DALACIN T TOPICAL SOLUTION 1%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CLINDAMYCIN PHOSPHATE EQV CLINDAMYCIN

Available from:

PFIZER PRIVATE LIMITED

ATC code:

D10AF01

Dosage:

10 mg/ml

Pharmaceutical form:

SOLUTION

Composition:

CLINDAMYCIN PHOSPHATE EQV CLINDAMYCIN 10 mg/ml

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

PFIZER MANUFACTURING BELGIUM NV

Authorization status:

ACTIVE

Authorization date:

1988-05-18

Patient Information leaflet

 
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

Summary of Product characteristics

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.
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.
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_