Product Data
Composition:
film-coated: 375 mg (250mg/125 mg). 625 mg (500mg/125 mg). 1 g (875mg/125 mg). Dry Powder Suspensions: Suspension: 200mg/28.5 /5 mL (7:1)400 mg/57 mg/5 ml (7:1)
Indications And Usage:
Amoxycillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower Respiratory Tract Infections — caused by ß-lactamase - producing strains of H. influenzae and M. (Branhamella) catarrhalis. Otitis Media–caused by ß-lactamase–producing strains of H. influenzae and M. catarrhalis. Sinusitis–caused by ß-lactamase–producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections – caused by ß-lactamase – producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections – caused by ß-lactamase – producing strains of E. coli, Klebsiella spp., and Enterobacter spp.
Contraindications:
Amoxycillin/clavulanate potassium is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxycillin/clavulanate potassium.
Dosage & Administration:
Pediatric Patients: Based on the amoxycillin component, Hibiotic® should be dosed as follows: Neonates and infants aged < 12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxycillin in this age group, the recommended dose of Hibiotic® is 30 mg/Kg/day divided q12h, based on the amoxycillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/5 mL formulation in this age group is limited and, thus, use of the 125 mg/5 mL oral suspension is recommended. Patients aged 12 weeks (3 months) and older
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.
INFECTIONS | DOSING REGIMEN |
Q12h | |
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.
Drug Interactions:
Interaction with other medicaments and other forms of interaction: Concomitant use of probenecid is not recommended. Concomitant use of allopurinol during treatment with amoxycillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Hibiotic® and allopurinol. Hibiotic® may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
Precautions:
Warnings Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Before initiating therapy with amoxycillin/clavulanate potassium, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, Cephalosporins or other allergens. If an allergic reaction occurs, amoxycillin/clavulanate potassium should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxycillin/clavulanate potassium, and has ranged in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluid and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis. Amoxycillin/clavulanate potassium should be used with caution in patients with evidence of hepatic dysfunction. \ Hepatic toxicity associated with the use of amoxycillin/clavulanate potassium is usually reversible On a rare occasions, deaths have been reported. These have generally been cases associated with serious underlying diseases or concomitant medications. Concomitant administration of amoxycillin and anticoagulants from the coumarin class, may prolong the bleeding time. A dose adjustment of anticoagulants may be necessary.
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.
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.
Storage:
Storage Conditions: Store at Temperature not Exceeding 25ºC, In dry place.
Pregnancy & Lactation:
Pregnancy & Lactation: Use in Pregnancy: use should be avoided in pregnancy, unless considered essential by the physician. Use in Lactation: Hibiotic® may be administered during the period of lactation. With the exception of the risk of sensitization, associated with the excretion of trace quantities in breast milk.
Adverse Effects:
Undesirable effects:
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.
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.
