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locate Sinografin Generic Name: Diatrizoate Meglumine and Iodipamide Meglumine (dye a tri ZOE ate MEG loo meen & eye oh DI pa mide MEG loo meen) Brand Name: Sinografin Overview Side Effects Dosage Professional Interactions More User Reviews Support Group Q & A Pricing & Coupons Uses of Sinografin: It is used before an x-ray of the uterus and fallopian tubes. It may be given to you for other reasons. Talk with the doctor. Slideshow Hives: The What, Where, And Why Of This Bizarre Skin Condition What do I need to tell my doctor BEFORE I take Sinografin? If you have an allergy to diatrizoate meglumine, iodipamide meglumine, or any other part of Sinografin (diatrizoate meglumine and iodipamide meglumine). 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 are having your menstrual period or you have a genital infection. If you have had a type of tissue taken out (curettage) or a type of cervix biopsy (conization) within the past 30 days. If you are pregnant or may be pregnant. Do not use this medicine if you are pregnant. If you have had a pregnancy ended within the past 6 months. This is not a list of all drugs or health problems that interact with Sinografin. 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 Sinografin? Tell all of your health care providers that you take Sinografin. This includes your doctors, nurses, pharmacists, and dentists. Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor. Thyroid problems have happened after use of this medicine. Some people had to be treated for these thyroid problems. Talk with the doctor. This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Sinografin. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. How is this medicine (Sinografin) best taken? Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely. This medicine will be put into the cervix by a doctor. 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. Slow heartbeat. Very bad dizziness or passing out. Chest pain or pressure. Sweating a lot. Flushing. Joint pain. Shortness of breath. What are some other side effects of Sinografin? 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: Dizziness. Fever or chills. Upset stomach or throwing up. Belly pain. 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 Sinografin? If you need to store Sinografin at home, talk with your doctor, nurse, or pharmacist about how to store it. 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. 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. 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 Sinografin 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 Sinografin. 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 Sinografin (diatrizoate / iodipamide) Side Effects Dosage Information Drug Interactions Support Group Pricing & Coupons 0 Reviews Add your own review/rating Drug class: ionic iodinated contrast media Professional resources Sinografin (FDA) Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Sinografin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Ionic iodinated contrast media Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More the actuality


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Photo :Sinografin
is a component Sinografin Generic Name: diatrizoate meglumine and iodipamide meglumine Dosage Form: injection, solution Overview Side Effects Dosage Professional Interactions More User Reviews Support Group Q & A Pricing & Coupons Sinografin Diatrizoate Meglumine and Iodipamide Meglumine Injection Sinografin Description Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is a sterile, nonpyrogenic, essentially colorless to pale yellow, aqueous radiopaque contrast medium for intrauterine instillation. Each mL provides 527 mg diatrizoate meglumine and 268 mg iodipamide meglumine with 3.2 mg sodium citrate as a buffer, and 0.4 mg edetate disodium; pH has been adjusted to 7.0 to 7.8 with meglumine and diatrizoic acid. Each mL contains approximately 0.91 mg (0.04 mEq) sodium and 380 mg organically bound iodine. At the time of manufacture, the air in the container is replaced with nitrogen. Diatrizoate meglumine is designated chemically as 1-deoxy-1-( methylamino)-D-glucitoI 3,5-diacetamido-2,4,6- triiodobenzoate (salt); iodipamide meglumine is 1-deoxy-1- (methylamino)-D-glucitoI 3,3 -(adipoyldiimino)bis[2,4,6- triiodobenzoate] (2:1) (salt). Structural formulas: diatrizoate meglumine C 11 H 9 I 3 N 2 O 4 C 7 H 17 NO 5 MW 809.13 Organically Bound Iodine: 47.1% CAS-131-49-7 iodipamide meglumine C 20 H 14 I 6 N 2 O 6 2C 7 H 17 NO 5 MW 1530.20 Organically Bound Iodine: 49.8% CAS-3521-84-4 Slideshow Mammogram Memos: What You Need To Know Sinografin - Clinical Pharmacology The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast of the uterus and uterine tubes with surrounding tissues. Diagnostic intrauterine radiopaque agents have few known pharmacological effects. Most of the medium within the uterine cavity is discharged immediately upon termination of the procedure. Any medium retained in the uterine cavity is completely absorbed within one hour, unless there is an obstruction and large hydrosalpinx, in which case absorption is generally complete within 24 hours. Any medium spilled into the peritoneal cavity is absorbed within 20 to 60 minutes and excreted by both the hepatic and renal systems. Indications and Usage for Sinografin Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is indicated for use in hysterosalpingography. Contraindications Hysterosalpingographic agents are contraindicated in pregnant women and those suspected of being pregnant. Hysterosalpingography should not be performed during the menstrual period nor when infection of the external genitalia or genital tract is present. The procedure should not be attempted within 30 days following curettage or conization or within six months following the termination of pregnancy. Precautions General Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. In patients having or suspected of having carcinoma of the uterus and/or uterine tubes, the possible dispersion of carcinogenic cells during hysterosalpingography should be borne in mind. The possibility of a reaction should always be considered. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se , and patients with a known clinical hypersensitivity: bronchial asthma, hay fever, and food allergies. A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is thought essential, but caution should be exercised (see ADVERSE REACTIONS , and PRECAUTIONS, Information for the Patient ). Information for the Patient Patients receiving diagnostic agents for intrauterine radiography should be given the following information: This drug has been prescribed to perform an X-ray study of the uterus and uterine tubes. Patients should be questioned regarding a recent history (within 30 days) of curettage or conization, pregnancy or a recent history (within six months) of termination of pregnancy, and a history of allergy to iodine, any foods, or X-ray dyes. Patients should consult the physician if, at some future date, any thyroid tests are planned. The iodine in this agent may interfere with some thyroid tests. This drug may cause adverse reactions (see ADVERSE REACTIONS ) in some patients but most reactions are mild and pass quickly. Drug/Laboratory Test Interactions Thyroid Function Tests Because a small amount of this medium may be absorbed, thyroid function tests such as protein bound iodine (PBI) and radioactive iodine