Omeprazole

(oh me' pray zol)

PCaution when used during lactation / LCaution when used during lactation : Caution - pregnancy &  lactation (breast feeding)

Molecule Info

|  See TERMINOLOGY & ABBREVIATIONS |

Indication(s)

Duodenal Ulcer (adults)

Omeprazole is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

Omeprazole in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults. Omeprazole in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Among patients who fail therapy, Omeprazole with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.

Gastric Ulcer (adults)

Omeprazole is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults.

Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)

Symptomatic GERD

Omeprazole is indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.

Erosive Esophagitis

Omeprazole is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults.

The efficacy of Omeprazole used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

Maintenance of Healing of Erosive Esophagitis (adults)

Omeprazole is indicated to maintain healing of erosive esophagitis in pediatric patients and adults.

Controlled studies do not extend beyond 12 months.

Pathological Hypersecretory Conditions (adults)

Omeprazole is indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

Dosage & Administration

Short-Term Treatment of Active Duodenal Ulcer

The recommended adult oral dose of Omeprazole is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

Triple Therapy (Omeprazole/clarithromycin/amoxicillin) : The recommended adult oral regimen is Omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy (Omeprazole/clarithromycin) : The recommended adult oral regimen is Omeprazole 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Gastric Ulcer

The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

Gastroesophageal Reflux Disease (GERD)

The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

Maintenance of Healing of Erosive Esophagitis

The recommended adult oral dose is 20 mg daily.

Pathological Hypersecretory Conditions

The dosage of Omeprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole for more than 5 years.

Pediatric Patients

For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows:

Patient Weight Omeprazole Daily Dose

5 <10 kg

5 mg

10 <20 kg

10 mg

≥ 20 kg

20 mg

On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule.

Alternative Administration Options

Omeprazole is available as a delayed-release capsule or as a delayed-release oral suspension.

For patients who have difficulty swallowing capsules, the contents of a Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

Omeprazole For Delayed-Release Oral Suspension should be administered as follows:

€¢ Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.
€¢ Empty the contents of a 10 mg packet into a container containing 15 mL of water.
€¢ Stir
€¢ Leave 2 to 3 minutes to thicken.
€¢ Stir and drink within 30 minutes.
€¢ If any material remains after drinking, add more water, stir and drink immediately.

For patients with a nasogastric or gastric tube in place:

€¢ Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). It is important to only use a catheter tipped syringe when administering Omeprazole through a nasogastric tube or gastric tube.
€¢ Immediately shake the syringe and leave 2 to 3 minutes to thicken.
€¢ Shake the syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes.
€¢ Refill the syringe with an equal amount of water.
€¢ Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Overdosage

Confusion, drowsiness, blurred vision, tachycardia, nausea, flushing, diaphoresis, headache, and dry mouth. Treatment is supportive; not dialysable.

Adverse Drug Reactions

Clinical Trials Experience with Omeprazole Monotherapy

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflects exposure to Omeprazole Delayed-Release Capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from Omeprazole-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).

Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%).

The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.

The clinical trial safety profile in pediatric patients who received Omeprazole Delayed-Release Capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in both the 1 to <2 and 2 to 16 year age groups (75.0% and 18.5%, respectively). Similarly, fever was frequently reported in the 1 to 2 year age group (33.0%), and accidental injuries were reported frequently in the 2 to 16 year age group (3.8%).

Clinical Trials Experience with Omeprazole in Combination Therapy for H. pylori Eradication

In clinical trials using either dual therapy with Omeprazole and clarithromycin, or triple therapy with Omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.

Dual Therapy (Omeprazole/clarithromycin)

Adverse reactions observed in controlled clinical trials using combination therapy with Omeprazole and clarithromycin (n = 346) that differed from those previously described for Omeprazole alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section).

Triple Therapy (Omeprazole/clarithromycin/amoxicillin)

The most frequent adverse reactions observed in clinical trials using combination therapy with Omeprazole, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections).

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of Omeprazole Delayed-Release Capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.

Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise;

Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema

Endocrine: Gynecomastia

Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued. Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with Omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.

Hepatic: Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin]

Infections and Infestations: Clostridium difficile associated diarrhea

Metabolism and Nutritional disorders: Hypoglycemia, hypomagnesemia, hyponatremia, weight gain

Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture

Nervous System/Psychiatric: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo

Respiratory: Epistaxis, pharyngeal pain

Skin: Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis

Special Senses: Tinnitus, taste perversion

Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision

Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain

Hematologic: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis.

Warning & Precautions

Concomitant Gastric Malignancy

Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

Atrophic Gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.

Clostridium difficile associated diarrhea

€‹Published observation studies suggest that PPI therapy like Omeprazole may be associated with an increase risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.

€‹Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

€‹Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with Omeprazole, refer to WARNINGS and PRECAUTIONS sections of those package inserts.

Interaction with Clopidogrel

€‹Avoid concomitant use of Omeprazole with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using Omeprazole, consider alternative anti-platelet therapy. 

Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.

Concomitant use of Omeprazole with St John's Wort or rifampin

Drugs which induce CYP2C19 or CYP3A4 (such as St John's Wort or rifampin) can substantially decrease omeprazole concentrations. Avoid concomitant use of Omeprazole with St John's Wort or rifampin.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop omeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

Concomitant use of Omeprazole with Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients.

Drug Interactions

Interference with Antiretroviral Therapy

Concomitant use of atazanavir and nelfinavir with proton pump inhibitors is not recommended. Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance. Co-administration of saquinavir with proton pump inhibitors is expected to increase saquinavir concentrations, which may increase toxicity and require dose reduction.

Omeprazole has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP 2C19.

Reduced concentrations of atazanavir and nelfinavir

For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Following multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole (40 mg daily), AUC was decreased by 36% and 92%, Cmax by 37% and 89% and Cmin by 39% and 75% respectively for nelfinavir and M8. Following multiple doses of atazanavir (400 mg, daily) and omeprazole (40 mg, daily, 2 hr before atazanavir), AUC was decreased by 94%, Cmax by 96%, and Cmin by 95%. Concomitant administration with omeprazole and drugs such as atazanavir and nelfinavir is therefore not recommended.

