NERHAFLUKS 40 MG ( FAMOTIDINE ) 20 ORO-DISPERSIBLE FILMS

Generic Name:
Famotidine

Dosage Form:
Orodispersible film (ODF)

Pharmacological Class:
Histamine H₂-Receptor Antagonist

Indications:

• Duodenal ulcer (short-term treatment and maintenance)
• Benign gastric ulcer
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome (higher doses like 40 mg often required)
• Prophylaxis of stress ulcers or NSAID-induced ulceration
• Nighttime acid suppression (40 mg typically used at bedtime)

Mechanism of Action:
Famotidine selectively inhibits histamine H₂ receptors on gastric parietal cells, reducing gastric acid secretion.

Pharmacokinetics:
Bioavailability: ~40–45%

Tmax: 1–3 hours

Half-life: ~2.5–3.5 hours (prolonged in renal impairment)

Excretion: Primarily renal (65–70% unchanged)

Dosing & Administration (Including 40 mg):

• Adults: Typical dose: 20 mg twice daily or 40 mg once daily, especially for nocturnal acid control or ulcer healing
• Pediatrics: Use under medical supervision; 40 mg not typically used in children without specialist guidance
• Route: Place on tongue; allow to dissolve; swallow saliva. No water required.

Formulation Notes for 40 mg Film:

• Requires larger film area or higher drug loading
• Common excipients: Pullulan or HPMC (film formers), plasticizers (glycerin, PEG), saliva-stimulating agents, sweeteners, and flavorings
• May require permeation enhancers or taste-masking strategies due to higher API load

Contraindications:

• Hypersensitivity to famotidine or other H₂ blockers

Precautions:

• Use caution in renal impairment — dose reduction recommended if CrCl <50 mL/min
• May mask signs of malignancy
• Rare CNS effects in elderly

Adverse Effects:

• Common: Headache, dizziness, constipation
• Less common: Arrhythmia, confusion, gynecomastia (rare), thrombocytopenia

Drug Interactions:

• Reduced efficacy of drugs needing acidic pH (e.g., ketoconazole, itraconazole)
• May alter absorption of certain antivirals and antifungals

Storage:

• Store below 25°C in a dry environment
• Protect from moisture and light

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