RiteMED Amoxicillin

RiteMED Amoxicillin

amoxicillin

Manufacturer:

RiteMED

Distributor:

United Lab
Concise Prescribing Info
Contents
Amoxicillin trihydrate
Indications/Uses
Upper & lower resp tract infections including ENT infections eg, acute otitis media; GIT infections; GUT infections; skin & skin structure infections; bone infections eg, osteomyelitis; gall bladder/biliary tract infections; H. pylori infections; Lyme disease; dental abscess. Step down treatment for severe infections due to susceptible organisms. Prophylaxis for endocarditis for prevention of bacteremia associated w/ procedures eg, dental extraction in patients at risk of developing bacterial endocarditis.
Dosage/Direction for Use
Duration: Most infections: 5-14 days depending on type & severity. Continue treatment for at least 48-72 hr after patient becomes asymptomatic or after evidence of bacterial eradication has been continued. β-hemolytic streptococcal infections: At least 10 days. Adult 250-500 mg every 8 hr or 500 mg every 12 hr depending on type & severity of infection. Max dose: 6 g daily in divided doses. ENT, 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 to reduce risk of recurrent duodenal ulcer Triple therapy regimen: Amoxicillin 1 g + clarithromycin 500 mg + omeprazole 20 mg, all 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 daily. Generalized manifestations: 6 g daily. Duration: At least 12 days. Endocarditis prophylaxis for dental procedures 2 g as single dose 30-60 min before procedure. Childn <40 kg & infant >3 mth 25-50 mg/kg daily in divided doses every 8 or 12 hr. ENT, GUT, skin & skin structure infections Mild to moderate: 25 mg/kg daily in divided doses every 12 hr or 20 mg/kg daily in divided doses every 8 hr. Severe: 45 mg/kg daily in divided doses every 12 hr or 40 mg/kg daily in divided doses every 8 hr. Acute otitis media 80-90 mg/kg daily in divided doses every 12 hr. LRTI 45 mg/kg daily in divided doses every 12 hr. Endocarditis prophylaxis for dental procedures in childn 50 mg/kg as single dose 30-60 min before procedure. Neonate & infant ≤3 mth 20-30 mg/kg daily 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 daily in divided doses every 12 hr in childn <40 kg, <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, hemodialysis 250 or 500 mg every 24 hr in adult depending on severity of infection w/ additional dose during & after each dialysis period.
Administration
May be taken with or without food: May be taken w/o regard to meals.
Contraindications
Hypersensitivity to penicillins or cephalosporins. Patient w/ infectious mononucleosis.
Special Precautions
Discontinue use if an allergic reaction occurs. Clostridium difficile-associated diarrhea (CDAD) & colitis. Prescribing in absence of proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit & increases the risk of development of drug-resistant bacteria. Long term or repeated use may result in overgrowth of non-susceptible organisms including fungi. Maintain adequate fluid intake & urinary output to reduce possibility of crystalluria in high doses. Periodic assessment of organ system functions including renal, hepatic & hematopoietic is recommended during prolonged therapy. Renal impairment. Pregnancy & lactation. Childn ≤3 mth. Elderly.
Adverse Reactions
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, SJS, TEN; nausea, vomiting, diarrhea, black "hairy" tongue, CDAD & 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, prolonged bleeding time, prothrombin time & aPTT, thrombocytopenia, thrombocytopenic purpura; moderate rise in AST &/or ALT, transient increases in serum alkaline phosphatase & LDH levels, hepatic dysfunction including cholestatic jaundice, hepatic cholestasis & acute cytolytic hepatitis; acute interstitial nephritis, crystalluria; tooth discoloration (brown, yellow or gray staining) mostly in ped patients.
Drug Interactions
Increased incidence of skin rashes w/ allopurinol. Prolongation of prothrombin time w/ anticoagulants. Bacteridical effects may be interfered 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 MTX. May lead to lower estrogen reabsorption & reduced efficacy of combined oral estrogen/progesterone contraceptives. Blood levels may be increased & prolonged w/ probenecid. May result in false +ve reactions in Clinitest, Benedict's soln. May interfere w/ protein testing when colorimetric methods are used.
MIMS Class
Penicillins
ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Presentation/Packing
Form
RiteMED Amoxicillin cap 250 mg
Packing/Price
100's (P5.5/cap, P550/pack)
Form
RiteMED Amoxicillin cap 500 mg
Packing/Price
100's (P7.5/cap, P750/pack)
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