Cleocin Vaginal Cream

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Cleocin Vaginal Cream

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Cleocin Vaginal Cream

Quick Facts

Property Description
Active ingredient Clindamycin phosphate
Form Vaginal cream (Semisolid)
Pharmacological class Lincosamide antibiotic
Common use Combating bacterial infection
Origin Semisynthetic

What Type of Medicine is Cleocin Vaginal Cream?

Cleocin Vaginal Cream is a prescription-only medication that belongs to the semisynthetic lincosamide antibiotic class and is used for its targeted anti-infective properties. Its core active component is clindamycin, which is a semisynthetic derivative of the naturally occurring antibiotic lincomycin. This classification is clinically recognized for its efficacy against key bacterial pathogens commonly associated with localized infections in adult women.

The medication is formally designated by its pharmacological class, lincosamide antibiotic, a group known for its effectiveness against specific types of anaerobic bacteria and Gram-positive cocci. Clindamycin is used to treat infections caused by susceptible bacteria.

Composition and Administration Form

The medicine is formulated as a vaginal cream, which is a semisolid formulation designed specifically for direct, topical administration to the target site. The cream contains clindamycin phosphate, a stable compound that functions as a prodrug.

This use of the phosphate salt is strategic: the compound requires hydrolysis to convert into the pharmacologically active clindamycin form once applied during localized therapy. The preparation is a single-ingredient product utilizing the cream base as the vehicle for precise delivery of the antibiotic. Using clindamycin phosphate in a cream formulation provides controlled, localized release of the active drug at the site of administration.

General Therapeutic Purpose

The overall goal of using this medication is to interrupt the growth cycle of susceptible bacteria and assist the body in resolving vaginal infection. This is achieved through the fundamental antibiotic action of clindamycin. The lincosamide antibiotic works by interfering with the internal machinery of the targeted bacterial cells, specifically by inhibiting protein synthesis. The medicine's general benefit is derived from this specific anti-infective capacity, which helps control the microbial population and contributes to the alleviation of discomfort caused by the bacterial overgrowth.

What side effects are possible with Cleocin Vaginal Cream?

Possible Side Effects and Safety Information

The safety profile of Cleocin Vaginal Cream (clindamycin phosphate) is officially documented by regulatory authorities, classifying potential adverse reactions by frequency and the body system affected. The most frequently documented adverse event is Vulvovaginal Candidiasis (Vaginal Moniliasis), which is categorized as Very Common (1/10) and reflects the potential for the overgrowth of non-susceptible organisms, such as Candida, during treatment.

Documented Adverse Reactions

Adverse reactions that are Common (1/100 to <1/10) include systemic effects like headache, dizziness, diarrhea, abdominal pain, and nausea, along with local effects such as vulvovaginitis and metrorrhagia. These effects are generally categorized within the Gastrointestinal Disorders, Nervous System Disorders, and Reproductive System and Breast Disorders system-organ classes.

Serious Safety Considerations

A critical, label-documented risk is the potential for Pseudomembranous Colitis (or Clostridioides difficile-associated diarrhea, CDAD), which is associated with systemic absorption of clindamycin and may occur during or after antimicrobial treatment has concluded. Use of the cream is contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Population and Product Constraints

Specific safety notes exist for certain populations, including a warning about the potential for adverse effects on the breast-fed infant's gastrointestinal flora when used by nursing mothers. Furthermore, the cream contains ingredients that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms, which is an important safety-related restriction noted in regulatory documents.

Overdose and Emergency Response

Official Regulatory Statements on Overdose

Cleocin Vaginal Cream is recognized by regulatory authorities as carrying the potential for systemic effects. This is due to the absorption of clindamycin phosphate into the bloodstream after vaginal administration. Although only a small amount is typically absorbed, the official overdose profile addresses the risks associated with this systemic exposure.

Documented Overdose Manifestations and Risks

The most significant and severe outcome documented in regulatory information linked to systemic clindamycin exposure is pseudomembranous colitis. This serious gastrointestinal condition is reported to range in severity from mild to potentially life-threatening, with the risk that severe colitis may end fatally. Clinical manifestations of systemic overexposure or overdose may include the development of colitis signs, such as diarrhea or bloody diarrhea. No population-specific overdose notes are explicitly documented in the official prescribing information.

Emergency Actions Required

Regulatory guidance specifies the necessary response to suspected overexposure, such as accidental oral ingestion. Individuals must seek immediate medical attention when overdosage is suspected. Furthermore, individuals are directed to contact a Poison Control center or call local emergency services immediately. There is no specific antidote known for clindamycin overdose; consequently, management relies on providing necessary symptomatic and supportive treatment.

