Pylotrip R

• Gastric Ulcer

Amoxicillin, Clarithromycin & Rabeprazol combination is indicated for the eradication of H. pylori in active chronic gastric, duodenal and gastric ulcers.

N/A

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

Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site.Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H+,K+ ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion.

Rabeprazole is metabolized through the cytochrome P450 system, specially through the CYP3A and CYP2C19 isozymes. Studies have shown that Rabeprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisolone, diazepam, clarithromycin or terfenadine in healthy subjects. Use of Clarithromycin in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. There have been reports of interactions of erythromycin and/or clarithromycin with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfetanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide & astemizole.

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 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.

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.