Description

This drug is contraindicated in patients with known hypersensitivity to any of its component.

Adverse reactions which were reported as possibly or probably related to treatment (<3%) in clinical trials when all three components of this therapy were given concomitantly are listed below and divided by body systems. Digestive system: Nausea, vomiting, diarrhoea, dark stools, dry mouth, glossitis, oral moniliasis, stomatitis, tongue discoloration; Musculoskeletal system: Myalgia; Nervous System: Confusion, headache, dizziness; Skin: Skin reactions; Urogenital System: Vaginitis, vaginal moniliasis.

There were no adequate and well-controlled studies of in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk of the mother. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug therapy, taking into account the importance of the therapy to the mother. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. Amoxicillin is excreted in human milk in very small amounts. There are no available human data on Rabeprazol use in pregnant women to inform the drug associated risk.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on Amoxicillin therapy.

Use in Geriatrics: Elderly patients may suffer from asymptomatic renal and hepatic dysfunction. Care should be taken when administering to this patient population. Renal Dose Adjustments: No adjustment recommended. Mild to moderate hepatic impairment: No adjustment recommended. Severe hepatic impairment: Use with caution.

There has been no experience of overdoses with Rabeprazole. In case of overdosage of Amoxicillin, medication is discontinued, treatment should be symptomatic and supportive measures are institued as required. Overdosage of Clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea and diarrhea.