Acizol Cap 40 Mg 14’s (Omeprazole)-Potential Overview

Pharmaceutical Class

• Class: Proton Pump Inhibitor (PPI)
• Type: Anti-ulcer agent

Indications for Use

1. Gastroesophageal Reflux Disease (GERD): Treatment of severe erosive esophagitis and symptom management.
2. Peptic Ulcer Disease: Healing and prevention of duodenal and gastric ulcers.
3. Zollinger-Ellison Syndrome: Management of hypersecretory conditions.
4. Helicobacter pylori Infection: Part of a combination regimen for eradication.
5. NSAID-Induced Ulcers: Prevention and treatment of ulcers related to NSAID use.

Common Side Effects

• Headache
• Nausea
• Vomiting
• Abdominal pain
• Diarrhea or constipation
• Flatulence

Serious Side Effects (Less Common)

• Severe allergic reactions (rash, swelling, difficulty breathing)
• Hypomagnesemia (muscle spasms, seizures)
• Clostridioides difficile-associated diarrhea
• Interstitial nephritis
• Bone fractures with long-term use

Dosage

• Adults: Typically 40 mg once daily for severe conditions (e.g., erosive esophagitis).
• Duration: 4–8 weeks, extendable based on condition and response to therapy.

Usage Instructions

• Take on an empty stomach, 30–60 minutes before a meal.
• Swallow the capsule whole with water; do not crush, chew, or open it.

Drug Interactions

• With Food: May slow absorption but does not reduce overall efficacy.
• With Other Medications:
  • Decreased effectiveness of drugs requiring acidic pH for absorption (e.g., ketoconazole, itraconazole).
  • Increased levels of warfarin, phenytoin, and diazepam due to slowed metabolism.
  • Reduced activation of clopidogrel, potentially decreasing its efficacy.
• Other Interactions: Avoid alcohol to prevent exacerbation of gastric irritation.

Regulatory Approval and Manufacturer

• Globally approved for treating acid-related conditions.
• Manufacturer: Varies depending on regional distributors.

Pharmacist-Related Data

Drug Name and Chemical Details

• Generic Name: Omeprazole
• Chemical Formula: C17H19N3O3S
• Molecular Weight: 345.42 g/mol

Pharmacodynamics

• Mechanism of Action:
  Omeprazole selectively inhibits the hydrogen-potassium ATPase enzyme in gastric parietal cells, irreversibly blocking the final step of acid production and reducing gastric acid secretion.
• Therapeutic Effects:
  • Relief from heartburn and acid reflux symptoms.
  • Promotion of ulcer healing and prevention of recurrence.
  • Management of conditions causing excessive acid production.

Pharmacokinetics

• Absorption: Rapidly absorbed, peak plasma levels reached within 1–2 hours.
• Bioavailability: Approximately 30–40%, increases with repeated doses.
• Distribution: High plasma protein binding (~95%).
• Metabolism: Extensively metabolized in the liver by CYP2C19 and CYP3A4 enzymes.
• Excretion:
  • Primarily through urine (~80%) as inactive metabolites.
  • Minor elimination via feces.
• Half-Life: 0.5–1 hour, though therapeutic effect persists longer due to enzyme binding.

Drug Interactions

1. With Food:
   Food delays absorption but does not reduce overall therapeutic efficacy.
2. With Other Medications:
   • Avoid combining with clopidogrel unless necessary due to reduced antiplatelet efficacy.
   • Monitor levels of drugs like warfarin, phenytoin, and benzodiazepines.
   • Reduced absorption of antifungal agents requiring an acidic gastric environment.
3. Other Interactions: Avoid combining with methotrexate to minimize toxicity risk.

Clinical Considerations

• Pregnancy Category: Category C (use only if benefits outweigh risks).
• Lactation: Caution advised; may be excreted in breast milk.
• Pediatric Use: Approved for children with specific conditions like GERD; dosing adjustments required.
• Geriatric Use: Generally safe, but prolonged use may increase risks of osteoporosis, fractures, or hypomagnesemia.
• Other Considerations:
  • Monitor for long-term complications such as vitamin B12 deficiency or gastric atrophy.
  • Caution in patients with severe liver impairment.