foreign places [0.05:<18 years of age. Gender There are no known differences in the absorption or excretion of omeprazole between males and females. Hepatic Insufficiency In patients with chronic hepatic disease, the bioavailability of omeprazole from a buffered solution increased to approximately 100% compared to an I.V. dose, reflecting decreased first-pass effect, and the mean plasma half-life of the drug increased to nearly 3 hours compared to the mean half-life of 1 hour in normal subjects. Plasma clearance averaged 70 mL/min, compared to a value of 500-600 mL/min in normal subjects. Renal Insufficiency In patients with chronic renal impairment, whose creatinine clearance ranged between 10 and 62 mL/min/1.73 m 2, the disposition of omeprazole from a buffered solution was very similar to that in healthy subjects, although there was a slight increase in bioavailability. Because urinary excretion is a primary route of excretion of omeprazole metabolites, their elimination slowed in proportion to the decreased creatinine clearance. Asian Population In pharmacokinetic studies of single 20 mg omeprazole doses, an increase in AUC of approximately four-fold was noted in Asian subjects compared to Caucasians. Dose adjustment, particularly where maintenance of healing of erosive esophagitis is indicated, for Asian subjects should be considered. Nonclinical Toxicology Carcinogenesis and Mutagenesis and Impairment of Fertility In two 24-month carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (approximately 0.5 to 28.5 times the human dose of 40 mg/day, based on body surface area) produced gastric ECL cell carcinoids in a dose-related manner in both male and female rats; the incidence of this effect was markedly higher in female rats, which had higher blood levels of omeprazole. Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with 13.8 mg omeprazole/kg/day (approximately 2.8 times the human dose of 40 mg/day, based on body surface area) for one year, then followed for an additional year without the drug. No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of one year (94% treated vs 10% controls). By the second year the difference between treated and control rats was much smaller (46% vs 26%) but still showed more hyperplasia in the treated group. Gastric adenocarcinoma was seen in one rat (2%). No similar tumor was seen in male or female rats treated for two years. For this strain of rat no similar tumor has been noted historically, but a finding involving only one tumor is difficult to interpret. In a 52-week toxicity study in Sprague-Dawley rats, brain astrocytomas were found in a small number of males that received omeprazole at dose levels of 0.4, 2, and 16 mg/kg/day (about 0.1 to 3.3 times the human dose of 40 mg/day, based on body surface area). No astrocytomas were observed in female rats in this study. In a 2-year carcinogenicity study in Sprague-Dawley rats, no astrocytomas were found in males and females at the high dose of 140.8 mg/kg/day (about 28.5 times the human dose of 40 mg/day, based on body surface area). A 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive. A 26-week p53 (+/-) transgenic mouse carcinogenicity study was not positive. Omeprazole was positive for clastogenic effects in an in vitro human lymphocyte chromosomal aberration assay, in one of two in vivo mouse micronucleus tests, and in an in vivo bone marrow cell chromosomal aberration assay. Omeprazole was negative in the in vitro Ames Test, an in vitro mouse lymphoma cell forward mutation assay and an in vivo rat liver DNA damage assay. In 24-month carcinogenicity studies in rats, a dose-related significant increase in gastric carcinoid tumors and ECL cell hyperplasia was observed in both male and female animals [See Warnings and Precautions (5)]. Carcinoid tumors have also been observed in rats subjected to fundectomy or long-term treatment with other proton pump inhibitors or high doses of H 2 -receptor antagonists. Omeprazole at oral doses up to 138 mg/kg/day (about 28 times the human dose of 40 mg/day, based on body surface area) was found to have no effect on the fertility and general reproductive performance in rats. Animal Pharmacology and/or Toxicology