NOSCLAV® – 375/625 Amoxicillin and Clavulanate Potassium Tablets B.P
Nosclav – 375: Each film-coated tablet contains Amoxicillin trihydrate BP equivalent to Amoxicillin 250mg and Clavulanate potassium BP (as diluted potassium clavulanate BP) equivalent to clavulanic acid 125mg.
Nosclav – 625: Each film coated tablet contains Amoxicillin trihydrate BP equivalent to Amoxicillin 500mg and Clavulanate potassium BP (as diluted potassium clavulanate BP) equivalent to clavulanic acid 125mg.
Pharmacology and Indications:
The efficacy of Amoxillin + Clavulanic acid is the result of bactericidal activity of Amoxicillin combined with the inhibitory activity of Clavulanic acid on 3- lactamases produced by different bacterial strains.
Nosclav is indicated for the treatment of
- Lower respiratory tract infections, Otitis media, Sinusitis, Skin and Skin structure infections, urinary tract infections.
Nosclav is contraindicated in patients with any history of allergic reactions to any penicillin and in patients with a previous history of Amoxicillin / clavulanate potassium – associated cholestatic jaundice / hepatic dysfunction.
Side effects/Adverse reactions
Nosclav is generally well tolerated. The most frequently reported adverse effects were diarrhea / loose stools, nausea, vomiting, skin rashes, urticaria and vaginitis. Other less frequently reported reactions include abdominal discomfort, flatulence and headache.
Probenecid decreases the renal tubular secretion of amoxicillin; concurrent use with Nosclav may result in increased and prolonged blood levels of Amoxicillin. Nosclav may reduce the efficacy of oral contraceptives.
Concomitant use of Nosclav with anticoagulants may result in prolonged bleeding time.
Use in Pregnancy and lactation
There are no adequate and well controlled studies in pregnant women therefore; the drug should be used during pregnancy only if clearly needed.
Caution should be exercised when Nosclav is administered to a nursing mother since it is excreted in the milk.
Dosage and administration
Usual oral dose is 250 to 500mg every 8 hours.
Children: Children up to the age of 10 years may be given 125 to 250mg every 8 hours.
Under 20kg body weight: a 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 incompletely developed renal function affecting elimination of Amoxicillin in this age group, the recommended dose of Nosclav is 30mg/kg/day in divided doses every 12 hours based on the Amoxicillin content.