Cleocin
100 mg · Suppository
- Prescription only
- Lincosamide Antibacterial
- Active substance
- Clindamycin Phosphate
- Made by
- Pharmacia & Upjohn Company LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-03-09
Not necessarily this product — shortages are reported per presentation. Your pharmacy will know. · Updated 2026-09-21 FDA drug shortages
Lincosamide Antibacterial
- CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women.
The recommended dose is one CLEOCIN 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.
Full directions ↓CLEOCIN Vaginal Ovules are contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal suppository.
All warnings ↓- Prescription only
- Mediclarum could not reach the FDA to check for recalls just now. This is not a result.
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
NOTE:
- CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women.
- There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women.
- 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, e.g., Trichomonas vaginalis , Chlamydia trachomatis , Neisseria gonorrhoeae , Candida albicans , and herpes simplex virus, should be ruled out.
From the official label · 2026-03-09 · DailyMed
How it works
From this product’s own US prescribing label.
Clindamycin is an antibacterial drug (See MICROBIOLOGY ).
Systemic absorption of clindamycin was estimated following a once-a-day intravaginal dose of one clindamycin phosphate vaginal suppository (equivalent to 100 mg clindamycin) administered to 11 healthy female volunteers for 3 days.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-09
Do not take it if
- CLEOCIN Vaginal Ovules are contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal suppository.
- CLEOCIN Vaginal Ovules are also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
The recommended dose is one CLEOCIN 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.
Quoted from the official label, section “Dosage & Administration”.
Other 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 and vaginal) formulations of clindamycin.
- Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of CLEOCIN 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 Clostridioides 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 Clostridioides difficile colitis.
- Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.
- General The use of CLEOCIN Vaginal Ovules may result in the overgrowth of nonsusceptible organisms in the vagina.
- In clinical studies using CLEOCIN Vaginal Ovules, treatment-related moniliasis was reported in 2.7% and vaginitis in 3.6% of 589 nonpregnant women.
- Moniliasis, as reported here, includes the terms:
- vaginal or nonvaginal moniliasis and fungal infection.
- Vaginitis includes the terms:
- vulvovaginal disorder, vaginal discharge, and vaginitis/vaginal infection.
- Drug Interactions Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.
- Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential.
- Genotoxicity tests performed included a rat micronucleus test and an Ames test.
- Both tests were negative.
- Fertility studies in rats treated orally with up to 300 mg/kg/day (31 times the human exposure based on mg/m 2 ) revealed no effects on fertility or mating ability.
- Pregnancy Teratogenic effects 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.
- Nursing Mothers Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL at dosages of 150 mg orally to 600 mg intravenously.
- Pediatric Use The safety and efficacy of CLEOCIN 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.
- Geriatric Use Clinical studies of CLEOCIN Vaginal Ovules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
- General The use of CLEOCIN Vaginal Ovules may result in the overgrowth of nonsusceptible organisms in the vagina.
- In clinical studies using CLEOCIN Vaginal Ovules, treatment-related moniliasis was reported in 2.7% and vaginitis in 3.6% of 589 nonpregnant women.
- Moniliasis, as reported here, includes the terms:
- vaginal or nonvaginal moniliasis and fungal infection.
- Vaginitis includes the terms:
- vulvovaginal disorder, vaginal discharge, and vaginitis/vaginal infection.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic effects 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 CLEOCIN Vaginal Ovules in pregnant women during the first trimester of pregnancy.
- CLEOCIN 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 CLEOCIN 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.
- Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL at dosages of 150 mg orally to 600 mg intravenously.
- It is not known if clindamycin is excreted in human breast milk following the use of vaginally administered clindamycin phosphate.
- Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora.
- If clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred.
- Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
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.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
Vaginally applied clindamycin phosphate contained in CLEOCIN Vaginal Ovules could be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS and ADVERSE REACTIONS .)
Quoted from the official label, section “Overdosage”.
Use in children
- The safety and efficacy of CLEOCIN 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 CLEOCIN Vaginal Ovules in pre-menarchal females have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
Clinical studies of CLEOCIN Vaginal Ovules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Quoted from the official label, section “Geriatric Use”.
Side effects
- Clinical Trials In clinical trials, 3 (0.5%) of 589 nonpregnant women who received treatment with CLEOCIN 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 CLEOCIN 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.
- Other clindamycin formulations The overall systemic exposure to clindamycin from CLEOCIN Vaginal Ovules is substantially lower than the systemic exposure from therapeutic doses of oral clindamycin hydrochloride (two-fold to 20-fold lower) or parenteral clindamycin phosphate (40-fold to 50-fold lower).
- (See CLINICAL PHARMACOLOGY .) Although these lower levels of exposure are less likely to produce the common reactions seen with oral or parenteral clindamycin, the possibility of these and other reactions cannot be excluded.
- The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin and may also occur following administration of CLEOCIN Vaginal Ovules:
- Infections and Infestations:
- Clostridioides difficile colitis Gastrointestinal:
- Abdominal pain, esophagitis, nausea, vomiting, diarrhea, and pseudomembranous colitis.
- (See WARNINGS .) 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 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 Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin.
- A few cases of anaphylactoid reactions have been reported.
- If a hypersensitivity reaction occurs, the drug should be discontinued.
- Liver:
- Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
- Musculoskeletal: Cases of polyarthritis have been reported.
- Renal:
- Acute kidney injury Immune System:
- Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.
- There have been reports of pseudomembranous colitis following the administration of clindamycin vaginal cream.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Information for the Patient The patient should be instructed not to engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with this product.
- The patient should also be advised that these suppositories use an oleaginous base that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms.
- Therefore, the use of such products within 72 hours following treatment with CLEOCIN Vaginal Ovules is not recommended.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- CLEOCIN Vaginal Ovule is supplied as follows:
- Carton of three suppositories without the applicator NDC 0009-7667-05 Important Information:
- Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature].
- Caution: Avoid heat over 30°C (86°F).
- Avoid high humidity.
- See end of carton for the lot number and expiration date.
Quoted from the official label, section “How Supplied”.
How to store it
- Important Information:
- Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Caution:
- Avoid heat over 30°C (86°F).
- Avoid high humidity. See end of carton for the lot number and expiration date.
Quoted from the official label, section “Storage and Handling”.
What is in it
- Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside 2-(dihydrogen phosphate). The monohydrate form has a molecular weight of 522.98, and the molecular formula is C 18 H 34 ClN 2 O 8 PS
- H 2 O. The structural formula is represented below:
- CLEOCIN Vaginal Ovules are semisolid, white to off-white suppositories for intravaginal administration. Each 2.5 g suppository contains clindamycin phosphate equivalent to 100 mg clindamycin in a base consisting of a mixture of glycerides of saturated fatty acids. Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Details
| Made by | Pharmacia & Upjohn Company LLC |
|---|---|
| Active substance | Clindamycin Phosphate |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 100 mg |
| Form | Suppository |
| Route | Vaginal |
| Packs | 1 BLISTER PACK in 1 CARTON / 3 SUPPOSITORY in 1 BLISTER PACK |
| NDC | 0009-7667 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Suppository1 products
- 100 mg
- Cream1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.