Acizol Cap 20 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): To reduce symptoms and heal esophagitis caused by stomach acid.
2. Peptic Ulcer Disease: Treatment of duodenal and gastric ulcers.
3. Zollinger-Ellison Syndrome: Management of hypersecretory conditions.
4. Helicobacter pylori Eradication: As part of combination therapy with antibiotics.
5. Prevention of NSAID-Induced Gastric Ulcers: For patients taking long-term NSAIDs.

Common Side Effects

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

Serious Side Effects (Less Common)

• Severe allergic reactions (rash, itching, swelling)
• Clostridioides difficile infection of the colon
• Bone fractures with long-term use
• Hypomagnesemia (low magnesium levels)
• Kidney inflammation (interstitial nephritis)

Dosage

• Typical dosage: 20 mg once daily.
• Duration: 4-8 weeks, depending on the condition treated.

Usage Instructions

• Take on an empty stomach, preferably 30-60 minutes before meals.
• Swallow the capsule whole; do not crush or chew.

Drug Interactions

1. With Food: Delayed absorption but does not reduce effectiveness.
2. With Other Medications:
   • Reduced efficacy of drugs requiring acidic pH (e.g., ketoconazole, itraconazole).
   • Increases blood levels of warfarin, phenytoin, and benzodiazepines.
   • Decreased clopidogrel activation, potentially reducing its effectiveness.
3. Other Interactions: Avoid alcohol, as it can worsen gastric irritation.

Regulatory Approval and Manufacturer

• Approved by global regulatory agencies (e.g., FDA).
• Manufacturer: Details depend on the specific distributor or pharmaceutical company.

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, suppressing the final step in gastric acid production.
• Therapeutic Effects:
  Relief of acid-related symptoms, healing of ulcers, and prevention of gastric mucosal damage.

Pharmacokinetics

• Absorption: Rapidly absorbed, with peak plasma concentrations in 1-2 hours.
• Bioavailability: Approximately 30-40%, increased after repeated dosing.
• Distribution: Widely distributed, plasma protein binding ~95%.
• Metabolism: Extensively metabolized in the liver via CYP450 enzymes (mainly CYP2C19 and CYP3A4).
• Excretion: Mainly via urine (~80%) as metabolites.
• Half-Life: 0.5-1 hour (effective duration much longer due to irreversible enzyme binding).

Drug Interactions

1. With Food: Food delays absorption but does not affect therapeutic efficacy.
2. With Other Medications:
   • Avoid combining with clopidogrel without physician oversight.
   • Monitor levels of drugs metabolized by CYP2C19 and CYP3A4.
3. Other Interactions: Avoid concurrent use of high-dose methotrexate without medical supervision.

Clinical Considerations

• Pregnancy Category: Category C (use only if the potential benefit justifies the risk).
• Lactation: May be excreted in breast milk; use with caution.
• Pediatric Use: Approved for use in children for GERD (specific dosing required).
• Geriatric Use: Generally safe; no significant dose adjustments needed but monitor long-term use for bone health.
• Other Considerations:
  • Caution in patients with liver impairment.
  • Avoid long-term use unless medically necessary due to risks of side effects like hypomagnesemia and bone fractures.