Therapeutic Uses of Cleocin Vaginal Cream

What Cleocin Vaginal Cream Treats: Main Uses and Benefits

This topical antibiotic cream is commonly used for managing Bacterial Vaginosis (BV), a condition where there is an imbalance and overgrowth of certain susceptible bacteria in the vagina. This therapeutic domain is relevant for easing symptoms associated with the infection.

Therapeutic Focus and Symptom Relief

The primary therapeutic focus is on conditions presenting with significant symptomatic burden, including abnormal vaginal discharge, foul, fishy vaginal odor, and localized irritation or discomfort. The medication is applied across domains where additional symptomatic support is needed for BV, and is considered relevant for use in non-pregnant women and those in their second or third trimester of pregnancy.

It is used in situations involving certain distressing symptoms and contributes to easing the overall symptom load. By reducing these manifestations, the treatment may assist with maintaining functional stability and supports general well-being during symptomatic phases.


Quick Fact: Symptomatic Support Domains

Symptom Domain Therapeutic Goal Context of Use
Abnormal Odor/Discharge Contributes to easing the overall symptom load Acute symptomatic episodes
Localized Irritation Supports general well-being during symptomatic phases Patients in second/third trimester of pregnancy

Regulatory References

  1. NIH DailyMed Label for Cleocin Vaginal Cream

Eligibility and Restrictions for Use

Official Eligibility Profile

The eligibility for Cleocin Vaginal Cream is strictly defined by regulatory documents, which establish specific populations that are eligible, restricted, or absolutely excluded from use.

Eligibility Scope Status (Official Regulatory Statement)
Populations Contraindicated Individuals with a history of hypersensitivity to clindamycin, lincomycin, or any component of the cream.
Gastrointestinal History Contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Age-Related Eligibility Safety and effectiveness have not been established in pre-menarchal females (pediatric patients).
Pregnancy Status Acceptable for use in pregnant women during the second and third trimesters. Use in the first trimester is not recommended unless clearly needed.
Lactation Status Requires a decision to discontinue nursing or discontinue the drug, due to potential for clindamycin excretion into human milk.
Barrier Contraceptives Use of latex or rubber barrier contraceptives is not recommended during treatment and for 72 hours following treatment.

Official labeling confirms the primary eligible population is adult women. The most significant non-eligibility rule is the absolute contraindication for patients with a history of colitis, due to the risk of exacerbating existing gastrointestinal disease. Conditional use rules apply for pregnant and lactating women.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Officially documented interaction patterns for Cleocin Vaginal Cream (clindamycin phosphate) focus on pharmacodynamic effects with other medicinal products and a specific substance interaction with certain medical devices. All interaction information is based on government regulatory labeling.


Drug–Drug Interactions: Pharmacodynamic Enhancement

Clindamycin, the active component, inherently possesses neuromuscular blocking properties. Co-administration with other neuromuscular blocking agents can lead to a pharmacodynamic interaction, potentially enhancing the action of these agents. This interaction pattern requires consideration when the medication is used concurrently with other muscle relaxants.


Drug–Substance Interactions: Timing Restriction

The formulation of the vaginal cream contains mineral oil, an excipient documented to weaken latex or rubber products. This substance interaction necessitates formal timing restrictions for certain products.

Interacting Product Category Official Regulatory Restriction
Latex or Rubber Products (e.g., condoms, diaphragms) Use is not recommended during treatment and for 72 hours (three days) after treatment is completed.

No interactions involving specific CYP450 enzymes, drug transporters, food, alcohol, or herbal products are specifically documented in the regulatory labeling for this vaginal cream formulation.

Mechanism of Action

Targeted Inhibition of Bacterial Protein Synthesis

The mechanism of action begins with the local activation of the prodrug clindamycin phosphate into the active clindamycin molecule. This molecule then exerts its primary effect by specifically binding to the 50S ribosomal subunit within susceptible bacteria. The molecule functions as a specific inhibitor by physically blocking the ribosomal exit tunnel, thereby halting the synthesis of all structural and enzymatic proteins necessary for bacterial growth and replication.


Molecular Cascade to Physiological Control

This molecular interference produces a bacteriostatic effect, meaning the microbial population's growth and proliferation are immediately stopped. The mechanism also extends to suppressing the production of harmful virulence factors and toxins by the pathogens. This action restricts pathogen proliferation and toxin synthesis, contributing to a reduction in microbial load via host immune mechanisms. This sequence defines the core mechanistic effect.


