资料单张
July 2011
CLINDATECH
®
ACNE TREATMENT TOPICAL SOLUTION
Clindamycin Hydrochloride 1%
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START CLINDATECH TREATMENT, EVEN IF
YOU HAVE USED CLINDATECH BEFORE. THIS
LEAFLET
ANSWERS
SOME
COMMON
QUESTIONS IN RELATION TO CLINDATECH. IT
DOES NOT CONTAIN ALL THE AVAILABLE
INFORMATION. IF YOU HAVE ANY QUESTIONS
OR CONCERNS ABOUT APPLYING THIS
MEDICINE, PLEASE ASK YOUR DOCTOR OR
PHARMACIST. KEEP THIS LEAFLET WITH YOUR
MEDICINE. YOU MAY NEED TO READ IT
AGAIN.
IDENTIFICATION
ClindaTech is the brand name of a skin
preparation
containing
clindamycin
hydrochloride
and
a
moisturiser.
ClindaTech Topical Solution is a clear
solution packed in a bottle with an outer
carton.
It contains clindamycin hydrochloride 1%
(active ingredient), ethanol, dioctyl
malate and purified water.
It is available in two pack types, i.e. 50mL
and 100mL.
WHAT CLINDATECH IS USED FOR
Clindamycin belongs to a group of
medicines called antibiotics. It is
available
only
with
a
doctor’s
prescription. Topical clindamycin is used
on the skin to treat certain forms of
acne. It works by decreasing acne lesions
and / or stopping the growth of skin
bacteria which cause acne. It is usually
used by itself, but your doctor may
prescribe one or more other medicines
that are applied on the skin or taken by
mouth. Your doctor may also prescribe
ClindaTech
for
another
purpose.
Therefore, ask your doctor if you have
any questions why ClindaTech has been
prescribed for yo
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产品特点
CLINDATECH
®
TOPICAL SOLUTION PRODUCT INFORMATION
i. NAME OF THE DRUG
Tradename: ClindaTech Topical Solution
clindamycin (as hydrochloride)
Non-proprietary name: clindamycin hydrochloride
Chemical name: methyl 6-amino-7-chloro-6,7,8-
trideoxy-N-[(2S,4R)-1-methyl-4-propylprolyl]-1-
thio-L-threo- -D-galacto-octopyranoside hydrochloride
Molecular formula: C18H33ClN2O5S.HCl
Molecular Structure:
Molecular Weight: 461.5
1.086g of clindamycin hydrochloride (anhydrous form) is
approximately equivalent to 1g of clindamycin.
ii. DESCRIPTION
ClindaTech Topical Solution is a clear hydroalcoholic solution
containing clindamycin hydrochloride 1%.
Dioctyl malate, a noncomedogenic humectant, is incorporated to
prevent skin dryness.
iii. PHARMACOLOGY
Pharmacological Action
Clindamycin is a lincosamide antibiotic obtained as a semi-
synthetic derivative from cultures of _Streptomyces lincolnensis_. It
is active _in vitro _and _in vivo _against most aerobic gram-positive
cocci and several anaerobic and micro-aerophilic gramnegative
and gram-positive organisms including _Propionibacterium acnes_,
a resident anaerobe found in acne-susceptible follicles.
Cross-resistance has been demonstrated between clindamycin
and lincomycin. Antagonism has been demonstrated between
clindamycin and erythromycin.
Clindamycin may be bacteriostatic or bactericidal in action,
depending on the concentration of the drug attained at the site of
infection and the susceptibility of the infecting organism. _In vitro _
studies showed that the minimum inhibitory concentration of
clindamycin against most wild strains of _P. acnes _(46 strains at
the concentration of 108/ml) ranged from 0.05 to 0.1 µg/ml or
below. The antibacterial action appears to relate to its ability i
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