Esomeprazole + Amoxicillin + Clarithromycin Kit

Indications

Esomeprazole + Amoxicillin + Clarithromycin Kit is used for: Eradication of H. pylori, in active chronic gastric,duodenal and gastric ulcers.

Adult Dose

Oral Each strip contain one Esomeprazole USP 20mg capsule, two Amoxicillin BP 500mg tablets and one Clarithromycin USP 500mg tablet Each strip twice daily for 7-14 days

Child Dose

Renal Dose

Administration

Contra Indications

Contraindicated in patients with known hypersensitivity to any of its compo-nent.

Precautions

Serious and occasionally fatal hypersensitivity reactions have been reported in patients on Amoxicillin therapy. These reactions are more apt to occur in indivduals with a history of penicillin hypersensitivity. Clarithromycin should not used in pregnant women except in clinical circumstances where no alternative is appropriate.

Pregnancy-Lactation

Interactions

Esomeprazole is metabolized through the cytochrome P450 system, specially through the CYP3A isozymes. Studies have shown that Esomeprazole 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 subject. Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. There have been reports of interactions of clarithromycin with carbamazepine, cyclosporine, tactrolimus, hexobarbital, phenytoin, alfetanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide & astemizole.

Adverse Effects

Side effects of Esomeprazole + Amoxicillin + Clarithromycin Kit : Common adverse reactions included diarrhoea and nausea. >10% Clarithromycin GI effects, general (13%) 1-10% Clarithromycin Headache (6%), Rash (children 3%), Abdominal pain (adults 2%, children 3%), Abnormal taste (adults 3-7%), Diarrhea (3-6%), Dyspepsia (2%), Heartburn (adults 2%), GI intolerance (oral-dose related), Nausea (adults 3-6%), Vomiting (adults 1%; children 6%), Decreased WBC, elevated BUN (4%), elevated PT (1%) Esomeprazole >10% Headache (2-11%) 1-10% Flatulence (10%), Indigestion (6%), Nausea (6%), Abdominal pain (1-6%), Diarrhea (2-4%), Xerostomia (3-4%), Dizziness (2-3%), Constipation (2-3%), Somnolence (1-2%), Pruritus (1%) Frequency Not Defined Amoxicillin Headache, Rash, Diarrhea, nausea, vomiting, Anemia, AST/ALT elevation, Acute exanthematous pustulosis, Exfoliative dermatitis Seizure, Insomnia, Hemorrhagic colitis, Toxic epidermal necrolysis, Urticaria, Stevens-Johnson syndrome, Anaphylaxis, Candidiasis (mucocutaneous), pseudomembranous colitis, serum sickness

Mechanism of Action

Amoxicillin: Inhibits bacterial cell wall synthesis by binding to one or more penicillin binding proteins that in turn inhibit the final transpeptidation step of peptoglycan synthesis in cell wall biosynthesis. Clarithromycin: Inhibits protein synthesis by binding to 50S ribosomal subunit causing antibacterial activity. Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell.