Bactoclav Tablets

Class: Anti bacterial agent

Manufacturer: Micro Labs Limited

Dosage Form: Tablet

Similar Brands:

Uses:

Amoxicillin; clavulanate potassium is indicated in the treatment of infections caused by susceptible strains listed below.

Lower Respiratory Tract Infections Caused by b-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Otitis media Caused by b-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Sinusitis Caused by b-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Skin and skin structure infections Caused by b-lactamase-producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp.

Urinary tract infections Caused by b-lactamase-producing strains of Escherichia coli, Klebsiella spp. and Enterobacter spp.

Dosage:

Adults

The usual dose in one 500/125mg tablet of amoxicillin and clavulanate potassium every 12 hour or one 250/125mg of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be 875/125mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500/125mg tablet on amoxicillin and clavulanate potassium every 8 hours.

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severally impaired patients with a glomerular filtration rate of >30mL/min. should not receive the 875/125mg tablet.

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

Children

Children upto the age of 10 years may be given 125 to 250mg every 8 hours. Children less than 20kg weight dose of 20 to 40mg/kg daily in divided doses every 8 hours may be employed.

Neonates and infants aged <12 weeks (3 months)

Due to incomplete developed renal functions affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and potassium clavulanate tablet is 30mg/kg/day in divided doses every 12 hours, based on amoxicillin component. Clavulanate elimination is unaltered in this age group.

Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, to minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at least at the start of a meal.

Side Effects:

Amoxicillin; clavulanate potassium is generally well tolerated. The majority of side effects observed in clinical trial were of a mild and transient nature. The most frequently reported adverse effects were diarrhea/loose stool, 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.

Warnings & 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), the drug should be discontinued and /or appropriate therapy instituted. While amoxicillin; calvulanate potassium possesses the characteristics low toxicity of the penicillin group of antibiotics, periodic assessment of organ system 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.

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.

Pregnancy & Lactation:

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if needed.

Nursing mothers; ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin; clavulanate potassium is administered to a nursing woman.

Drug Interactions:

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin; clavulante potassium may result in increased and prolonged blood levels of amoxicillin. Amoxicillin; clavulanate  potassium may reduce the efficacy of oral contraceptives. The possibilities of prolonged bleeding time in individuals receiving anti-coagulants concurrently should be borne in mind.

Contraindications:

Amoxicillin; clavulanate potassium is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated I patients with a previous history of amoxicillin; clavulanate potassium associated cholestatic jaundice/hepatic dysfunction.

Price: Ksh 450

Notes:

Date of publication June 2007