uptake, if indicated, generally should be performed prior to instillation. However, thyroid function can be evaluated after use of any iodinated contrast agents by using T 3 resin uptake or free thyroxine assays. Pregnancy See CONTRAINDICATIONS . Nursing Mothers Diatrizoate meglumine and iodipamide meglumine administered intravascularly has been found to be excreted in breast milk. Because small amounts of these agents may be absorbed following intrauterine instillation, caution should be exercised when any diagnostic intrauterine radiopaque agent is administered to a nursing woman. Pediatric Use Safety and effectiveness of hysterosalpingography has not been established in pediatric patients. Adverse Reactions Sudden onset of bradycardia, hypotension, cardiac arrest and death have rarely been reported. Hypersensitivity reactions, which include sweating, flushing, pruritus, urticaria, skin rashes, arthralgia, respiratory distress, and circulatory collapse have occurred. Dizziness, syncope, hypotension, chills, fever, nausea, vomiting, and abdominal pain and tenderness are occasionally seen following instillation of the contrast medium. It should be kept in mind that the serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes. Sinografin Dosage and Administration As a convenience to the physician, the following guidelines which have proven satisfactory are provided (see PRECAUTIONS, General ). Patients should be counseled prior to radiographic examination (see PRECAUTIONS, Information for the Patient ). Preparation of the patient: Hysterosalpingography should be performed three to five days after the cessation of the patient s menstrual period as a precautionary measure. An enema and vaginal douche one hour before the examination are helpful, but not essential. The patient should empty her bladder before the examination. Since the procedure is remarkably free of pain when Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is used, the use of a narcotic or anesthesia is unnecessary. Dosage: 3 to 4 mL of Sinografin, administered in fractional doses of approximately 1 mL, are usually adequate to visualize the uterus; an additional 3 to 4 mL will demonstrate the tubes. Total doses varying from 1.5 to 10 mL have been employed with satisfactory results. Administration: The patient is placed in the lithotomy position and the vulva is cleansed with a suitable antiseptic solution. A Graves-type vaginal speculum is introduced, the cervix is exposed, and the vaginal vault is sponged with antiseptic solution. A tenaculum is placed on the cervical lip, usually the anterior lip. A sterile sound may be passed to determine the position of the uterus and the direction of the cervical canal, and, when necessary, the cervical canal may be dilated. (Sounding the uterine cavity and dilatation of the canal are not usually required when a flexible cannula tip is used.) A sterile syringe containing the Sinografin is attached by Luer-Lok to a uterine cannula. The two-way cannula valve is opened and all air bubbles in the cannula and syringe are expressed. About 1.5 to 2 mL of Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) are required to fill the cannula. (If preferred, a tubal insufflator under controlled pressure with a salpingogram attachment may be used instead of the syringe.) The cannula tip is inserted into the cervical canal so that the adjustable rubber acorn obturator fits snugly at the external os. Careful placement of the cannula is important to avoid trauma and pain. Squeezing the trigger of the cannula to provide simultaneous traction on the tenaculum and forward pressure on the cannula should give a nonleaking cervical seal. Sinografin flows freely so that only gentle pressure on the plunger is necessary; however, the medium should be used as promptly as possible following withdrawal into the syringe. The syringe should be rinsed as soon after the procedure as possible to prevent freezing of the plunger. The connection at the external os is checked for leakage. If the acorn obturator is inadequate, an inflatable balloon-obturator may be used to seal the cervical canal. When the equipment has been positioned satisfactorily, the tenaculum and cannula may be fixed in position until the procedure is terminated. Radiography: A scout film may be made before the medium is administered. After the initial fractional injection, a film should be made using a Bucky diaphragm. After each successive injection of 1 mL, a film is taken, developed immediately, and inspected in the dark room before the next fractional dose of Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is given, until the procedure is completed. Further injection and subsequent films can be made as required using posterior-anterior or oblique angles. Clinical experience indicates that tubal patency, if present, will be demonstrable at the time of the injection and delayed films have not been required. General Diatrizoate Meglumine and lodipamide Meglumine Injection should be inspected visually for particulate matter and discoloration prior to instillation whenever solution and container permit. The solution may vary in color from essentially colorless to pale yellow. Solutions which may have become substantially darker should not be used. In the event that crystallization occurs, the solution may be clarified by placing the vial in hot water and shaking gently for several minutes or until the solution is clear. If cloudiness persists, the preparation should not be used. Allow the solution to cool to body temperature before administering. How is Sinografin Supplied Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) Packages of ten single-dose 10 mL vials (NDC 0270-0523-30). Storage Store at 20-25 C (68-77 F) [See USP]. Protect from light. Manufactured for Bracco Diagnostics Inc. Monroe Township,NJ 08831 by Patheon Italia S.p.A. 03013 Ferentino (Italy) Revised October 2013 CL64C01 255762 Sinografin Diatrizoate Meglumine and Iodipamide Meglumine Injection Sinografin diatrizoate meglumine and iodipamide meglumine injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0270-0523 Route of Administration INTRAUTERINE DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength diatrizoate meglumine (diatrizoic acid) diatrizoate meglumine 527 mg in 1 mL iodipamide meglumine (iodipamide) iodipamide meglumine 268 mg in 1 mL Inactive Ingredients Ingredient Name Strength sodium citrate 3.2 mg in 1 mL edetate disodium .4 mg in 1 mL Packaging # Item Code Package Description 1 NDC:0270-0523-30 10 VIAL, SINGLE-DOSE in 1 PACKAGE 1 10 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA011324 12/02/1958 Labeler - BRACCO DIAGNOSTICS INC (849234661) Registrant - BRACCO DIAGNOSTICS INC (849234661) Establishment Name Address ID/FEI Operations Patheon Italia S.p.A 434078638 MANUFACTURE(0270-0523) Establishment Name Address ID/FEI Operations Justesa Imagen, S.A.U 477020325 API MANUFACTURE(0270-0523) Establishment Name Address ID/FEI Operations Interpharma Praha, a.s 644354706 API MANUFACTURE(0270-0523) Revised: 12/2014 BRACCO DIAGNOSTICS INC Next Interactions Print this page Add to My Med List More about Sinografin (diatrizoate / iodipamide) Side Effects Dosage Information Drug Interactions Support Group Pricing & Coupons 0 Reviews Add your own review/rating Drug class: ionic iodinated contrast media Consumer resources Sinografin} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Ionic iodinated contrast media Related Drugs ionic iodinated contrast media Gastrografin , diatrizoate , Hexabrix , Hypaque , Cysto-Conray II Sinografin Rating No Reviews - Be the first! 