Section Reproductive Toxicology Studie s Reproduction studies conducted in pregnant rats at omeprazole doses up to 138 mg/kg/day (about 28 times the human dose of 40 mg/day, based on body surface area) and in pregnant rabbits at doses up to 69 mg/kg/day (about 28 times the human dose of 40 mg/day, based on body surface area) did not disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.9 to 69 mg/kg/day (about 2.8 to 28 times the human dose of 40 mg/day, based on body surface area) produced dose-related increases in embryo-lethality, fetal resorptions and pregnancy disruptions. In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 2.8 to 28 times the human dose of 40 mg/day, based on body surface area). Clinical Studies Duodenal Ulcer Disease Active Duodenal Ulcer In a multicenter, double-blind, placebo controlled study of 147 patients with endoscopically documented duodenal ulcer, the percentage of patients healed (per protocol) at 2 and 4 weeks was significantly higher with omeprazole 20 mg once a day than with placebo (p 0.01). (See Table 7.) Table 6: Treatment of Active Duodenal Ulcer % of Patients Healed * (p 0.01) Omeprazole20 mg a.m.(n = 99) Placeboa.m.(n = 48) Week 2 Week 4 41* 75* 13 27 Complete daytime and nighttime pain relief occurred significantly faster (p 0.01) in patients treated with omeprazole 20 mg than in patients treated with placebo. At the end of the study, significantly more patients who had received omeprazole had complete relief of daytime pain (p 0.05) and nighttime pain (p 0.01). In a multicenter, double-blind study of 293 patients with endoscopically documented duodenal ulcer, the percentage of patients healed (per protocol) at 4 weeks was significantly higher with omeprazole 20 mg once a day than with ranitidine 150 mg b.i.d. (p> < 0.01). (See Table 7) Table 7: Treatment of Active Duodenal Ulcer % of Patients Healed * (p < 0.01) Omeprazole20 mg a.m.(n = 145) Ranitidine 150 mg b.i.d.(n = 148) Week 2 Week 4 42 82* 34 63 Healing occurred significantly faster in patients treated with omeprazole than in those treated with ranitidine 150 mg b.i.d. (p < 0.01). In a foreign multinational randomized, double-blind study of 105 patients with endoscopically documented duodenal ulcer, 40 mg and 20 mg of omeprazole were compared to 150 mg b.i.d. of ranitidine at 2, 4 and 8 weeks. At 2 and 4 weeks both doses of omeprazole were statistically superior (per protocol) to ranitidine, but 40 mg was not superior to 20 mg of omeprazole, and at 8 weeks there was no significant difference between any of the active drugs. (See Table 8) Table 8: Treatment of Active Duodenal Ulcer % of Patients Healed * (p < 0.01) Omeprazole Ranitidine 40 mg(n = 36) 20 mg(n = 34) 150 mg b.i.d.(n = 35) Week 2 Week 4 ..Week 8 83* 100* 100 83* 97* 100 53 82 94 Gastric Ulcer In a U.S. multicenter, double-blind study of omeprazole 40 mg once a day, 20 mg once a day, and placebo in 520 patients with endoscopically diagnosed gastric ulcer, the following results were obtained. (See Table 9) Table 9: Treatment of Gastric Ulcer % of Patients Healed (All Patients Treated) ** (p < 0.01) Omeprazole 40 mg or 20 mg versus placebo + (p < 0.05) Omeprazole 40 mg versus 20 mg Omeprazole40 mg q.d.(n = 214) Omeprazole20 mg q.d.(n = 202) Placebo(n = 104) Week 4 Week 8 55.6** 82.7** ,+ 47.5** 74.8** 30.8 48.1 For the stratified groups of patients with ulcer size less than or equal to 1 cm, no difference in healing rates between 40 mg and 20 mg was detected at either 4 or 8 weeks. For patients with ulcer size greater than 1 cm, 40 mg was significantly more effective than 20 mg at 8 weeks. In a foreign, multinational, double-blind study of 602 patients with endoscopically diagnosed gastric ulcer, omeprazole 40 mg once a day, 20 mg once a day, and ranitidine 150 mg twice a day were evaluated. (See Table 10.) Table 10: Treatment of Gastric Ulcer % of Patients Healed (All Patients Treated) ** (p < 0.01) Omeprazole 40 mg versus ranitidine ++ (p < 0.01) Omeprazole 40 mg versus 20 mg Omeprazole40 mg q.d.(n = 187) Omeprazole20 mg q.d.(n = 200) Ranitidine150 mg b.i.d.