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Roxatidine information from DrugsUpdate  

See Available Brands of Roxatidine in India

P - Caution when used during pregnancy
L - Contraindicated in lactation

Roxatidine acetate is a specific and competitive H2 receptor antagonist. The antisecretory effect of roxatidine acetate is mediated by its main metabolite, roxatidine.

Pharmacodynamics

Pharmacokinetics

Roxatidine is a potent and selective inhibitor of basal and stimulated gastric acid secretion through competitive blockade of H2-receptors. Total pepsin secretion is reduced in a dose-dependent manner. There is an independent mucosal protection action.

Absorption
Absorbed rapidly and almost completely from the GI tract (oral); peak plasma concentrations after 1-3 hours.

Distribution
Enters breast milk (small amounts).

Metabolism
Liver, small intestines and serum; hydrolysed to the desacetyl metabolite.

Excretion
Via urine (90% as roxatidine and metabolites); 6 hours (elimination half-life).

Roxatidine Indications / Roxatidine Uses

Information Not Available

Roxatidine Adverse Reactions / Roxatidine Side Effects

Occasional headache, GI disturbances, gynaecomastia, alopoecia, blood dyscrasias, pancreatitis, sleep disturbances, restlessness, rarely dizziness. Hypersensitivity reactions e.g. rash and itching reported occasionally. Changes in pulse rate and transient impairment of sexual drive. Possible increase in liver enzyme activity. May reduce leucocytes and/or thrombocytes.

Precautions

Information Not Available

Special Precautions

Renal and hepatic impairment, pregnancy. May mask the symptoms of gastric malignancy.

Other Drug Interactions

May affect serum levels of protease inhibitors

Other Interactions

Information Not Available

Dosage

Oral
Peptic ulcer
Adult: 150 mg at bedtime or 75 mg bid daily for 4-6 weeks. Maintenance: 75 mg at bedtime.
CrCl (ml/min)    Dosage Recommendation
20-50               75 mg at bedtime.
<20                  75 mg every 2 days.

Oral
Gastro-oesophageal reflux disease
Adult: 75 mg bid or 150 mg at bedtime for 6-8 weeks.
CrCl (ml/min)    Dosage Recommendation
20-50               75 mg at bedtime.
<20                  75 mg every 2 days.

Oral
Gastritis
Adult: 75 mg once daily in the evening.
CrCl (ml/min)    Dosage Recommendation
20-50               75 mg at bedtime.
<20                  75 mg every 2 days.

Oral
Zollinger-Ellison syndrome
Adult: 75 mg bid.
CrCl (ml/min)    Dosage Recommendation
20-50               75 mg at bedtime.
<20                  75 mg every 2 days.

Oral

Premedication before anaesthesia
Adult: 75 mg in the evening on the day before surgery and repeated 2 hours before induction of anaesthesia. Alternatively, 150 mg once on the night before surgery.

Intravenous
Upper gastrointestinal haemorrhage
Adult: 75 mg bid via slow injection or infusion.

Food(before/after)

Information Not Available

List of Contraindications

Roxatidine and Pregnancy

Caution when used during pregnancy

Roxatidine and Lactation

Contraindicated in lactation

Roxatidine and Children

Information Not Available

Roxatidine and Geriatic

Information Not Available

Roxatidine and Other Contraindications

Lactation. Porphyria.

Storage

Information Not Available

Lab interference

Information Not Available

Roxatidine brands in India:

Rotane Zorpex

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