Increased concentrations of saquinavir

For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported, with an increase in AUC by 82%, in Cmax by 75%, and in Cmin by 106%, following multiple dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg daily co-administered days 11 to 15. Therefore, clinical and laboratory monitoring for saquinavir toxicity is recommended during concurrent use with Omeprazole. Dose reduction of saquinavir should be considered from the safety perspective for individual patients.

There are also some antiretroviral drugs of which unchanged serum levels have been reported when given with omeprazole.

Drugs for Which Gastric pH Can Affect Bioavailability

Because of its profound and long lasting inhibition of gastric acid secretion, it is theoretically possible that omeprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability. Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, ampicillin esters, iron salts and erlotinib can decrease, while the absorption of drugs such as digoxin can increase during treatment with omeprazole. Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (30% in two subjects). Therefore, patients may need to be monitored when digoxin is taken concomitantly with omeprazole. In the clinical trials, antacids were used concomitantly with the administration of Omeprazole.

Effects on Hepatic Metabolism/Cytochrome P-450 Pathways

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver. There have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin may need to be monitored for increases in INR and prothrombin time.

Although in normal subjects no interaction with theophylline or propranolol was found, there have been clinical reports of interaction with other drugs metabolized via the cytochrome P450 system (e.g., cyclosporine, disulfiram, benzodiazepines). Patients should be monitored to determine if it is necessary to adjust the dosage of these drugs when taken concomitantly with Omeprazole.

Concomitant administration of omeprazole and voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) resulted in more than doubling of the omeprazole exposure. Dose adjustment of omeprazole is not normally required. However, in patients with Zollinger-Ellison syndrome, who may require higher doses up to 240 mg/day, dose adjustment may be considered. When voriconazole (400 mg Q12h x 1 day, then 200 mg x 6 days) was given with omeprazole (40 mg once daily x 7 days) to healthy subjects, it significantly increased the steady-state Cmax and AUC0-24 of omeprazole, an average of 2 times (90% CI: 1.8, 2.6) and 4 times (90% CI: 3.3, 4.4) respectively as compared to when omeprazole was given without voriconazole.

Omeprazole acts as an inhibitor of CYP 2C19. Omeprazole, given in doses of 40 mg daily for one week to 20 healthy subjects in cross-over study, increased Cmax and AUC of cilostazol by 18% and 26% respectively. Cmax and AUC of one of its active metabolites, 3,4- dihydro-cilostazol, which has 4-7 times the activity of cilostazol, were increased by 29% and 69% respectively. Co-administration of cilostazol with omeprazole is expected to increase concentrations of cilostazol and its above mentioned active metabolite. Therefore a dose reduction of cilostazol from 100 mg twice daily to 50 mg twice daily should be considered.

Drugs known to induce CYP2C19 or CYP3A4 (such as rifampin) may lead to decreased omeprazole serum levels. In a cross-over study in 12 healthy male subjects, St John's wort (300 mg three times daily for 14 days), an inducer of CYP3A4, decreased the systemic exposure of omeprazole in CYP2C19 poor metabolisers (Cmax and AUC decreased by 37.5% and 37.9%, respectively) and extensive metabolisers (Cmax and AUC decreased by 49.6% and 43.9%, respectively). Avoid concomitant use of St. John's Wort or rifampin with omeprazole.

Clopidogrel

Omeprazole is an inhibitor of CYP2C19 enzyme. Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant administration of Omeprazole with clopidogrel. When using Omeprazole, consider use of alternative anti-platelet therapy.

There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel.

Tacrolimus

Concomitant administration of omeprazole and tacrolimus may increase the serum levels of tacrolimus.

Interactions with Investigations of Neuroendocrine Tumors

Drug-induced decrease in gastric acidity results in enterochromaffin-like cell hyperplasia and increased Chromogranin A levels which may interfere with investigations for neuroendocrine tumors. 

Combination Therapy with Clarithromycin

Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions [see Warnings and Precautions in prescribing information for clarithromycin]. Because of these drug interactions, clarithromycin is contraindicated for co-administration with certain drugs [see Contraindications in prescribing information for clarithromycin].

Methotrexate

Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted

Food Interaction

Absorption may be delayed. St John's wort decreases omeprazole levels. Avoid ethanol (may cause gastric mucosal irritation).

Lab Interference

False negative results in the urea breath test.

FDA Pregnancy Category & Use in Special population

Pregnancy

Pregnancy Category C

Risk Summary

There are no adequate and well-controlled studies with Omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryolethality at omeprazole doses that were approximately 5.5 - 56 times higher than the human dose. Omeprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Human Data

Four epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H2€‘receptor antagonists or other controls.

A population€‘based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy.The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population. The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population.

A population-based retrospective cohort study covering all live births in Denmark from 1996-2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837, 317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.

A retrospective cohort study reported on 689 pregnant women exposed to either H2€‘blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an H2-blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively.

A small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% first trimester exposures). The reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease€‘paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups.

Several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.

Animal Data

Reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 56 times the human dose on a body surface area basis) and in rabbits at doses up to 69 mg/kg/day (about 56 times the human dose on a body surface area basis) did not disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 5.5 to 56 times the human dose on a body surface area basis) 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 5.6 to 56 times the human doses on a body surface area basis).

 Nursing Mothers

Omeprazole is present in human milk. Omeprazole concentrations were measured in breast milk of a woman following oral administration of 20 mg. The peak concentration of omeprazole in breast milk was less than 7% of the peak serum concentration. This concentration would correspond to 0.004 mg of omeprazole in 200 mL of milk. Caution should be exercised when Omeprazole is administered to a nursing woman.

Pediatric Use

Use of Omeprazole in pediatric and adolescent patients 1 to 16 years of age for the treatment of GERD and maintenance of healing of erosive esophagitis is supported by a) extrapolation of results from adequate and well-controlled studies that supported the approval of Omeprazole for adults, and b) safety and pharmacokinetic studies performed in pediatric and adolescent patients. [SeeClinical Pharmacology, Pharmacokinetics,Pediatric for pharmacokinetic information(12.3) and Dosage and Administration (2),Adverse Reactions (6.1and Clinical Studies, (14.6)].The safety and effectiveness of Omeprazole for the treatment of GERD in patients <1 year of age have not been established. The safety and effectiveness of Omeprazole for other pediatric uses have not been established.

Geriatric Use

Omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the U.S. and Europe. There were no differences in safety and effectiveness between the elderly and younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Pharmacokinetic studies have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. The plasma clearance of omeprazole was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers. However, no dosage adjustment is necessary in the elderly.

