DALACIN C CAPSULE 300 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CLINDAMYCIN HCl EQV CLINDAMYCIN

Available from:

PFIZER PRIVATE LIMITED

ATC code:

J01FF01

Dosage:

300 mg

Pharmaceutical form:

CAPSULE

Composition:

CLINDAMYCIN HCl EQV CLINDAMYCIN 300 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Fareva Amboise

Authorization status:

ACTIVE

Authorization date:

1997-09-12

Patient Information leaflet

1. NAME OF THE MEDICINAL PRODUCT 
DALACIN. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active Ingredient: clindamycin
hydrochloride or palmitate hydrochloride or phosphate. 

Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution
of 
the 7(R)-hydroxyl group of the parent compound lincomycin. 

Clindamycin hydrochloride is the hydrated
hydrochloride salt of clindamycin. Each 
capsule contains clindamycin hydrochloride equivalent to 150
mg or 300 mg of 
clindamycin. 

Clindamycin palmitate hydrochloride is a water soluble
salt of the ester of 
clindamycin and palmitic acid. Clindamycin
pediatric flavored granules contain 
clindamycin palmitate hydrochloride for reconstitution. Each 5
mL contains the 
equivalent of 75 mg clindamycin. 

Clindamycin phosphate is a
water-soluble ester of clindamycin and phosphoric acid. 
Each mL contains the equivalent of 150 mg clindamycin, 0.5
mg disodium edetate 
and 9.45 mg benzyl alcohol added as preservative in each mL. 

3. PHARMACEUTICAL FORM 
Capsules, Granules for oral solution, Solution for injection. 

4. CLINICAL PARTICULARS 
4.1. THERAPEUTIC INDICATIONS 
Clindamycin has been shown to be effective in
the treatment of the following infections 
when caused
by susceptible anaerobic bacteria or susceptible strains of gram positive aerobic 
bacteria such as streptococci, staphylococci and pneumococci. 

1.  Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media 
and scarlet fever. 
2.  Lower respiratory infections including bronchitis, pneumonia,
empyema and lung 
abscess. 
3.  Skin and soft tissue infections including acne, furuncles,
cellulitis, impetigo, 
abscesses and wound infections, specific skin
and soft tissue infections caused by 
susceptible organisms like erysipelas and
paranychia (panaritium). 
4.  Bone 

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
DALACIN™
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: clindamycin hydrochloride or clindamycin phosphate.
Clindamycin is a semisynthetic antibiotic produced by a
7(S)-chloro-substitution of the 7(R)-
hydroxyl group of the parent compound lincomycin.
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin. Each capsule
contains clindamycin hydrochloride equivalent to 150 mg or 300 mg of
clindamycin.
Clindamycin phosphate is a water-soluble ester of clindamycin and
phosphoric acid. Each mL
contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate
and 9.45 mg benzyl
alcohol added as preservative in each mL.
3.
PHARMACEUTICAL FORM
Capsules, Solution for injection.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Clindamycin has been shown to be effective in the treatment of the
following infections when
caused by susceptible anaerobic bacteria or susceptible strains of
gram-positive aerobic
bacteria such as streptococci, staphylococci and pneumococci.
1.
Upper respiratory infections including tonsillitis, pharyngitis,
sinusitis, otitis media and
scarlet fever.
2.
Lower respiratory infections including bronchitis, pneumonia, empyema
and lung
abscess.
3.
Skin and soft tissue infections including acne, furuncles, cellulitis,
impetigo, abscesses
and wound infections, specific skin and soft tissue infections caused
by susceptible
organisms like erysipelas and paronychia (panaritium).
4.
Bone and joint infections including osteomyelitis and septic
arthritis.
5.
Gynecological infections including endometritis, cellulitis, vaginal
cuff infection, tubo-
ovarian abscess, salpingitis, and pelvic inflammatory disease when
given in conjunction
with an antibiotic of appropriate gram-negative spectrum.
6.
Intra-abdominal infections including peritonitis and abdominal abscess
when given in
conjunction with an antibiotic of appropriate gram-negative spectrum.
7.
Septicemia and endocarditis. The effectiveness of clindamycin in the
treatment of
se