Dalacin Vaginal Cream (Clindamycin Phosphate)


Pharmacia & Upjohn

Clindamycin Phosphate


Action And Clinical Pharmacology: Although clindamycin phosphate is inactive in vitro, in vivo hydrolysis converts this compound to the antibacterially-active clindamycin. Clindamycin inhibits bacterial protein synthesis by its action at the bacterial ribosome. The antibiotic preferentially binds to the 50S ribosomal subunit, and affects the process of peptide chain initiation. Clindamycin may inhibit the binding of aminoacyl-tRNA or inhibit the translocation reaction following amino acid binding on the ribosome.

Clindamycin has been shown to have in vitro activity against the following organisms: Mobiluncus species. M. hominis, G. vaginalis, Bacteroides species and Peptostreptococcus species.

Following once a day dosing of 100 mg of vaginally-administered Dalacin Vaginal Cream in normal volunteers, at a concentration equivalent to 20 mg clindamycin/g of cream, peak serum clindamycin levels average 25 ng/mL (range 6 to 61 ng/mL). Approximately 4% (range 0.6 to 11%) of the administered dose is absorbed systemically. In women with bacterial vaginosis, the amount of clindamycin absorbed systemically following vaginal administration of 5 g of Dalacin Vaginal Cream is also approximately 4% (range 2 to 8%).

Indications And Clinical Uses: For the treatment of bacterial vaginosis (also known as H. vaginalis vaginitis, G. vaginalis vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

Diagnosis: The clinical diagnosis of bacterial vaginosis is usually made on the basis of 4 criteria: (1) presence of a milky homogeneous vaginal discharge; (2) an unpleasant, fishy, amine odor accentuated by addition of 10% KOH to the vaginal fluid; (3) vaginal fluid pH greater than 4.5; and (4) presence of clue cells in the vaginal fluid. In general, if 3 or more of the above criteria are present, the patient is considered to have bacterial vaginosis.

An alternate method of diagnosis is a Gram stain of the vaginal fluid. If the Gram stain reveals an absence or marked decrease in Lactobacillus morphotype (large gram-positive rods) and a predominance of G. vaginalis/Bacteroides species morphotypes (small gram variable/gram-negative rods) it is considered compatible with the diagnosis of bacterial vaginosis.

Other pathogens commonly associated with vulvovaginitis (e.g., T. vaginalis and C. albicans) should be ruled out by appropriate laboratory methods.

Contra-Indications: In individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any components of the cream (see Supplied).

Manufacturers’ Warnings In Clinical States: The use of antibiotics occasionally results in overgrowth of nonsusceptible organisms, particularly yeasts. Should superinfections occur, take appropriate measures as dictated by the clinical situation.

Oral and parenteral clindamycin have been associated with severe diarrhea and antibiotic-associated colitis. Therefore, the physician should be alert to the possible development of antibiotic-associated diarrhea or colitis. Minimal systemic absorption (approximately 4%) of clindamycin occurs following the use of clindamycin phosphate cream intravaginally; however, if significant or prolonged diarrhea occurs, clindamycin phosphate vaginal cream should be discontinued and appropriate diagnostic procedures and treatment instituted as necessary.

Precautions: General: Clindamycin should be prescribed with caution in atopic individuals.

Cross resistance has been demonstrated between clindamycin and lincomycin.

The effect of concomitant use of clindamycin phosphate vaginal cream with other intravaginal products is not known.

This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with the vaginal cream, is not recommended.

In menstruating patients, treatment should be delayed until menstruation is completed.

Pregnancy: Reproduction studies have been performed in rats and mice using s.c. and oral doses of clindamycin ranging from 20 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin. In one mouse strain, cleft palates were observed in treated fetuses; this response was not produced in other mouse strains or in other species, and therefore may be a strain-specific effect.

In clinical trials, use of vaginally-applied clindamycin phosphate cream in pregnant women in their second trimester, and systemically-administered clindamycin during their second and third trimesters, has not been associated with adverse effects.

There are however, no adequate and well-controlled studies in pregnant women during their first trimester, and because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Lactation: It is not known if clindamycin is excreted in breast milk following the use of vaginally-administered clindamycin phosphate. However, orally and parenterally-administered clindamycin have been reported to appear in breast milk. Therefore, a full assessment of benefit-risk should be made when consideration is given to using the vaginal cream in a nursing mother. Approximately 4 mg of an administered dose of 100 mg clindamycin (as clindamycin phosphate) is systemically absorbed following vaginal administration to the mother.

Drug Interactions: The potency of the combination of erythromycin and clindamycin was less than the potency of either drug alone in an in vitro E. coli culture.

Adverse Reactions: In clinical trials, involving 764 patients, the following adverse reactions were judged to be associated with the administration of clindamycin phosphate vaginal cream. The most frequently reported adverse reaction was symptomatic vaginitis/cervicitis.

Genital Tract: symptomatic vaginitis/cervicitis (13.6%), symptomatic vaginitis/cervicitis positive for C. albicans (10.2%), symptomatic vaginitis/cervicitis positive for T. vaginalis (1.3%), vulvovaginal irritation (6.2%).

Gastrointestinal: nausea/vomiting, diarrhea/loose stools, abdominal pain, constipation, heartburn.

CNS: dizziness, headache, vertigo.

Dermatological: rash, exanthema.

Hypersensitivity: urticaria, hives.

Note: Unless the percentages are otherwise indicated, the incidence was less than 1%.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Intravaginal overdosage is unlikely with clindamycin phosphate vaginal cream. Only 4 mg of a total daily dose of 100 mg clindamycin (as clindamycin phosphate) is systemically absorbed when administered vaginally. By comparison, the usual i.v. total daily dose of clindamycin is 2 700 mg. Accidental ingestion could be accompanied by effects related to therapeutic levels of oral clindamycin.

Dosage And Administration: The recommended dose is 1 applicatorful (5 g) of vaginal cream intravaginally at bedtime for 7 consecutive nights. This is equivalent to approximately 100 mg of clindamycin (as clindamycin phosphate).

This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with the vaginal cream, is not recommended.

In menstruating patients, treatment should be delayed until menstruation is completed.

Availability And Storage: Each g of semi-solid white cream contains: clindamycin 20 mg (as clindamycin phosphate). Each full applicator (one dose) contains: clindamycin 100 mg (as clindamycin phosphate) in 5 g of cream. Nonmedicinal ingredients: benzyl alcohol, cetostearyl alcohol, cetyl palmitate, mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate and stearic acid. Collapsible laminate tubes of 40 g with 7 disposable applicators for intravaginal use. Store at controlled room temperature (15 to 30°C). Protect from freezing.

DALACIN® VAGINAL CREAM Pharmacia & Upjohn Clindamycin Phosphate Antibacterial

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