DALACIN T TOPICAL LOTION 10 MG/ML CUTANEOUS EMULSI
국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
제품 특성 요약
(SPC)
07-05-2024
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유효 성분:
CLINDAMYCIN PHOSPHATE
제공처:
Pharmacia Ireland
복용량:
10 Base mg/ml
약제 형태:
Cutaneous Emulsion
승인 날짜:
2001-01-03
제품 특성 요약
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dalacin T Topical Lotion 10 mg/ml Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of emulsion contains clindamycin phosphate equivalent to 10 mg clindamycin.
Excipients: Cetostearyl alcohol 25 mg/ml
Methyl parahydroxybenzoate (E218) 3 mg/ml
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous emulsion.
Smooth, white to off-white emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply a thin film of Dalacin T Topical Lotion twice daily to the affected area.
4.3 CONTRAINDICATIONS
Dalacin T is contraindicated in patients previously found to be hypersensitive to preparations containing clindamycin or
lincomycin. This is also contra-indicated in patients with a history of inflammatory bowel disease or a history of
antibiotic-associated colitis.
Dalacin T should not be used in patients with systemic infections for which antimicrobials are being used.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe
pseudomembranous colitis. However, post-marketing studies have indicated a very low incidence of colitis with
Dalacin T Lotion. The physician should, nonetheless, be alert to the development of antibiotic-associated diarrhoea or
colitis. If diarrhoea occurs, the product should be discontinued immediately.
Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic-
associated colitis. Colitis is usually characterized by persistent, severe diarrhoea and abdominal cramps. Endoscopic
examination may reveal pseudomembranous colitis. Stool culture for C. difficile and/or assay for
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