Abnil Cap(Ranitidine) 120Mg, 30’s-Potential Overview

• Generic Information

  • Brand Name: Abnil Cap
  • Generic Name: Ranitidine
  • Strength: 120 mg per capsule, pack of 30
  • Pharmaceutical Class:
    • Class: Histamine-2 (H2) Receptor Antagonist
    • Type: Antacid, Antiulcer medication

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  Indications for Use

  Ranitidine is primarily used to reduce stomach acid production and is indicated for the treatment of:

  1. Gastroesophageal Reflux Disease (GERD):
     • Treatment of GERD symptoms such as heartburn and acid regurgitation.
  2. Peptic Ulcer Disease (PUD):
     • Used in the treatment of duodenal ulcers and gastric ulcers to promote healing.
  3. Zollinger-Ellison Syndrome:
     • A condition characterized by excessive stomach acid production.
  4. Prevention of Aspiration Pneumonitis:
     • Ranitidine is sometimes used prior to surgery to prevent acid aspiration.
  5. Other Indications:
     • Symptomatic relief of acid indigestion and heartburn, peptic ulcers, and for the prevention of gastric ulcers in certain cases.

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  Common Side Effects

  • Headache
  • Dizziness
  • Constipation or diarrhea
  • Abdominal discomfort or pain
  • Nausea
  • Fatigue

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  Serious Side Effects (Less Common)

  • Allergic Reactions:
    • Anaphylaxis, swelling of the lips, face, and tongue, difficulty breathing.
  • CNS Effects:
    • Confusion, hallucinations, depression (especially in elderly patients or those with kidney dysfunction).
  • Hematologic Effects:
    • Thrombocytopenia (low platelets), leukopenia (low white blood cells), or anemia.
  • Liver Toxicity:
    • Hepatitis, jaundice, or elevated liver enzymes.
  • Renal:
    • Acute renal failure (in rare cases), especially in those with pre-existing kidney issues.

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  Dosage and Usage Instructions

  1. For Peptic Ulcer Disease (PUD):
     • Adult Dosage: 150 mg twice daily or 300 mg once daily at bedtime for up to 4-8 weeks.
     • For Healing of Gastric Ulcers: 150 mg twice daily or 300 mg once daily at bedtime.
  2. For GERD:
     • Adult Dosage: 150 mg twice daily.
     • Duration may vary, typically for 4-8 weeks depending on the severity.
  3. For Zollinger-Ellison Syndrome:
     • Adult Dosage: Initial dose of 150 mg every 6 hours, which may be adjusted based on response, up to 600 mg daily.
  4. For Prevention of Aspiration Pneumonitis (pre-surgery):
     • Adult Dosage: 150 mg before surgery.

  Usage Instructions:

  • Ranitidine is typically taken once or twice daily, with or without food.
  • For best results, take it consistently at the same time each day.
  • Missed Dose: If a dose is missed, take it as soon as remembered, unless it is near the time for the next dose. Do not double the dose.

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  Drug Interactions

  • With Food:
    • Food does not significantly affect the absorption of ranitidine, though taking it with food can reduce stomach irritation.
  • With Other Medications:
    • Antacids: Taking antacids simultaneously with ranitidine can reduce its absorption. It is best to space out the doses by at least 1 hour.
    • Warfarin: Ranitidine may enhance the anticoagulant effect of warfarin, increasing the risk of bleeding. Close monitoring of INR levels is advised.
    • Theophylline: Ranitidine may increase the plasma levels of theophylline, requiring dose adjustments.
    • Ketoconazole and Itraconazole: These antifungal agents’ absorption can be decreased in the presence of ranitidine.
    • Probenecid: Probenecid may increase the serum concentration of ranitidine.
    • Digoxin: Ranitidine can interfere with the absorption of digoxin, increasing its effects.
  • Other Interactions:
    • Cimetidine: Both ranitidine and cimetidine are H2 blockers, and taking them together may reduce their effectiveness.

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  Regulatory Approval and Manufacturer

  • Regulatory Approval:
    • Ranitidine has been approved by regulatory bodies worldwide, including the FDA, for the treatment of acid-related conditions like GERD and peptic ulcers. It has been widely used for several decades.
  • Manufacturer:
    • Ranitidine is marketed under various brand names, including Abnil, by different pharmaceutical companies worldwide. The specific manufacturer for Abnil may vary based on the region, but it is often produced by large pharmaceutical companies in countries such as India, China, and others.

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  Pharmacist-Related Data

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  Drug Name and Chemical Details

  • Generic Name: Ranitidine
  • Chemical Formula: C13H22N4O3S
  • Molecular Weight: 314.41 g/mol
  • CAS Number: 66357-39-3

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  Pharmacodynamics

  1. Mechanism of Action:
     • Ranitidine is a selective histamine H2-receptor antagonist that inhibits the action of histamine at the H2 receptors in the parietal cells of the stomach lining. This results in a decrease in gastric acid secretion and an increase in gastric pH, providing relief from acid-related stomach conditions.
  2. Therapeutic Effects:
     • Ranitidine effectively reduces gastric acid secretion, promotes ulcer healing, relieves symptoms of GERD (such as heartburn), and prevents aspiration pneumonia in surgical settings.

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  Pharmacokinetics

  1. Absorption:
     • Ranitidine is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 2-3 hours.
     • Bioavailability is approximately 50-60% after oral administration.
  2. Distribution:
     • Ranitidine is widely distributed throughout the body, including the lungs, liver, kidneys, and intestines.
     • It has a moderate protein binding rate of around 15%.
  3. Metabolism:
     • Ranitidine undergoes minimal metabolism in the liver, mainly by the cytochrome P450 enzyme system.
     • It produces an inactive metabolite, ranitidine N-oxide.
  4. Excretion:
     • Ranitidine is primarily excreted in the urine, with 60-70% of the drug eliminated unchanged.
  5. Half-Life:
     • The elimination half-life of ranitidine is approximately 2-3 hours in healthy adults, which can be prolonged in patients with renal impairment.

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  Drug Interactions

  1. With Food:
     • The absorption of ranitidine is not significantly affected by food intake. However, to reduce stomach discomfort, it is often recommended to take it with food.
  2. With Other Medications:
     • Warfarin: Monitor INR levels closely.
     • Theophylline: May require dose adjustment.
     • Antacids: Delay the absorption of ranitidine, so it should be spaced out by at least 1 hour.
     • Ketoconazole, Itraconazole: Absorption may be reduced when taken with ranitidine.
  3. Other Interactions:
     • Cimetidine: Should not be used simultaneously with ranitidine as it may reduce efficacy.

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  Clinical Considerations

  1. Pregnancy Category:
     • FDA Category B: Ranitidine has not shown any teratogenic effects in animal studies. However, it should be used during pregnancy only if clearly needed.
  2. Lactation:
     • Ranitidine is excreted in breast milk in small amounts, but it is generally considered safe for use during breastfeeding. However, if adverse effects occur in the infant, alternative treatments should be considered.
  3. Pediatric Use:
     • Ranitidine is used in children, especially for the treatment of GERD and peptic ulcers. Pediatric doses are generally based on weight. For infants and young children, lower doses are typically prescribed.
  4. Geriatric Use:
     • Elderly patients may have a reduced renal function, and thus, dose adjustments may be necessary. Careful monitoring is advised.
  5. Other Considerations:
     • Renal Impairment: Dose adjustments may be needed in patients with renal insufficiency.
     • Hepatic Impairment: Caution should be exercised in patients with severe liver disease.