OMEPRAZOLE

OMEPRAZOLE
OMEPRAZOLE

OMEPRAZOLE

Overview & Uses

Omeprazole is a drug used to reduce the amount of acid secreted in the stomach.

Indication (uses)

  • For the treatment of duodenal ulcers in adults.
  • For the treatment of gastric ulcers in adults.
  • For the treatment of symptoms of Gastroesophageal Reflux Disease (GERD) in adults and pediatric patients, for both erosive esophagitis and symptomatic GERD.
  • Indicated for the maintenance of Healing of Erosive esophagitis in adults and pediatric patients.
  • For the treatment of Pathological Hypersecretory Conditions in adults.

Pharmacological classification

Proton pump inhibitor for the reduction of gastric acid secretion

Brand names

Prilosec, Zegerid

Dosage form

  • Delayed release capsules for oral use in strengths of 10 mg, 20 mg and 40 mg.
  • Delayed release suspension for oral use in strengths of 2.5 mg and 10 mg powder(granules) sachet.

Mechanism of action

All proton pump inhibitors are inactive at neutral pH. But, as soon as pH drops below 5, the drug rearranges into two positively charged ions and binds with H+K+ATPase enzyme by forming a covalent bond and inactivates the enzyme. It also inhibits the mucosal carbonic anhydrase enzyme.

How to take Omeprazole capsules or suspension?

  • Omeprazole suspension and capsules should be taken on empty stomach before meals.
  • For oral suspension, follow the instructions mentioned on the packet.

Dosage

  • For Short-Term Treatment of Active Duodenal Ulcer:
    • 1 capsule of Omeprazole 20 mg delayed-release capsule once a day for adult patients for 4 weeks. Treatment can be extended for another 4 weeks if required.
  • For the treatment of Gastric Ulcer:
    • 40 mg once a day for 4-8 weeks.
  • For the treatment of Gastroesophageal Reflux Disease (GERD):
    • Adult Dose:
      • For patients with symptomatic GERD and no esophageal lesions, the dose is 20 mg once a day for up to 4 weeks.
      • For patients with erosive esophagitis and GERD, the dose is 20 mg once a day for 4 to 8 weeks.
    • For the treatment of Helicobacter pylori infection:
      • For adults: 1 capsule of Omeprazole 20 mg delayed-release capsule with amoxicillin 1000 mg and clarithromycin 500 mg – all three drugs to be taken twice a day for 10 days, preferably after morning meals and evening meals. Also, for 18 days Omeprazole 20 mg once a day is recommended for ulcer healing and symptomatic relief in patients with an ulcer present at the time of initiation of treatment.
      • For adults: 1 capsule of Omeprazole 40 mg delayed-release capsule once a day clarithromycin 500 mg 3 times a day should be taken for 14 days, preferably after morning meals and evening meals. Also, for 14 days, Omeprazole 20 mg once a day is recommended for ulcer healing and symptomatic relief in patients with an ulcer present at the time of initiation of treatment.
    • For pathological Hypersecretory Conditions:
      • The recommended adult dose is 60 mg once a day and can go up to 120 mg three times a day.
      • Doses should be adjusted as per individual patient needs and treatment should be continued for as long as clinically indicated.
    • For the maintenance of Healing of Erosive Esophagitis:
      • 20 mg once a day, orally for adult patients.
    • For pediatric patients (based on body weight):
      • For the treatment of GERD and maintenance of healing of erosive esophagitis:
        • 5 kg or more but less than 10 kg body weight: 5 mg once a day.
        • 10 kg or more but less than 20 kg bodyweight: 10 mg once a day.
        • 20 kg or more body weight: 20 mg once a day.
      • On the basis of body weight, the dose required for pediatric patients may be greater than the adult dose.

RENAL DOSE ADJUSTMENTS

  • No adjustments needed.

HEPATIC DOSE ADJUSTMENT

  • Avoid combination therapy with clarithromycin.
  • 10 mg once a day for the maintenance of the healing of erosive esophagitis.

ELDERLY PATIENTS

  • Elimination rate was decreased and bioavailability was increased in elderly patients.

