Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLINDAMYCIN HYDROCHLORIDE
B & S Healthcare
150 Base Milligrams
Capsules Hard
2010-01-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dalacin C 150 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains clindamycin hydrochloride equivalent to 150 mg of clindamycin base. Excipients: Lactose monohydrate For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard _Product Imported from France:_ Size 1, hard gelatin capsules with an opaque white body and an opaque white cap, containing a white to off-white powder. The capsule is imprinted with ‘CLIN 150’ and ‘Pfizer’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of serious infections due to organisms susceptible to this anti-infective. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be taken orally. Dalacin C Capsules should always be taken with a glass of water. Absorption of Dalacin C is not appreciably modified by the presence of food. ADULTS (INCLUDING THE ELDERLY): Moderately severe infection: 150 - 300 mg every six hours CHILDREN (OVER 1 MONTH OF AGE): The usual daily dosage is 12 - 24 mg/kg in 4 divided doses. In children under one year of age or weighing 10 kg or less, the minimum recommended dosage is 37.5 mg every eight hours. DOSAGE IN ELDERLY The dosage of clindamycin may require reduction in patients with renal impairment due to prolongation of the serum half-life of this drug. This is particularly important with parenteral dosage. DOSAGE IN RENAL IMPAIRMENT Clindamycin dosage modification is not necessary in patients with renal insufficiency. Note: In cases of beta-haemolytic streptococcal infection, treatment with Dalacin C should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis. IRISH MEDICINES BOARD _______________________________________________ Read the complete document