INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
DALACIN™ VC (Vaginal Cream)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DALACIN™ VC (Vaginal Cream)

COMPOSITION:
DALACIN VC cream contains the following per gram:
Clindamycin phosphate equivalent to clindamycin base: 20 mg
Benzyl alcohol (preservative): 1%m/m

PHARMACOLOGICAL CLASSIFICATION:
A: 20.1.1 Broad and medium spectrum antibiotics

PHARMACOLOGICAL ACTION:
Clindamycin phosphate is a synthetic antibiotic produced from lincomycin.
Mechanism of action: Clindamycin phosphate is hydrolysed in vivo to clindamycin, which inhibits bacterial protein synthesis. It binds to the 50S subunit of the bacterial ribosome and thereby prevents peptide bond formation.
Microbiology: Clindamycin is an antimicrobial agent which has been shown to have in vitro activity against the following organisms which are associated with bacterial vaginosis:
Garderella vaginalis
Mobiluncus spp
Bacteroides spp
Mycoplasma hominis
Peptostreptococcus spp
Pharmacokinetics: Following once a day dosing of 100 mg of vaginally administered clindamycin phosphate, at a concentration equivalent to 20 mg of clindamycin per gram of cream, peak serum clindamycin levels average 20 ng/mL (range, 3 to 93 ng/mL) in normal volunteers. Approximately 3% (range, 0,1 to 7%) of the administered dose is absorbed systemically. In women with bacterial vaginosis, the amount of clindamycin absorbed following vaginal administration of 5 grams of DALACIN VC (clindamycin 20 mg/g) is 4% (range, 0,8 to 8%) which is approximately the same as in normal volunteers.

INDICATIONS:
DALACIN VC is indicated in the treatment of symptomatic bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, Corynnebacterium vaginitis or anaerobic vaginosis) in non-pregnant women.
Other pathogens commonly associated with vulvovaginitis e.g. Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis, Neisseria gonorrhoeae and Herpes simplex virus should be ruled out by appropriate methods.

CONTRA-INDICATIONS:
DALACIN VC cream is contra-indicated in patients with a history of hypersensitivity to clindamycin or lincomycin.
Pregnancy and lactation, as safety has not been demonstrated.

DOSAGE AND DIRECTIONS FOR USE:
Dosage:
The recommended dose is one applicator full (approximately 5 grams, which contains approximately 100 mg of clindamycin phosphate) of cream intravaginally, preferably at bedtime, for 3 to 7 consecutive days.
Concomitant use with other intra-vaginal products is not recommended.
Directions for use:

1.	Plastic disposable applicators are provided with this package. They are designed to allow proper vaginal administration of the cream.
2.	Remove cap from cream tube. Screw a plastic applicator on the threaded end of the tube.
3.	Rolling tube from the bottom, squeeze gently and force the medication into the applicator. The applicator is filled when the plunger reaches its pre-determined stopping point.
4.	Unscrew the applicator from the tube and replace the cap.
5.	While lying on your back, firmly grasp the applicator barrel and insert into vagina as far as possible without causing discomfort.
6.	Slowly push the plunger until it stops.
7.	Carefully withdraw applicator from the vagina, and discard applicator.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Genital tract:

	C albicans and T. vaginalis overgrowth
	Symptomatic cervicitis
	Vulvar irritation

Central nervous system:

	Dizziness
	Headache
	Vertigo

Gastro-intestinal:

	Heartburn
	Nausea
	Vomiting
	Diarrhoea
	Constipation
	Abdominal pain
	Oderiferous breath

Dermatologic:

	Rash
	Pruritus

Hypersensitivity:

Urticaria

Special precautions:
The use of clindamycin may result in the overgrowth of non-susceptible organisms particularly yeasts (like Candida albicans).
Clindamycin has been associated with diarrhoea and in some cases pseudomembranous colitis. Minimal absorption (approximately 4%) occurs following the use of clindamycin phosphate cream intravaginally; however, if significant or prolonged diarrhoea occurs the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary.
Safety in pregnancy has not been established. Safety in lactation has not been established.
Interactions:
Cross-resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin in vitro.
Incompatibilities:
DALACIN VC cream contains mineral oil that may weaken latex or rubber products, such as condoms or vaginal contraceptive diaphragms. The use of such products within 72 hours following treatment with DALACIN VC cream is not recommended.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Intravaginal overdose is not possible. Accidental ingestion of the product could be accompanied by effects related to therapeutic levels of oral clindaamycin. Treatment should be symptomatic and supportive.

IDENTIFICATION:
A white, semi-solid cream

PRESENTATION:
Cream containing 2% clindamycin base (as the phosphate), intended for intravaginal use. DALACIN VC is packaged in a 21 gram or 40 gram tube, accompanied by 3 or 7 disposable applicators. Each applicator full of cream (i.e one dose), contains approximately 5 grams of cream (100 mg of clindamycin).

STORAGE INSTRUCTIONS:
Store at room temperature (15 - 30°C). Protect from freezing. Keep out of reach of children.

REGISTRATION NUMBER:
27/20.1.1/0292

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 August 2000

New addition to this site: February 2005
Source: Pharmaceutical Industry
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