Tiopronine may be available in the countries listed below.
Tiopronine (DCF) is known as Tiopronin in the US.
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| DCF | Dénomination Commune Française |
Haloperidol Akri may be available in the countries listed below.
Haloperidol is reported as an ingredient of Haloperidol Akri in the following countries:
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Exomuc may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of Exomuc in the following countries:
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Neotrax may be available in the countries listed below.
Levamisole hydrochloride (a derivative of Levamisole) is reported as an ingredient of Neotrax in the following countries:
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Trilac may be available in the countries listed below.
Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Trilac in the following countries:
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Fosinopril Qualimed may be available in the countries listed below.
Fosinopril sodium salt (a derivative of Fosinopril) is reported as an ingredient of Fosinopril Qualimed in the following countries:
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Cexime may be available in the countries listed below.
Cefixime is reported as an ingredient of Cexime in the following countries:
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Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
Molecular Formula: C17H19N3O3S
CAS Number: 73590-58-6
Brands: Prilosec, Zegerid
Special Alerts:
[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.
BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.
RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .
[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.
The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .
Acid- or proton-pump inhibitor; gastric antisecretory agent.1 2 3 4 5 8 132 207 208
Short-term treatment of symptomatic GERD (e.g., heartburn).1 5 97 207 208 b
Short-term treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.1 2 3 4 5 8 92 93 94 95 96 97 98 b
Maintain healing and decrease recurrence of erosive esophagitis.1 92 93 94 95 96 207 208 b
Short-term self-medication with omeprazole magnesium for symptomatic relief of frequent (e.g., 2 or more days a week) heartburn in adults 18 years of age or older.187
Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).1 2 3 4 8 207 208 b
Treatment of Helicobacter pylori infection and duodenal ulcer disease.1 138 Used in conjunction with amoxicillin and clarithromycin (triple therapy) or clarithromycin (dual therapy);1 138 has been used in other multidrug regimens†.27 28 29 37 38 39 61 62 66 67 75 76 77 78 79 81 82 106 108 110 111 112 113 115 138
Short-term treatment and symptomatic relief of active benign gastric ulcer.1 207 208 b
Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn's disease†, including esophageal, gastroduodenal, and jejunoileal disease.190 191 192 194 195 196
Long-term treatment of Zollinger-Ellison syndrome, multiple endocrine adenomas, or systemic mastocytosis in adults.1 2 3 4 5 8 13
Used to decrease risk of upper GI bleeding in critically ill patients.207 208 211 b
Omeprazole is acid-labile.1 207 208 b To avoid decomposition in acidic pH of the stomach, delayed-release capsules contain enteric-coated granules of the drug;1 2 4 the conventional immediate-release capsules and powder for oral suspension contain sodium bicarbonate to protect the drug.207 208 b
Swallow intact with a glass of water at least 1 hour prior to a meal.b Do not use with any other liquid.b Do not open capsules or mix the contents with food.b
Do not substitute two 20-mg capsules for one 40-mg capsule because the 20-mg and 40-mg capsules contain the same amount of sodium bicarbonate.b
Administer orally before a meal (preferably 30 minutes before eating).1 3 5 108 132
Swallow capsules intact; do not chew or crush.1
Antacids may be used concomitantly as needed for pain relief.1 3
Alternatively, open capsule and mix contents with 1 tablespoon applesauce; swallow immediately without chewing and with glass of cool water to ensure complete swallowing.1 Applesauce should not be hot and should be soft enough to swallow without chewing.1
Tablets for self-medication: swallow intact with a glass of water before breakfast; do not chew, crush, or crush in food.187 189
Administer at least 1 hour prior to a meal.207 208 b
Empty 20- or 40-mg single-dose packet for oral suspension into small cup containing 15–30 mL (1–2 tablespoons) of water, stir well, and swallow immediately.207 208 b Rinse container with more water and swallow to ensure complete consumption of the dose.207 208 b Do not mix with any other liquid or food.207 208 b
Do not substitute two 20-mg packets for one 40-mg packet because the 20- and 40-mg powder for oral suspension packets contain the same amount of sodium bicarbonate.b
May use antacids, antacid/alginic acid combinations, histamine H2-receptor antagonists, or histamine H2-receptor antagonist and antacid combinations for “breakthrough” symptoms, but efficacy of these preparations has not been established.208
