NIZATIDINE Capsule, hard Ref.[9149] Active ingredients: Nizatidine

Posology

Adults

1. For treatment of duodenal ulcer: the recommended daily dose is 300 mg in the evening. Treatment should continue for four weeks, although this period may be reduced if healing is confirmed earlier by endoscopy. Most ulcers will heal within four weeks, but if complete ulcer healing has not occurred after four weeks therapy, patients should continue therapy for a further four weeks.
2. For the treatment of benign gastric ulcer: the recommended daily dose is 300 mg in the evening for four or, if necessary, eight weeks. Prior to treatment with nizatidine, care should be taken to exclude the possibility of gastric cancer.

If preferred, the 300 mg daily dose for the treatment of duodenal or benign gastric ulcer may be given as two divided doses of 150 mg in the morning and evening.

1. For the prevention of duodenal or benign gastric ulcer recurrence (prophylactic maintenance therapy): the recommended daily dose is 150 mg in the evening.
2. For the treatment of gastric oesophageal reflux disease: the recommended dosage is from 150 mg twice daily up to 300 mg twice daily. Therapy for up to 12 weeks is indicated for erosions, ulcerations and associated heartburn.
3. For the treatment of gastric and/or duodenal ulcer associated with concomitant use of non-steroidal anti-inflammatory drugs: the recommended daily dose is 300 mg daily (either 300 mg at bedtime or 150 mg twice daily, in the morning and in the evening) for up to 8 weeks. In most patients, the ulcers will heal within 4 weeks. During treatment, the use of non-steroidal anti-inflammatory drugs may continue.

The elderly

Age does not significantly influence efficacy or safety. Normally dosage modification is not required except in patients who have moderate to severe renal impairment (creatinine clearance less than 50 ml/min).

Paediatric population

The safety and efficacy of nizatidine in children have not been established. No data are available.

Patients with impaired renal function

For patients who have moderate renal impairment (creatinine clearance less than 50 ml/min) or patients who have severe renal impairment (creatinine clearance less than 20 ml/min), the dosage should be reduced as follows:

Method of administration

For oral administration.

Symptoms

There is little experience of overdose in humans. Tested at very high doses in animals, nizatidine has been shown to be relatively non-toxic. Animal studies suggest that cholinergic-type effects, including lacrimation, salivation, emesis, miosis and diarrhoea, may occur following very large oral doses.

Treatment

Symptomatic and supportive therapy is recommended. Activated charcoal, emesis or lavage may reduce nizatidine absorption. The ability of haemodialysis to remove nizatidine from the body has not been conclusively demonstrated. However, this method is not expected to be efficient, since nizatidine has a large volume of distribution.

Shelf life: 3 years.

Do not store above 25°C.

High density polyethylene bottles with polypropylene snap-on caps containing 28 or 30 capsules or PVC/Aluminium blister packs containing 28 or 30 capsules.

Not all pack sizes may be marketed.

No special requirements.