DALACIN T LOTION 1%

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

CLINDAMYCIN PHOSPHATE EQV CLINDAMYCIN

Tilgængelig fra:

PFIZER PRIVATE LIMITED

ATC-kode:

D10AF01

Dosering:

1.00%

Lægemiddelform:

LOTION

Sammensætning:

CLINDAMYCIN PHOSPHATE EQV CLINDAMYCIN 1%

Indgivelsesvej:

TOPICAL

Recept type:

Prescription Only

Fremstillet af:

Pfizer Manufacturing Belgium NV

Autorisation status:

ACTIVE

Autorisation dato:

1993-02-11

Indlægsseddel

 
DALACIN T
®

PHARMACEUTICAL FORM 
Topical Solution and Topical Lotion. 

FOR EXTERNAL USE 
DESCRIPTION 
Each mL of DALACIN
T Topical Solution contains clindamycin phosphate equivalent to 10 mg of 
clindamycin base. 

Each mL of DALACIN T Topical
Lotion contains clindamycin phosphate equivalent to 10 mg of 
clindamycin base. 

Clindamycin phosphate is a water soluble ester
of the semi-synthetic antibiotic produced by a 
7(S)-chloro-substitution of the 7(R)-hydroxyl
group of the parent antibiotic lincomycin. 

The structural formula is represented below: 

Molecular formula: C
18
H
34
ClN
2
O
8
PS 

The chemical name for clindamycin phosphate is
7(S)-chloro-7-deoxylincomycin-2-phosphate 
(MW=504.96). 

DALACIN T Topical Solution is
supplied in bottles containing 30 mL of topical solution. In addition 
to clindamycin phosphate, the topical
solution contains propylene glycol, isopropyl alcohol 0.5 mL, 
and purified water. 

DALACIN T Topical Lotion is supplied in bottles
containing either 30 mL or 60 mL of lotion. In 
addition to clindamycin phosphate, the topical
lotion contains sodium lauroyl sarcosinate, 
methylparahydroxybenzoate, glycerol, stearic acid, lexemul T,
cetostearyl alcohol, isostearyl 
alcohol, and purified water. 

CLINICAL PHARMACOLOGY 
PHARMACODYNAMICS 
Although clindamycin phosphate is
inactive _in vitro_, rapid _in vivo_ hydrolysis converts this
compound 
to the antibacterially active clindamycin. Clindamycin has
been shown to have _in vitro_ activity 
against all isolates
of _Propionibacterium acnes_ cultures tested (MICs 0.4 mcg/mL).
This may 
account for its
usefulness in acne. Free fatty acids on the skin surface have been decreased from 
approximately 14% to 2% following application of clindamycin. 

In addition, clindamycin has shown a wide range of _in vitro_ activi

Produktets egenskaber

Page 1 of 6
DALACIN T
®
PHARMACEUTICAL FORM
Topical Lotion.
FOR EXTERNAL USE
DESCRIPTION
Each mL of DALACIN T Lotion contains clindamycin phosphate equivalent
to 10 mg
of clindamycin base.
Clindamycin phosphate is a water soluble ester of the semi-synthetic
antibiotic
produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of
the parent
antibiotic lincomycin.
The structural formula is represented below:
Molecular formula: C
18
H
34
ClN
2
O
8
PS
The chemical name for clindamycin phosphate is
7(S)-chloro-7-deoxylincomycin-2-
phosphate (MW=504.96).
DALACIN T Lotion is supplied in bottles containing either 30 mL or 60
mL of lotion.
In addition to clindamycin phosphate, the topical lotion contains
sodium lauroyl
sarcosinate, methylparahydroxybenzoate, glycerol, stearic acid,
lexemul T, cetostearyl
alcohol, isostearyl alcohol, and purified water.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Mechanism of action
Clindamycin is a lincosamide antibiotic that inhibits bacterial
protein synthesis. It
binds to the 50S ribosomal subunit and affects both ribosome assembly
and the
translation process. Although clindamycin phosphate is inactive _in
vitro_, rapid _in vivo_
hydrolysis converts this compound to the antibacterially active
clindamycin.
Page 2 of 6
Clindamycin has been shown to have _in vitro_ activity against
isolates of the following
organisms;
Anaerobic gram positive non spore forming _bacilli_, including:
_Propionibacterium acnes._
Pharmacodynamic effects
Efficacy is related to the time period that the agent level is above
the minimum
inhibitory concentration (MIC) of the pathogen (%T/MIC).
Resistance
Resistance to clindamycin in _Propionibacterium acnes_ can be caused
by mutations at
the rRNA antibiotic binding site or by methylation of specific
nucleotides in the 23S
RNA of the 50S ribosomal subunit. These alterations can determine
cross resistance
to macrolides and streptogramins B (MLS
B
phenotype). Macrolide-resistant isolates
should be tested for inducible resistance to clindamycin using t