Hepatic Impairment

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis.

Renal Impairment

No dosage reduction is necessary.

Asian Population

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis.

Storage

Intravenous: Store at 15-30 °C. Protect from light. Oral: Store at 15-30 °C. Protect from light.

Pharmacology

Mechanism of Action

Reference Omeprazole brand: Prilosec.

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Animal studies indicate that after rapid disappearance from plasma, omeprazole can be found within the gastric mucosa for a day or more.

Pharmacodynamics

Antisecretory Activity

After oral administration, the onset of the antisecretory effect of omeprazole occurs within one hour, with the maximum effect occurring within two hours. Inhibition of secretion is about 50% of maximum at 24 hours and the duration of inhibition lasts up to 72 hours. The antisecretory effect thus lasts far longer than would be expected from the very short (less than one hour) plasma half-life, apparently due to prolonged binding to the parietal H+/K+ ATPase enzyme. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days. The inhibitory effect of omeprazole on acid secretion increases with repeated once-daily dosing, reaching a plateau after four days.

Results from numerous studies of the antisecretory effect of multiple doses of 20 mg and 40 mg of omeprazole in normal volunteers and patients are shown below. The €œmax€ value represents determinations at a time of maximum effect (2-6 hours after dosing), while €œmin€ values are those 24 hours after the last dose of omeprazole.

Table 1 Range of Mean Values from Multiple Studies of the Mean Antisecretory Effects of Omeprazole After Multiple Daily Dosing
*Single Studies
€ Single Studies
 

Omeprazole 20 mg

Omeprazole 40 mg

Parameter

Max

Min

Max

Min

% Decrease in Basal Acid Output

78*

58-80

94€ 

80-93

% Decrease in Peak Acid Output

79€ 

50-59

88€ 

62-68

% Decrease in 24-hr. Intragastric Acidity

 

80-97

 

92-94

Single daily oral doses of omeprazole ranging from a dose of 10 mg to 40 mg have produced 100% inhibition of 24-hour intragastric acidity in some patients.

Serum Gastrin Effects

In studies involving more than 200 patients, serum gastrin levels increased during the first 1 to 2 weeks of once-daily administration of therapeutic doses of omeprazole in parallel with inhibition of acid secretion. No further increase in serum gastrin occurred with continued treatment. In comparison with histamine H2-receptor antagonists, the median increases produced by 20 mg doses of omeprazole were higher (1.3 to 3.6 fold vs. 1.1 to 1.8 fold increase). Gastrin values returned to pretreatment levels, usually within 1 to 2 weeks after discontinuation of therapy.

Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum Chromogranin A (CgA) levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors.

Enterochromaffin-like (ECL) Cell Effects

Human gastric biopsy specimens have been obtained from more than 3000 patients treated with omeprazole in long-term clinical trials. The incidence of ECL cell hyperplasia in these studies increased with time; however, no case of ECL cell carcinoids, dysplasia, or neoplasia has been found in these patients. However, these studies are of insufficient duration and size to rule out the possible influence of long-term administration of omeprazole on the development of any premalignant or malignant conditions.

Other Effects

Systemic effects of omeprazole in the CNS, cardiovascular and respiratory systems have not been found to date. Omeprazole, given in oral doses of 30 or 40 mg for 2 to 4 weeks, had no effect on thyroid function, carbohydrate metabolism, or circulating levels of parathyroid hormone, cortisol, estradiol, testosterone, prolactin, cholecystokinin or secretin.

No effect on gastric emptying of the solid and liquid components of a test meal was demonstrated after a single dose of omeprazole 90 mg. In healthy subjects, a single I.V. dose of omeprazole (0.35 mg/kg) had no effect on intrinsic factor secretion. No systematic dose-dependent effect has been observed on basal or stimulated pepsin output in humans.

However, when intragastric pH is maintained at 4.0 or above, basal pepsin output is low, and pepsin activity is decreased.

As do other agents that elevate intragastric pH, omeprazole administered for 14 days in healthy subjects produced a significant increase in the intragastric concentrations of viable bacteria. The pattern of the bacterial species was unchanged from that commonly found in saliva. All changes resolved within three days of stopping treatment.

The course of Barrett's esophagus in 106 patients was evaluated in a U.S. double-blind controlled study of Omeprazole 40 mg twice daily for 12 months followed by 20 mg twice daily for 12 months or ranitidine 300 mg twice daily for 24 months. No clinically significant impact on Barrett's mucosa by antisecretory therapy was observed. Although neosquamous epithelium developed during antisecretory therapy, complete elimination of Barrett's mucosa was not achieved. No significant difference was observed between treatment groups in development of dysplasia in Barrett's mucosa and no patient developed esophageal carcinoma during treatment. No significant differences between treatment groups were observed in development of ECL cell hyperplasia, corpus atrophic gastritis, corpus intestinal metaplasia, or colon polyps exceeding 3 mm in diameter.

Pharmacokinetics

Absorption

Omeprazole Delayed-Release Capsules contain an enteric-coated granule formulation of omeprazole (because omeprazole is acid-labile), so that absorption of omeprazole begins only after the granules leave the stomach. Absorption is rapid, with peak plasma levels of omeprazole occurring within 0.5 to 3.5 hours. Peak plasma concentrations of omeprazole and AUC are approximately proportional to doses up to 40 mg, but because of a saturable first-pass effect, a greater than linear response in peak plasma concentration and AUC occurs with doses greater than 40 mg. Absolute bioavailability (compared with intravenous administration) is about 30-40% at doses of 20-40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour, and the total body clearance is 500-600 mL/min.

Based on a relative bioavailability study, the AUC and Cmax of Omeprazole (omeprazole magnesium) for Delayed-Release Oral Suspension were 87% and 88% of those for Omeprazole Delayed-Release Capsules, respectively.

The bioavailability of omeprazole increases slightly upon repeated administration of Omeprazole Delayed-Release Capsules.

Omeprazole Delayed-Release Capsule 40 mg was bioequivalent when administered with and without applesauce. However, Omeprazole Delayed-Release Capsule 20 mg was not bioequivalent when administered with and without applesauce. When administered with applesauce, a mean 25% reduction in Cmax was observed without a significant change in AUC for Omeprazole Delayed-Release Capsule 20 mg. The clinical relevance of this finding is unknown.

