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Razo D Gastro

Composition How to use Where to use What are the Side Effects Safety Advice

Composition

Razo D (Rabeprazole and Domperidone) SR tablets 20 mg and 30 mg each capsule contains Rabeprazole Sodium 20 mg (as enteric-coated pellets) Domperidone BP 30 mg (as sustained release pellets), excipients q.s.

Colours: Red Oxide of Iron, Yellow Oxide of Iron, Black Oxide of Iron & Titanium Dioxide IP approved colours used in the capsule shell.

How to use?

One Razo-D Capsule is to be taken once daily for 4 to 8 weeks before breakfast in the morning. Razo-D capsule should be swallowed whole but should not be chewed or crushed.

Where to use?

Gastroesophageal reflux disease (GERD) not responding to Rabeprazole alone

What are the Side Effects?

In general, both drugs are well tolerated separately. Following adverse drug reactions may occur with this fixed drug combination: headache, abdominal pain, dizziness, peripheral edema, asthenia, skin rash, diarrhea, flatulence, constipation, dry mouth & hepatic enzyme increase. Rare reports of hepatic encephalopathy have been received in patients with underlying cirrhosis. Rare reports of thrombocytopenia, neutropenia, leukopenia, bullous or urticarial skin eruptions, and acute systemic allergic reactions, hepatitis, jaundice, myalgia, arthralgia, acute kidney injury, increased prolactin levels, QTc prolongation (frequency not known), galactorrhea, gynecomastia and amenorrhea are seen.

Over dosage: Symptoms of overdose may include drowsiness, disorientation and extrapyramidal reactions. Anticholinergic, anti-Parkinson medicines or antihistamines with anticholinergic properties may be helpful. There is no specific antidote to either drug and hence overdose treatment should be symptomatic and supportive, gastric lavage & the administration of activated charcoal may be useful.

Safety Advice

Contraindications: Hypersensitivity to Rabeprazole, Domperidone or substituted Benzimidazoles or any excipient used in the formulation. It is contraindicated in patients with hepatic and/or renal impairment, prolactin-releasing pituitary tumour (prolactinoma), in pregnancy and during breastfeeding. It should not be used when stimulation of the gastric motility could be harmful, like gastrointestinal haemorrhage, mechanical obstruction or perforation.

Special Warnings and Precautions for Use: Co-administration of Razo-D with Atazanavir, Ketoconazole, Erythromycin or other potent CYP3A4 inhibitors are not recommended. Patients with Severe Hepatic Dysfunction: Although no evidence of significant drug-related safety problems, caution should be exercised when treatment with Rabeprazole sodium is first initiated in patients with severe hepatic dysfunction.

Pediatrics: It is not recommended for use in children under 16 years of age, as there is no experience of its use in this group.

Geriatrics: No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects in the clinical studies with Rabeprazole.

Use in specific populations: Pregnancy and Lactation: It is contraindicated during pregnancy and should not be used during breastfeeding.

Effects on Ability to Drive and Use Machines: Razo-D has no or negligible effect.

Adverse Reactions: In general, both drugs are well tolerated separately. Following adverse drug reactions may occur with this fixed drug combination: headache, abdominal pain, dizziness, peripheral edema, asthenia, skin rash, diarrhea, flatulence, constipation, dry mouth, hepatic enzyme increase. Rare reports of hepatic encephalopathy have been received in patients with underlying cirrhosis. Rare reports of thrombocytopenia, neutropenia, leukopenia, bullous or urticarial skin eruptions, acute systemic allergic reactions, hepatitis, jaundice, myalgia, arthralgia, acute kidney injury, increased prolactin levels, QTc prolongation (frequency not known), galactorrhea, gynecomastia and amenorrhea are seen.

GGI-CO-A1-AQS-300023273-WM-I23-0022

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