PEDIATRIC PATIENTS

  • For 1 year or more of age.

OVERDOSAGE

  • Confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache and dry mouth are some of the symptoms of overdose.
  • No specific antidote is known.
  • Dialysis does not aid in excess drug removal as Omeprazole is extensively protein bound.
  • Supportive treatment should be given as and when required.
  • Contact the emergency department of your local hospital in cases of overdose or suspected overdose.

Side effects or unwanted effects

  • Bloating or swelling of the face, arms, hands, lower legs or feet, cough or hoarseness, dark urine, dry mouth, fever or chills, general tiredness and weakness, light-colored stools, lower back or side pain, nausea and vomiting, painful or difficult urination, rapid weight gain, tingling of the hands or feet, unusual weight gain or loss, yellow eyes and skin are some of the major side effects.
    • Consult your doctor as soon as possible.
  • Change of taste or a bad taste is often experienced by patients taking Omeprazole for a long period of time.
    • Ask your pharmacist to recommend a suitable medicine and consult your doctor.
  • Atrophic gastritis.
  • Longtime treatment with Omeprazole may increase the risk of osteoporosis-related fractures of hip, wrist or spine.
  • Treatment with proton pump inhibitor may be associated with an increased risk of Clostridium difficile associated diarrhea, particularly in hospitalized patients.
  • Hypomagnesemia in patients taking proton pump inhibitors for over a year, characterized by arrhythmias, seizures and tetany.
    • Consult your doctor as soon as possible. This may require magnesium supplement and discontinuation of the proton pump inhibitor.

WARNINGS

  • Concomitant use of Omeprazole and warfarin should be done under strict monitoring, particularly for the increases in INR and prothrombin time.
  • Treatment with proton pump inhibitor may be associated with an increased risk of Clostridium difficile associated diarrhea, particularly in hospitalized patients.
  • Longtime treatment with Omeprazole may increase the risk of osteoporosis-related fractures of hip, wrist or spine.
  • Concomitant use of methotrexate should be avoided with Omeprazole as it may cause methotrexate related toxicities.

Pregnancy

Category C, which means that Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Nursing

  • Omeprazole is secreted in human (breast) milk.
  • Because of the potential for the side effects and carcinogenicity, either nursing or omeprazole treatment in mothers should be discontinued.

Interactions

Drug interactions of Omeprazole

  • The pharmacological activity of Clopidogrel was reduced when co-administered with Omeprazole.
  • Omeprazole increases the concentration of Saquinavir.
  • Omeprazole decreases the concentrations of Atazanavir and Nelfinavir.
  • Omeprazole decreases gastric pH. Any drug, whose absorption is dependent on gastric pH, affects the absorption of that drug when co-administered with Omeprazole.
    • Absorption of Ketoconazole, Atazanavir, Erlotinib, iron salts and mycophenolate mofetil is decreased while absorption of digoxin in increased.
  • Concomitant use of Omeprazole and warfarin should be done under strict monitoring, particularly for the increases in INR and prothrombin time.
  • Elimination of diazepam, warfarin and phenytoin was prolonged by Omeprazole.
  • Patients taking other drugs that are metabolized by CYP450 should be closely monitored. The dose should be adjusted if required.
  • Voriconazole increases the concentration of Omeprazole by more than double.
  • Omeprazole increases the concentrations of Cilostazol.
  • Concomitant use of St. John’s wart and Rifampin should be avoided.
  • Concomitant use of Omeprazole and Tacrolimus may increase the concentration of Tacrolimus.
  • Concomitant use of Rabeprazole and methotrexate may lead to increased and prolonged plasma concentration of methotrexate and/or its metabolite hydromethotrexate.
  • Strictly avoid concomitant use of ergotamine, dihydroergotamine and Pimozide.

Drug-food interactions

  • Omeprazole should be taken on empty stomach before meals.

Note: The sole purpose of every information shared inthis article is to bring awareness. Do not use this information as aa piece of medical adviceor prescription advice or as a tool for the treatment, diagnosis or prevention of the disease.