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truly SetonET-EC DHA Generic Name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplement Dosage Form: tablets and softgel capsules Overview Side Effects Interactions Reviews Images More Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. SetonET-EC DHA R x Only Slideshow OTC Medication Use In Pregnancy: Wise or Worrisome? DESCRIPTION: SetonET-EC DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and enteric-coated softgel capsules. Each green oval SetonET-EC Tablet contains: VITAMINS A (beta carotene) 3,000 IU C (ascorbic acid) 120 mg D (cholecalciferol) 400 IU E (dl-alpha tocopheryl acetate) 3 mg B 1 (thiamine mononitrate) 1.8 mg B 2 (riboflavin) 4 mg Niacinamide 20 mg B 6 (pyridoxine HCI) 25 mg Folic acid 1 mg B 12 (cyanocobalamin) 12 mcg MINERALS Calcium (calcium carbonate) 200 mg Iron (ferrous bisglycinate HCl and iron protein succinylate) 29 mg Magnesium (magnesium oxide) 25 mg Zinc (zinc oxide) 25 mg Copper (cupric oxide) 2 mg Each frosted, clear, oval enteric-coated DHA softgel capsule contains: 430 mg purified omega-3 fatty acids including: At least 295 mg DHA (docosahexaenoic acid); also contains EPA (eicosapentaenoic acid) and other omega-3 fatty acids. OTHER INGREDIENTS (SetonET-EC Tablet): Ethyl Cellulose, FD&C Blue #1 Lake, FD&C Yellow #5 Lake, FD&C Yellow #6 Lake, Fumed Silica, Hypromellose, Iron Oxide Brown, Kollidon 30, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Talc, Titanium Dioxide, Vegetable Oil. OTHER INGREDIENTS (Enteric-coated DHA softgel capsule): Acetylated Monoglycerides, Ethyl Vanillin, Gelatin, Glycerin, Polysorbate 80, Potassium Sorbate, Purified Water, Shellac Ammonium Salt, Sodium Alginate, Specially Denatured Alcohol, Stearic Acid, Vitamin E. INDICATIONS: SetonET-EC DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. SetonET-EC DHA is also useful in improving nutritional status prior to conception. CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil. WARNINGS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a poison control center immediately. THIS PRODUCT CONTAINS FISH OIL. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. PRECAUTIONS: Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). DRUG INTERACTIONS: Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized. ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, one tablet and one enteric-coated softgel capsule taken by mouth daily, or as directed by a physician. The tablet and enteric-coated softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1gram (1,000 mg) per day. HOW SUPPLIED: SetonET-EC DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 SetonET-EC tablet and 1 enteric-coated DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 6 cards with 5 unit-doses per card which is a 30-day supply. SetonET-EC is a green oval tablet debossed with MVC-005 . The enteric-coated DHA softgel capsule is frosted colorless and oval. Unit dose blisters are child-resistant to opening as a safeguard against ingestion by children. NDC 13925-101-60 STORAGE: Store at USP controlled room temperature 20-25 C (68-77 F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Rx Only Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 Made In Canada 07/11 SETON PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 30 Tablets and 30 Softgel Capsules NDC 13925- 101 -60 SetonET-EC DHA Prenatal Vitamins Enteric-Coated R x Only 30-day supply - 30 tablets and 30 softgel capsules SETONET-EC beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide,omega-3 fatty acids kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-101 Packaging # Item Code Package Description 1 NDC:13925-101-60 1 KIT (1 KIT) in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 30 Part 2 30 Part 1 of 2 SETONET-EC beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide tablet Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 3 mg THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.8 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg FERROUS BISGLYCINATE HYDROCHLORIDE (FERROUS CATION) FERROUS CATION 29 mg MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSES FD&C BLUE NO. 1 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 SILICON DIOXIDE HYPROMELLOSES BROWN IRON OXIDE POVIDONE K30 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 TALC TITANIUM DIOXIDE CORN OIL Product Characteristics Color GREEN Score no score Shape OVAL (OVAL) Size 19mm Flavor Imprint Code MVC005 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Part 2 of 2 SETONET-EC-DHA omega-3 fatty acids capsule, liquid filled Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 430 mg Inactive Ingredients Ingredient Name Strength DIACETYLATED MONOGLYCERIDES ETHYL VANILLIN GELATIN GLYCERIN POLYSORBATE 80 POTASSIUM SORBATE WATER SHELLAC SODIUM ALGINATE ALCOHOL STEARIC ACID ALPHA-TOCOPHEROL Product Characteristics Color YELLOW (Frosted colorless) Score no score Shape OVAL (OVAL) Size 23mm Flavor Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Labeler - Seton Pharmaceuticals (828898002) Revised: 01/2014 Seton Pharmaceuticals Print this page Add to My Med List More about multivitamin, prenatal Side Effects Drug Images Drug Interactions Support Group 60 Reviews Add your own review/rating Drug class: iron products Consumer resources Prenatal Vitamin Chewable Tablet ... +6 more Professional resources Other brands: Prenatal Plus , PreNexa , Prenatal 19 , Docosavit , ... +75 more Related treatment guides Vitamin/Mineral Supplementation during Pregnancy/Lactation} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Iron products Vitamin and mineral combinations Related Drugs iron products ferrous sulfate , Feosol Original , Iron-150 , Dialyvite vitamin and mineral combinations multivitamin , Citracal + D Vitamin / Mineral Supplementation during Pregnancy / Lactation ferrous sulfate , Feosol Original , Prenatal Multivitamins , Fergon , Ferrousal , FeroSul , Prenatal Plus , Slow Fe , Hemocyte , PreNexa , Prenatal 19 , Ferrocite , Stuart Prenatal with Beta Carotene , OB Complete , Docosavit , Prenatal H , Ferate , More... Multivitamin, prenatal Rating 60 User Reviews 8.5 /10 60 User Reviews 8.5 Rate it! Multivitamin, prenatal Images Multivitamin, prenatal systemic (S 0260 ) View all images} } vast


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Photo :SetonET
