Himox Capsule

Amoxicillin trihydrate

Treatment of infections caused by susceptible organisms on upper & lower resp tract including ear, nose & throat (eg, acute otitis media), GIT, GUT, skin & skin structure, bone (eg, osteomyelitis), gall bladder/biliary tract, H. pylori infections. Lyme disease; dental abscess. Prophylaxis for endocarditis; prevention of bacteremia, associated w/ procedures eg, dental extraction in patients at risk of developing bacterial endocarditis.

Adult 250-500 mg every 8 hr or 500 mg every 12 hr depending on the type & severity of infection. Max: 6 g/day in divided doses. Ear, nose, throat, GUT, skin & skin structure infections Mild to moderate: 250 mg every 8 hr or 500 mg every 12 hr. Severe: 500 mg every 8 hr. Mild to moderate lower resp tract infections (LRTI) 500 mg every 8 hr. H. pylori infection to reduce the risk of recurrent duodenal ulcer Triple therapy regimen: Amoxicillin 1 g + clarithromycin 500 mg + omeprazole 20 mg each given every 12 hr for 10 days. Dual therapy regimen: Amoxicillin 1 g + lansoprazole 30 mg each given every 8 hr for 14 days. Lyme disease Isolated erythema chronicum migrans: 4 g/day. Generalized manifestations: 6 g/day. Endocarditis prophylaxis for dental procedures 2 g as single dose 30-60 min before procedure. Infant >3 mth & childn <40 kg Usual dose: 25-50 mg/kg/day in divided doses every 8 or 12 hr. Ear, nose, throat, GUT, skin & skin structure infections Mild to moderate: 25 mg/kg/day every 12 hr or 20 mg/kg/day every 8 hr. Severe: 45 mg/kg/day every 12 hr or 40 mg/kg/day every 8 hr. Acute otitis media 80-90 mg/kg/day every 12 hr. LRTI 45 mg/kg/day every 12 hr. Endocarditis prophylaxis for dental procedures Childn 50 mg/kg as single dose given 30-60 min before procedure. Neonate & infant ≤3 mth 20-30 mg/kg/day in divided doses every 12 hr. Renal impairment CrCl 10-30 mL/min 250 or 500 mg every 12 hr in adult & childn ≥40 kg OR 15 mg/kg/day every 12 hr in childn <40 kg. CrCl <10 mL/min 250 or 500 mg every 24 hr in adult & childn ≥40 kg OR 15 mg/kg as single daily dose in childn <40 kg.

May be taken with or without food: May be taken w/ meals for better absorption & to reduce GI discomfort.

Hypersensitivity to penicillins or cephalosporins. Patient w/ infectious mononucleosis.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions; hypersensitivity to amoxicillin, penicillins, cephalosporins & multiple allergens. Discontinue if allergic reaction occurs. C. difficile-associated diarrhea & colitis. Maintain adequate fluid intake & urinary output to reduce the possibility of crystalluria in high doses. Periodic assessment of organ system functions including renal, hepatic, hematopoietic, is recommended during prolonged therapy. Prophylactic indication is unlikely to provide benefit to the patient & increases the risk of the development of drug-resistant bacteria. Long term or repeated use may result in overgrowth of nonsusceptible organisms including fungi. Hepatic & renal impairment. Pregnancy & lactation. Childn ≤3 mth. Elderly.

Anaphylaxis, serum sickness-like reactions, severe allergic reactions including angioedema, exanthema, acute & generalized exanthematous pustulosis, bullous & exfoliative dermatitis, erythematous maculopapular rashes, erythema multiforme, hypersensitivity vasculitis, mucocutaneous/oral & vag candidiasis, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis; nausea, vomiting, diarrhea, black "hairy" tongue, C. difficile-associated diarrhea & colitis, hemorrhagic colitis, acute, transient enterocolitis w/ severe abdominal pain & bloody diarrhea; glossitis, stomatitis, epigastric distress, gastritis, flatulence, soft stools, loss of appetite/anorexia, enanthemas/sore mouth or tongue, dry mouth, taste disturbances; agitation, anxiety, behavioral changes, confusion, convulsions (at extremely high doses), dizziness, reversible hyperactivity, hyperkinesia, insomnia; anemia including hemolytic anemia, agranulocytosis, abnormal platelet aggregation, eosinophilia, leukopenia, neutropenia, prolongation of bleeding time, prothrombin time & activated partial thromboplastin time, thrombocytopenia, thrombocytopenic purpura; moderate rise in AST &/or ALT, transient increases in serum alkaline phosphatase & lactate dehydrogenase levels; hepatic dysfunction including cholestatic jaundice, hepatic cholestasis & acute cytolytic hepatitis; acute interstitial nephritis, crystalluria.

Increased incidence of skin rashes w/ allopurinol. Prolongation of prothrombin time w/ anticoagulants. May interfere w/ the bactericidal effects w/ bacteriostatic agents (eg, chloramphenicol, macrolides, sulfonamides & tetracyclines). Synergistic bactericidal effect w/ β-lactamase inhibitors. May increase absorption of digoxin. May decrease renal clearance of methotrexate. May reduce estrogen reabsorption & efficacy of OCs. Increased & prolonged blood levels w/ probenecid. False +ve reaction in Clinitest, Benedict's soln. May interfere w/ protein testing when colorimetric methods are used.

Penicillins

J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.

Rx