Distribution

Protein binding is approximately 95%.

Metabolism

Omeprazole is extensively metabolized by the cytochrome P450 (CYP) enzyme system.

Excretion

Following single dose oral administration of a buffered solution of omeprazole, little if any unchanged drug was excreted in urine. The majority of the dose (about 77%) was eliminated in urine as at least six metabolites. Two were identified as hydroxyomeprazole and the corresponding carboxylic acid. The remainder of the dose was recoverable in feces. This implies a significant biliary excretion of the metabolites of omeprazole. Three metabolites have been identified in plasma: the sulfide and sulfone derivatives of omeprazole, and hydroxyomeprazole. These metabolites have very little or no antisecretory activity.

Combination Therapy with Antimicrobials

Omeprazole 40 mg daily was given in combination with clarithromycin 500 mg every 8 hours to healthy adult male subjects. The steady state plasma concentrations of omeprazole were increased (Cmax, AUC0-24, and T1/2 increases of 30%, 89% and 34% respectively) by the concomitant administration of clarithromycin. The observed increases in omeprazole plasma concentration were associated with the following pharmacological effects. The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when co-administered with clarithromycin.

The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of omeprazole. For clarithromycin, the mean Cmax was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when clarithromycin was administered with omeprazole than when clarithromycin was administered alone. Similar results were seen for 14-hydroxy-clarithromycin, the mean Cmax was 45% greater, the mean Cmin was 57% greater, and the mean AUC0-8 was 45% greater. Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole.

Table 2: Clarithromycin Tissue Concentrations 2 hours after Dose*
*Mean ± SD (μg/g)

Tissue

Clarithromycin

Clarithromycin + Omeprazole

Antrum

10.48 ± 2.01 (n = 5)

19.96 ± 4.71 (n = 5)

Fundus

20.81 ± 7.64 (n = 5)

24.25 ± 6.37 (n = 5)

Mucus

4.15 ± 7.74 (n = 4)

39.29 ± 32.79 (n = 4)

Concomitant Use with Clopidogrel

In a crossover clinical study, 72 healthy subjects were administered clopidogrel (300 mg loading dose followed by 75 mg per day) alone and with omeprazole (80 mg at the same time as clopidogrel) for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together.

Results from a crossover study in healthy subjects showed a similar pharmacokinetic interaction between clopidogrel (300 mg loading does/75 mg daily maintenance does) and omeprazole 80 mg daily when co-administered for 30 days. Exposure to the active metabolite of clopidogrel was reduced by 41% to 46% over this time period.

In another study, 72 healthy subjects were given the same doses of clopidogrel and 80 mg omeprazole but the drugs were administered 12 hours apart; the results were similar, indicating that administering clopidogrel and omeprazole at different times does not prevent their interaction

Special Populations

Geriatric Population

The elimination rate of omeprazole was somewhat decreased in the elderly, and bioavailability was increased. Omeprazole was 76% bioavailable when a single 40 mg oral dose of omeprazole (buffered solution) was administered to healthy elderly volunteers, versus 58% in young volunteers given the same dose. Nearly 70% of the dose was recovered in urine as metabolites of omeprazole and no unchanged drug was detected. The plasma clearance of omeprazole was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers.

Pediatric Use

The pharmacokinetics of omeprazole have been investigated in pediatric patients 2 to 16 years of age:

Table 3 Pharmacokinetic Parameters of Omeprazole Following Single and Repeated Oral Administration in Pediatric Populations compared with Adults
* Data from single and repeated dose studies. Doses of 10, 20 and 40 mg omeprazole as enteric-coated granules.
€ Data from a single and repeated dose study. Doses of 10, 20 and 40 mg omeprazole as enteric-coated granules.
€¡Plasma concentration adjusted to an oral dose of 1 mg/kg.

Single or Repeated Oral Dosing/Parameter

Children* <20 kg

2-5 years

Children* > 20 kg

6-16 years

Adults€ (mean 76 kg)

23-29 years (n=12)

 

10 mg

 
20 mg

Single Dosing

     

Cmax€¡ (ng/mL)

288 (n=10)

495 (n=49)

668

AUC€¡ (ng h/mL)

511 (n=7)

1140 (n=32)

1220

Repeated Dosing

     

Cmax€¡ (ng/mL)

539 (n=4)

851 (n=32)

1458

AUC€¡ (ng h/mL)

1179 (n=2)

2276 (n=23)

3352

Following comparable mg/kg doses of omeprazole, younger children (2 to 5 years of age) have lower AUCs than children 6 to 16 years of age or adults; AUCs of the latter two groups did not differ.

Hepatic Impairment

In patients with chronic hepatic disease, the bioavailability increased to approximately 100% compared with an I.V. dose, reflecting decreased first-pass effect, and the plasma half-life of the drug increased to nearly 3 hours compared with the half-life in normals of 0.5-1 hour. Plasma clearance averaged 70 mL/min, compared with a value of 500-600 mL/min in normal subjects. Dose reduction, particularly where maintenance of healing of erosive esophagitis is indicated, for the hepatically impaired should be considered.

Renal Impairment

In patients with chronic renal impairment, whose creatinine clearance ranged between 10 and 62 mL/min/1.73 m2, the disposition of omeprazole was very similar to that in healthy volunteers, 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. No dose reduction is necessary in patients with renal impairment.

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 with Caucasians. Dose reduction, particularly where maintenance of healing of erosive esophagitis is indicated, for Asian subjects should be considered.

Microbiology

Omeprazole and clarithromycin dual therapy and omeprazole, clarithromycin and amoxicillin triple therapy have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections as described in the Indications and Usage section.

Helicobacter

Helicobacter pylori- Pretreatment Resistance

Clarithromycin pretreatment resistance rates were 3.5% (4/113) in the omeprazole/clarithromycin dual therapy studies (4 and 5) and 9.3% (41/439) in omeprazole/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3).

Amoxicillin pretreatment susceptible isolates (<0.25 µg/mL) were found in 99.3% (436/439) of the patients in the omeprazole/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3). Amoxicillin pretreatment minimum inhibitory concentrations (MICs) > 0.25 µg/mL occurred in 0.7% (3/439) of the patients, all of whom were in the clarithromycin and amoxicillin study arm. One patient had an unconfirmed pretreatment amoxicillin minimum inhibitory concentration (MIC) of > 256 µg/mL by Etest®.

Amoxicillin Susceptibility Test Results and Clinical/Bacteriological OutcomesPatients not eradicated of H. pylori following omeprazole/clarithromycin/amoxicillin triple therapy or omeprazole/clarithromycin dual therapy will likely have clarithromycin resistant H. pyloriisolates. Therefore, clarithromycin susceptibility testing should be done, if possible. Patients with clarithromycin resistant H. pylori should not be treated with any of the following: omeprazole/clarithromycin dual therapy, omeprazole/clarithromycin/amoxicillin triple therapy, or other regimens which include clarithromycin as the sole antimicrobial agent.

In the triple therapy clinical trials, 84.9% (157/185) of the patients in the omeprazole/clarithromycin/amoxicillin treatment group who had pretreatment amoxicillin susceptible MICs (<0.25 µg/mL) were eradicated of H. pylori and 15.1% (28/185) failed therapy. Of the 28 patients who failed triple therapy, 11 had no post-treatment susceptibility test results and 17 had post-treatment H. pylori isolates with amoxicillin susceptible MICs. Eleven of the patients who failed triple therapy also had post-treatment H. pylori isolates with clarithromycin resistant MICs.

Susceptibility Test for Helicobacter pylori

For susceptibility testing information about Helicobacter pylori, see Microbiology section in prescribing information for clarithromycin and amoxicillin.

Effects on Gastrointestinal Microbial Ecology

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalized patients, possibly also Clostridium difficile.

ATC Classification

A02BC01 - omeprazole; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

 