that youngsters SetonET Generic Name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplement Dosage Form: tablet Overview Side Effects Interactions Reviews Images More Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. SetonET Rx Only DESCRIPTION: SetonET is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and softgel capsules. Each light green oblong SetonET Tablet* contains: VITAMINS A (beta carotene) 3,000 IU C (ascorbic acid) 120 mg D (cholecalciferol) 400 IU E (dl-alpha tocopheryl acetate) 30 mg B 1 (thiamine mononitrate) 1.8 mg B 2 (riboflavin) 4 mg Niacinamide 20 mg B 6 (pyridoxine hydrochloride) 25 mg Folic acid 1 mg B 12 (cyanocobalamin) 12 mcg MINERALS Calcium (calcium carbonate) 200 mg Iron (ferrous bisglycinate HCl and iron protein succinylate) 29 mg Magnesium (magnesium oxide) 25 mg Zinc (zinc oxide) 25 mg Copper (cupric oxide) 2 mg Each translucent oblong DHA Softgel Capsule* contains: 430 mg purified omega-3 fatty acids including: At least 295 mg DHA (docosahexaenoic acid); also contains EPA (eicosapentaenoic acid) and other omega-3 fatty acids. OTHER INGREDIENTS (SetonET Tablet): Gum Arabic, PVP K30, Citric Acid, TriPotassium Citrate, Microcrystalline Cellulose, Fumed Silica, Magnesium Stearate, Croscarmellose Sodium, Hypromellose, Polyethylene Glycol, Ethyl Cellulose, Vegetable Oil, Polysorbate 80, Titanium Dioxide, Talc, FD&C Yellow #6 Lake, FD&C Blue #1 Lake, FD&C Yellow #5 Lake, Brown Iron Oxide. *USP Compliance: SetonET tablet is formulated in conformance with official U.S. Pharmacopeia (USP) standards of quality for potency, purity and dissolution. DHA softgel capsule complies with the standards and methods outlined in the CRN Voluntary Monograph for potency and purity. Slideshow Don't Believe The Hype: How Multivitamins Conquered The Land Of The Free INDICATIONS: SetonET is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. SetonET is also useful in improving nutritional status prior to conception. CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil. WARNINGS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately . PRECAUTIONS: Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). DRUG INTERACTIONS: Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized. ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, one tablet and one softgel capsule taken by mouth daily, or as directed by a physician. The tablet and softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day. HOW SUPPLIED: SetonET is supplied in a carton containing 30 tablets and 30 softgels in blister cards. SetonET is a light green oblong tablet imprinted with MVC-001 . The DHA softgel capsule is a translucent oblong softgel capsule. Unit dose blisters are child-resistant to opening, as a safeguard against ingestion by children. NDC 13925-100-60 . STORAGE: 20 -25 C (68 -77 F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discolorations of the tablet. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Rx Only Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA 06/10 SETON PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 30 Tablets and 30 Softgel Capsules NDC 13925- 100 -60 SetonET PRENATAL VITAMINS High potency nutrition with an easy-to-tolerate iron formulation, plus DHA, an Omega-3 fatty acid R x Only PRENATAL VITAMINS 30-Day Supply 30 Tablets and 30 Softgel Capsules SETON PHARMACEUTICALS SetonET beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide,omega-3 fatty acids kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-100 Packaging # Item Code Package Description 1 NDC:13925-100-60 1 KIT (1 KIT) in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 Part 2 6 Part 1 of 2 SetonET beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide tablet Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 mg THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.8 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 200 mg IRON (IRON) IRON 29 mg MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 25 mg ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength ACACIA POVIDONE K30 CITRIC ACID MONOHYDRATE POTASSIUM CITRATE ANHYDROUS CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE MAGNESIUM STEARATE CROSCARMELLOSE SODIUM HYPROMELLOSES POLYETHYLENE GLYCOLS ETHYLCELLULOSES CASTOR OIL CORN OIL POLYSORBATE 80 TITANIUM DIOXIDE TALC FD&C YELLOW NO. 6 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 BROWN IRON OXIDE Product Characteristics Color GREEN (LIGHT GREEN) Score no score Shape OVAL (OVAL) Size 15mm Flavor Imprint Code MVC001 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Part 2 of 2 DHA SOFTGEL omega-3 fatty acids capsule, gelatin coated Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 430 mg Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL GELATIN GLYCERIN ETHYL VANILLIN WATER Product Characteristics Color yellow (TRANSLUCENT) Score no score Shape OVAL (OVAL) Size 21mm Flavor Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Labeler - Seton Pharmaceuticals (828898002) Revised: 01/2014 Seton Pharmaceuticals Print this page Add to My Med List More about multivitamin, prenatal Side Effects Drug Images Drug Interactions Support Group 60 Reviews Add your own review/rating Drug class: iron products Consumer resources Prenatal Vitamin Chewable Tablet ... +6 more Professional resources Other brands: Prenatal Plus , PreNexa , Prenatal 19 , Docosavit , ... +75 more Related treatment guides Vitamin/Mineral Supplementation during Pregnancy/Lactation} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Iron products Vitamin and mineral combinations Related Drugs iron products ferrous sulfate , Feosol Original , Iron-150 , Dialyvite vitamin and mineral combinations multivitamin , Citracal + D Vitamin / Mineral Supplementation during Pregnancy / Lactation ferrous sulfate , Feosol Original , Prenatal Multivitamins , Fergon , Ferrousal , FeroSul , Prenatal Plus , Slow Fe , Hemocyte , PreNexa , Prenatal 19 , Ferrocite , Stuart Prenatal with Beta Carotene , OB Complete , Docosavit , Prenatal H , Ferate , More... Multivitamin, prenatal Rating 60 User Reviews 8.5 /10 60 User Reviews 8.5 Rate it! Multivitamin, prenatal Images Multivitamin, prenatal systemic (S 0260 ) View all images} } end result


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Photo :Setlakin
product or service Setlakin Generic Name: Ethinyl Estradiol and Levonorgestrel (ETH in il es tra DYE ole & LEE voe nor jes trel) Brand Name: Altavera, Amethia, Amethia Lo, Amethyst, Ashlyna, ...show all 38 brand names. Aubra, Aviane, camrese, camrese lo, Chateal, Daysee, Delyla, Enpresse, FaLessa Kit, Falmina, Fayosim, Introvale, Jolessa, Kurvelo, Larissia, Lessina, Levonest, Levora, Lillow, LoSeasonique, Lutera, Marlissa, Myzilra, Orsythia, Portia, Quartette, Quasense, Rivelsa, Seasonique, Setlakin, Sronyx, Trivora, Vienva Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons Warning Smoking cigarettes while using Setlakin (ethinyl estradiol and levonorgestrel) raises the chance of very bad heart and blood-related side effects. This chance is raised with age (mainly in women older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this medicine if you smoke and are older than 35 years of age. Uses of Setlakin: It is used to prevent pregnancy. It may be given to you for other reasons. Talk with the doctor. Slideshow Birth Control: Your Contraceptive Questions Answered What do I need to tell my doctor BEFORE I take Setlakin? If you have an allergy to ethinyl estradiol, levonorgestrel, or any other part of Setlakin. 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 had any of these health problems: Blood clots, blood clotting problem, breast cancer, diseased arteries in the brain, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, high cholesterol, a pancreas problem (pancreatitis) due to high blood triglycerides, liver disease, liver tumor, very bad headache or migraine, diabetes that affects blood flow, or tumor where estrogen makes it grow. If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known. If you have surgery and need bedrest. If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use. If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant. If you are breast-feeding or plan to breast-feed. If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir). This is not a list of all drugs or health problems that interact with Setlakin. 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 Setlakin? Tell all of your health care providers that you take Setlakin. This includes your doctors, nurses, pharmacists, and dentists. This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor. Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots. 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. High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor. Have blood work checked as you have been told by the doctor. Talk with the doctor. Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor. This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine. Certain drugs, herbal products, or health problems could cause Setlakin to not work as well. Be sure your doctor knows about all of your drugs and health problems. This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor. Do not use in children who have not had their first menstrual period. If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away. How is this medicine (Setlakin) best taken? Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely. Follow how to use as you have been told by the doctor or read the package insert. Take Setlakin at the same time of day. Take with or without food. Take with food if it causes an upset stomach. Do not skip doses, even if you do not have sex very often. After starting this medicine, you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about using a non-hormone type of birth control. If you throw up or have diarrhea, Setlakin may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor. If your monthly cycle is 28 days and you miss 2 periods in a row, take a pregnancy test before starting a new dosing cycle. If you have a cycle longer than 91 days and you miss one period, take a pregnancy test before starting a new dosing cycle. What do I do if I miss a dose? If a dose is missed, check the package insert or call the doctor to find out what to do. If using this medicine to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy. 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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight. Coughing up blood. Shortness of breath. Chest pain or pressure. Very upset stomach or throwing up. Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight. Swelling, warmth, numbness, change of color, or pain in a leg or arm. Mood changes. Low mood (depression). Feeling very tired or weak. Very bad belly pain. Swelling. Not able to pass urine or change in how much urine is passed. A lump in the breast, breast soreness, or nipple discharge. Vaginal itching or discharge. Spotting or vaginal bleeding that is very bad or does not go away. Bulging eyes. Loss of eyesight. Change in how contact lenses feel in the eyes. What are some other side effects of Setlakin? 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: Feeling more or less hungry. Dizziness. Weight gain. Headache. Upset stomach or throwing up. Cramps. Bloating. Enlarged breasts. Breast soreness. Hair loss. Pimples (acne). Period (menstrual) changes. These include spotting or bleeding between cycles. Lowered interest in sex. This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun. 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 Setlakin? Store at room temperature. 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 Setlakin (ethinyl estradiol and levonorgestrel), 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 this medicine 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 Setlakin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 Setlakin. Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about Setlakin (ethinyl estradiol / levonorgestrel) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons 1 Review Add your own review/rating Drug class: contraceptives Consumer resources Other brands: Aviane , Alesse , Seasonique , Lutera , ... +38 more Professional resources Setlakin (FDA) Related treatment guides Birth Control} 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 Setlakin Rating 1 User Review 1 User Review Not Rated - Be the first! Manufacturer NorthStar Rx LLC Drug Class Contraceptives Related Drugs Birth Control medroxyprogesterone , Provera , Depo-Provera , norethindrone , Mirena , Nexplanon , Sprintec , levonorgestrel , NuvaRing , Ortho Tri-Cyclen , Yasmin , Yaz , TriNessa , Aviane , Lo Loestrin Fe , Apri , Alesse , Mononessa , Microgestin Fe 1 / 20 , Xulane , Camila , Seasonique , Lutera , Ortho Evra , Levora , More... Setlakin Images Setlakin inert (P N) View larger images} } anybody


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without delay Servira Generic Name: phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide Dosage Form: tablet, extended release Side Effects Dosage Professional Interactions Pregnancy More User Reviews Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Servira EXTENDED RELEASE TABLETS Servira Description Each Servira Extended Release tablet contains: Phenobarbital, USP ........................................ 48.6 mg (Warning: May be habit forming) Hyoscyamine Sulfate, USP................................ 0.3111 mg Atropine Sulfate, USP........................................ 0.0582 mg Scopolamine Hydrobromide, USP .................... 0.0195 mg Servira Extended Release Tablets are designed to release the ingredients gradually to provide effects for up to twelve (12) hours. In addition, each tablet contains the following inactive ingredients: DC Yellow #10 Aluminum Lake, FDC Blue #1 Aluminum Lake, FDC Yellow #6 Aluminum Lake, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, PEG 3350, Polyvinyl Alcohol, Povidone, Silicon Dioxide, Stearic Acid, Talc, Titanium Dioxide. Slideshow Bowled Over By Your Bowel: IBS Causes, Risk Factors and Treatments Servira - Clinical Pharmacology This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation. Indications and Usage for Servira Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the following indications as "possibly" effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS. Contraindications Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis. Servira is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement. Warnings In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful. Servira may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. Phenobarbital may decrease the effect of anticoagulants and necessitate larger doses of the anticoagulant for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs. Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction. Precautions Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension. Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Theoretically, with overdosage, a curare-like action may occur. Carcinogenesis, Mutagenesis Long-term studies in animals have not been performed to evaluate carcinogenic potential. Pregnancy Category C Animal reproduction studies have not been conducted with Servira. It is not known whether Servira can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Servira should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Servira is administered to a nursing mother. Adverse Reactions Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions. Servira Dosage and Administration The dosage of Servira should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The usual dose is one tablet every twelve (12) hours. If indicated, one tablet every eight (8) hours may be given. Overdosage The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils; hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, CNS stimulation. Treatment should mconsist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be added. How is Servira Supplied Servira Extended Release Tablets are supplied as: green, round tablets debossed 256 , bottles of 100 tablets, NDC 49769-256-10. Store at 20 -25 C (68 -77 F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a well-closed, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Kylemore Pharmaceuticals Suwanee, GA 30024 Rev 12/09 PACKAGING: Servira Extended Release Tablet labeling: Servira phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide tablet, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-256 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 48.6 mg HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE .3111 mg ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE .0582 mg SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE .0195 mg Product Characteristics Color green Score no score Shape ROUND Size 12mm Flavor Imprint Code 256 Contains Packaging # Item Code Package Description 1 NDC:49769-256-10 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010 09/30/2011 Labeler - Kylemore Pharmaceuticals, LLC (831892471) Revised: 01/2010 Kylemore Pharmaceuticals, LLC Next Interactions Print this page Add to My Med List More about Servira (atropine / hyoscyamine / phenobarbital / scopolamine) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: anticholinergics/antispasmodics Consumer resources Professional resources Belladonna Alkaloids with Phenobarbital (FDA) Other brands: Donnatal , Phenohytro , B-Donna Tablets , Me-PB-Hyos , ... +5 more Related treatment guides Duodenal Ulcer Enterocolitis Irritable Bowel Syndrome} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Anticholinergics / antispasmodics Related Drugs anticholinergics / antispasmodics dicyclomine , Bentyl , hyoscyamine , Levsin , atropine , scopolamine Irritable Bowel Syndrome dicyclomine , Amitiza , Bentyl , Metamucil , psyllium , hyoscyamine , Levsin , Librax , More... Enterocolitis doxycycline , vancomycin , Librax , Donnatal , Vibramycin , albendazole , Monodox , Vancocin , More... Duodenal Ulcer omeprazole , pantoprazole , ranitidine , famotidine , Prilosec , Protonix , calcium carbonate , Zantac , More... Servira Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } asserting


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treatments abciximab (Intravenous route) ab-SIX-i-mab Overview Side Effects Professional Interactions Pregnancy More User Reviews Support Group Q & A Commonly used brand name(s) In the U.S. Reopro Available Dosage Forms: Solution Therapeutic Class: Platelet Aggregation Inhibitor Pharmacologic Class: Glycoprotein IIb/IIIa Inhibitor Slideshow Inherited Risk: The BRCA Gene Explained Uses For abciximab Abciximab is used to lessen the chance of heart attack in people who need percutaneous coronary intervention (PCI), a procedure to open blocked arteries of the heart. A heart attack may occur when a blood vessel in the heart is blocked by a blood clot. Blood clots can sometimes form during PCI. Abciximab reduces the chance that a harmful clot will form by preventing certain cells in the blood from clumping together. Abciximab is used with aspirin and heparin, which are other medicines used to keep your blood from clotting. abciximab is available only with your doctor's prescription. Before Using abciximab 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 abciximab, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to abciximab 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 Studies on abciximab have been done only in adult patients, and there is no specific information comparing use of abciximab in children with use in other age groups. Geriatric Bleeding problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults tot the effects of abciximab. It is important that you discuss the use of abciximab with your doctor. 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. When you are taking abciximab, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using abciximab with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Defibrotide Eptifibatide Using abciximab with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Aceclofenac Acemetacin Acenocoumarol Alipogene Tiparvovec Alteplase, Recombinant Amtolmetin Guacil Anagrelide Apixaban Ardeparin Argatroban Bemiparin Betrixaban Bivalirudin Bromfenac Bufexamac Celecoxib Certoparin Choline Salicylate Cilostazol Citalopram Clonixin Dabigatran Etexilate Dalteparin Danaparoid Desirudin Desvenlafaxine Dexibuprofen Dexketoprofen Dextran Diclofenac Diflunisal Dipyridamole Dipyrone Drotrecogin Alfa Droxicam Duloxetine Edoxaban Enoxaparin Escitalopram Etodolac Etofenamate Etoricoxib Felbinac Fenoprofen Fepradinol Feprazone Floctafenine Flufenamic Acid Fluoxetine Flurbiprofen Fluvoxamine Fondaparinux Heparin Ibuprofen Indomethacin Ketoprofen Ketorolac Lepirudin Levomilnacipran Lornoxicam Loxoprofen Lumiracoxib Meclofenamate Mefenamic Acid Meloxicam Milnacipran Morniflumate Nabumetone Nadroparin Naproxen Nefazodone Nepafenac Niflumic Acid Nimesulide Nimesulide Beta Cyclodextrin Oxaprozin Oxyphenbutazone Parecoxib Parnaparin Paroxetine Phenindione Phenprocoumon Phenylbutazone Piketoprofen Piracetam Piroxicam Proglumetacin Propyphenazone Proquazone Protein C Reviparin Rivaroxaban Rofecoxib Salicylic Acid Salsalate Sertraline Sodium Salicylate Sulindac Tenoxicam Tiaprofenic Acid Ticlopidine Tinzaparin Tolfenamic Acid Tolmetin Valdecoxib Vilazodone Vortioxetine Warfarin Using abciximab with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Vitamin A 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Other Medical Problems The presence of other medical problems may affect the use of abciximab. Make sure you tell your doctor if you have any other medical problems, especially: Aneurysm (swelling in a blood vessel) especially in the head or Blood disease or a history of unusual bleeding or Brain problems which may include bleeding, disease, injury or tumor or If you weigh less than 150 pounds or If you are over 65 years of age or Injury to any part of the body or Liver disease or Stroke The risk of bleeding may be increased Also, tell your doctor if you have received abciximab or heparin before and had a reaction to either of them called thrombocytopenia (a low platelet count in the blood), or if new blood clots formed while you were receiving the medicine. In addition, tell your doctor if you have recently had any bleeding from the stomach, previously had a stroke, recently fallen or suffered a blow to the body or head, or had major medical or dental surgery . These events may increase the risk of serious bleeding when you are taking abciximab. Proper Use of abciximab Dosing The dose of abciximab 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 abciximab. 