Dalacin-T: Product Information
DALACIN TŪ
Clindamycin phosphate
USP
1% Topical Solution,
Presentation
DALACIN T Topical Solution is a
clear alcoholic solution containing clindamycin phosphate at a
concentration equivalent to 10mg clindamycin per
millilitre.
Action
Clindamycin has been shown to
have in vitro activity against isolates of Propionibacterium
acnes.
Following multiple topical
applications of clindamycin phosphate at a concentration
equivalent to 10mg clindamycin per ml (1%) in an isopropyl
alcohol and water solution, very low levels of clindamycin are
present in the serum (0 - 3 nanograms/ml) and approximately
0.25% of the dose is recovered in urine as
clindamycin.
Clindamycin activity has been
demonstrated in comedones from acne patients. The mean
concentration of antibiotic activity in extracted comedones
after application of DALACIN T Solution for four weeks was
597mcg/g of comedonal material (range 0-1490). Clindamycin in
vitro inhibits all Propionibacterium acnes cultures tested
(MICs 0.4mcg/ml). Free fatty acids on the skin surface have
been decreased from approximately 14% to 2% following
application of clindamycin.Indications
DALACIN T (topical clindamycin
phosphate) is indicated in the treatment of mild to moderate
acne.
Dosage
and Administration
Apply a thin film of DALACIN T
Topical (clindamycin phosphate) twice daily to affected area.
If condition worsens or does not respond within 21 days, seek
medical advice.Contraindications
DALACIN T Topical (clindamycin
phosphate) is contraindicated in individuals with a history of
hypersensitivity to preparations containing clindamycin or
lincomycin.Warnings and
Precautions
Oral and parenteral clindamycin,
as well as most other antibiotics, have been associated with
severe diarrhoea and pseudomembranous colitis. Diarrhoea and
colitis have been reported infrequently with topical
clindamycin. However, the physician should be alert to the
possible development of antibiotic-associated diarrhoea or
colitis. If significant or prolonged diarrhoea occurs, the
drug should be discontinued and appropriate diagnostic
procedures and treatment provided as necessary.
Safety for use of DALACIN T
Topical in pregnancy has not been established.
It is not known whether
clindamycin is excreted in human milk following use of DALACIN
T Topical. However, orally and parenterally administered
clindamycin has been reported to appear in breast milk. As a
general rule, nursing should not be undertaken while a patient
is on a drug since many drugs are excreted in human
milk.
DALACIN T
Topical
should be prescribed with caution in atopic
individuals.
Adverse Effects
Reports of side effects with
DALACIN T Topical (clindamycin phosphate) have been
infrequent, with skin dryness being the most common adverse
effect seen with the solution.
Effects which have been reported
in association with the use of topical formulations of
clindamycin include:
oily skin
skin irritation
contact dermatitis
stinging of the eye
gastrointestinal disturbances
abdominal pain
gram-negative folliculitis
Interactions
Nil
Overdosage
Nil