Brands/Products Info


Total Products : 151                                                                                                                                                       
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ANASEC Novo Healthcare and Pharma Ltd. Omeprazole BP 20mg Capsule 60's: 240.00 MRP
ANASEC Injection Novo Healthcare and Pharma Ltd. Omeprazole BP 40mg I/V Injection 1 amp's: 70.00 MRP
ASPRA Apex Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 40's, 40mg x 28's: 160.00 & 196.00 MRP
ASPRA-20 Apex Pharmaceuticals Ltd. Omeprazole 20mg/capsule Capsule 20mg x 40s pack: 140.00 MRP
AU-20 Decent Pharma Laboratories Ltd. Omeprazole BP 20mg Capsule 20mg x 100's: 400.00 MRP
AUMI Hudson Pharmaceuticals Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 60's, 40mg x 50's: 240.00 & 375.00 MRP
COSEC Drug International Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 10's, 40mg x 42's: 400.00 & 294.00 MRP
COSEC-40 Drug International Ltd Omeprazole BP 40mg I/V Injection 1 amp's: 70.00 MRP
DEU 20 Monico Pharma Limited Omeprazole BP 20mg Capsule 48's: 192.00 MRP
DEU-40 IV Monico Pharma Limited Omeprazole BP 40mg I/V Injection 1 amp's: 70.00 MRP
ELIPRAZOLE Elixir Pharmaceuticals Ltd Omeprazole 20mg & 40mg/capsule Capsule 20mg x 40s pack: 160.00 MRP; 40mg x 40s pack: ?
EMEZ Edruc Limited Omeprazole BP 20mg Capsule 60's: 240.00 IP
EPZ-40 Reman Drug Laboratories Ltd. Omeprazole BP 20mg Capsule 20's: 150.40 MRP
G-OMEPRAZOLE Gonoshasthaya Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 40's: 120.40 MRP
GAP-20 Euro Pharma Ltd. Omeprazole BP 20mg Capsule 60's: 240.00 MRP
GEM-20 Millat Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 60's: 240.00 MRP
HEALER Amico Laboratories Ltd. Omeprazole BP 20mg Capsule 50's: 200.00 MRP
HK-20 Apollo Pharmaceutical Laboratories Ltd. Omeprazole BP 20mg Capsule 96's: 384.00 IP
INHIBITA Delta Pharma Limited Omeprazole BP 20mg & 40mg Capsule 20mg x 60's, 40mg x 20's: 240.00 & 140.00 MRP
INPRO Biopharma Laboratories Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 96's, 40mg x 20's: 385.92 & 140.60 MRP
INPRO Injection Biopharma Laboratories Ltd Omeprazole BP 40mg I/V Injection 1amp: 70.00 MRP
LOMESEC 20 Aexim Pharmaceutical Ltd. Omeprazole BP 20mg Capsule 60's: 180.00 MRP
LOSECTIL Eskayef Bangladesh Ltd Omeprazole BP 20mg Capsule 10mgx 48's, 20mg x100's, 40mg x24's & 48's MRP: 96.00,400.00, 168.00 & 336.00
LOSECTIL 20 Eskayef Bangladesh Ltd Omeprazole BP 20mg/pack Suspension 20mg x20's & 30's MRP: 100.00 & 150.00
LOSECTIL 40 Eskayef Bangladesh Ltd Omeprazole BP 40mg/pack Suspension 40mg x20's & 30's MRP: 160.00 & 240.00
LOSECTIL DR Eskayef Bangladesh Ltd Omeprazole magnesium 20mg Tablet (delayed release) 60's MRP: 240.00
LOSECTIL Injection Eskayef Bangladesh Ltd Omeprazole BP 40mg ampoule Injection 1 amp. MRP: 70.00
LOSEK Bristol Pharma Limited Omeprazole BP 20mg Capsule 60's 240.00 MRP
LUMISEC 20 Rasa Pharmaceuticals Ltd. Omeprazole 20mg/capsule Capsule 20mg x 30s pack: 90.00 MRP
MEPRA 20 Marksman Pharmaceuticals Ltd Omeprazole 20mg/capsule Capsule 20mg x 60s pack: 240.00 MRP
NEOPRA 20 Supreme Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 30's 105.00 MRP
NIL90 I V Opso Saline Ltd. Omeprazole BP 40mg I/V Injection 40mg vial: 70.26 MRP
NORAIN GlaxoSmithKline Bangladesh Limited Omeprazole BP 20mg Capsule 60's 300.00 MRP
NUPRAZOL Nuvista Pharma Limited Omeprazole BP 20mg Capsule 50's 343.00 MRP
O-20 Asiatic Laboratories Ltd. Omeprazole BP 20mg Capsule 100's 400.00 MRP
O-40 Asiatic Laboratories Ltd. Omeprazole BP 40mg Capsule 40mg x 12's: 84.00 MRP
OC-20 Central Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 60's 240.00 MRP
OM-CAPSULE Ambee Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 40's, 40mg x 20's: 120.80 & 100.20 MRP
OMAG-DR Rangs Pharmaceuticals Ltd. Omeprazole magnesium 20mg Tablet (delayed release) 100's 200.00 MRP
OMAPRIN-20 Doctors Chemical Works Ltd Omeprazole BP 20mg Capsule 40's: 120.00 MRP
OME Somatec Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 40's, 40mg x 20's: 180.60 & 100.40 MRP
OMEBEN Benham Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 60's 234.00 MRP
OMECAP-20 Chemist Laboratories Ltd. Omeprazole BP 20mg Capsule 100's 300.00 MRP
OMECRON NIPRO JMI Pharma Ltd. Omeprazole BP 20mg Capsule 50's 201.00 MRP
OMEFAST S.N. Pharmaceuticals Ltd. Omeprazole magnesium 20mg Tablet 60's 240.00 MRP
OMEGUT Popular Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 100's, 40mg x 32's: 402.06 & 224.97 MRP
OMEGUT Injection Popular Pharmaceuticals Ltd. Omeprazole BP 40mg I/V Injection 1amp: 70.26 MRP
OMEL-20 Medicon Laboratories Ltd Omeprazole BP 20mg Capsule 100's: 400.00 MRP
Omenix 20 Incepta Pharmaceuticals Limited Omeprazole BP 20mg capsule 10x8's :MRP 400 Tk
OMENIX 20 Suspension Incepta Pharmaceuticals Limited Omeprazole BP 20mg/pack Suspension 30's: 180.00 MRP
Omenix 40 Incepta Pharmaceuticals Limited Omeprazole BP 40mg Capsule 4x5's :MRP 160 Tk
OMENIX 40 Injection Incepta Pharmaceuticals Limited Omeprazole 40mg (as lyophilized powder of Omeprazole Sodium BP) Injection 1's: 70.00 MRP
Omenix 40 Susp Incepta Pharmaceuticals Limited Omeprazole BP 40mg Suspension 30x1's :MRP 300 Tk
OMENTA 20 R A K Pharmaceuticals Pvt. Ltd. Omeprazole BP 20mg Capsule 60's: 240.00 MRP
OMENTA IV R A K Pharmaceuticals Pvt. Ltd. Omeprazole BP 40mg I/V Injection 40mg vial: 70.00 MRP
OMEP Aristopharma Ltd. Omeprazole BP 10, 20 & 40mg Capsule 10mg x48's, 20mg x 100's, 40mg x 30's: 96.00, 500.00 & 210.00 MRP
OMEP IV Aristopharma Ltd. Omeprazole BP 20mg & 40mg Injection 40mg vial: 80.00 MRP
OMEPRA Alco Pharma Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 50's, 40mg x 30's: 200.00 & 210.00 MRP
OMEPRAZOLE-20 APC Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 60's: 150.00 MRP
OMEPROL Ziska Pharmaceuticals Ltd. Omeprazole BP 40mg I/V Injection 1amp: 70.00 MRP
OMEPROL-20 Ziska Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 56's: 224.00 MRP
OMESIL Silva Pharmaceuticals Limited Omeprazole magnesium 20mg & 40mg Tablet 20mg x 60's, 40mg x 30's: 240.90 & 210.79 MRP
OMESIL Capsule Silva Pharmaceuticals Limited Omeprazole BP 20mg & 40mg Capsule 20mg x 60's, 40mg x 20's: 240.90 & 140.53 MRP
OMESIL Fast 20 Silva Pharmaceuticals Limited Omeprazole BP 20mg/pack Suspension 20mgx 30's: 150.57 MRP
OMESIL Fast 40 Silva Pharmaceuticals Limited Omeprazole BP 40mg/pack Suspension 40mgx 30's: 240.90 MRP
OMESIL IR 20 Silva Pharmaceuticals Limited Omeprazole BP 20mg Capsule (immediate release) 60's: 240.90 MRP
OMESIL IR 40 Silva Pharmaceuticals Limited Omeprazole BP 40mg Capsule (immediate release) 28's: 196.73 MRP
OMET - 20 Pharmadesh Laboratories Limited Omeprazole 20mg/capsule Capsule 20mg x 60s pack: 55.00 MRP
OMET-20 Pharmadesh Laboratories Limited Omeprazole BP 20mg Capsule 60's: 180.00 MRP
OMETAC Navana Pharmaceuticals Limited Omeprazole BP 20mg & 40mg Capsule 20mg x 100's, 40mg x 24's: 402.00 & 144.48 MRP
OMETID Opsonin Pharma Limited Omeprazole BP 20mg & 40mg Capsule 20mg x 90's, 40mg x 30's: 360.00 & 210.00 MRP
OMETID 40 Opsonin Pharma Limited Omeprazole sodium BP 40mg/vial (as lyophilized powder for solution) I.V Injection 40mg (10ml) vial x 1s pack: 70.00 MRP
OMETID 40 IV Opsonin Pharma Limited Omeprazole BP 40mg I/V Injection 40mg vial: 70.00 MRP
OMETOP-20 Novus Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 30's: 120.00 MRP
OMEX Kemiko Pharmaceuticals Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 60's, 40mg x 20's: 240.00 & 140.00 MRP