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 prevention of blood clots during percutaneous coronary intervention (the procedure to open blocked blood vessels): Adults Initial dose: 250 micrograms (mcg) per kilogram (kg) of body weight injected 10 to 60 minutes before the procedure. Maintenance dose: 0.125 mcg per kg of body weight per minute (maximum of 10 mcg per minute) by IV for 12 hours. Children Use and dose must be determined by your doctor. For patients with unstable angina that will undergo percutaneous coronary intervention within 24 hours: Adults Initial dose: 250 micrograms (mcg) per kilogram (kg) of body weight injected. Maintenance dose: 10 mcg per minute by IV for 18 to 24 hours, ending 1 hour after the procedure. Children Use and dose must be determined by your doctor. Precautions While Using abciximab Tell all of your medical doctors and dentists that you are using abciximab. Check with your doctor immediately if you notice any of the following side effects: Bruising or bleeding, especially bleeding that is hard to stop. Bleeding inside the body sometimes appears as bloody or black, tarry stools, or faintness. Back pain; burning, pricking, tickling, or tingling sensation; leg weakness; numbness; paralysis; or problems with bowel or bladder function. abciximab 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 Bleeding blurred vision; confusion; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; unusual tiredness or weakness Less common Black, tarry stools bleeding gums blood in urine or stools pinpoint red spots on skin unusual bleeding or bruising Rare Chest pain or discomfort chills cough eye pain fever general feeling of illness headache pale skin rapid weight gain shortness of breath slow or irregular heartbeat sneezing sore throat swelling of hands, ankles, feet, or lower legs tightness in chest tingling of hands or feet troubled breathing unusual tiredness wheezing 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 Back pain Less common Acid or sour stomach belching burning, crawling, itching, numbness, prickling, pins and needles , or tingling feelings changes in vision delusions dementia fear heartburn indigestion or stomach discomfort, upset or pain mood or mental changes nausea nervousness vomiting 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 abciximab Side Effects During Pregnancy Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: glycoprotein platelet inhibitors Consumer resources Abciximab Other brands: ReoPro Professional resources Abciximab (AHFS Monograph) Abciximab (Wolters Kluwer) Related treatment guides High Risk Percutaneous Transluminal Angioplasty} 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 Drug Class Glycoprotein platelet inhibitors Related Drugs High Risk Percutaneous Transluminal Angioplasty abciximab , ReoPro , More... Abciximab Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Help and Support Looking for answers? Ask a question or go join the abciximab support group to connect with others who have similar interests.} } discover


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addiction [20%:<100,000 cells/mcL); recent (within 6 weeks) major surgery or trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; history of vasculitis (presumed or documented); use of dextran before PCI or intent to use dextran during PCI. Dosing: Adult Percutaneous coronary intervention (PCI): IV: 0.25 mg/kg bolus administered 10 to 60 minutes prior to start of PCI followed by an infusion of 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours Unstable angina/non-ST-elevation MI (UA/NSTEMI) unresponsive to conventional medical therapy with planned PCI within 24 hours: IV: 0.25 mg/kg bolus followed by an 18- to 24-hour infusion of 10 mcg/minute, concluding 1 hour after PCI. ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) (off-label use) (ACCF/AHA [O'Gara 2013]): IV: Loading dose: 0.25 mg/kg bolus administered at the time of PCI Maintenance infusion: 0.125 mcg/kg/minute (maximum: 10 mcg/minute) continued for up to 12 hours Intracoronary (off-label route): 0.25 mg/kg bolus administered directly to the site of the infarct lesion; may be followed with an intravenous maintenance infusion if refractory intraprocedural thrombotic complications occur (Stone 2012) Dosing: Geriatric Refer to adult dosing. Dosing: Renal Impairment There are no dosage adjustments provided in the manufacturer's labeling. Hemodialysis: Dialyzable: Unknown, but unlikely (NCS/SCCM [Frontera 2016]) Dosing: Hepatic Impairment There are no dosage adjustments provided in the manufacturer's labeling. Reconstitution Bolus dose: Withdraw required amount of abciximab into a syringe using a 0.2 or 5 micron low protein-binding syringe filter (or equivalent); the bolus should be administered 10 to 60 minutes before the procedure. Continuous infusion: Withdraw required amount of abciximab into a syringe using a 0.2 or 5 micron low protein-binding syringe filter (or equivalent) and inject into an appropriate container of NS or D5W. If a syringe filter was not used to prepare the infusion, administer using an in-line 0.2 or 0.22 micron low protein-binding filter. Note: A standard concentration of 7.2 mg in 250 mL of NS or D5W may also be prepared for all patients and administered at the standard dose (0.125 mcg/kg/minute; maximum: 10 mcg/minute) with a variable rate in mL/hour. Infuse for 12 to 24 hours via pump after bolus dose; length of therapy dependent on indication. Some institutions use a standard concentration of 9 mg in 250 mL of D5W or NS. Administration For IV administration. Solution must be filtered using a 0.2 or 5 micron low protein-binding syringe filter during preparation or via a 0.2 to 0.22 micron low protein-binding inline filter during administration. Do not shake vial. Intracoronary administration (off-label route): In select STEMI cases (eg, anterior STEMI), abciximab bolus may be administered through the guiding catheter directly to the culprit lesion site (Stone 2012; Thiele 2012) Storage Store intact vials at 2 C to 8 C (36 F to 46 F). Do not freeze or shake. After admixture in NS or D5W, the prepared solution is stable for 12 hours. Discard any unused portion. The following stability information has also been reported: May store intact vials at 24 C to 28 C (76 F to 82 F) for up to 8 days (data on file [Eli Lilly, 2011]). However, the manufacturer recommends storage under refrigeration. Room temperature stability information should only be utilized in situations where the drug has been inadvertently exposed to prolonged room temperature. Drug Interactions Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Monitor therapy Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Monitor therapy Apixaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely. Monitor therapy Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Monitor therapy Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Monitor therapy Dabigatran Etexilate: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Dabigatran Etexilate. Agents with Antiplatelet Properties may increase the serum concentration of Dabigatran Etexilate. This mechanism applies specifically to clopidogrel. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Monitor therapy Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Monitor therapy Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy Dextran: May enhance the anticoagulant effect of Abciximab. Avoid combination Edoxaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Monitor therapy Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Consider therapy modification Ibritumomab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Monitor therapy Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Monitor therapy Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. Monitor therapy Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Monitor therapy Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Rivaroxaban: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Rivaroxaban. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Monitor therapy Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Monitor therapy Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Monitor therapy Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Tositumomab and Iodine I 131 Tositumomab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Tositumomab and Iodine I 131 Tositumomab. Specifically, the risk of bleeding-related adverse events may be increased. Monitor therapy Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Avoid combination Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy Adverse Reactions As with all drugs which may affect hemostasis, bleeding is associated with abciximab. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the concurrent use of multiple agents which alter hemostasis and patient susceptibility.> 10%: Cardiovascular: Hypotension (14%), chest pain (11%) Gastrointestinal: Nausea (14%) Hematologic & oncologic: Minor hemorrhage (4% to 17%), major hemorrhage (1% to 14%) Neuromuscular & skeletal: Back pain (18%) Miscellaneous: Antibody development (HACA, first exposure: 6%; readministration: 27%; four or more exposures: 44%) 1% to 10%: Cardiovascular: Bradycardia (5%), peripheral edema (2%) Gastrointestinal: Abdominal pain (3%) Hematologic & oncologic: Thrombocytopenia: <100,000 cells/mm 3 (3% to 6%);> <50,000 cells/mm 3 (0.4% to 2%) Local: Pain at injection site (4%)> <1% (Limited to important or life-threatening): Abnormality in thinking, abscess, allergic reaction (possible), anaphylaxis (possible), arteriovenous fistula, bronchitis, bullous skin disease, cellulitis, cerebrovascular accident, coma, complete atrioventricular block, confusion, diabetes mellitus, edema, embolism, gastroesophageal reflux disease, hyperkalemia, hypertonia, incomplete atrioventricular block, inflammation, intestinal obstruction, intracranial hemorrhage, leukocytosis, nodal arrhythmia, pleural effusion, pleurisy, pneumonia, prostatitis, pseudoaneurysm, pulmonary alveolar hemorrhage, pulmonary embolism, renal insufficiency, thrombophlebitis, urinary retention, ventricular tachycardia Warnings/Precautions Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Administration may result in human antichimeric antibody formation that can cause hypersensitivity reactions (including anaphylaxis [rare], sometimes fatal). Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; monitor closely for bleeding, especially the arterial access site for the cardiac catheterization. Use with extreme caution in patients with platelet counts> <150,000/mm 3 , hemorrhagic retinopathy, previous history of GI disease, recent thrombolytic therapy and in chronic dialysis patients. Use caution with administration of other drugs affecting hemostasis. Minimize other procedures, including arterial and venous punctures, IM injections, use of urinary catheters, nasogastric tubes, and automatic blood pressure cuffs. Increased risk of hemorrhage during or following angioplasty is associated with unsuccessful PCI, PCI procedure> 70 minutes duration, or PCI performed within 12 hours of symptom onset for acute myocardial infarction. When attempting IV access, avoid noncompressible sites (eg, subclavian or jugular veins). If serious uncontrolled bleeding or the need for emergency surgery arises, discontinue abciximab. Thrombocytopenia: Administration may result in human antichimeric antibody formation that can cause thrombocytopenia, including severe cases; immediately discontinue if thrombocytopenia occurs. Readministration within 30 days or in patients with human antichimeric antibodies (HACA) increases the incidence and severity of thrombocytopenia. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations: Elderly: Use with caution in patients >65 years; may have increased risk of bleeding. Low weight patients: Use with caution in patients weighing <75 kg; may have increased risk of bleeding. Other warnings/precautions: Diminished efficacy: Administration may result in human antichimeric antibody formation that can cause diminished efficacy upon readministration. Sheath removal: Discontinuation of heparin immediately upon completion of the procedure and removal of the sheath within 6 hours is strongly recommended as long as ACT> <150 to 180 seconds or aPTT> <50 seconds (ACCF/AHA/SCAI [Levine 2011]). Use standard compression techniques after sheath removal. Monitor the site closely afterwards for further bleeding. Surgery: Discontinue 12 hours prior to coronary artery bypass graft surgery (ACC/AHA [Amsterdam 2014]). Monitoring Parameters Prothrombin time, activated partial thromboplastin time (aPTT), hemoglobin, hematocrit, platelet count, fibrinogen, fibrin split products, transfusion requirements, signs of hypersensitivity reactions, guaiac stools, Hemastix urine. Platelet count should be monitored at baseline, 2 to 4 hours following bolus infusion, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding: Abciximab initiated 18 to 24 hours prior to PCI: Maintain aPTT between 60 to 85 seconds during the heparin/abciximab infusion period During PCI: Maintain ACT between 200 to 300 seconds Following PCI (if anticoagulation is maintained): Maintain aPTT between 50 to 75 seconds Sheath removal should not occur until aPTT is 50 seconds or ACT 175 seconds. Maintain bleeding precautions, avoid unnecessary arterial and venous punctures, use saline or heparin lock for blood drawing, assess sheath insertion site and distal pulses of affected leg every 15 minutes for the first hour and then every 1 hour for the next 6 hours if femoral access utilized for percutaneous coronary intervention. Arterial access site care is important to prevent bleeding. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured, avoiding a Seldinger (through and through) technique for obtaining sheath access. Femoral vein sheath placement should be avoided unless needed. While the vascular sheath is in place, patients should be maintained on complete bedrest with the head of the bed at a 30 angle and the affected limb restrained in a straight position. Observe patient for mental status changes, hemorrhage; assess nose and mouth mucous membranes, puncture sites for oozing, ecchymosis, and hematoma formation; examine urine, stool, and emesis for presence of occult or frank blood; gentle care should be provided when removing dressings. Pregnancy Risk Factor C Pregnancy Considerations Animal reproduction studies have not been conducted. In vitro studies have shown only small amounts of abciximab to cross the placenta (Miller 2003). Information related to the use of abciximab in pregnancy is limited (Santiago-Diaz 2009; Sebastian 1998). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience back pain, nausea, vomiting, or headache. Have patient report immediately to prescriber signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), severe dizziness, passing out, angina, bradycardia, fall or crash hitting head, or severe loss of strength and energy (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Interactions Print this page Add to My Med List More about abciximab Side Effects During Pregnancy Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: glycoprotein platelet inhibitors Consumer resources Abciximab Abciximab Intravenous (Advanced Reading) Professional resources Abciximab (AHFS Monograph) Other brands: ReoPro Related treatment guides High Risk Percutaneous Transluminal Angioplasty> ]} 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 Abciximab Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Glycoprotein platelet inhibitors Related Drugs glycoprotein platelet inhibitors Integrilin , tirofiban , Aggrastat , eptifibatide , ReoPro High Risk Percutaneous Transluminal Angioplasty ReoPro , More...} } reliable


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