Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLINDAMYCIN HYDROCHLORIDE
Chanelle Healthcare Limited
150 Milligram
Capsules Hard
2008-07-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clindamycin 150 mg Capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains clindamycin hydrochloride equivalent to 150 mg clindamycin. Also contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. A capsule with a lavender body and maroon cap imprinted with "CL 150" in white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clindamycin is indicated for the treatment of severe infections caused by susceptible gram-positive aerobic organisms or by susceptible anaerobic organisms. Consideration should be given to official guidance regarding the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be taken orally. Clindamycin Capsules should always be taken with a glass of water and in an upright position. Absorption of Clindamycin Capsules is not appreciably modified by the presence of food. Adults (including the elderly): Moderately severe infection: 150 - 300 mg every six hours Severe infections: 300 - 450 mg every six hours Children: 3 - 6 mg/kg every six hours depending on the severity of the infection. Dosage in Reneal/Hepatic Impairment: Clindamycin dose modification is not necessary in patients with renal or hepatic insufficency. Note: In cases of beta-haemolytic streptococcal infections, treatment with Clindamycin Capsules should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis. 4.3 CONTRAINDICATIONS Clindamycin is contraindicated in patients previously found to be hypersensitive to this antibiotic. Although cross- sensitisation to lincomycin has not been demonstrated, it is recommended that clindamycin is not used in patients who have demonstrated lincomycin Read the complete document