Reactions Occurring in at least 5% of Patients in one of the Treatment Groups, and at an Incidence Greater than Placebo Placebo 0.1 mg/kg every other day Serostim 0.1 mg/kg daily Serostim Patients (n=247) Patients (n=257) Patients (n=253) Body System Preferred Term % % % Musculoskeletal System Disorders Arthralgia 11.3 24.5 36.4 Myalgia 11.7 17.9 30.4 Arthrosis 3.6 7.8 10.7 Gastrointestinal System Disorders Nausea 4.9 5.4 9.1 Body As A Whole - General Disorders Edema Peripheral 2.8 11.3 26.1 Fatigue 4.5 3.5 5.1 Endocrine Disorders Gynecomastia 0.4 3.5 5.5 Central and Peripheral Nervous System Disorders Paresthesia 4.5 7.4 7.9 Hypoesthesia 2.4 1.6 5.1 Metabolic and Nutritional Disorders Edema Generalized 1.2 1.2 5.9 Adverse reactions that occurred in 1% to less than 5% of trial participants receiving Serostim during the first 12 weeks of Clinical Trial 2 thought to be related to Serostim included dose dependent edema, periorbital edema, carpal tunnel syndrome, hyperglycemia and hypertriglyceridemia. During the 12-week, placebo-controlled portion of Clinical Trial 2, the incidence of hyperglycemia reported as an adverse reaction was 3.6% for the placebo group, 1.9% for the 0.1 mg/kg every other day group and 3.2% for the 0.1 mg/kg daily group. One case of diabetes mellitus was noted in the 0.1 mg/kg daily group during the first 12-weeks of therapy. In addition, during the extension phase of Clinical Trial 2, two patients converted from placebo to full dose Serostim, and 1 patient converted from placebo to half-dose Serostim, were discontinued because of the development of diabetes mellitus. The types and incidences of adverse reactions reported during the Clinical Trial 2 extension phase were not different from, or greater in frequency than those observed during the 12-week, placebo-controlled portion of Clinical Trial 2. Adverse reactions from treatment with Serostim in clinical trials in HIV lipodystrophy Serostim was evaluated for the treatment of patients with HIV lipodystrophy in two double-blind, placebo-controlled trials that excluded patients with a history of diabetes, impaired fasting glucose or impaired glucose (approximately 20% of the patients screened were excluded from study enrollment as a result of a diagnosis of diabetes or glucose intolerance). The studies included a 12-week double-blind, placebo-controlled, parallel group "induction" phase followed by maintenance phases of different durations (12 and 24 weeks, respectively). In the initial 12-week treatment periods of the two, placebocontrolled clinical trials, 406 patients were treated with Serostim. Clinical adverse reactions which occurred during the first 12 weeks of both studies combined in at least 5% of the patients in either of the two active treatment groups are listed by treatment group in Table 2, without regard to causality assessment. The most common adverse reactions judged to be associated with Serostim were edema, arthralgia, pain in extremity, hypoesthesia, myalgia, and blood glucose increased, all of which were more frequently observed when Serostim 4 mg was administered on a daily basis compared with alternate days. These symptoms often subsided with dose reduction. During the 12-week induction phase, 1) approximately 26% of patients receiving Serostim 4 mg daily and 19% of patients receiving Serostim4 mg every other day required dose reductions; and 2) discontinuations as a result of adverse reactions occurred in 13% of patients receiving Serostim 4 mg daily and 5% of patients receiving Serostim 4 mg every other day. The most common reasons for dose reduction and/or drug discontinuation were peripheral edema, hyperglycemia (including blood glucose increased, blood glucose abnormal, and hyperglycemia), and arthralgia. Table 2: Controlled HIV Lipodystrophy Studies 1 and 2 Combined Adverse Reactions with> 5% Incidence in Either Active Treatment Arm Placebo Serostim 4 mg every other day * Serostim 4 mg daily Patients (n=159) Patients (n=80) Patients (n=326) System Organ Class Preferred Term % % % * Study 22388 only similar terms were grouped together and reported below Musculoskeletal and connective tissue disorders Arthralgia 11.9 27.8 37.1 Pain in extremity 3.8 5.0 19.3 Myalgia 3.8 2.5 12.6 Musculoskeletal stiffness 1.9 3.8 8.0 Joint stiffness 1.3 3.8 7.7 Joint swelling 0.6 5.0 6.1 General disorders and administration site conditions Edema peripheral 3.8 18.8 45.4 Fatigue 1.9 6.3 8.9 Nervous system disorders Hypoesthesia 0.6 8.8 15.0 Paraesthesia 2.5 12.5 11.0 Investigations (Laboratory Evaluations) Blood glucose increased 2.5 3.8 13.8 Metabolism and nutrition disorders Hyperglycemia 0.6 8.8 7.1 Fluid retention 0.6 2.5 5.2 Gastrointestinal disorders Nausea 2.5 1.3 6.1 Glucose metabolism related adverse reactions: During the initial 12-week treatment periods of Studies 1 and 2, the incidence of glucose-related adverse reactions was 4% for the placebo group, 13% for the 4 mg every other day group and 22% for the 4 mg daily group. Twenty-three patients discontinued due to hyperglycemia while receiving Serostim during any phase of these studies (3.2% in the 12-week induction phases and 2.1% in the extension phases). Breast-Related Terms: When grouped together, breast-related adverse reactions (e.g. nipple pain, gynecomastia, breast pain/mass/tenderness/swelling/edema/hypertrophy) had an incidence of 1% for the placebo group, 3% for the Serostim 4 mg every other day group and 6% for the Serostim 4 mg daily group. Adverse reactions that occurred in 1% to less than 5% of trial participants receiving Serostim during the first 12 weeks of HIV Lipodystrophy Studies 1 and 2 thought to be related to Serostim include carpal tunnel syndrome, Tinel's sign and facial edema. The adverse reactions reported for Serostim 4 mg every other day during the maintenance phase of HIV Lipodystrophy Study 1 (Week 12 to Week 24) were similar in frequency and quality to those observed after treatment with Serostim 4 mg every other day during the 12-week induction phase. IGF-1 serum concentrations increased statistically in Serostim-treated patients when compared to placebo (Table 3). In the Serostim treated patients at baseline, the proportion of subjects with serum IGF-1 SDS levels +2 was approximately 10 to 20%, while with treatment with either dose regimen of Serostim the percentage increased to 80 to 90% by Week 12. Table 3: Change from Baseline to Week 12 in Serum IGF-1 SDS After Treatment with Serostim 4 mg daily vs. Placebo (Modified ITT Population; Studies 1 and 2 Combined) Placebo Serostim 4 mg every other day Serostim 4 mg daily Time Point Statistic (n=145) (n=79) (n=290) * P-value from a Wilcoxon Signed Rank test on the change from baseline to Week 12. Proportionally weighted least squares means from a two-way ANOVA model on raw data including effects for treatment, sex, and the treatment by sex interaction. P-value from a two-way ANOVA model on ranked data including effects for treatment, sex, and the treatment by sex interaction. Baseline Mean (SD) Range 0.4 (1.4) (-2.5, 4.8) 1.3 (2.1) (-2.0, 13.7) 0.0 (1.6) (-3.0, 11.9) Week 12 Mean (SD) Range 0.8 (1.6) (-2.6, 6.7) 5.1 (3.4) (-0.7, 17.2) 6.1 (5.0) (-1.8, 29.2) Change from Baseline to Mean (SD) Range 0.4 (1.3) (-2.9, 7.7) 3.9 (3.1) (-9.4, 11.8) 6.1 (4.6) (-2.4, 24.3) Week 12 p-value * <0.001> <0.001> <0.001 Mean diff (SEM) 3.5 (0.5) 5.7 (0.4) p-value > <0.001> <0.001 As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influences by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Serostim with the incidence of antibodies to other products may be misleading. After 12 weeks of treatment, none of the 651 study participants with HIV-associated wasting treated with Serostim for the first time developed detectable antibodies to growth hormone (> 4 pg binding). Patients were not rechallenged. Data beyond 3 months is not available. Post-Marketing Experience The following adverse reactions have been identified during post approval use of Serostim. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products [see Warnings and Precautions (5.6) ]. Endocrine: new onset impaired glucose tolerance new onset type 2 diabetes mellitus exacerbation of preexisting diabetes mellitus diabetic ketoacidosis diabetic coma In some patients, these conditions improved when Serostim was discontinued, while in others the glucose intolerance persisted. Some of these patients required initiation or adjustment of antidiabetic treatment while on Serostim [see Warnings and Precautions (5.4) ] . Gastrointestinal: Pancreatitis [see Warnings and Precautions (5.9) ] . Drug Interactions Formal drug interaction studies have not been conducted. No data are available on drug interactions between Serostim and HIV protease inhibitors or the non-nucleoside reverse transcriptase inhibitors. 11ฮฒ-Hydroxysteroid Dehydrogenase Type 1 The microsomal enzyme 11ฮฒ-hydroxysteroid dehydrogenase type 1 (11ฮฒHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Somatropin inhibits 11ฮฒHSD-1. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11ฮฒHSD-1. Cytochrome P450-metabolized drugs Limited published data indicate that somatropin treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance in man. These data suggest that somatropin administration may alter the clearance of compounds metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Therefore, careful monitoring is advised when somatropin is administered in combination with drugs metabolized by CYP450 liver enzymes. However, formal drug interaction studies have not been conducted. Oral Estrogen Because oral estrogens may reduce the serum IGF-1 response to somatropin treatment, girls and women receiving oral estrogen replacement may require greater somatropin dosages [see Dosage and Administration (2) ] . Insulin and/or Other Oral/Injectable Hypoglycemic Agents Patients with diabetes mellitus who receive concomitant treatment with somatropin may require adjustment of their doses of insulin and/or other hypoglycemic agents [see Warnings and Precautions (5.4) ] . USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Doses up to 5 to 10 times the human dose, based on body surface area, have revealed no evidence of impaired fertility or harm to the fetus due to Serostim. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Serostim should be used during pregnancy only if clearly needed. Nursing Women It is not known whether Serostim is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Serostim is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients with HIV have not been established. Available evidence suggests that somatropin clearance is similar in adults and children, but no pharmacokinetic studies have been conducted in children with HIV. In two small studies, 11 children with HIV-associated failure to thrive were treated subcutaneously with human growth hormone. In one study, five children (age range, 6 to 17 years) were treated with 0.04 mg/kg/day for 26 weeks. In a second study, six children (age range, 8 to 14 years) were treated with 0.07 mg/kg/day for 4 weeks. Treatment appeared to be well tolerated in both studies. The preliminary data collected on a limited number of patients with HIV-associated failure to thrive appear to be consistent with safety observations in growth hormone-treated adults with HIV wasting. Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The "gasping syndrome," (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources. Geriatric Use Clinical studies with Serostim did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be more sensitive to the action of somatropin, and therefore, may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2) ]. Hepatic Impairment No studies have been conducted for Serostim in patients with hepatic impairment [see Clinical Pharmacology (12.3) ]. Renal Impairment Subjects with chronic renal failure tend to have decreased somatropin clearance compared to those with normal renal function. However, no studies have been conducted for Serostim in patients with renal impairment [see Clinical Pharmacology (12.3) ]. Gender Effect Biomedical literature indicates that a gender-related difference in the mean clearance of r-hGH could exist (clearance of r-hGH in males > clearance of r-hGH in females). However, no gender-based analysis is available for Serostim in normal volunteers or patients infected with HIV. Overdosage Short-Term Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Long-Term Long-term overdosage could result in signs and symptoms of acromegaly consistent with the known effects of excess growth hormone. Serostim Description Serostim is a human growth hormone (hGH) produced by recombinant DNA technology. Serostim has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. Serostim is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. Serostim is secreted directly through the cell membrane into the cell-culture medium for collection and purification. Serostim is a sterile lyophilized powder intended for subcutaneous injection after reconstitution to its liquid form. Vials of Serostim contain either 4 mg, 5 mg, or 6 mg. Each vial contains the following: Vials 4 mg 5 mg 6 mg Component Somatropin 4 mg 5 mg 6 mg Sucrose 27.3 mg 34.2 mg 41 mg Phosphoric acid 0.9 mg 1.2 mg 1.4 mg Each 4 mg multi-vial is supplied in a combination package with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution. Each 5 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 6.5 to 8.5 after reconstitution. Each 6 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution. Serostim - Clinical Pharmacology Mechanism of Action Serostim is an anabolic and anticatabolic agent which exerts its influence by interacting with specific receptors on a variety of cell types including myocytes, hepatocytes, adipocytes, lymphocytes, and hematopoietic cells. Some, but not all of its effects, are mediated by insulin-like growth factor-1 (IGF-1). Pharmacodynamics Effects on Protein, Lipid and Carbohydrate Metabolism A one-week study in 6 patients with HIV-associated wasting has shown that treatment with Serostim 0.1 mg/kg/day improved nitrogen balance, increased protein-sparing lipid oxidation, and had little effect on overall carbohydrate metabolism. Decreases in trunk fat and total body fat, and increases in lean body mass were observed during two double-blind, placebo-controlled studies wherein Serostim vs. placebo were administered daily for 12 weeks to patients with HIV Lipodystrophy [see Clinical Studies (14) ] . Effects on Nitrogen and Mineral Retention In the one-week study in 6 patients with HIV-associated wasting, treatment with Serostim resulted in the retention of phosphorous, potassium, nitrogen, and sodium. The ratio of retained potassium and nitrogen during Serostim therapy was consistent with retention of these elements in lean tissue. Physical Performance Cycle ergometry work output and treadmill performance were examined in separate 12-week, placebocontrolled trials [see Clinical Studies (14) ]. In both studies, work output improved significantly in the group receiving Serostim 0.1 mg/kg/day subcutaneously vs placebo. Isometric muscle performance, as measured by grip strength dynamometry, declined, probably as a result of a transient increase in tissue turgor known to occur with Serostim therapy. Pharmacokinetics Absorption: The absolute bioavailability after subcutaneous administration was determined to be 70 to 90%. The mean t after subcutaneous administration is significantly longer than that seen after intravenous administration in normal male volunteers down-regulated with somatostatin (approximately 4.0 hrs. vs. 0.6 hrs.), indicating that the subcutaneous absorption of somatropin is a rate-limiting process. Distribution: The steady-state volume of distribution (Mean SD) following intravenous administration of somatropin in normal male volunteers is 12.0 1.08 L. Metabolism: Although the liver plays a role in the metabolism of GH, GH is primarily cleaved in the kidney. GH undergoes glomerular filtration and, after cleavage within the renal cells, the peptides and amino acids are returned to the systemic circulation. Elimination: The t in nine patients with HIV-associated wasting with an average weight of 56.7 6.8 kg, given a fixed dose of 6.0 mg somatropin subcutaneously was 4.28 2.15 hrs, similar to that observed in normal male volunteers. The renal clearance of r-hGH after subcutaneous administration in nine patients with HIV-associated wasting was 0.0015 0.0037 L/h. No significant accumulation of r-hGH appears to occur after 6 weeks of daily dosing as indicated. Specific Populations: Pediatric: Available evidence suggests that r-hGH clearances are similar in adults and children, but no pharmacokinetic studies have been conducted in children with HIV. Gender: Biomedical literature indicates that a gender-related difference in the mean clearance of r-hGH could exist (clearance of r-hGH in males > clearance of r-hGH in females). However, no gender-based analysis is available in normal volunteers or patients infected with HIV. Race: No studies have been conducted to determine the effect of race on the pharmacokinetics of Serostim. Renal Impairment: Subjects with chronic renal failure tend to have decreased somatropin clearan foremost


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optimal Serostim Generic Name: somatropin, mammalian derived (Injection route, Subcutaneous route) soe-ma-TROE-pin, mam-MAY-lee-un dee-RIVED Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons Commonly used brand name(s) In the U.S. Saizen Serostim Zorbtive In Canada Nutropin Nutropin Aq Available Dosage Forms: Powder for Solution Therapeutic Class: Endocrine-Metabolic Agent Pharmacologic Class: Somatropin Slideshow HIV & AIDS Update: New Treatments, Easier Options Uses For Serostim Somatropin injection is a man-made version of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in adults or children who have certain conditions that prevent normal growth. These conditions include growth failure caused by growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), or Turner syndrome. Somatropin injection is also used together with a proper diet to treat short bowel syndrome (SBS), which is a condition that prevents the intestine or gut from absorbing food properly. This medicine is available only with your doctor's prescription. Before Using Serostim In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatropin injection in children with growth hormone deficiency. Appropriate studies have not been performed on the relationship of age to the effects of somatropin injection in children with short bowel syndrome. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin injection in the elderly. However, elderly patients are more sensitive to the effects of somatropin, which may require an adjustment of dosage in patients receiving somatropin injection. Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Brain tumor or Cancer, active or Closed epiphyses (normal bone growth stopped) in children or Diabetic retinopathy (eye condition) or Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems or Severe illness after surgery or major medical emergency (eg, open heart surgery, abdominal surgery, accidental trauma, or respiratory failure) Should not be used in patients with these conditions. Cancer, history of or Fluid retention, history of or Hypopituitarism (pituitary gland produces low hormone levels) or Hypothyroidism (underactive thyroid gland) or Otitis media (ear infection) in children, history of or Pancreatitis (inflammation or swelling of the pancreas) or Scoliosis (abnormally curved spine) Use with caution. May make these conditions worse. Diabetes, or a family history of Use with caution. May prevent insulin from working properly. . Kidney disease Use with caution. The effects may be increased because of slower removal of the medicine from the body. Turner syndrome May increase risk of having thyroid and hearing problems. Proper Use of somatropin, mammalian derived This section provides information on the proper use of a number of products that contain somatropin, mammalian derived. It may not be specific to Serostim. Please read with care. This medicine is given as a shot under your skin or into a muscle. Somatropin may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected . If you are using this medicine to treat short bowel syndrome , carefully follow your doctor's instructions about any special diet. Take all other medicines or supplements your doctor has prescribed as part of your combination treatment. This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions. There are many different forms (eg, vial, cartridge, injection device) available for this medicine. Make sure your doctor, nurse, or pharmacist instructs you on how to prepare and administer this medication. Also, read all instructions carefully to be sure you know how to use your device. Each time you get your medicine, check to be sure you have received the proper device. Talk to your pharmacist if you have questions about the device that you were given. You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot . Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Use a new needle, unopened vial, or syringe each time you inject your medicine. You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it. Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For injection dosage form: For treatment of growth hormone deficiency: Adults Nutropin or Nutropin AQ : Non-weight based: At first, the usual dose is 0.15 to 0.3 milligrams (mg) injected under the skin once a day. Your doctor may adjust your dose if needed. Weight-based: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.006 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 0.025 to 0.0125 mg per kg of body weight per day. Saizen : Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.005 mg per kg of body weight injected under the skin once a day. Your doctor may adjust your dose if needed. Children Nutropin or Nutropin AQ : Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 to 0.7 mg per kg of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed. Saizen : Dose is based on body weight and must be determined by your doctor. The usual dose is 0.06 mg per kg of body weight, given 3 times per week and injected under the skin or into a muscle. Your doctor may adjust your dose if needed. . For treatment of growth failure due to chronic kidney disease: Children Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.35 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed. For treatment of idiopathic short stature: Children Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed. For treatment of short bowel syndrome: Adults Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day for 4 weeks. Your doctor may adjust your dose if needed. Children Use and dose must be determined by your doctor. For treatment of short stature with Turner syndrome: Children Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.375 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into equal doses 3 to 7 times per week. Your doctor may adjust your dose if needed. Missed Dose This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions. Storage Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store unopened vials, cartridges, and injection devices of Nutropin and Nutropin AQ in the refrigerator, away from heat and direct light. Do not freeze. Store unopened vials of Saizen and Zorbtive at room temperature, away from heat and direct light. Do not freeze. Store the medicine that has been mixed in the refrigerator. The Nutropin or Saizen vials and Zorbtive that has been mixed should be used within 14 days. The Saizen click.easy cartridge that has been mixed should be used within 21 days. Nutropin AQ vial, cartridge, and injection device should be used within 28 days. Make sure you understand how long you can store the medicine after it has been mixed . Throw away any mixed medicine that has not been used within this time. Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets. Precautions While Using Serostim It is very important that your doctor check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine. This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection. This medicine may cause a dislocation in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you or your child has a limp or pain in the hip or knee. Pancreatitis (an inflamed pancreas) may occur while you are using this medicine. Check with your doctor right away if you or your child are having more than one of these symptoms: bloating, chills, constipation, darkened urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pains in stomach, side, or abdomen possibly radiating to the back, vomiting, or yellow eyes or skin. This medicine may affect blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests or if you have any questions. This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor). This medicine may cause fluid retention (extra water in the body). Tell your doctor if you or your child have burning, numbness, pain, or tingling in all fingers except smallest finger, swelling of the hands and feet, or pain, swelling, or stiffness of the muscles. Your doctor may adjust your dose to reduce these side effects. This medicine is usually mixed with Bacteriostatic Water for Injection . You should not use Bacteriostatic Water for Injection if you have had an allergic reaction to benzyl alcohol. If this is a concern, ask your doctor about other ways to mix this medicine. Serostim Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Abnormal or decreased touch sensation bleeding after defecation bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site bloating or swelling of the face, arms, hands, lower legs, or feet blood in the urine burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings changes in skin color cold flu-like symptoms cold hands and feet confusion constipation cough or hoarseness darkened urine decreased urination diarrhea difficult urination dizziness dry mouth fainting or loss of consciousness fast heartbeat fast or irregular breathing feeling unusually cold fever or chills full or bloated feeling general feeling of discomfort or illness headache increase in heart rate itching or skin rash joint pain light-colored stools lightheadedness loss of appetite lower back or side pain muscle aching or cramping muscle pain or stiffness nausea pain pain, redness, or swelling in the arm or leg pains in the stomach, side, or abdomen, possibly radiating to the back pressure in the stomach rapid, shallow breathing rapid weight gain rectal bleeding runny nose shivering sneezing sore mouth or tongue sore throat stomach bloating, burning, cramping, or pain sudden decrease in the amount of urine sweating swelling of the abdominal or stomach area swelling of the eyes or eyelids swelling or puffiness of the face swollen joints thirst tightness in the chest tingling of the hands or feet trouble breathing trouble sleeping uncomfortable swelling around the anus unpleasant breath odor unusual tiredness or weakness unusual weight gain or loss vomiting vomiting of blood white patches in the mouth, tongue, or throat wrinkled skin yellow eyes or skin Less common Bone or skeletal pain burning, numbness, pain, or tingling in all fingers except smallest finger chest pain depressed mood dry skin and hair feeling cold hair loss hoarseness or husky voice slowed heartbeat swelling of the ankles Get emergency help immediately if any of the following symptoms of overdose occur: Symptoms of overdose Anxiety blurred vision changes in vision cold sweats coma cool, pale skin decrease in the amount of urine depression excessive sweating extreme weakness flushed, dry skin frequent urination fruit-like breath odor increase in hands and feet size increased hunger increased thirst increased urination increased volume of pale, diluted urine nightmares noisy, rattling breathing pain in the arms or legs seizures shakiness slurred speech stop in menstruation swelling of the fingers or hands troubled breathing at rest Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Body aches or pain breast pain change in the color, amount, or odor of vaginal discharge congestion discoloration of the fingernails or toenails dryness or soreness of the throat excess air or gas in the stomach or intestines frequent urge to defecate increased sweating passing gas sneezing straining while passing stool stuffy nose tender, swollen glands in neck trouble with swallowing voice changes Less common Discouragement feeling sad or empty irritability lack of appetite loss of interest or pleasure tiredness trouble concentrating Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Side Effects (complete list) The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved. Next Side Effects Print this page Add to My Med List More about Serostim (somatropin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Espaรฑol 1 Review Add your own review/rating Drug class: growth hormones Consumer resources Serostim Other brands: Genotropin , Humatrope , Omnitrope , Norditropin , ... +9 more Professional resources Serostim (FDA) Related treatment guides AIDS Related Wasting Cachexia Prader-Willi Syndrome Short Stature for Age} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer EMD Serono, Inc. Drug Class Growth hormones Related Drugs Short Stature for Age somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Saizen , More... Prader-Willi Syndrome somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Saizen , More... Cachexia somatropin , Norditropin FlexPro , Norditropin Nordiflex , Accretropin , More... AIDS Related Wasting megestrol , Megace , Marinol , dronabinol , somatropin , Megace ES , More... Serostim Rating 1 User Review 5.0 /10 1 User Review 5.0 Rate it! Related Questions & Answers Are you currently taking Serostim? If so .. What side effects have you experienced? In particular? I have myastenia gravis I have been on mestinon for 3 weeks, so far I am not getting much relief on? Is serostim a steroid? there is a direct correlation between esophageal candidiasis and steroids? Does serostim make you hungry or angry? Norditropin - Serostim and Norditopin? Read more questions} } common


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traditional Serostim Generic Name: somatropin (soe ma TROE pin) Brand Name: Genotropin, Genotropin Miniquick, Humatrope, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin AQ NuSpin 10, Nutropin AQ Pen 10 Cartridge, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons What is Serostim (somatropin)? Somatropin is a form of human growth hormone important for the growth of bones and muscles. Somatropin is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome. Somatropin may also be used for purposes not listed in this medication guide. Slideshow HIV & AIDS Update: New Treatments, Easier Options What is the most important information I should know about Serostim (somatropin)? You should not use somatropin if you have cancer, eye problems caused by diabetes, or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems. You should not use somatropin if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma. What should I discuss with my healthcare provider before using Serostim (somatropin)? You should not use this medicine if you are allergic to somatropin or benzyl alcohol, or if you have: a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma; cancer; eye problems caused by diabetes (diabetic retinopathy); or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea). To make sure somatropin is safe for you, tell your doctor if you have: diabetes; a pituitary gland disorder; abnormal curvature of the spine (scoliosis); underactive thyroid; history of head injury or brain tumor; or a history of childhood brain cancer and radiation treatment. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive . It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin . Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. How should I use Serostim (somatropin)? Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes. Your care provider will show you the best places on your body to inject somatropin. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine. Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets. While using somatropin, you may need frequent blood tests. Your growth progress will need to be tested often. Your eyes may also need to be checked. If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome. If you have Prader-Willi syndrome, your treatment program may also include weight control. Follow your doctor's instructions very closely. If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use. How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication. Throw away any somatropin left over after the expiration date on the label has passed. What happens if I miss a dose? Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. Call your doctor if you miss more than 3 doses in a row. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth. What should I avoid while using Serostim (somatropin)? If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive. Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse. Serostim (somatropin) side effects Get emergency medical help if you have signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat. Serious breathing problems may occur in patients with Prader-Willi syndrome who use somatropin. If you have Prader-Willi syndrome , call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Also call your doctor at once if you have: vision changes with sudden and severe pain behind your eyes and nausea or vomiting; pain in your knees or hips, or walking with a limp; ear pain, swelling, warmth, or drainage; numbness or tingling in your wrist, hand, or fingers; severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss. Common side effects may include: swelling, rapid weight gain; muscle or joint pain; headache; or pain, itching, or skin changes where the medicine was injected. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) What other drugs will affect Serostim (somatropin)? Tell your doctor about all your current medicines and any you start or stop using, especially: birth control pills or hormone replacement therapy insulin or oral diabetes medicine; or steroid medicine (prednisone, dexamethasone, methylprednisolone, and others). This list is not complete. Other drugs may interact with somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Next Side Effects Print this page Add to My Med List More about Serostim (somatropin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Espaรฑol 1 Review Add your own review/rating Drug class: growth hormones Consumer resources Serostim Serostim (Advanced Reading) Other brands: Genotropin , Humatrope , Omnitrope , Norditropin , ... +9 more Professional resources Serostim (FDA) Related treatment guides AIDS Related Wasting Cachexia Prader-Willi Syndrome Short Stature for Age Where can I get more information? Your pharmacist can provide more information about somatropin. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 13.03. Date modified: December 03, 2017 Last reviewed: January 04, 2017} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer EMD Serono, Inc. Drug Class Growth hormones Related Drugs Short Stature for Age somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Saizen , More... Prader-Willi Syndrome somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Saizen , More... Cachexia somatropin , Norditropin FlexPro , Accretropin , Norditropin Nordiflex , More... AIDS Related Wasting megestrol , Megace , Marinol , dronabinol , somatropin , Megace ES , More... Serostim Rating 1 User Review 5.0 /10 1 User Review 5.0 Rate it! Related Questions & Answers Are you currently taking Serostim? If so .. What side effects have you experienced? In particular? I have myastenia gravis I have been on mestinon for 3 weeks, so far I am not getting much relief on? Is serostim a steroid? there is a direct correlation between esophageal candidiasis and steroids? Does serostim make you hungry or angry? Norditropin - Serostim and Norditopin? Read more questions} } the loads


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collect Serostim Generic Name: Somatropin for Weight Gain (SOE ma TROE pin) Brand Name: Serostim Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons Uses of Serostim: It is used to help patients with HIV gain weight. It may be given to you for other reasons. Talk with the doctor. Slideshow HIV & AIDS Update: New Treatments, Easier Options What do I need to tell my doctor BEFORE I take Serostim? If you have an allergy to human growth hormone or any other part of Serostim (somatropin for weight gain). If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. If you have any of these health problems: Brain tumor, cancer, diabetic eye disease, illness shortly after open heart or belly surgery, many injuries from a crash, lung disease, or sleep apnea. This is not a list of all drugs or health problems that interact with this medicine. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Serostim with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. What are some things I need to know or do while I take Serostim? For all patients taking this medicine: Tell all of your health care providers that you take Serostim. This includes your doctors, nurses, pharmacists, and dentists. If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar. Check your blood sugar as you have been told by your doctor. Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit. This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine. Have blood work checked as you have been told by the doctor. Talk with the doctor. Avoid drinking alcohol while taking Serostim. Follow the diet and workout plan that your doctor told you about. If you have a history of cancer or tumors, talk with your doctor. The chance of new tumors may be raised in some patients. If you have Turner syndrome, talk with your doctor. The chance of ear infections, high blood pressure, and very bad blood vessel problems like stroke and bleeding in the brain may be raised. This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs. If you are 65 or older, use Serostim with care. You could have more side effects. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. Children: Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn. Talk with the doctor to see if this product has benzyl alcohol in it. How is this medicine (Serostim) best taken? Use Serostim as ordered by your doctor. Read all information given to you. Follow all instructions closely. It is given as a shot into the fatty part of the skin. If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot. Follow how to use as you have been told by the doctor or read the package insert. Move the site where you give the shot with each shot. Do not give into skin that is irritated, bruised, red, infected, or scarred. Do not shake the solution. Do not use if the solution is cloudy, leaking, or has particles. Do not use if solution changes color. Wash your hands before and after use. Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions. What do I do if I miss a dose? Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. Dosage Information (comprehensive) What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up. Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss. Signs of low thyroid levels like hard stools (constipation); not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal. Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight. Shortness of breath. Mood changes. Low mood (depression). Change in eyesight. Very bad headache. Chest pain. Numbness or tingling in the hands or feet. Swelling in the arms or legs. Bone pain. Very bad muscle or joint pain. Change in color or size of a mole. Blood in the urine. Redness or swelling where the shot is given. Skin breakdown where this medicine is used. Thinning of the skin. Raised pressure in the head has rarely happened with Serostim. The risk may be greater in patients with Turner syndrome or Prader-Willi syndrome. Signs most often happen within the first 8 weeks of starting this medicine. Call your doctor right away if you have change in eyesight, a very bad headache, upset stomach, or throwing up. What are some other side effects of Serostim? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Headache. Feeling tired or weak. Muscle or joint pain. Muscle stiffness. Not able to sleep. Upset stomach or throwing up. Gas. Belly pain. Irritation where the shot is given. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Serostim? Store at room temperature. After mixing, store in a refrigerator. Check with the doctor or pharmacist if you have questions about how long Serostim (somatropin for weight gain) may be used after mixing. Protect from light. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take Serostim or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Serostim. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about Serostim (somatropin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Espaรฑol 1 Review Add your own review/rating Drug class: growth hormones Consumer resources Serostim Serostim (Advanced Reading) Other brands: Genotropin , Humatrope , Omnitrope , Norditropin , ... +9 more Professional resources Serostim (FDA) Related treatment guides AIDS Related Wasting Cachexia Prader-Willi Syndrome Short Stature for Age} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Serostim Rating 1 User Review 5.0 /10 1 User Review 5.0 Rate it! Manufacturer EMD Serono, Inc. Drug Class Growth hormones Related Drugs Short Stature for Age somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Saizen , More... Prader-Willi Syndrome somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Saizen , More... Cachexia somatropin , Norditropin FlexPro , Norditropin Nordiflex , Accretropin , More... AIDS Related Wasting megestrol , Megace , Marinol , dronabinol , somatropin , Megace ES , More...} } the infant


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wrestle Serophene Generic Name: Clomiphene (KLOE mi feen) Brand Name: Serophene Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Drug Images Support Group Q & A Uses of Serophene: It is used to help women get pregnant. It may be given to you for other reasons. Talk with the doctor. Slideshow Fertility Facts: Women's Fertility Issues Explained What do I need to tell my doctor BEFORE I take Serophene? If you have an allergy to clomiphene or any other part of Serophene (clomiphene). If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. If you have any of these health problems: Liver disease, pituitary tumor, adrenal gland disease, or thyroid gland disease. If you have ever had liver problems. If you have any of these health problems: Ovarian cysts or vaginal bleeding. If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant. This is not a list of all drugs or health problems that interact with Serophene. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. What are some things I need to know or do while I take Serophene? Tell all of your health care providers that you take Serophene. This includes your doctors, nurses, pharmacists, and dentists. Have blood work checked as you have been told by the doctor. Talk with the doctor. Follow up with the doctor as you have been told. Long-term use may raise the chance of ovarian cancer. A pregnancy test will be done to show that you are NOT pregnant before starting this medicine. If you get pregnant while taking Serophene, call your doctor right away. To raise the chance of getting pregnant, talk with your doctor about the best time to have sex while taking this medicine. This medicine may raise the chance of getting pregnant with more than one baby. This medicine may raise the chance of tubal pregnancy. Sometimes this may be deadly. Talk with your doctor. If you do not ovulate or get pregnant after 3 courses of Serophene, do not take any more. Talk with your doctor. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. How is this medicine (Serophene) best taken? Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely. Follow how to take Serophene as you have been told by your doctor. Do not use more than you were told to use. What do I do if I miss a dose? Call your doctor to find out what to do. Dosage Information (comprehensive) What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Very bad dizziness or passing out. Swelling, warmth, numbness, change of color, or pain in a leg or arm. Eyesight changes, like blurred eyesight or seeing spots or flashes, may happen. They may show up or get worse in bright light. The chance that this will happen is greater in people who take this medicine in higher doses or for a long time. Eyesight most often gets back to normal when the drug is stopped. The changes may be long-lasting or may not go away even after the drug is stopped. Use care when driving or doing other tasks that call for clear eyesight. Call your doctor right away if you have a change in eyesight. A very bad ovary problem may happen with Serophene. Call your doctor right away if you have very bad stomach pain or bloating, upset stomach or throwing up, loose stools (diarrhea), weight gain, shortness of breath, or a change in how much urine is passed. What are some other side effects of Serophene? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Hot flashes. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Serophene? Store at room temperature. Protect from heat. Protect from light. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take Serophene (clomiphene) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Serophene. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about Serophene (clomiphene) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group En Espaรฑol 0 Reviews Add your own review/rating Drug class: synthetic ovulation stimulants Consumer resources Serophene Serophene (Advanced Reading) Other brands: Clomid Professional resources Serophene (FDA) Clomiphene Citrate (AHFS Monograph) Related treatment guides Female Infertility Lactation Suppression Oligospermia Ovulation Induction Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA WADA Class Anti-Doping Classification Serophene Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Synthetic ovulation stimulants Related Drugs Female Infertility Clomid , clomiphene , HCG , Menopur , Pregnyl , Ovidrel , More... Ovulation Induction Clomid , clomiphene , HCG , Menopur , Pregnyl , Ovidrel , More... Oligospermia Clomid , clomiphene , More... Lactation Suppression Clomid , clomiphene , More... Serophene Images Serophene 50 mg (S ) View larger images Related: Female Infertility present day