OMEZOLE Medimet Pharmaceuticals Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 50's, 20mg x 56's, 100's 200.00, 224.00 & 400.00 MRP
OMIDEX Modern Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 100's: 300.00 MRP
OMILOC 20 Kumudini Pharma Ltd Omeprazole BP 20mg Capsule 100's: 400.00 MRP
OMIREX Jayson Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 40's, 40mg x 20's: 118.40 IP, 101.40 IP
OMITAC-20 Gaco Pharmaceutical Ltd. Omeprazole BP 20mg Capsule 48's: 144.00 MRP
OMITIN Nipa Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 60's, 40mg x 30's: 240.00 & 210.00 MRP
OMIZIT-20 The White Horse Pharma Omeprazole BP 20mg Capsule 30's: 120.00 MRP
OMPA-20 Seema Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 60's: 300.00 MRP
OMRAZOL Ad-din pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 100's, 40mg x 20's: 398.00 & 140.00 MRP
OMSEC Techno Drugs Omeprazole BP 20mg Capsule 60's: 240.00 MRP
OMSEC 40 Techno Drugs Omeprazole sodium BP 40mg/vial (as lyophilized powder for solution) I.V Injection 40mg (10ml) vial x 1s pack: 70.00 MRP
OMSEC 40 IV Techno Drugs Omeprazole BP 40mg I/V Injection 40mg vial: 70.00 MRP
OMTRIC Belsen Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 100's: 400.00 MRP
OP MAX-20 Concord Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 60's: 240.00 MRP
OP-20 Globe Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 60's: 240.00 MRP
OP-40 Globe Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 40's: 280.00 MRP
OP-40 IV Globe Pharmaceuticals Ltd Omeprazole BP 40mg I/V Injection 40mg vial: 70.00 MRP
OPAL Healthcare Pharmacuticals Ltd. Omeprazole 20mg & 40mg/capsule Capsule 20mg x 60s pack: 2120.00 MRP; 40mg x 30s pack: 225.00 MRP
OPAL 20 Healthcare Pharmacuticals Ltd. Omeprazole BP 20mg Capsule 60's MRP 300 Tk
OPAL 40 Healthcare Pharmacuticals Ltd. Omeprazole BP 40mg Capsule 30's MRP 240 Tk
OPAZOL Skylab Pharmaceuticals Ltd. Omeprazole 20mg/capsule Capsule 20mg x 60s pack: 300.00 MRP
OPEZEN Zenith Pharmaceuticals Ltd. Omeprazole magnesium 20mg & 40mg Tablet 20mg x 60's, 40mg x 20's: 240.00 & 140.00 MRP
OPRA Cosmo Pharma Laboratories Ltd. Omeprazole BP 20mg Capsule 60's: 242.00 MRP
OSECTON Salton Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 60's: 210.00 MRP
OSYN-20 Syntho Laboratories Ltd. Omeprazole BP 20mg Capsule 30's: 120.00 MRP
OZ-20 Ultra Pharma Ltd. Omeprazole 20mg/capsule Capsule 20mg x 30s pack: 90.00 MRP
OZOLE Peoples Pharma Ltd. Omeprazole BP 20mg & 40mg Capsule 60's & 90's: 150.00 & 225.00 MRP
PIAZOL-20 Globex Pharmaceuticals Ltd. Omeprazole 20mg/capsule Capsule 20mg x 60s pack: 240.00 MRP
PPI The Acme Laboratories Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 40's, 20mg x 100's, 40mg x 20's: 160.40, 401.00 & 140.40 MRP
PPI IV The Acme Laboratories Ltd. Omeprazole BP 40mg I/V Injection 40mg vial: 70.26 MRP
PRAM Mystic Pharmaceuticals Limited Omeprazole BP 20mg Capsule 28's: 105.00 MRP
PRAZO Pacific Pharmaceuticals Ltd. Omeprazole 20mg/capsule Capsule 20mg x 50s pack: 200.00 MRP
PRAZO 20 Pacific Pharmaceuticals Ltd. Omeprazole magnesium 20mg Tablet 100's: 200.00 MRP
PRAZO 20 Capsule Pacific Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 100's, 20mg x 200's: 200.00 & 400.00 MRP
PRAZO Plus Pacific Pharmaceuticals Ltd. Omeprazole BP 20mg+ Sodium bicarbonate BP 1100mg Capsule 32's: 160.00 MRP
PRAZOLE Renata Limited Omeprazole BP 20mg Capsule 60's: 241.00 MRP
PRESEC Unimed & Unihealth Manufacturers Ltd. Omeprazole BP 20mg Capsule 28's: 112.00 MRP
PREVAS General Pharmaceuticals Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 50's, 40mg x 30's: 201.00 & 210.90 MRP
PREVENCID Rangs Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 60's, 40mg x 20's: 240.00 & 140.00 MRP
PROBITOR Sandoz/Novartis Omeprazole 20mg & 40mg Capsule 20mg x 60's: MRP 420.00; 40mg x 28's: MRP 280.00
PROCAP Orion Pharma Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 100's, 40mg x 20's: 402.00 & 140.60 MRP
PROCAP 40 IV Orion Pharma Ltd. Omeprazole BP 40mg I/V Injection 40mg vial: 70.26 MRP
PROCEPTIN Beximco Pharmaceuticals Ltd Omeprazole 20mg & 40mg/capsule Capsule 20mgx 60 & 100's: 300 & 500 MRP; 40mgx 30's: 240.00 MRP
PROCEPTIN 20 Beximco Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 60 & 100's: 300 & 500.00 MRP
PROCEPTIN 40 IV Beximco Pharmaceuticals Ltd Omeprazole 40mg IV Injection Injection 1's: 100.00 MRP
PROLOK IBN SINA Pharmaceutical Industry Ltd. Omeprazole BP 20mg Capsule 100's: 400.00 IP
PROMISEC Sharif Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x 40's, 40mg x 20's: 160.00 & 140.00 MRP
PROPIN Hallmark Pharmaceuticals Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 28's, 20mg x 40's, 40mg x 20's: 98.28, 140.40 & 150.60 MRP
PROTOBIT Indo-Bangla Pharmaceuticals Works Ltd. Omeprazole BP 20mg Capsule 60's: 240.00 MRP
PROVOXIA Pharmasia Limited Omeprazole 20mg/capsule Capsule 20mg x 30s pack: 120.00 MRP
PROVOXIA l.V Pharmasia Limited Omeprazole BP 40mg I/V Injection 40mg vial: 80.00 MRP
PROVOXIA-20 Pharmasia Limited Omeprazole BP 20mg & 40mg Capsule 20mg x 30's, 40mg x 60's: 120.60 & 241.20 MRP
RE-20 Reman Drug Laboratories Ltd. Omeprazole BP 20mg Capsule 40's: 124.00 IP
RE-40 Reman Drug Laboratories Ltd. Omeprazole BP 20mg Capsule 20's: 110.00 IP
ROCEPTIN-20 Desh Pharmaceuticals (Pvt) Ltd Omeprazole BP 20mg & 40mg Capsule 20mg x 30's, 40mg x 60's: 120.00 & 240.00 MRP
ROME-20 Rephco Laboratories Ltd. Omeprazole BP 20mg Capsule 100's: 400.00 MRP
ROMILOK Reliance Pharmaceuticals Ltd. Omeprazole BP 20mg Capsule 60's: 240.00 MRP
S-OME Somatec Pharmaceuticals Ltd. Omeprazole magnesium 20mg & 40mg Tablet 20mg x 50's, 40mg x 30's: 200.50 & 210.90 MRP
SECLO 20 Square Pharmaceuticals Ltd. Omeprazole 20mg Capsule 10x10's: 502.00 MRP
SECLO 20 DR Square Pharmaceuticals Ltd. Omeprazole 20mg Tablet 6x10's: 301.20 MRP
SECLO 40 Square Pharmaceuticals Ltd. Omeprazole 40mg Capsule 5x6's: 240.90 MRP
SECLO 40 IV Square Pharmaceuticals Ltd. Omeprazole 40mg/vial IV Injection 1x1's: 80.24 MRP
SECTIL 20 Cosmic Chemical Industries Limited Omeprazole BP 20mg Capsule 100's: 400.00 MRP
SECTIL20 Cosmic Chemical Industries Limited Omeprazole 20mg/capsule Capsule 20mg x 60s pack: 240.00 MRP
SOM-20 Shamsul Alamin Pharmaceuticals Ltd Omeprazole BP 20mg Capsule 60's: 240.00 MRP
TYLO 20 Proteety Pharmaceuticals Ltd. Omeprazole 20mg/capsule Capsule 20mg x 20s pack: 80.00 MRP; 20mg x 60s pack: 240.00 MRP
TYLO 40 Proteety Pharmaceuticals Ltd. Omeprazole 40mg/capsule Capsule 40mg x 20s pack: 160.00 MRP
XELDRIN ACI Ltd. Omeprazole BP 10, 20 & 40mg Capsule 10mg x48's,10mg x50's, 20mg x100's, 40mg x40's: 96.48, 100.50, 402.00 & 281.20 MRP
XELDRIN 20 ACI Ltd. Omeprazole 20mg/tablet Tablet 20mg x 70s pack: 280.00 IP
XELDRIN 40 ACI Ltd. Omeprazole sodium BP 40mg/vial(as lyophilized powder for solution) I.V Injection 40mg vial x 1s pack: 70.00 IP
XELDRIN 40 IV ACI Ltd. Omeprazole BP 40mg I/V Injection 40mg vial: 70.26 MRP
XELOPES Beacon Pharmaceuticals Limited Omeprazole BP 20mg & 40mg Capsule 20mg x120's, 40mg x30's: 600.00 & 209.00 MRP
XELOPES Injection Beacon Pharmaceuticals Limited Omeprazole BP 40mg I/V Injection 40mg vial: 70.26 MRP
XEROSEC Sanofi Omeprazole BP 10, 20 & 40mg Capsule 10mg x30's, 20mg x100's, 40mg x30's: 75.30, 401.00 & 210.90 MRP
ZILON Radiant Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x60's, 40mg x24's: 300.00 & 180.00 MRP
ZOOM Everest Pharmaceuticals Ltd. Omeprazole BP 20mg & 40mg Capsule 20mg x50's, 40mg x30's: 175.00 & 210.00 MRP

Gen. MedInfo

 

What's the use of this medicine?

It is used to treat conditions caused by excessive acidity in your stomach, such as stomach ulcers and reflux disease (reflux is also known as "heartburn", in which food or acid from your stomach backs up into your mouth, leaving a sour or bitter taste).

Omeprazole treats these conditions by reducing the amount of acid your stomach makes.

Omeprazole may also be used together with other medicines to treat a specific type of gastric problem called Helicobacter pylori or H. pylori gastritis.

How to take this medicine?

Take Omeprazole exactly as directed by your doctor. Do not take more or less than instructed by your doctor.

You may need to take Omeprazole for some time before the full benefits can be felt. Continue to take it even when you feel better and do not stop taking it unless advised by your doctor to do so.

Generally, Omeprazole can be taken with or without food. However, there may be different brands of Omeprazole available and these may be taken differently. Ask your doctor or pharmacist about how to take your particular brand of Omeprazole. Try to take it at the same time each day.

What should be done for missing dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

Remember to take your medicine regularly. Omeprazole must be taken exactly as directed for it to be effective. If you often forget to take your medicine, let your doctor know.

When should not to use this medicine?

Inform your doctor if you have ever had an allergic reaction to other gastric medicines such as esomeprazole, pantoprazole or lansoprazole.

What should noted while taking this medicine?

Inform your doctor if you are pregnant or breastfeeding.

Do not breastfeed while you are being treated with Omeprazole.

Alert your doctor if you have liver disease.

Let your doctor know if your gastric problem seems to be getting worse. Do not take Omeprazole for a long period of time unless instructed by your doctor.

What side effects may appear?

Omeprazole may cause dizziness. If you feel dizzy, do not drive or take part in any activity in which you need to be alert.

Other side effects with Omeprazole may include headache, diarrhoea, nausea and wind in the stomach. These should get better or go away as your body adjusts to the medicine.

Let your doctor know if these side effects bother you or if they do not go away.

Can this be taken with other medicines?

Inform your doctor if you are taking any other medicines, especially those listed here:

- warfarin (a blood-thinning medicine)
- ketoconazole, itraconazole, voriconazole or similar antifungal medicines
- phenytoin (an epilepsy medicine)
- transplant medicines such as cyclosporin and tacrolimus
- sleeping pills such as diazepam, lorazepam and related medicines
- other medicines such as atazanavir and iron pills

Avoid a blood-thinning medicine called clopidogrel. Alert your doctor if you are taking clopidogrel.

Do not take antacids together with Omeprazole. If you must take antacids, take them at least 1 hour before or 2 hours after you have taken Omeprazole. Antacids can reduce the effectiveness of Omeprazole when taken together.

Always inform your doctor if you are taking any other medicines, including herbal tonics, supplements and medicines that you buy without a prescription.

What special dietary instructions to follow?

It may be helpful to discuss your diet with your doctor or dietitian. A change in diet may help improve your symptoms. For example, spicy food tends to worsen reflux and should be avoided. Likewise, carbonated drinks such as soft drinks should also be avoided.

You should also try to avoid lying down soon after eating as this will worsen the reflux symptoms.

Avoid alcohol.

How to store this medicine?

Store in a cool, dry place away from the reach of children.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

 See Brand Manufacturer's Prescribing Information | Back to top |