(n = 199) Week 4 Week 8 78.1** ,++ 91.4** ,++ 63.5 81.5 56.3 78.4 Gastroesophageal Reflux Disease (GERD) Symptomatic GERD A placebo controlled study was conducted in Scandinavia to compare the efficacy of omeprazole 20 mg or 10 mg once daily for up to 4 weeks in the treatment of heartburn and other symptoms in GERD patients without erosive esophagitis. Results are shown in Table 11. Table 11: % Successful Symptomatic Outcome a a Defined as complete resolution of heartburn * (p < 0.005) versus 10 mg (p < 0.005) versus placebo Omeprazole20 mg a.m. Omeprazole10 mg a.m. Placeboa.m. All patients Patients with confirmed GERD 46* , (n = 205) 56* , (n = 115) 31 (n = 199) 36 (n = 109) 13 (n = 105) 14 (n = 59) Erosive Esophagitis In a U.S. multicenter double-blind placebo controlled study of 40 mg or 20 mg of omeprazole in patients with symptoms of GERD and endoscopically diagnosed erosive esophagitis of grade 2 or above, the percentage healing rates (per protocol) were as shown in Table 12. Table 12: % Patients Healed *(p < 0.01) Omeprazole versus placebo. Omeprazole40 mg(n = 87) Omeprazole20 mg(n = 83) Placebo(n = 43) Week 4 Week 8 45* 75* 39 * 74* 7 14 In this study, the 40 mg dose was not superior to the 20 mg dose of omeprazole in the percentage healing rate. Other controlled clinical trials have also shown that omeprazole is effective in severe GERD. In comparisons with histamine H2-receptor antagonists in patients with erosive esophagitis, grade 2 or above, omeprazole in a dose of 20 mg was significantly more effective than the active controls. Complete daytime and nighttime heartburn relief ocurred significantly faster (p < 0.01) in patients treated with omeprazole than in those taking placebo or histamine H2-receptor antagonists. In this and five other controlled GERD studies, significantly more patients taking 20 mg omeprazole (84%) reported complete relief of GERD symptoms than patients receiving placebo (12%). Long Term Maintenance Treatment of Erosive Esophagitis In a U.S. double-blind, randomized, multicenter, placebo controlled study, two dose regimens of omeprazole were studied in patients with endoscopically confirmed healed esophagitis. Results to determine maintenance of healing of erosive esophagitis are shown in Table 13. Table 13: Life Table Analysis *(p < 0.01) Omeprazole 20 mg once daily versus Omeprazole 20 mg 3 consecutive days per week or placebo. Omeprazole20 mg q.d.(n = 138) Omeprazole20 mg 3 days per week(n = 137) Placebo(n = 131) Percent in endoscopic remission at 6 months 70* 34 11 In an international multicenter double-blind study, omeprazole 20 mg daily and 10 mg daily were compared to ranitidine 150 mg twice daily in patients with endoscopically confirmed healed esophagitis. Table 15 provides the results of this study for maintenance of healing of erosive esophagitis. Table 14: Life Table Analysis *(p = 0.01) Omeprazole 20 mg once daily versus Omeprazole 10 mg once daily or Ranitidine. (p = 0.03) Omeprazole 10 mg once daily versus Ranitidine. Omeprazole20 mg q.d.(n = 131) Omeprazole 1 0 mg q.d.(n = 133) Ranitidine150 mg b.i.d . (n = 128) Percent in endoscopic remission at 12 months 77* 58 46 In patients who initially had grades 3 or 4 erosive esophagitis, for maintenance after healing 20 mg daily of omeprazole was effective, while 10 mg did not demonstrate effectiveness. Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients A double-blind, multicenter, randomized, non-inferiority clinical trial was conducted to compare Omeprazole and Sodium Bicarbonate for oral suspension 40 mg/1680 mg and I.V. cimetidine for the reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients (mean APACHE II score = 23.7). The primary endpoint was significant upper GI bleeding defined as bright red blood which did not clear after adjustment of the nasogastric tube and a 5 to 10 minute lavage, or persistent Gastroccult positive coffee grounds for 8 consecutive hours which did not clear with 100 cc lavage. Omeprazole/sodium bicarbonate oral suspension 40 mg/1680 mg (two doses administered 6 to 8 hours apart on the first day via orogastric or nasogastric tube, followed by 40 mg q.d. thereafter) was compared to continuous I.V. cimetidine (300 mg bolus, and 50 to 100 mg/hr continuously thereafter) for up to 14 days (mean = 6.8 days). A total of 359 patients were studied, age range 16 to 91 (mean = 56 yrs), 58.5% were males, and 64% were Caucasians. The results of the study showed that Omeprazole and Sodium Bicarbonate was non-inferior to I.V. cimetidine, 10/181(5.5%) patients in the cimetidine group vs. 7/178 (3.9%) patients in the Omeprazole and Sodium Bicarbonate group experienced clinically significant upper GI bleeding. REFERENCES 1.Friedman JM and Polifka JE. Omeprazole. In: Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). 