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

Generic Information

• Brand Name: Acireg Cap
• Generic Name: Omeprazole
• Strength: 40 mg per capsule
• Pack Size: 14 capsules
• Pharmaceutical Class:
  • Class: Proton Pump Inhibitor (PPI)
  • Type: Gastric Acid Secretion Inhibitor

Indications for Use

Acireg (Omeprazole) is used for the treatment and management of:

1. Gastroesophageal Reflux Disease (GERD):
   • Relieves symptoms such as heartburn and acid regurgitation.
2. Peptic Ulcer Disease (PUD):
   • Heals gastric and duodenal ulcers and prevents recurrence.
3. Erosive Esophagitis:
   • Promotes healing of esophageal damage due to acid reflux.
4. Helicobacter pylori Infection:
   • Used in combination with antibiotics for eradication therapy.
5. Zollinger-Ellison Syndrome:
   • Reduces excessive gastric acid production in hypersecretory conditions.
6. Stress Ulcer Prophylaxis:
   • Prevents ulcer formation in critically ill patients.
7. Nonsteroidal Anti-inflammatory Drug (NSAID)-Induced Ulcers:
   • Treats and prevents ulcers caused by NSAIDs.

Common Side Effects

• Gastrointestinal:
  • Nausea, vomiting, abdominal pain, diarrhea, flatulence, constipation.
• Central Nervous System:
  • Headache, dizziness, fatigue, somnolence.
• General:
  • Dry mouth, taste alterations.

Serious Side Effects (Less Common)

• Electrolyte Imbalances:
  • Hypomagnesemia (low magnesium levels), especially with prolonged use.
• Bone Fractures:
  • Increased risk of osteoporosis-related fractures with long-term use.
• Kidney Damage:
  • Acute interstitial nephritis or chronic kidney disease.
• Clostridioides difficile Infection:
  • Higher risk of diarrhea caused by C. difficile.
• Liver Toxicity:
  • Rare cases of hepatitis, jaundice, and liver enzyme elevations.
• Severe Allergic Reactions:
  • Rash, itching, swelling of the face/throat, difficulty breathing.

Dosage and Usage Instructions

1. Recommended Dosage:
   • GERD/Erosive Esophagitis: 20-40 mg once daily for 4-8 weeks.
   • Peptic Ulcer Disease: 20 mg once daily for 4-8 weeks.
   • H. pylori Eradication: 20-40 mg twice daily combined with antibiotics for 7-14 days.
   • Zollinger-Ellison Syndrome: Initial dose of 60 mg once daily; adjust as needed.
   • Stress Ulcer Prophylaxis: 20-40 mg once daily.
   • NSAID-Induced Ulcers: 20-40 mg once daily for 4-8 weeks.
2. Administration Instructions:
   • Take Acireg capsules at least 30 minutes before a meal for optimal effectiveness.
   • Swallow capsules whole with a glass of water. Do not chew or crush.
   • Missed Dose: Take it as soon as remembered unless it is close to the next dose. Do not double the dose.

Drug Interactions

1. With Food:
   • Food may slightly reduce the absorption of Omeprazole, but the clinical effect remains unaffected.
2. With Other Medications:
   • Clopidogrel: Reduces the activation of clopidogrel, potentially lowering its antiplatelet effects.
   • Warfarin: Enhances the anticoagulant effect, increasing the risk of bleeding.
   • Methotrexate: May increase serum methotrexate levels, leading to toxicity.
   • Digoxin: May increase digoxin levels and risk of toxicity.
   • Antiretrovirals (e.g., Atazanavir): Reduces the efficacy of antiretroviral drugs by lowering their absorption.
   • Ketoconazole/Itraconazole: Reduces the absorption of these antifungals due to increased gastric pH.
3. Other Interactions:
   • Alcohol: No significant interaction, but alcohol may exacerbate gastric irritation.

Regulatory Approval and Manufacturer

• Regulatory Approval:
  • Omeprazole has been approved globally (FDA, EMA, etc.) for its efficacy and safety in treating acid-related disorders.
• Manufacturer:
  • Produced by various pharmaceutical companies under different brand names, including AstraZeneca (as Prilosec).

Pharmacist-Related Data

Drug Name and Chemical Details

• Generic Name: Omeprazole
• Chemical Formula: C17H19N3O3S
• CAS Number: 73590-58-6
• Molecular Weight: 345.4 g/mol

Pharmacodynamics

1. Mechanism of Action:
   • Omeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system (proton pump) in the gastric parietal cells. This results in a significant reduction in basal and stimulated gastric acid production.
2. Therapeutic Effects:
   • Acid Suppression: Provides relief from acid-related symptoms such as heartburn and indigestion.
   • Ulcer Healing: Promotes mucosal healing in peptic ulcers and erosive esophagitis.
   • H. pylori Eradication: Reduces gastric acid, enhancing the effectiveness of antibiotics in eradication therapy.

Pharmacokinetics

1. Absorption:
   • Omeprazole is rapidly absorbed after oral administration, with peak plasma concentrations achieved within 0.5 to 3.5 hours. The bioavailability ranges from 35-40%.
2. Distribution:
   • It is approximately 95% plasma protein-bound and distributed primarily in the stomach lining and liver.
3. Metabolism:
   • Omeprazole is extensively metabolized in the liver via the cytochrome P450 system (mainly CYP2C19 and CYP3A4).
4. Excretion:
   • Eliminated primarily through urine (80%) and feces (20%) as metabolites.
5. Half-Life:
   • The plasma elimination half-life is approximately 1-1.5 hours, but the acid-suppressive effect lasts up to 72 hours due to irreversible binding to the proton pump.

Drug Interactions

1. With Food:
   • Food may delay absorption slightly, but clinical effectiveness is unaffected.
2. With Other Medications:
   • Clopidogrel: Reduces the activation of clopidogrel, lowering its efficacy.
   • Warfarin: Increases the risk of bleeding.
   • Methotrexate: May increase methotrexate toxicity due to reduced clearance.
   • Digoxin: May increase serum digoxin levels.
3. Other Interactions:
   • Grapefruit Juice: Avoid as it may alter Omeprazole metabolism.

Clinical Considerations

1. Pregnancy Category:
   • Category C (FDA): Use only if clearly needed and the benefits outweigh the risks.
2. Lactation:
   • Omeprazole is excreted in breast milk. While generally considered safe, consult a healthcare provider before use during breastfeeding.
3. Pediatric Use:
   • Approved for use in children aged 1 year and older for conditions like GERD and erosive esophagitis. Dosage adjustments based on weight.
4. Geriatric Use:
   • No specific dosage adjustment is required, but elderly patients may be more susceptible to side effects such as bone fractures and kidney issues.
5. Other Considerations:
   • Long-Term Use Risks: Prolonged use may increase the risk of bone fractures, vitamin B12 deficiency, and chronic kidney disease.
   • Renal and Hepatic Impairment: Use with caution, especially in patients with severe liver dysfunction.