DEXRABEPRAZOLE SODIUM Enteric-coated tablet Ref.[51201] Active ingredients: Dexrabeprazole

Source: Web Search  Publisher: Stallion laboratories Pvt. Ltd., C-1B, 305/2,3,4 & 5, GIDC, Kerala (Bavla) Dist: Ahmedabad-382220, Gujarat, India

4.3. Contraindications

Hypersensitivity to Dexrabeprazole Sodium.

4.4. Special warnings and precautions for use

General

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Drug interaction

No clinically significant interactions with drugs metabolized by CYP450 system. An interaction with compounds (e.g Ketoconazole) which are dependent on gastric pH for absorption may occour due to the magnitude of acid suppression.

4.5. Interaction with other medicinal products and other forms of interaction

May reduce absorption of ketoconazole and itraconazole. May prolong the elimination of diazepam, phenytoin and warfarin.

4.6. Pregnancy and lactation

Pregnancy

Studies in animals have shown no risk to the fetus, however there are no sufficient studies in humans. Patients should follow the advice of the doctor regarding its use.

Lactation

Safer: Drug has been studied in few breastfeeding women and the evidence shows that there is no increase in side effects in the infants, or the possibility of harm to the breastfed infants is expected to be rare. Patients should follow the advice of the doctor regarding its use.

4.7. Effects on ability to drive and use machines

There are no data to suggest that Dexrabeprazole affects the ability to drive or use machines.

4.8. Undesirable effects

Headache, diarrhea, nervousness, abdominal pain, pharyngitis, rash and dry mouth.

6.2. Incompatibilities

Not applicable.

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