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grow to be Serophene (Oral) Generic Name: clomiphene (Oral route) KLOE-mi-feen Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Drug Images Support Group Q & A Commonly used brand name(s) In the U.S. Clomid Serophene Available Dosage Forms: Tablet Therapeutic Class: Female Reproductive Agent Pharmacologic Class: Gonadotropin Slideshow Fertility Facts: Women's Fertility Issues Explained Uses For Serophene Clomiphene is used as a fertility medicine in some women who are unable to become pregnant. Clomiphene probably works by changing the hormone balance of the body. In women, this causes ovulation to occur and prepares the body for pregnancy. Clomiphene may also be used for other conditions in both females and males as determined by your doctor. The following information applies only to female patients taking clomiphene. Check with your doctor if you are a male and have any questions about the use of clomiphene. Clomiphene is available only with your doctor's prescription. Before Using Serophene In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Breast Feeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Unusually large ovary or Cyst on ovary Clomiphene may cause the cyst to increase in size Endometriosis Inducing ovulation (including using clomiphene) may worsen endometriosis because the body estrogen level is increased; estrogen can cause growth of endometriosis implants Fibroid tumors of the uterus Clomiphene may cause fibroid tumors to increase in size Inflamed veins due to blood clots Clomiphene may make condition worse Liver disease (or history of) Clomiphene may make any liver disease worse Mental depression Existing depression may become worse because of hormone changes caused by clomiphene Unusual vaginal bleeding Some irregular vaginal bleeding is a sign that the lining of the uterus is growing too much or is a sign of cancer of the uterus lining; these problems must be ruled out before clomiphene is used because clomiphene can make these conditions worse Proper Use of clomiphene This section provides information on the proper use of a number of products that contain clomiphene. It may not be specific to Serophene. Please read with care. Take this medicine only as directed by your doctor. If you are to begin on Day 5, count the first day of your menstrual period as Day 1. Beginning on Day 5, take the correct dose every day for as many days as your doctor ordered. To help you to remember to take your dose of medicine, take it at the same time every day. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (tablets): For treating infertility: Adults 50 milligrams (mg) a day for five days of a menstrual cycle. The treatment is usually started on the fifth day of your menstrual period. If you do not have menstrual cycles, you can begin taking your medicine at any time. If you do not become pregnant after the first course, your doctor may increase your dose a little at a time up to 250 mg a day. Your treatment may be repeated until you do become pregnant or for up to four treatment cycles. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you do not remember until it is time for the next dose, take both doses together; then go back to your regular dosing schedule. If you miss more than one dose, check with your doctor. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Precautions While Using Serophene It is very important that your doctor check your progress at regular visits to make sure this medicine is working and to check for unwanted effects. At certain times in your menstrual cycle, your doctor may want you to use an ovulation prediction test kit. Follow your doctor's instructions carefully. Ovulation is controlled by luteinizing hormone (LH). LH is present in the blood and urine in very small amounts during most of the menstrual cycle but rises suddenly for a short time in the middle of the menstrual cycle. This sharp rise, the LH surge, usually causes ovulation within about 30 hours. A woman is most likely to become pregnant if she has intercourse within the 24 hours after detecting the LH surge. Ovulation prediction test kits are used to test for this large amount of LH in the urine. This method is better for predicting ovulation than measuring daily basal body temperature. It is important that intercourse take place at the correct time to give you the best chance of becoming pregnant. There is a chance that clomiphene may cause birth defects if it is taken after you become pregnant. Stop taking this medicine and tell your doctor immediately if you think you have become pregnant while still taking clomiphene. This medicine may cause blurred vision, difficulty in reading, or other changes in vision. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not clear-headed or able to see well. If these reactions are especially bothersome, check with your doctor. Serophene Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Bloating stomach or pelvic pain Check with your doctor as soon as possible if any of the following side effects occur: Less common or rare Blurred vision decreased or double vision or other vision problems seeing flashes of light sensitivity of eyes to light yellow eyes or skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Hot flashes Less common or rare Breast discomfort dizziness or lightheadedness headache heavy menstrual periods or bleeding between periods mental depression nausea or vomiting nervousness restlessness tiredness trouble in sleeping Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Side Effects (complete list) The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved. Next Side Effects Print this page Add to My Med List More about Serophene (clomiphene) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group En Espaรฑol 0 Reviews Add your own review/rating Drug class: synthetic ovulation stimulants Consumer resources Serophene Other brands: Clomid Professional resources Serophene (FDA) Clomiphene Citrate (AHFS Monograph) Related treatment guides Female Infertility Lactation Suppression Oligospermia Ovulation Induction} Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA WADA Class Anti-Doping Classification Drug Class Synthetic ovulation stimulants Related Drugs Female Infertility Clomid , clomiphene , HCG , Menopur , Pregnyl , Ovidrel , More... Ovulation Induction Clomid , clomiphene , HCG , Menopur , Pregnyl , Ovidrel , More... Oligospermia Clomid , clomiphene , More... Lactation Suppression Clomid , clomiphene , More... Serophene Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Serophene Images Serophene 50 mg (S ) View larger images Related Questions & Answers Would you please tell me if serophene could be prescribed for men? Do you suppose to menstrate after taking serophene? Read more questions} } foremost


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