Otitis media, sinusitis, lower
respiratory tract infections, and
more severe infections
45 mg/kg/day q12h
Less severe infections
25 mg/kg/day q12h
Duration of therapy for acute otitis media is 10 days - Pediatric patients weighing 40 Kg and more: should be dosed according to the adult recommendations.- Adults: The usual adult dose is one 500/125mg tablets of amoxycillin/clavulanate potassium every 12 hours ,or one 250 mg /62.5 mg tablets every 8 hours For more severe infections and infections of the respiratory tract,the dose should be one 875 mg /125 mg amoxycillin/clavulanate potassium every 12 hours Or one 500/125mg tablets of amoxycillin/clavulanate potassium every 8 hours. Renal Impairment: Dosing adjustments are based on the maximum recommended level of amoxycillin. - Children: Creatinine clearance > 30mL/min No adjustment necessary. Creatinine clearance 10-30 mL/min. 15/3.75 mg/kg give b.i.d. Creatinine clearance <10 mL/min 15/3.75 mg/kg give as a single daily dose In the majority of cases,parenteral therapy,where available , may be preferred. - Adult: Creatinine clearance > 30 mL/min No adjustment necessary. Creatinine clearance 10-30 mL/min 1 times 625 mg given b.i.d.; OR 1-2 times 375 mg, depending upon severity of infection, given b.i.d. Creatinine clearance <10 mL/min 1 times 625 mg given o.d.; OR 1-2 times 375 mg, depending upon severity of infection, given o.d. Haemodialysis. - Children: Dosing adjustments are based on the maximum recommended level of amoxycillin. 15/3.75 mg/kg/day gives as a single daily dose. Prior to haemodialysis one additional dose of 15/3.75 mg/Kg should be administered in order to restore circulating drug levels,another dose of 15/3.75 mg/kg should be administered after Haemodialysis. - Adult: 1 times 625 mg OR 2 times 375 mg every 24 hours, PLUS : 1 dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxycillin and clavulanic acid are decreased). The 1 g presentation should only be used in patients with a creatinine clearance of > 30 mL/min. Hepatic impairment: Dose with caution; monitor hepatic function at regular intervals. There are insufficient data on which to base a dosage recommendation. Method of Administration: Oral Route: To minimize potential gastrointestinal intolerance, administer at the start of a meal. Treatment should not be extended beyond 14 days without review. Therapy can be started with parenteral B-Lactam and continued with an oral preparation.
Precautions: periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy. A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, usually pseudomonas or candidate the drug should be discontinued and/or appropriate therapy instituted. Prescribing amoxycillin/clavulanate potassium in the absence of a proven or strongly suspected bacterial infection is to provide benifits and increase the risk of the development of drug-resistant bacteria.
Effects on the ability to drive or operate machinery: Adverse effects on the ability to drive or operate machinery have not been observed.
Mucocutaneous candidiasis, diarrhoea, nausea and vomiting, have been reported. Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking Hibiotic® at the start of a meal skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Hypersensitivity Reactions: Skin rashes, pruritus, urticaria, angioedema, serum sickness—like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids, Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin. Liver: A moderate rise in AST ( SGOT) and/ or ALT ( SGPT) has been noted in patients treated with ampicillin-class antibiotics, but the significance of these findings is unknown. Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin and/or alkaline phosphatase, has been infrequently reported with amoxycillin/clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible.