Endclav-625

Endclav-625

amoxicillin + clavulanic acid

Manufacturer:

Endurance

Distributor:

Ambica
Full Prescribing Info
Contents
Co-amoxiclav: Amoxicillin, potassium clavulanate.
Description
Each film-coated tablet contains: Amoxicillin Trihydrate Equivalent to Amoxicillin 500 mg, Clavulanic Acid Equivalent to Potassium Clavulanate diluted 125 mg.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Co-Amoxiclav is a novel concept in antibiotic therapy. Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The Clavulanate anticipates this defense mechanism by blocking the β-lactamase enzymes, thus rendering the organisms sensitive to amoxicillin's rapid bactericidal effect of concentrations readily attainable in the body. Clavulanate by itself has little antibacterial activity, however, in association with amoxicillin it produces a novel antibiotic agent of broad spectrum with wide application in hospital and general practice.
Indications/Uses
Indicated in the treatment of infections of lower respiratory tract infection, otitis media, sinusitis, skin and skin structure infections and urinary tract infections.
Dosage/Direction for Use
Adults: The usual adult dose is 625 mg tablets of co-amoxiclav every 12 hours or one 375 mg tablet of co-amoxiclav every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 1000 mg tablet of co-amoxiclav every 12 hours or one 625 mg tablet of co-amoxiclav every 8 hours. Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
Severely impaired patients with a glomerular filtration rate of <30 mL/min should not receive the 1000 mg tablet. Severely impaired patients with a glomerular filtration rate of 10 to 30 mL/min should receive 625 mg or 375 mg or every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 625 or 375 every 24 hours, depending on severity of the infection.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.
Pediatric Patients: Pediatric patients weighing 40 kg or more should be dosed according to the adult recommendations. Due to the different amoxicillin to clavulanic acid ratios in the 375 mg tablet of co-amoxiclav versus 250 mg chewable tablet of co-amoxiclav should not be used until the pediatric patients weighs at least 40 kg or more.
Administration: Co-amoxiclav may be taken without regard to meals, however, absorption of Clavulanate potassium is enhanced when co-amoxiclav is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, co-amoxiclav should be taken all the start of a meal or as directed by the physician.
Overdosage
Co-amoxiclav may be removed from the circulation by haemodialysis.
Contraindications
A history of allergic reaction to β-lactams eg. penicillins or cephalosporins is a contraindication.
Co-amoxiclav is contraindicated in patients with previous history of Co-amoxiclav associated jaundice/hepatic dysfunction.
Warnings
Drugs that delay peristalsis, eg opiates and diphenoxylate with atropine may prolong and/or worsen the condition and should not be used.
Fluids, electrolytes and protein replacement therapy should be provided when indicated.
Special Precautions
Co-amoxiclav should be used with care in patients with evidence of hepatic dysfunction.
Use In Pregnancy & Lactation
Use in Pregnancy: There is limited experience of the use of Co-amoxiclav in human pregnancy. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.
Use in Pregnancy: Amoxicillin is excreted in breast milk; there are no data on the excretion of Clavulanic Acid in human milk. Therefore, caution should be exercised when administering to a nursing woman.
Adverse Reactions
Gastrointestinal Reactions: Gastritis, stomatitis, glossitis, black "hair" tongue, indigestions, nausea, vomiting, diarrhea, enterocolitis, pseudomembranous colitis and candidiasis have been reported.
Hypersensitivity Reactions: Skin rashes and urticaria have been reported. These reactions may be controlled with antihistamines and if necessary, systemic corticosteroids. Rare cases of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and an occasional case of exfoliative dermatitis have been reported. Interstitial nephritis can occur rarely. Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema have been reported in patients on penicillin therapy. Cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins, may occur.
Hepatic Effects: As with some other agents, a few cases of transient hepatitis and cholestatic jaundice have been reported.
Haematologic Effects: Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillins.
Drug Interactions
Following administration of ampicillin to pregnant women a transient decrease in plasma concentration of total conjugated oestriol, estradiol has been noted. This effect may also occur with amoxicillin and therefore with Co-amoxiclav. Probenecid decreases the renal tubular secretion of amoxicillin but does not affect clavulanic acid excretion. Concurrent use with Co-amoxiclav may result in increased and prolonged blood levels of amoxicillin but not to clavulanic acid. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both medicines as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. No information is available about the concurrent use of Co-amoxiclav and Alcohol. However, the ingestion of alcohol while being treated with the beta-1 lactam antibiotics latamoxef, cefoperazone and cephamandole has precipitated a disulfiram (Antabuse) like reaction in some patients. Therefore the ingestion of alcohol should be avoided during and for several days after treatment with Co-amoxiclav.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 14's.
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