Reconstitute 20- or 40-mg single-dose packet for oral suspension with 20 mL of water, stir well, administer immediately through a NG or orogastric tube using appropriately sized syringe.207 208 b Flush the tube with 20 mL of water after administration.207 208 b Temporarily stop continuous enteral feeding via NG or orogastric tube for 3 hours before and 1 hour after administration.207 208 b
Available as omeprazole and omeprazole magnesium; dosage expressed in terms of omeprazole.1 187
Children >2 years of age: Children weighing <20 kg: 10 mg once daily.1 198 Those weighing ≥20 kg: 20 mg once daily.1 198 Administered for 4 weeks in one study.1 198
Children >2 years of age: Children weighing <20 kg: 10 mg daily.1 198 Those weighing ≥20 kg: 20 mg daily.1 198
On a mg/kg basis, dosage of omeprazole required to heal erosive esophagitis is greater in children than that required in adults.1 197 198 In an uncontrolled open-label study, dosages required for healing were 0.7–3.5 mg/kg daily (maximum 80 mg daily) for 3–6 months; about 90% of children healed in the first 3 months, and about 5% required a second course of treatment.1 197 198 Dosage of 0.7 mg/kg daily resulted in healing in 44% of children; an additional 28% of the children studied required a dosage of 1.4 mg/kg daily for healing to occur.1 197 198
Children >2 years of age: Children weighing <20 kg: 10 mg daily.1 198 Those weighing ≥20 kg: 20 mg daily.1 198 Maintenance therapy continued 2 years in one study.1 198 In an uncontrolled open-label study, maintenance dosages were half the dosages required for initial healing in 54% of children, while 46% required dosage increase (0.7–2.8 mg/kg daily) for all or part of the study.1 198
20 mg once daily for up to 4 weeks.1 2 207 208 b
20 mg once daily until healing occurs (usually within 4–8 weeks);1 2 207 208 b 40 mg once daily may be required.2 98 May give an additional 4 weeks of therapy (up to 12 weeks for a single course).1 2 98 207 b If recurs, consider additional 4–8 weeks of therapy.1 b
20 mg once daily.1 207 208 b Chronic, lifelong therapy may be appropriate.143
20 mg daily in the morning for 14 days.187 188 Do not exceed recommended dosage or duration; do not administer more than one course every 4 months.187 188 May relieve symptoms within 24 hours, but 1–4 days may be required for complete relief.187 188 189
20 mg once daily until healing occurs (usually within 2–4 weeks); an additional 4 weeks of therapy may be beneficial.1 2 207 208 b Patients who responded poorly to histamine H2-receptor antagonists may require up to 40 mg daily.2
Triple therapy: 20 mg twice daily (morning and evening) for 10 days in conjunction with amoxicillin and clarithromycin; additional omeprazole therapy of 20 mg once daily for 18 days recommended if active ulcer present initially.1
Dual therapy: 40 mg once daily (in the morning) for 14 days in conjunction with clarithromycin; omeprazole 20 mg once daily for additional 14 days recommended if active ulcer present initially.1
40 mg once daily for 4–8 weeks.1 207 208 b
60 mg once daily initially.1 2 Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.1 2 13 Administer daily dosages >80 mg in divided doses.1 13 May require dosages of up to 360 mg daily (given in 3 divided doses).1 2
60 mg once daily initially.1 2 Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.1 2 13 Administer daily dosages >80 mg in divided doses.1 13 May require dosages of up to 360 mg daily (given in 3 divided doses).1 2
60 mg once daily initially.1 2 Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.1 2 13 Administer daily dosages >80 mg in divided doses.1 13 May require dosages of up to 360 mg daily (given in 3 divided doses).1 2
Initially, 40 mg followed by 40 mg after 6–8 hours on the first day, then 40 mg once daily for up to 14 days.207 Safety and efficacy for >14 days not established.207
Consider dosage reduction, particularly in patients receiving long-term therapy for maintenance of healing of erosive esophagitis.1 207 b
Consider dosage reduction, especially in patients receiving long-term therapy for maintenance of healing of erosive esophagitis.1 207 b
Known hypersensitivity to omeprazole, any ingredient in the formulation, or esomeprazole or other substituted benzimidazoles (e.g., lansoprazole, pantoprazole, rabeprazole).1 25 139 b
Response to omeprazole does not preclude presence of occult gastric neoplasm.1 207 208 b Atrophic gastritis reported occasionally with long-term use.1 207 208 b
Each 20- and 40- mg conventional immediate-release capsule contains 1100 mg of sodium bicarbonate (300 mg [13 mEq] of sodium), and each 20- and 40-mg single-dose packet of Zegerid contains 1680 mg of sodium bicarbonate (460 mg [20 mEq] of sodium).207 b Consider sodium content when used in patients requiring restricted salt intake.b
Caution in patients with Bartter's syndrome, hypokalemia, respiratory alkalosis, and acid-base abnormalities.207 208 b Long-term administration of sodium bicarbonate with calcium or milk may cause milk-alkali syndrome.b Sodium bicarbonate is contraindicated in patients with metabolic alkalosis or hypocalcemia.207 208 b
Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).199 200
Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.212 300 301 302 303 304 305 309 Magnitude of risk is unclear;212 300 301 302 303 304 305 310 causality not established.305 FDA is continuing to evaluate this safety concern.305
Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.212 301 303 305 307 309
Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients' bone health according to current standards of care.212 303 305 307 309
Preliminary safety data from 2 long-term clinical trials comparing esomeprazole or omeprazole with antireflux surgery in patients with severe GERD raised concerns about a potential increased risk of cardiac events (e.g., MI, heart failure, sudden death) in patients receiving these drugs.213 214 215 After reviewing data from these and other studies, FDA has concluded that long-term use of these drugs is not likely to be associated with an increased risk of such cardiac events.213 214 215 FDA recommends that clinicians continue to prescribe and patients continue to use these drugs in the manner described in the manufacturers' labelings.213 214 215
Category C.1 207 208 b
Distributed into milk.1 139 202 207 b Discontinue nursing or the drug.1 139 207 b
Safety and efficacy of delayed-release capsules not established in children <2 years of age.1 198 Safety and efficacy for self-medication of frequent heartburn not established in children <18 years of age.187 Safety and efficacy of conventional immediate-release capsules or powder for oral suspension not established in pediatric patients.207 b
No substantial differences in efficacy and safety relative to younger adults, but increased sensitivity cannot be ruled out.1 207 b
Increased bioavailability and decreased clearance.1 207 b Monitor patients receiving >20 mg daily for possible adverse effects.3 (See Hepatic Impairment under Dosage and Administration.)
In adults, diarrhea, nausea, constipation, abdominal pain, vomiting, headache, dizziness, rash.1 2 3 207 208 b
In pediatric patients, respiratory effects, otitis media (in children 0–2 years of age), accidental injuries (in children 2–16 years of age); otherwise, adverse effects generally similar to those in adults.1
Metabolized in the liver by CYP isoenzymes, principally CYP2C19, and to lesser extent by CYP3A4.1 139
Potential to prolong elimination of drugs metabolized by oxidation in the liver.1 2 207 b Interaction reported with drugs metabolized by CYP isoenzymes; monitor and adjust dosage of these drugs if necessary.1 207 b
Drug | Interaction | Comments |
|---|---|---|
Atazanavir | Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response216 218 b | Manufacturer of omeprazole states that concomitant use with atazanavir is not recommended216 Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir217 218 For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)217 218 Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended217 218 |
Benzodiazepines | Potential for altered benzodiazepine metabolism1 207 b | Monitor and adjust benzodiazepine dosage if needed1 207 b |
Clarithromycin | Increased plasma concentrations of omeprazole, clarithromycin, and 14-hydroxyclarithromycin 1 207 b | |
Clopidogrel | Possible reduction in clinical efficacy of clopidogrel; additional data needed to fully elucidate potential clinical consequences (e.g., increased cardiovascular events)219 220 221 224 229 230 234 235 236 237 238 240 243 244 245 246 247 248 249 250 251 252 311 Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown219 220 221 224 232 | Assess risks and benefits of concomitant proton-pump inhibitor use in individual patients.237 240 243 248 250 311 American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs; H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311 If concomitant therapy with a proton-pump inhibitor and clopidogrel is considered necessary, some clinicians prefer pantoprazole (which appears to be the weakest CYP2C19 inhibitor among proton-pump inhibitors);223 230 234 alternatively, consider use of a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine)223 230 234 251 but not cimetidine (also a potent CYP2C19 inhibitor)232 233 |
Cyanocobalamin | Potential for decreased cyanocobalamin absorption86 98 99 100 101 | Monitor serum cyanocobalamin concentrations during long-term omeprazole therapy99 |
Cyclosporine | Potential for altered cyclosporine metabolism1 207 b | Monitor and adjust cyclosporine dosage if needed1 207 b |
Diazepam | Potential for prolonged diazepam elimination1 207 b | |
Disulfiram | Potential for altered disulfiram metabolism1 207 b | Monitor and adjust disulfiram dosage if needed1 207 b |
Gastric pH-dependent drugs (e.g., ampicillin esters, iron salts, ketoconazole) | Omeprazole may decrease drug absorption1 207 b | |
Phenytoin | Potential for prolonged phenytoin elimination1 207 b | |
Sucralfate | Possible delayed proton-pump inhibitor absorption and decreased bioavailability134 | Administer proton-pump inhibitor at least 30 minutes before sucralfate134 |
Tacrolimus | Potential for increased tacrolimus concentrationsb | |
Warfarin | Potential for decreased warfarin metabolism and changes in prothrombin measures1 134 139 207 b | Monitor prothrombin time and INR1 134 139 207 b |
Absolute bioavailability with 20–40 mg dose is about 30–40%.1 b Bioavailability increases slightly with repeated dosing.1 207 b
In children 2–5 years of age, AUCs were lower than in children 6–16 years of age or in adults.1
Within 1 hour; maximum effect within 2 hours.1
Duration of secretion inhibition is up to 72 hours; inhibition is 50% of maximum at 24 hours.1 Inhibition increases with repeated daily dosing, reaching steady-state plateau at 4 days.1 After discontinuance, gastric secretion gradually increases over 3–5 days.1
Rate of absorption is decreased with meals.3 5 Most effective given about 30 minutes before a meal;5 108 132 bioavailability may be unaffected if given up to 2 minutes before a meal.3
Administration of oral suspension 1 hour after a meal decreases peak plasma concentrations (by 62%) and AUCs (by 26%).207 208 b
In patients with chronic hepatic disease, bioavailability is increased to 100% due to decreased first-pass effect.1 207 b
In Asians, AUCs increased 4-fold after a 20-mg dose.1 207 b
Omeprazole crosses the placenta and is distributed into milk.1 139 202 207 209 210 b
Prolonged binding to gastric parietal proton pump enzyme.1 207 b
95%.1 207 b
Undergoes first-pass metabolism.1 b Metabolized to inactive metabolites in the liver by CYP isoenzymes, principally CYP2C19, and to lesser extent by CYP3A4.1 139
Excreted principally in urine (77%) as metabolites and to a lesser extent in feces.1 b
0.5–1 hour.1 b
In patients with chronic hepatic disease, clearance is decreased, and plasma half-life is increased to almost 3 hours.1 207 b
25°C (may be exposed to 15–30°C).b
Tight, light-resistant containers at 15–30°C.1
Single-dose packets: 25°C (may be exposed to 15–30°C).207 b
Tight containers at 20–25°C; protect from high heat, humidity, and moisture.187
Inhibits basal and stimulated gastric acid secretion.1 2 3 4 5 207 b
Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that irreversibly binds to and inactivates hydrogen-potassium ATPase (proton- or acid pump),2 3 5 132 blocking final step in secretion of hydrochloric acid.1 2 3 4 5 8 132 207 b Acid secretion inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.2 3 4 5 8 132
Suppresses H. pylori in patients with duodenal ulcer and/or reflux esophagitis infected with the organism.2 Combined therapy with omeprazole and 1 or more appropriate anti-infectives (e.g., amoxicillin, clarithromycin) can effectively eradicate H. pylori gastric infection.1 2 67 98 138
Importance of swallowing delayed-release capsule intact, without crushing or chewing.1 Importance of taking delayed-release capsule before a meal (preferably 30 minutes before eating).1 5 108 132
If mixed with applesauce, importance of mixing delayed-release capsule contents with applesauce soft enough to swallow without chewing.1 Importance of not using hot applesauce.1 Importance of immediately swallowing mixture with a glass of cool water, without crushing or chewing; importance of not storing for later use.1
Importance of swallowing immediate-release capsule intact with water and not with other fluid.b Importance of not opening capsule or mixing the contents with food.b
Importance of taking immediate-release capsule and oral suspension at least 1 hour before a meal.207 208 b
Importance of not substituting two 20-mg immediate-release capsules for one 40-mg capsule or two 20-mg powder for oral suspension packets for one 40-mg packet.b
Importance of mixing powder for oral suspension in small cup with water, not with other fluids or food.207 208 b Importance of swallowing suspension immediately, then refilling cup with water and swallowing to ensure complete ingestion of dose.207 208 b
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 Antacids may be used concomitantly with delayed-release capsules (Prilosec) as needed for pain relief.1 Antacids, antacids/alginic acid combinations, histamine H2-receptor antagonists, or histamine H2-receptor antagonist and antacid combinations may be used in conjunction with omeprazole oral suspension for “breakthrough” symptoms.208
Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.305 309
Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of following dosage instructions when omeprazole magnesium is administered for self-medication.187 188 Advise patients that they should use the drug for self-medication only as directed
Calcium Chloratum may be available in the countries listed below.
Calcium Chloride is reported as an ingredient of Calcium Chloratum in the following countries:
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Norfloxacin is reported as an ingredient of Uricin in the following countries:
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