Clindamycin hydrochloride (vaginal)

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# Overview
Clindamycin hydrochloride (vaginal) is an antibiotic that is FDA approved for the treatment of bacterial vaginosis in non-pregnant women.   Common adverse reactions include vaginitis, vaginal pain, and diarrhea.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Clindamycin Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of Clindamycin hydrochloride Vaginal Ovules in pregnant women.
- NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
- Other pathogens commonly associated with vulvovaginitis, eg, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.
- The recommended dose is one Clindamycin hydrochloride Vaginal Ovule (containing clindamycin phosphate equivalent to 100 mg clindamycin per 2.5 g suppository) intravaginally per day, preferably at bedtime, for 3 consecutive days.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- Bacterial endocarditis; Prophylaxis

### NonGuideline-Supported Use
- Babesiosis

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Clindamycin hydrochloride (vaginal) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
- Bacterial endocarditis; Prophylaxis

### NonGuideline-Supported Use
- Babesiosis

# Contraindications
- Clindamycin hydrochloride Vaginal Ovules are contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal suppository. Clindamycin hydrochloride Vaginal Ovules are also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.

# Warnings
- Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of Clindamycin hydrochloride Vaginal Ovules, because approximately 30% of the clindamycin dose is systemically absorbed from the vagina.
- Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated" colitis.
- After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
- Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.

# Adverse Reactions

## Clinical Trials Experience
- In clinical trials, 3 (0.5%) of 589 nonpregnant women who received treatment with Clindamycin hydrochloride Vaginal Ovules discontinued therapy due to drug-related adverse events. Adverse events judged to have a reasonable possibility of having been caused by clindamycin phosphate vaginal suppositories were reported for 10.5% of patients. Events reported by 1% or more of patients receiving Clindamycin hydrochloride Vaginal Ovules were as follows:
- Urogenital system: Vulvovaginal disorder (3.4%), vaginal pain (1.9%), and vaginal moniliasis (1.5%).
- Body as a whole: Fungal infection (1.0%).
- Other events reported by <1% of patients included:
- Urogenital system: Menstrual disorder, dysuria, pyelonephritis, vaginal discharge, and vaginitis/vaginal infection.
- Body as a whole: Abdominal cramps, localized abdominal pain, fever, flank pain, generalized pain, headache, localized edema, and moniliasis.
- Digestive system: Diarrhea, nausea, and vomiting.
- Skin: Nonapplication-site pruritis, rash, application-site pain, and application-site pruritis.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Clindamycin hydrochloride (vaginal) in the drug label.

# Drug Interactions
- Systemic clindamycin has been shown to have 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.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
- In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities.
- Clindamycin vaginal ovules should be used during the first trimester of pregnancy only if clearly needed and the benefits outweigh the risks. There are no adequate and well-controlled studies of Clindamycin hydrochloride Vaginal Ovules in pregnant women during the first trimester of pregnancy.
- Clindamycin hydrochloride Vaginal Cream, 2%, has been studied in pregnant women during the second trimester. In women treated for 7 days, abnormal labor was reported more frequently in patients who received Clindamycin hydrochloride Vaginal Cream compared to those receiving placebo (1.1% vs. 0.5% of patients, respectively).
- Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600 mg/kg/day (62 and 25 times, respectively, the maximum human dose based on body surface area) and have revealed no evidence of harm to the fetus due to clindamycin. Cleft palates were observed in fetuses from one mouse strain treated intraperitoneally with clindamycin at 200 mg/kg/day (about 10 times the recommended dose based on body surface area conversions). Since this effect was not observed in other mouse strains or in other species, the effect may be strain specific.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clindamycin hydrochloride (vaginal) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Clindamycin hydrochloride (vaginal) during labor and delivery.

### Nursing Mothers
- Clindamycin has been detected in human milk after oral or parenteral administration. It is not known if clindamycin is excreted in human milk following the use of vaginally administered clindamycin phosphate.
- Because of the potential for serious adverse reactions in nursing infants from clindamycin phosphate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

### Pediatric Use
- The safety and efficacy of Clindamycin hydrochloride Vaginal Ovules in the treatment of bacterial vaginosis in post-menarchal females have been established on the extrapolation of clinical trial data from adult women. When a post-menarchal adolescent presents to a health professional with bacterial vaginosis symptoms, a careful evaluation for sexually transmitted diseases and other risk factors for bacterial vaginosis should be considered. The safety and efficacy of Clindamycin hydrochloride Vaginal Ovules in pre-menarchal females have not been established.

### Geriatic Use
- Clinical studies of Clindamycin hydrochloride Vaginal Ovules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

### Gender
There is no FDA guidance on the use of Clindamycin hydrochloride (vaginal) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Clindamycin hydrochloride (vaginal) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Clindamycin hydrochloride (vaginal) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Clindamycin hydrochloride (vaginal) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Clindamycin hydrochloride (vaginal) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Clindamycin hydrochloride (vaginal) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Vaginal

### Monitoring
There is limited information regarding Monitoring of Clindamycin hydrochloride (vaginal) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Clindamycin hydrochloride (vaginal) in the drug label.

# Overdosage
Vaginally applied clindamycin phosphate contained in Clindamycin hydrochloride Vaginal Ovules could be absorbed in sufficient amounts to produce systemic effects.

# Pharmacology
There is limited information regarding Clindamycin hydrochloride (vaginal) Pharmacology in the drug label.

## Mechanism of Action
- Clindamycin has a primarily bacteriostatic effect. It is a bacterial protein synthesis inhibitor by inhibiting ribosomal translocation, in a similar way to macrolides. It does so by binding to the 50S rRNA of the large bacterial ribosome subunit.
- The structures of the complexes between several antibiotics (including clindamycin) and a Deinococcus radiodurans ribosome have been solved by X-ray crystallography by a team from the Max Planck Working Groups for Structural Molecular Biology, and published in the journal Nature.

## Structure
There is limited information regarding Clindamycin hydrochloride (vaginal) Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Clindamycin hydrochloride (vaginal) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Clindamycin hydrochloride (vaginal) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Clindamycin hydrochloride (vaginal) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Clindamycin hydrochloride (vaginal) in the drug label.

# How Supplied
- Clindamycin hydrochloride Vaginal Ovules are supplied as follows: Carton of three suppositories with one applicator - NDC 0009-7667-01

## Storage
Store at 25C (77F); excursions permitted to 15  30C (59  86F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information

# Precautions with Alcohol
- Alcohol-Clindamycin hydrochloride (vaginal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- CLEOCIN

# Look-Alike Drug Names
There is limited information regarding Clindamycin hydrochloride (vaginal) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price