2nd ed. Baltimore, MD: The Johns Hopkins University Press 2000; p. 516. 2.Kallen BAJ. Use of omeprazole during pregnancy no hazard demonstrated in 955 infants exposed during pregnancy. Eur Obstet Gynecol Reprod Biol 2001; 96(1):63-8. 3.Ruigomez A, Rodriguez LUG, Cattaruzzi C, et al. Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol 1999; 150:476-81. 4.Lalkin A, Loebstein, Addis A, et al. The safety of omeprazole during pregnancy: a multicenter prospective controlled study. Am J Obstet Gynecol 1998; 179:727-30. How Supplied/Storage and Handling Omeprazole and Sodium Bicarbonate for oral suspension is a white to off white, granular powder packaged in individual dose packets. Each packet contains either 20 mg or 40 mg omeprazole and 1680 mg sodium bicarbonate. NDC 49884-268-11 Cartons of 30: 20 mg/1680 mg unit dose packets NDC 49884-269-11Cartons of 30: 40 mg/1680 mg unit dose packets Store at 25 C (77 F); excursions permitted to 15 - 30 C (59 - 86 F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Patient Counseling Information See FDA-Approved Medication Guide. Instruct patients that Omeprazole and Sodium Bicarbonate should be taken on an empty stomach at least one hour prior to a meal. [See Dosage and Administration ( 2 )] Instruct patients in Directions for Use as follows: For Oral Suspension: Empty packet contents into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink. Omeprazole and Sodium Bicarbonate is available either as 40 mg or 20 mg single-dose packets for oral suspension with 1680 mg sodium bicarbonate. Patients should be instructed not to substitute Omeprazole and Sodium Bicarbonate for oral suspension for other Omeprazole and Sodium Bicarbonate dosage forms because different dosage forms contain different amounts of sodium bicarbonate and magnesium hydroxide. [See Dosage and Administration ( 2 )] Patients should be advised that since both the 20 mg and 40 mg oral suspension packets contain the same amount of sodium bicarbonate (1680 mg), two packets of 20 mg are not equivalent to one packet of Omeprazole and Sodium Bicarbonate 40 mg; therefore, two 20 mg packets of Omeprazole and Sodium Bicarbonate should not be substituted for one packet of Omeprazole and Sodium Bicarbonate 40 mg. Conversely of a 40 mg packet should not be substituted for one 20 mg packet. [See Dosage and Administration ( 2 )] Patients should be advised that this drug is not approved for patients less than 18 years of age. [See Pediatric Use ( 8.4 )] Patients on a sodium restricted diet or patients at risk of developing congestive heart failure (CHF) should be informed of the sodium content of Omeprazole and Sodium Bicarbonate for oral suspension (460 mg per packet). Patients should be informed that chronic use of sodium bicarbonate may cause problems and increased sodium intake can cause swelling and weight gain. If this occurs, they should contact their healthcare provider. [See Warnings and Precautions ( 5.3 ] Patients should be informed that the most frequent adverse reactions associated with Omeprazole and Sodium Bicarbonate include headache, abdominal pain, nausea, diarrhea, vomiting and flatulence. [See Adverse Reactions ( 6 )] Pregnant women should be advised that a harmful effect of Omeprazole and Sodium Bicarbonate on the fetus can not be ruled out and that the drug should be used with caution during pregnancy. [See Pregnancy ( 8.1 )] Patients should be advised to use this drug with caution if they are regularly taking calcium supplements. [See Warnings and Precautions ( 5.4 )] Advise patients to immediately report and seek care for diarrhea that does not improve. This may be a sign of Clostridium difficile associated diarrhea (see Warnings and Precautions ( 5.4 )]. Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures and tetany as these may be signs of hypomagnesemia. (see WARNINGS AND PRECAUTIONS ( 5.7 )]. Manufactured by: PAR PHARMACEUTICAL Chestnut Ridge, NY 10977 Revised: 06/2016 FDA-APPROVED MEDICATION GUIDE Omeprazole and Sodium Bicarbonate for Oral Suspension Read this Medication Guide before you start taking Omeprazole and Sodium Bicarbonate and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about Omeprazole and Sodium Bicarbonate for Oral Suspension? Omeprazole and Sodium Bicarbonate for Oral Suspension may help with your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole and Sodium Bicarbonate for Oral Suspension can cause serious side effects, including: Omeprazole and Sodium Bicarbontate for oral suspension contains sodium bicarbonate . Tell your doctor if you are on a sodium restricted diet or if you have Bartter s Syndrome (a rare kidney disorder). Tell your doctor right away if you have confusion, shaking hands, dizziness, muscle twitching, nausea, vomiting, and numbness or tingling in the face, arms, or legs. Diarrhea . Omeprazole and Sodium Bicarbonate for oral suspension may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. Bone fractures . People who take multiple daily doses of Proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take Omeprazole and Sodium Bicarbonate for oral suspension exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take Omeprazole and Sodium Bicarbonate for oral suspension.. Omeprazole and Sodium Bicarbonate for oral suspension can have other serious side effects. See What are the possible side effects of Omeprazole and Sodium Bicarbonate for Oral Suspension? What is Omeprazole and Sodium Bicarbonate for Oral Suspension? Omeprazole and Sodium Bicarbonate for oral suspension is a prescription medicine called a proton pump inhibitor (PPI). Omeprazole and Sodium Bicarbonate for oral suspension reduces the amount of acid in your stomach. Omeprazole and Sodium Bicarbonate for oral suspension is used in adults for: for 4 weeks to heal ulcers in the first part of the small bowel (duodenal ulcers). Your doctor may prescribe another 4 weeks of Omeprazole and Sodium Bicarbonate for oral suspension.. for up to 8 weeks for healing stomach ulcers for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). GERD happens when acid from the stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping. for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) to maintain healing of the esophagus. It is not known if Omeprazole and Sodium Bicarbonate for oral suspension is safe and effective if used longer than 12 months (1 year). to lower the risk of stomach bleeding in critically ill people(40 mg Oral Suspension only) It is not known if Omeprazole and Sodium Bicarbonate for oral suspension is safe and effective in children less than 18 years of age. Who should not take Omeprazole and Sodium Bicarbonate for Oral Suspension? Do not take Omeprazole and Sodium Bicarbonate for oral suspension if you: are allergic to omeprazole or any of the other ingredients in Omeprazole and Sodium Bicarbonate for oral suspension. See the end of this Medication Guide for a complete list of ingredients in Omeprazole and Sodium Bicarbonate for oral suspension. are allergic to any other proton pump inhibitor (PPI) medicine. What should I tell my doctor before I take Omeprazole and Sodium Bicarbonate for Oral Suspension? Before you take Omeprazole and Sodium Bicarbonate for Oral Suspension, tell your doctor if you: have been told that you have low magnesium, calcium, or potassium levels in your blood. have liver problems have heart failure have Bartter s syndrome (a rare kidney disorder) have any allergies have any other medical conditions are pregnant or plan to become pregnant. It is not known if Omeprazole and Sodium Bicarbonate for oral suspension can harm your unborn baby. are breastfeeding or plan to breastfeed. Omeprazole and Sodium Bicarbonate can pass into your breast milk and may harm your baby. You and your doctor should decide if you will take Omeprazole and Sodium Bicarbonate for oral suspension or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Omeprazole and Sodium Bicarbonate for oral suspension. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Omeprazole and Sodium Bicarbonate for oral suspension may affect how other medicines work, and other medicines may affect how Omeprazole and Sodium Bicarbonate for oral suspension works. Especially tell your doctor if you take: diazepam (Valium ) warfarin (Coumadin Jantoven) phenytoin (Dilantin ) cyclosporine (Gengraf, Neoral, Sandimmune) disulfiram (Antabuse ) a benzodiazepine medicine ketoconazole (Nizoral ) an antibiotic that contains ampicillin products that contain iron digoxin (Lanoxin ) voriconazole (Vfend ) atazanavir (Reyataz ) nelfinavir (Viracept ) tacrolimus (Prograf ) saquinavir (Fortovase ) clarithromycin (Biaxin , Biaxin XL) clopidogrel (Plavix ) St. John s Wort (Hypericum perforatum) rifampin (Rifater, Rifamate, Rimactane, Rifadin) methotrexate Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take Omeprazole and Sodium Bicarbonate for Oral Suspension? Take Omeprazole and Sodium Bicarbonate for oral suspension exactly as prescribed by your doctor. Do not change your dose or stop taking Omeprazole and Sodium Bicarbonate for oral suspension without talking to your doctor. Take Omeprazole and Sodium Bicarbonate for oral suspension on an empty stomach at least one hour before a meal. Empty the contents of a packet of Omeprazole and Sodium Bicarbonate for oral suspension into a small cup containing 1 to 2 tablespoons of water. Do not use other liquids or foods. Stir well and drink immediately. Refill cup with water and drink. If you miss a dose of Omeprazole and Sodium Bicarbonate for oral suspension, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses to make up for a missed dose. Do not substitute two 20 mg packets for one 40 mg packet of Omeprazole and Sodium Bicarbonate for oral suspension because you will receive twice the amount of sodium bicarbonate. Talk to your doctor if you have questions. If you take too much Omeprazole and Sodium Bicarbonate for oral suspension, call your doctor or Poison Control Center right away, or go to the nearest hospital emergency room. Your doctor may prescribe antibiotic medicines with Omeprazole and Sodium Bicarbonate for oral suspension to help treat a stomach infection and heal stomach- area (duodenal) ulcers that are caused by bacteria called H. pylori. Make sure you read the patient information that comes with an antibiotic before you start taking it. See the Instructions for Use at the end of this Medication Guide for instructions on how to mix and give Omeprazole and Sodium Bicarbonate for oral suspension through a nasogastric tube or orogastric tube. What are the possible side effects of Omeprazole and Sodium Bicarbonate for Oral Suspension? Omeprazole and Sodium Bicarbonate for Oral Suspension may cause serious side effects, including: See What is the most important information I should know about Omeprazole and Sodium Bicarbonate for Oral Suspension? Chronic (lasting a long time) inflammation of the stomach lining (Atrophic Gastritis ). Taking Omeprazole and Sodium Bicarbonate for oral suspension for a long period of time may increase the risk of inflammation to your stomach lining. You may or may not have symptoms. Tell your doctor if you have stomach pain, nausea, vomiting, or weight loss. Low magnesium levels in your body . This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium. Tell your doctor right away if you develop any of these symptoms: seizures dizziness abnormal or fast heartbeat jitteriness jerking movements or shaking (tremors) muscle weakness spasms of the hands and feet cramps or muscle aches spasm of the voice box Your doctor may check the level of magnesium in your body before you start taking Omeprazole and Sodium Bicarbonate for oral suspension, or during treatment, if you will be taking Omeprazole and Sodium Bicarbonate for oral suspension for a long period of time. The most common side effects with Omeprazole and Sodium Bicarbonate for oral suspension include: headache abdominal pain nausea diarrhea vomiting gas Other side effects: Serious allergic reactions. Tell your doctor if you get any of the following symptoms with Omeprazole and Sodium Bicarbonate for oral suspension. rash face swelling throat tightness difficulty breathing Your doctor may stop Omeprazole and Sodium Bicarbonate for oral suspension if these symptoms happen. Using Omeprazole and Sodium Bicarbonate for oral suspension for a long time may cause problems such as swelling and weight gain. Tell your doctor if this happens. If you are on a low-sodium diet or at risk of developing congestive heart failure (CHF), you and your doctor should decide if you will take Omeprazole and Sodium Bicarbonate for oral suspension. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Omeprazole and Sodium Bicarbonate for oral suspension. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Omeprazole and Sodium Bicarbonate for Oral Suspension? Store omeprazole and sodium, bicarbonate for oral suspension in a dry place at 25 C (77 F); excursions permitted to 15 -30 C (59 -86 F). [See USP Controlled Room Temperature]. Keep Omeprazole and Sodium Bicarbonate for oral suspension in a dry place and out of the light. Keep Omeprazole and Sodium Bicarbonate for Oral Suspension and all medicines out of the reach of children. General information about Omeprazole and Sodium Bicarbonate for Oral Suspension Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Omeprazole and Sodium Bicarbonate for oral suspension for any condition for which it was not prescribed by your doctor. Do not give Omeprazole and Sodium Bicarbonate for oral suspension to other people, even if they have the same symptoms as you. It may harm them. This Medication Guide summarizes the most important information about Omeprazole and Sodium Bicarbonate for oral suspension. If you would like more information, talk to your doctor. You can also ask your doctor or pharmacist for information about Omeprazole and Sodium Bicarbonate for oral suspension that is written for healthcare professionals. For more information, go to www.parpharm.com or 1-800-828-9393. What are the ingredients in Omeprazole and Sodium Bicarbonate for Oral Suspension? Active ingredients: Omeprazole and Sodium Bicarbonate Inactive ingredients of Omeprazole and Sodium Bicarbonate for oral suspension: xylitol, xanthan gum, sucralose powder, peach powder, sucrose and peppermint flavor. Instructions for Use For instructions on taking Omeprazole and Sodium Bicarbonate for oral suspension by mouth, see How should I take Omeprazole and Sodium Bicarbonate for Oral Suspension? Giving Omeprazole and Sodium Bicarbonate for Oral Suspension through a nasogastric tube (NG tube) or gastric tube: Add 20 mL of water to a catheter tipped syringe and then add the contents of a packet as prescribed by your doctor. Use only a catheter tipped syringe to give Omeprazole and Sodium Bicarbonate for oral suspension through a NG tube or orogastric tube. Shake the syringe to dissolve the powder. Give the medicine through the NG or orogastric tube into the stomach right away. Refill the syringe with an equal amount of water. Shake and flush any remaining contents from the NG tube or orogastric tube into the stomach. This Medication Guide has been approved by the U.S. Food and Drug Administration. For prescription only Manufactured by: PAR PHARMACEUTICAL Chestnut Ridge, NY 10977 Revised: 06/2016 PRINCIPAL DISPLAY PANEL: - 20 MG POUCH PRINCIPAL DISPLAY PANEL 40 MG POUCH OMEPRAZOLE/SODIUM BICARBONATE Omeprazole and Sodium Bicarbonate powder, for suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-269 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 40 mg SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1680 mg Inactive Ingredients Ingredient Name Strength XYLITOL XANTHAN GUM SUCRALOSE PEACH SUCROSE PEPPERMINT Packaging # Item Code Package Description 1 NDC:49884-269-11 30 PACKET in 1 CARTON 1 NDC:49884-269-52 1 POWDER, FOR SUSPENSION in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079182 07/18/2016 OMEPRAZOLE/SODIUM BICARBONATE Omeprazole and Sodium Bicarbonate powder, for suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-268 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 20 mg SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1680 mg Inactive Ingredients Ingredien surgical procedure
morning time Omeprazole and Sodium Bicarbonate most excellent
EmoticonEmoticon