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Logo DALACIN T™ (Solution)
DALACIN T™ (Lotion)
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DALACIN T™ (Solution)
DALACIN T™ (Lotion)

COMPOSITION:
DALACIN T Solution contains the following per mL:
Clindamycin phosphate equivalent to
  Clindamycin base         10 mg
  Isopropyl alcohol (preservative)         50% m/v
  Propylene glycol (preservative)         5% m/v
DALACIN T Lotion contains the following per mL:
Clindamycin phosphate equivalent to:
  Clindamycin base 10 mg
  Methylparaben (preservative) 0,3% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.6 Topical antibiotics.

PHARMACOLOGICAL ACTION:
Microbiology:
Although clindamycin phosphate is inactivein vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.
Clindamycin has been shown to have in vitro activity against isolates of Propionibacterium acnes. This may account for its usefulness in acne.
Cross resistance has been demonstrated between clindamycin and lincomycin.
Antagonism has been demonstrated between clindamycin and erythromycin.
Clindamycin activity has been demonstrated in comedonal extracts from acne patients. The mean concentration of antibiotic activity in comedonal extracts was 597 micrograms/g of comedonal material. Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0,4 micrograms/mL).
Free fatty acids on skin surface have been decreased from approximately 14% to 2% following application of topical clindamycin.
Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, low levels of clindamycin are present in the serum (+ 3 ng/mL).

INDICATIONS:
DALACIN T Solution and DALACIN T Lotion are indicated in the treatment of acne vulgaris.

CONTRA-INDICATIONS:
DALACIN T Solution and DALACIN T Lotion are contra-indicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

DOSAGE AND DIRECTIONS FOR USE:
Apply a thin film of DALACIN T Solution or DALACIN T Lotion twice daily to the affected area.
DALACIN T Lotion should be shaken immediately before using.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Skin dryness is the most common adverse reaction seen with the solution.
The following adverse effects have been reported with the use of topical clindamycin:
  abdominal pain
  skin irritation
  contact dermatitis
  gastro-intestinal disturbances
  stinging of the eyes
  gram negative folliculitis
  skin oiliness
The use of clindamycin has been associated with severe diarrhoea and pseudomembranous colitis. Diarrhoea has been reported with topical clindamycin. Therefore the physician should be alert to the possible development of antibiotic-associated diarrhoea or colitis. If significant or prolonged diarrhoea occurs, the medication should be discontinued and appropriate diagnostic procedures and treatment provided as necessary.
DALACIN T Solution contains an alcohol base which can cause burning and irritation of the eyes, mucous membranes and abraded skin. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying the medication around the mouth.
DALACIN T Solution should be prescribed with caution in atopic individuals.
Pregnancy: Safe use of DALACIN T Solution and DALACIN T Lotion in pregnancy and lactation has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment should be symptomatic and supportive.

IDENTIFICATION:
DALACIN T Solution: Clear solution.
DALACIN T Lotion: A smooth white to off-white emulsion with no evidence of phase separation.

PRESENTATION:
DALACIN T Solution is available in 30 mL applicator bottles (10 mg clindamycin per millilitre). The applicator is designed so that the solution may be applied directly to the involved skin.
DALACIN T Lotion is available in 30 mL plastic bottles (10 mg clindamycin per millilitre).

STORAGE INSTRUCTIONS:
Store below 30°C.
Keep out of reach of children.

REGISTRATION NUMBERS:
DALACIN T™ Solution:         P/20.1.6/63
DALACIN T™ Lotion:         Y/20.1.6/326

NAME AND ADDRESS OF APPLICANT:
Pharmacia South Africa (Pty) Limited
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 February 1992

™ = TRADE MARK

New addition to this site: February 2005
Source: Pharmaceutical Industry

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