Zolbi Cap 20 Mg 14’s (Omeprazole)-Potential Overview

• Brand Name: Zolbi
• Generic Name: Omeprazole
• Strength: 20 mg per capsule
• Pack Size: 14 capsules per pack

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Zolbi 20 mg (Omeprazole) is a proton pump inhibitor (PPI) used primarily for managing conditions that result from excess stomach acid production. It is commonly prescribed for gastroesophageal reflux disease (GERD), gastric ulcers, duodenal ulcers, and Helicobacter pylori eradication (when used in combination with antibiotics).

Indications and Uses:

1. Gastroesophageal Reflux Disease (GERD): Omeprazole reduces stomach acid production and provides relief from the symptoms of acid reflux, such as heartburn and regurgitation.
2. Peptic Ulcers: It helps in the healing of gastric and duodenal ulcers by reducing stomach acid and preventing irritation.
3. Helicobacter pylori Eradication: In combination with antibiotics, it assists in eradicating the H. pylori infection, a major cause of ulcers.
4. Zollinger-Ellison Syndrome: Used in this rare condition to control excessive gastric acid production.
5. Prevention of Ulcer Formation: Especially in patients taking NSAIDs (non-steroidal anti-inflammatory drugs) who are at risk for ulcer formation.

Mechanism of Action:

• Omeprazole works by irreversibly inhibiting the proton pump (H+/K+ ATPase enzyme) in the parietal cells of the stomach, which is responsible for the final step of gastric acid secretion. By blocking this pump, omeprazole effectively reduces the secretion of gastric acid, providing symptom relief and promoting ulcer healing.

Side Effects:

• Common Side Effects: Headache, nausea, abdominal pain, diarrhea, and flatulence.
• Serious Side Effects (with long-term use): Risk of osteoporosis, hypomagnesemia (low magnesium levels), and vitamin B12 deficiency. There is also an increased risk of Clostridium difficile infections in the colon.

Drug Interactions:

1. Clopidogrel: Omeprazole may reduce the effectiveness of clopidogrel, an anti-platelet drug, by inhibiting the CYP2C19 enzyme that activates it.
2. Methotrexate: Use with high-dose methotrexate can increase its levels, leading to toxicity.
3. Warfarin: Omeprazole can enhance the anticoagulant effect of warfarin, increasing the risk of bleeding.
4. Other drugs metabolized by CYP enzymes (e.g., diazepam, phenytoin): Omeprazole may affect their metabolism and increase plasma levels, leading to enhanced effects or side effects.

Food and Drug Interactions:

• Food: While food can delay the absorption of omeprazole, it does not significantly affect its overall bioavailability. However, omeprazole should be taken 30 minutes before meals to optimize its absorption and effectiveness.
• Alcohol: Alcohol may irritate the gastrointestinal tract and should be consumed in moderation, as it may reduce the effectiveness of omeprazole in some cases.

Pharmacist Related Data

Chemical Name:

• Omeprazole: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]benzimidazole.

Molecular Formula:

• C17H19N3O3S

Pharmacokinetics:

1. Absorption:
   • Omeprazole is well absorbed in the small intestine after oral administration. The bioavailability after a single dose is about 40-60%. The peak plasma concentration is reached in 1 to 2 hours after oral ingestion, although the time to reach maximum concentration may be delayed with food intake.
2. Distribution:
   • Omeprazole is highly protein-bound (approximately 95%), particularly to albumin in the bloodstream. It is widely distributed, including to the gastric mucosa, where it exerts its therapeutic effect.
3. Half-Life:
   • The half-life of omeprazole is relatively short at about 1 hour. However, the acid-suppressing effects last much longer, typically up to 24 hours due to the irreversible inhibition of the proton pump in the stomach lining.
4. Metabolism:
   • Omeprazole is metabolized primarily in the liver by the CYP2C19 and CYP3A4 enzymes into inactive metabolites. Genetic variations in these enzymes can affect drug metabolism, making some individuals poor metabolizers, thus increasing drug levels and potential side effects.
5. Excretion:
   • Omeprazole and its metabolites are mainly excreted via the urine (approximately 80% of the dose), with the rest being excreted in the feces.

Pharmacodynamics:

1. Mechanism of Action:
   • Omeprazole is a proton pump inhibitor (PPI). It works by irreversibly binding to the H+/K+ ATPase enzyme (proton pump) on the parietal cells in the stomach lining. This inhibits the final step in the production of gastric acid, leading to a decrease in stomach acid secretion. Its effect is not immediate but rather develops gradually, with maximum acid suppression occurring after a few days of treatment.
2. Therapeutic Effects:
   • Reduces gastric acid secretion: Helps in the management of conditions like GERD, gastric ulcers, duodenal ulcers, and Zollinger-Ellison syndrome.
   • Promotes ulcer healing: By reducing stomach acid, omeprazole aids in the healing of gastric and duodenal ulcers.
   • Prevention of acid reflux: Reduces symptoms of acid reflux such as heartburn and helps prevent damage to the esophagus.

Drug Interactions:

1. Clopidogrel:
   • Omeprazole may reduce the effectiveness of clopidogrel, an anti-platelet medication, by inhibiting CYP2C19, the enzyme responsible for activating clopidogrel. This interaction can increase the risk of cardiovascular events due to reduced anti-platelet effect.
2. Methotrexate:
   • High doses of methotrexate (especially for cancer treatment) may have increased levels when taken with omeprazole, potentially leading to methotrexate toxicity.
3. Warfarin:
   • Omeprazole may increase the anticoagulant effect of warfarin, raising the risk of bleeding. This requires careful monitoring of prothrombin time (PT) and INR.
4. Diazepam, Phenytoin, Theophylline:
   • Omeprazole can increase the plasma concentrations of drugs metabolized by CYP2C19, such as diazepam, phenytoin, and theophylline, potentially leading to enhanced side effects.
5. Iron and Calcium Supplements:
   • Omeprazole may reduce the absorption of iron and calcium salts, especially with prolonged use, which could contribute to deficiencies in these nutrients.

Food and Drug Interactions:

1. Food:
   • Food does not significantly affect the bioavailability of omeprazole, but it can delay the absorption rate. To optimize its absorption, omeprazole should be taken on an empty stomach about 30 minutes before meals.
2. Alcohol:
   • Alcohol may irritate the gastrointestinal tract and exacerbate acid-related symptoms, so it should be used in moderation or avoided when on omeprazole therapy.