FIXIT 150/MG CAP 28/CAP

Indications

Approved Uses

Active duodenal ulcer, Maintenance of healed duodenal ulcer, Active benign gastric ulcer, Gastroesophageal reflux disease (GERD), Endoscopically diagnosed esophagitis.

Off-Label Uses

Stress-ulcer prophylaxis (institution-specific), functional dyspepsia/episodic heartburn, and adjunctive use in some H. pylori regimens (historical/less common now).

Dosage & Administration

Dosing by Condition

Active duodenal ulcer: 300mg once daily at bedtime or 150mg twice daily for 4-8 weeks. Active gastric ulcer: 150mg twice daily or 300mg once daily at bedtime for up to 8 weeks. GERD/Erosive esophagitis: 150mg twice daily for up to 12 weeks. Maintenance of duodenal ulcer: 150mg once daily at bedtime

Initial Dose

150mg twice daily or 300mg once daily at bedtime.

Maintenance Dose

150mg once daily at bedtime.

Maximum Dose

300mg per day for most indications; up to 600mg per day has been used for GERD.

Children's Dosage

Safety and efficacy not established in children younger than 12 years. In patients 12 years and older with suspected or endoscopically diagnosed GERD, generally safe and well-tolerated.

Dose Adjustment Notes

Dosage reduction is required in moderate to severe renal impairment (reduced creatinine clearance); no routine titration is needed for standard indications.

How to Take

Swallow the capsule whole with water; may be taken with or without food. If prescribed once daily, take at bedtime; if twice daily, take in the morning and at bedtime.

Side Effects

Common Side Effects

Headache, dizziness, diarrhea, nausea, abdominal pain; less commonly constipation, somnolence/drowsiness, and fatigue.

Side Effect Frequency

Common (≥1%): headache (up to 16.6%), diarrhea, rhinitis, dizziness, asthenia, infection, pain, dry mouth, somnolence. Less common: nausea, abdominal pain, constipation, fatigue, sweating, insomnia, rash, urticaria, elevated liver enzymes, thrombocytopenia, hypersensitivity.

Safety & Warnings

Contraindications

Hypersensitivity to nizatidine or other H2-receptor antagonists

Warnings & Precautions

May mask gastric malignancy-evaluate alarm features; adjust dose in renal impairment; consider vitamin B12 deficiency with long-term acid suppression; use caution/monitoring in hepatic disease and if signs of blood dyscrasia or hypersensitivity occur.

Age Restriction

Not approved under 12 years.

Driving Warning

Safe

Drug Interactions

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Children

Safety and efficacy not established in children younger than 12 years. In patients 12 years and older with suspected or endoscopically diagnosed GERD, generally safe and well-tolerated.

Elderly

No overall differences in safety or effectiveness observed between elderly and younger subjects; care should be taken in dose selection and monitor renal function due to age-related decline.

Kidney Impairment

Dose reduction required in renal impairment: commonly CrCl 20-50 mL/min: 150 mg once daily; CrCl <20 mL/min: 150 mg every 48 hours (individualize by indication and response).

Liver Impairment

No routine dose adjustment in hepatic impairment if renal function is normal; use caution in severe hepatic disease.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without clinician advice if treating an ulcer/GERD; complete the prescribed course (may stop if short-term PRN use and symptoms resolve, but confirm plan).

Overdose

Symptoms not well-defined; may include cholinergic-like effects (e.g., lacrimation, salivation, vomiting, diarrhea, miosis); management is supportive/symptomatic (consider activated charcoal if early) and seek urgent medical care.

Patient Counseling

Take exactly as prescribed; swallow capsule whole with water, with or without food. If once daily, take at bedtime; complete the prescribed course for ulcer healing. Avoid starting other acid-reducing medicines without advice; separate antacids/sucralfate by about 2 hours if used. Seek urgent care for alarm symptoms (black/tarry stools, vomiting blood, severe/persistent abdominal pain, unexplained weight loss, trouble swallowing) and report persistent symptoms; use caution in kidney disease/older age and inform your clinician.

Monitoring Requirements

No routine laboratory monitoring for most patients; assess symptom response and consider evaluation for malignancy if alarm features. Monitor renal function in elderly patients or those with known renal impairment; check liver tests if clinical signs of hepatic dysfunction occur.

Pharmacology

Mechanism of Action

Competitively and reversibly blocks histamine H2 receptors on gastric parietal cells, reducing basal and stimulated gastric acid secretion and decreasing gastric volume and pepsin output.

Duration of Effect

Approximately up to 12 hours (notably for nocturnal acid suppression).

Half-Life

1-2 hours.

Bioavailability

>70%.

Metabolism

Limited hepatic metabolism; a minority of the dose is metabolized (e.g., to N2-oxide and other minor metabolites), with most eliminated unchanged in urine.

Excretion

Primarily renal elimination: >90% recovered in urine within ~12 hours, with ~60% excreted unchanged.

Product Information

Available Dosage Forms

Capsule, hard; Oral Solution.

Composition per Dose

Each capsule: 150mg nizatidine

Generic Availability

Yes

OTC Alternatives

OTC alternatives for mild acid-related symptoms include famotidine and (where available) cimetidine; OTC PPIs such as omeprazole (and in some markets esomeprazole) are alternatives for frequent symptoms.

Gi Condition

Ulcer, Acid Reflux/GERD

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 20-05-2026