Dalacin C Capsules

Abbreviated Prescribing Information

Presentation: Capsules containing 75 or 150mg clindamycin.

Indications: Serious infections caused by susceptible Gram-positive organisms, staphylococci, streptococci and pneumococci and susceptible anaerobic pathogens.
Dosage: See Summary of Product Characteristics for full details. Take with water.

Adults: 150-300mg every 6 hours increasing to 300-450mg every 6 hours in severe infection. Elderly: No age related increase in toxicity. Children: 3-6mg/kg every 6 hours.

Contraindications: Previous sensitivity to clindamycin, lincomycin or to any component of the formulation.
Warnings / Precautions: Only use for serious infections. Colitis has been reported during and after administration. Discontinue immediately on appearance of marked diarrhoea. Caution in patients with a history of gastrointestinal disease/colitis. Periodic liver and kidney function tests during prolonged therapy and in neonates and infants. Dose reduction may be needed in patients with renal or hepatic impairment. Prolonged administration may lead to super-infection. Care in atopic individuals. Caution in patients receiving neuromuscular blocking agents. Do not use with erythromycin. Caution if administered to nursing mother.

Adverse Effects: Gastro-intestinal: Nausea, vomiting, abdominal pain, diarrhoea and oesophagitis Haematopoietic: No direct relationship has been established for transient neutropenia, eosinophilia, agranulocytosis,. Skin: Pruritus, vaginitis, exfoliative (rare) and vesiculobullous dermatitis (rare). Hypersensitivity reactions: Rash and urticaria, erythema multiforme (rare), anaphylactoid reactions (few cases) and Stevens-Johnson syndrome (rare). Liver: Jaundice, liver function test abnormalities.

Package Quantity and Basic NHS Price: Pack of 24 capsules: 75mg £7.45; 150mg £13.72. Pack of 100 capsules 150mg £55.08
Marketing Authorization Numbers and Holder: PL00032/5006R and PL00032/5007R. Pharmacia Limited, Davy Avenue, Milton Keynes, MK5 8PH.

Legal Category: POM.
Further information is available on request from Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS

Date of Preparation October 2004

 

P 9094/2/03

 

DAF/G 2_0