Nizatidine

Brands of Nizatidine in Kenya

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Nizatidine in Kenya
Nizatidine Chemical Structure

Mechanism of Action:

Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-receptors, particularly those in the gastric parietal cells.

Nizatidine is a histamine H2 receptor antagonist that inhibits stomach acid production, and is commonly used in the treatment of peptic ulcer disease and gastroesophageal reflux disease.
Nizatidine was developed by Eli Lilly, and was first marketed in 1987. It is considered to be equipotent with ranitidine and differs by the substitution of a thiazole ring in place of the furan ring in ranitidine.

INDICATIONS

For the treatment of the following diseases where reduction of gastric acid is indicated:

1) Duodenal ulcer

2) Benign gastric ulcer

3) Prevention of duodenal or benign gastric ulcer recurrence

4) Gastric oesophageal reflux disease (including erosions, ulcerations and associated heartburn)

5) Gastric and/or duodenal ulcer associated with concomitant use of non- steroidal anti-inflammatory drugs

DOSAGE AND ADMINISTRATION

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.

3) For the prevention of duodenal or benign gastric ulcer recurrence (prophylactic maintenance therapy): the recommended daily dose is 150 mg in the evening.

4) 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.

5) 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:

DOSAGE RECOMMENDED
IndicationsModerate Renal ImpairmentSevere Renal Impairment
Duodenal ulcer150 mg in the evening150 mg on alternate days
Benign gastric ulcer150 mg in the evening150 mg on alternate days
Prevention of duodenal or benign gastric ulcer recurrence150 mg in the evening on alternate days150 mg in the evening every third day
Gastric oesophageal reflux diseaseFrom 150 mg daily, up to 150 mg twice dailyFrom 150 mg on alternate days, up to 150 mg daily
Gastric and/or duodenal ulcer associated with concomitant use of non- steroidal anti- inflammatory drugs150 mg in the evening150 mg on alternate days

Method of administration

For oral administration.

CONTRAINDICATIONS

Nizatidine capsules are contraindicated in patients with known hypersensitivity to the drug. Because cross sensitivity in this class of compounds has been observed, H2-receptor antagonists, including nizatidine, should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.

DRUG INTERACTIONS:

There is evidence that oral nizatidine does not affect the serum levels of concomitantly-administered aminophylline, theophylline, chlordiazepoxide, diazepam, lidocaine, phenytoin, ibuprofen, metoprolol, warfarin or lorazepam.

Nizatidine does not inhibit the hepatic cytochrome P450-linked drug metabolising enzyme system, but may increase absorption of salicylates when they are used in very high dosage. However, nizatidine and other histamine H2– receptor antagonists can reduce the gastric absorption of drugs whose absorption is dependent on an acidic gastric pH. Approximately 35% of nizatidine is bound to plasma protein. Warfarin, diazepam, paracetamol, propantheline, phenobarbitone, and propranolol did not affect plasma protein binding of nizatidine in vitro.

Absorption of nizatidine is not clinically significantly affected by food intake, anticholinergic agents, or antacids.

ADVERSE DRUG REACTIONS

Hepatic
Hepatocellular injury, evidenced by elevated liver enzyme tests (SGOT [AST], SGPT [ALT], or alkaline phosphatase), occurred in some patients and was possibly or probably related to nizatidine
Cardiovascular
In clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in 2 individuals administered nizatidine and in 3 untreated subjects.
CNS
Rare cases of reversible mental confusion have been reported.
Endocrine
Clinical pharmacology studies and controlled clinical trials showed no evidence of antiandrogenic activity due to nizatidine.
Hematologic
Anemia was reported significantly more frequently in nizatidine- than in placebo-treated patients. Fatal thrombocytopenia was reported in a patient who was treated with nizatidine and another H2-receptor antagonist.
Integumental
Sweating and urticaria were reported significantly more frequently in nizatidine than in placebo-treated patients
Hypersensitivity
As with other H2-receptor antagonists, rare cases of anaphylaxis following administration of nizatidine have been reported.
Body as a Whole
Serum sickness-like reactions have occurred rarely in conjunction with nizatidine use.
Genitourinary
Reports of impotence have occurred.
Other
Hyperuricemia unassociated with gout or nephrolithiasis was reported. Eosinophilia, fever, and nausea related to nizatidine administration have been reported.

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:


Price of Nizatidine in Kenya
Nizatidine in Kenya
Nizatidine in Kenya
Nizatidine in Kenya
Nizatidine in Kenya
Nizatidine in Kenya

Clinical | Pharmacokinetic data


Pregnancy Category: B3
Routes of Administration: Oral
Bioavailability: >70%
Protein Binding: 35%
Metabolosim: Liver
Onset of Action: Not Available
Elimination Half life: 1–2 hours
Excretion: Kidney

Legal Status | Dosage forms & Strengths


Prescription Category:
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:


Drug Indentifiers:

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References/ Citation:

  • PPB Drugs Retention Register
  • Romero M, Franzosi MG (1989). “[Nizatidine]”. Medicina (Florence, Italy) (in Italian). 9 (1): 93–6. PMID 2567957
  • “Nizatidine”. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. NCBI Bookshelf. 25 January 2018.



What was the patient being treated for
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