Bactoclav

Bactoclav

amoxicillin + clavulanic acid

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Co-amoxiclav: Amoxicillin & clavulanate potassium.
Description
Each 375-mg and 625-mg tablet contain co-amoxiclav: Amoxicillin equivalent to anhydrous amoxicillin 250 mg and 500 mg, respectively, and clavulanate potassium equivalent to clavulanic acid 125 mg.
Action
Pharmacological Category: β-lactam antibiotic.
Pharmacology: Mode of Action: The efficacy of amoxicillin with clavulanic acid is the result of bactericidal activity of amoxicillin combined with the inhibitory activity of clavulanic acid on β-lactamases produced by different bacterial strains. Like other β-lactams, clavulanic acid penetrates through the bacterial cell wall but it generally possesses poor intrinsic antimicrobial activity and is generally a more potent inhibitor of cell free β-lactamases. The binding of β-lactamases with clavulanic acid is a complex physiochemical process, which rapidly leads to lysis of the cell.
Pharmacokinetics: Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract (GIT) after oral administration of amoxicillin with clavulanate potassium. The safety and efficacy of amoxicillin with clavulanate potassium have been established in clinical trials where amoxicillin with clavulanate potassium was taken without regard to meals. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, eg, amoxicillin, is well distributed in body tissues. Approximately 50-70% of the amoxicillin and approximately 25-40% of the clavulanic acid are excreted unchanged in urine during the 1st 6 hrs after oral administration of 500+125 mg of amoxicillin with clavulanate potassium tablets. Concurrent administration of probenecid delays renal excretion of amoxicillin but does not delay renal excretion of clavulanic acid.
Indications/Uses
Treatment of infections caused by susceptible strains listed as follows:
Lower Respiratory Tract Infections, Otitis Media and Sinusitis: Caused by β-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
Skin and Skin Structure Infections: Caused by β-lactamase-producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella sp.
Urinary Tract Infections: Caused by β-lactamase-producing strains of Escherichia coli, Klebsiella sp and Enterobacter sp.
Dosage/Direction for Use
Usual Dose: 250-500 mg with respect to the amoxicillin component every 8 hrs.
Children <10 years: 125-250 mg with respect to the amoxicillin component every 8 hrs; <20 kg bodyweight: 20-40 mg/kg daily in divided doses every 8 hrs.
Neonates and Infants <12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose is 30 mg/kg/day in divided doses every 12 hrs, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group.
Administration: Amoxicillin with clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin with clavulanate potassium is administered at the start of a meal. To minimize the potential for GI intolerance, amoxicillin with clavulanate potassium should be taken at the start of a meal.
Overdosage
Most patients have been asymptomatic following overdosage or have experienced primarily GI symptoms including stomach and abdominal pain, vomiting and diarrhoea. Rash, hyperactivity or drowsiness have also been observed in a small number of patients.
In the case of overdosage, discontinue amoxicillin with clavulanate potassium, treat symptomatically and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed.
Contraindications
Patients with a history of allergic reactions to any penicillin, previous history of amoxicillin with clavulanate potassium-associated cholestatic jaundice/hepatic dysfunction.
Warnings
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
Special Precautions
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Pseudomonas or Candida), Bactoclav should be discontinued and/or appropriate therapy instituted. While amoxicillin with clavulanate potassium possesses the characteristic low toxicity of the penicillin group of antibiotics, 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.
Use in pregnancy & lactation: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Bactoclav should be used during pregnancy only if clearly needed.
Ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin with clavulanate potassium is administered to a nursing woman.
Use In Pregnancy & Lactation
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Bactoclav should be used during pregnancy only if clearly needed.
Ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin with clavulanate potassium is administered to a nursing woman.
Adverse Reactions
Amoxicillin with clavulanate potassium is generally well tolerated. The majority of side effects observed in clinical trials were of a mild and transient nature. The most frequently reported adverse effects were diarrhoea/loose stools, nausea, skin rashes and urticaria, vomiting and vaginitis (1%). The overall incidence of side effects and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence and headache.
Drug Interactions
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin with clavulanate potassium may result in increased and prolonged blood levels of amoxicillin. Amoxicillin with clavulanate potassium may reduce the efficacy of oral contraceptives. The possibilities of prolonged bleeding time in individuals receiving anticoagulants concurrently should be borne in mind.
Storage
Store below 25°C, in dry place. Protect from direct sunlight.
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 375 mg 1 x 6's. 625 mg 3 x 6's.
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