Data from FDA - Curated by EPG Health - Last updated 21 December 2016

Indication(s)

1 INDICATIONS AND USAGE Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women (1.1) 1.1 Treatment of Bacterial Vaginosis Clindesse is indication for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerellavaginitis, nonspecific vaginitis, Corynebacteriumvaginitis, or anaerobic vaginosis) in non-pregnant women.

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Advisory information

contraindications

4 CONTRAINDICATIONS •History of hypersensitivity to clindamycin or other lincosamides (4.1) •History of regional enteritis, ulcerative colitis, or a history of C. difficile-associated diarrhea (4.2, 5.1) 4.1 Hypersensitivity Do not administer Clindesse to individuals with a history of hypersensitivity to clindamycin or other lincosamides.

Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme, and anaphylactoid reactions [see Adverse Reactions (6.2)].

4.2 History of Bowel Disease Do not administer Clindesse to patients with regional enteritis, ulcerative colitis, or a history of Clostridium difficile-associated diarrhea.

Adverse reactions

6 ADVERSE REACTIONS Most common adverse reactions reported in ?2 % of patients and at a higher rate in the Clindesse group than in the placebo group are vaginosis fungal (14 %), headache (7 %), back pain (5 %), constipation (2 %), and urinary tract infection (2 %) (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Clindesse in 368 patients.

Clindesse was studied in three clinical studies: placebo-controlled (n=85), active-controlled (n=263), and single-arm (n=20).

The population was female, aged 18 to 78, who were diagnosed with bacterial vaginosis.

Patient demographics in the trials were 51 % Caucasian, 36 % Black, 10 % Hispanic, and 3 % Asian, other or unknown.

All patients received 100 mg clindamycin phosphate cream intravaginally in a single dose.

Of the 368 women treated with a single dose of Clindesse, 1.6 % of the patients discontinued therapy due to adverse reactions.

Adverse reactions occurred in 126 of 368 patients (34 %) treated with Clindesse and in 32 of 85 patients (38 %) treated with placebo.

Adverse reactions occurring in?2 % of patients receiving Clindesse in the placebo-controlled clinical trial are shown in Table 1.

Table 1.

Adverse Reactions Occurring in?

2 % of Clindesse -Treated Patients and at a Higher Rate than Placebo-Treated Patients N = number of patients in intent-to-treat population n (%) = number and percentage of patients with reported adverse reaction NOS = not otherwise specified The use of clindamycin may result in the overgrowth of non-susceptible fungal organisms in the vagina and may require antifungal treatment Other reactions reported by <1 % of those women treated with Clindesse include: Dermatologic: Pruritic rash Gastrointestinal: Diarrhea, vomiting General: Fatigue Immune System: Hypersensitivity Nervous System: Dizziness Reproductive System: Dysfunctional uterine bleeding, dysmennorrhea, intermenstrual bleeding, pelvic pain, vaginal burning, vaginal irritation, vulvar erythema, vulvitis, vulvovaginal discomfort

vulvovaginal dryness, vulvovaginitis Table 1 6.2 Other Clindamycin Formulations Clindesse affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin [see Clinical Pharmacology (12.1)].

Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.

The following additional adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin: Gastrointestinal: Abdominal pain, esophagitis, nausea, Clostridium difficile-associated diarrhea [see Warnings and Precautions (5.1)].

Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported.

No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports.

Hypersensitivity Reactions: Maculopapular rash, vesiculobullous rash, and urticaria have been observed during drug therapy.

Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions.

Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin.

A few cases of anaphylactoid reactions have been reported.

Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Musculoskeletal: Cases of polyarthritis have been reported.

Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances.

6.3 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Clindesse.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: Rash Gastrointestinal: Hematochezia Reproductive System: Vaginal erythema, vulvovaginal pruritis, vaginal discharge, vaginal swelling, vaginal bleeding, vaginal pain

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended dose is the complete contents of a single pre-filled applicator containing 5 g of Clindesse cream administered once intravaginally at any time of the day. Not for ophthalmic, dermal, or oral use. •A single applicator of cream administered once intravaginally at any time of the day (2) •Not for ophthalmic, dermal, or oral use
Use in special populations

8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Caution should be exercised when administered to a nursing woman (8.3) 8.1 Pregnancy Pregnancy Category B Clindesse should be used during pregnancy only if clearly needed.

There are no adequate and well-controlled studies of Clindesse in pregnant women.

Another intravaginal formulation containing 2 % clindamycin phosphate has been studied in pregnant women during the second trimester.

In women treated for seven days, abnormal labor was reported in 1.1 % of patients who received that clindamycin vaginal cream formulation compared with 0.5 % of patients who received placebo.

Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600/ mg/kg/day (58 and 29 times, respectively, the recommended human dose based on body surface area comparisons) and have revealed no evidence of harm to the fetus due to clindamycin.

Because animal reproduction studies are not always predictive of human response, Clindesse should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers Caution should be exercised when Clindesse is administered to a nursing woman.

It is not known if clindamycin is excreted in human milk following the use of vaginally administered clindamycin.

Clindamycin has been detected in human milk after oral or parenteral administration.

Because of the potential for serious adverse reactions in nursing infants, a decision to continue or discontinue nursing should take into account the importance of the drug to the mother.

8.4 Pediatric Use The safety and efficacy of Clindesse in the treatment of bacterial vaginosis in post-menarchal females have been established on the extrapolation of clinical trial data from adult women.

The safety and efficacy of Clindesse in pre-menarchal females have not been established.

8.5 Geriatric Use Clinical studies with Clindesse did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently than younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Pregnancy and lactation

8.3 Nursing Mothers Caution should be exercised when Clindesse is administered to a nursing woman.

It is not known if clindamycin is excreted in human milk following the use of vaginally administered clindamycin.

Clindamycin has been detected in human milk after oral or parenteral administration.

Because of the potential for serious adverse reactions in nursing infants, a decision to continue or discontinue nursing should take into account the importance of the drug to the mother.

Interactions

7 DRUG INTERACTIONS No formal drug interaction studies have been conducted for Clindesse.

Neuromuscular blocking agents: Enhanced action of neuromuscular blocking agents can occur; use with caution (7.1) 7.1 Neuromuscular Blocking Agents Orally or intravenously administered clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.

Therefore, it should be used with caution in patients receiving such agents.

More information

Category Value
Authorisation number NDA050793
Orphan designation No
Product NDC 45802-042
Date Last Revised 20-08-2015
Type HUMAN PRESCRIPTION DRUG
RXCUI 309337
Marketing authorisation holder Perrigo New York Inc