Constraints and Limitations of the Mechanism

The biological action of clindamycin is strictly dependent on the integrity of its target site. The mechanism's functional capacity is lost when bacteria develop resistance by chemically altering the 50S ribosomal target, most commonly through methylation of the 23S rRNA. Such a modification physically prevents clindamycin from binding, rendering the drug biologically inert and functionally unable to exert its intended mechanism of protein inhibition.

Dosage and Administration Information

How to Use Cleocin Vaginal Cream

This section describes the usage principles for Clindamycin phosphate 2% Vaginal Cream.


Administration Scope

Instruction Detail
Route of administration Intravaginal use only. The cream is exclusively for topical application to the vagina.
Dosing schedule One full applicatorful (approximately 5 grams of cream, delivering 100 mg clindamycin phosphate).
Timing and Frequency The dose is administered once daily, typically scheduled to occur at bedtime to promote local retention.
Preparation The cream is ready to use and is applied using the disposable applicator provided with the product.

Course Duration and Procedural Conditions

Instruction Detail
Standard Duration The regimen is prescribed for either 3 or 7 consecutive days for non-pregnant individuals.
Population Rule A duration of 7 consecutive days is the standard course for patients in the second and third trimesters of pregnancy.
Procedural Constraint The use of other intravaginal products (e.g., tampons, douches) is to be avoided during treatment.
Excipient Constraint Avoidance of latex or rubber products (e.g., condoms or diaphragms) is specified during the treatment period and for 72 hours following the final dose.

The usage protocol dictates a precise, localized therapeutic approach through the defined intravaginal route. The standardized regimen requires a once-daily, 100 mg dose completed over a specific 3- or 7-day course, ensuring consistency in the frequency and duration of administration. Special procedural instructions address the compatibility of the cream with other products and mandate the avoidance of certain concurrent items to maintain the integrity of the treatment.

Recent Clinical Evidence

Research evidence / Overview of Studies for Cleocin Vaginal Cream

Evidence for Use in Bacterial Vaginosis (BV)

The research into Cleocin Vaginal Cream primarily involves studies that evaluated Bacterial Vaginosis (BV), a condition characterized by fluctuating or episodic manifestations. Research in this area utilizes randomized controlled trials (RCTs), which are a specific study type used to examine the cream against an inactive vehicle (placebo) or other established therapies. Research examined how symptoms changed over time in the observed populations by evaluating both clinical endpoints—outcomes related to physical discomfort like abnormal discharge and odor—and microbiological endpoints, which involve laboratory evaluation of the balance of bacteria in the vagina.

Studies conducted during periods of increased symptom activity findings describe patterns observed in the studies related to initial changes in both clinical and microbiological status. Studies report how symptoms evolved in the observed populations and research examined short-term changes after the defined study interval.

Research on Durability and Long-Term Follow-up

Studies exploring short-term symptom changes typically observed responses over defined time intervals, with follow-up durations were limited to a few weeks after the defined study interval. Some studies also monitored outcomes over extended intervals, with follow-up durations extending for up to six months.

Studies monitored the re-occurrence of BV, which was observed in some studies as a pattern of relapse across antibiotic monotherapy trials. Data show patterns related to the return of BV symptoms and microbial imbalance in the months following the initial study interval.

Evidence in Specific Patient Groups

The majority of the initial data for this treatment was evaluated in non-pregnant adult women. Findings describe group patterns observed in this primary study population.

Studies on Pregnant Women

Specific research was studied for use in pregnant women. Studies explored the treatment specifically in women during their second and third trimesters of pregnancy. These studies evaluated outcomes related to BV in this specific population.

Evidence Gaps and Areas for Future Study

The research describes group patterns, not individual predictions. Evidence highlights what is known — and what is still uncertain. Despite the existing research, there are still areas where data are insufficient or evidence is limited, which applies only to the populations studied. One significant limitation is that long-term effects are not fully established; there is limited information for long-term outcomes and the follow-up durations were limited in many trials.

Furthermore, data for certain groups remain insufficient. Data for certain groups remain insufficient for the first trimester, as adequate, well-controlled studies evaluating use during this period are not available. Similarly, clinical trials did not include a sufficient number of patients aged 65 and older; results apply only to the populations studied.

Key Studies & References

  1. Label: CLEOCIN- clindamycin phosphate cream (FDA/DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Cleocin Vaginal Cream (FAQ)


Q: Does Cleocin Vaginal Cream treat yeast infections?

A: The official indication for this cream is the treatment of bacterial vaginosis (BV). Regulatory documents state that one of the most common reported adverse reactions is vulvovaginal candidiasis, which is a yeast infection. The official documentation describes its purpose as treating BV, and not yeast infections.


Q: Can this cream cause a yeast infection after treatment?

A: It is possible. Official safety data lists the potential for developing vulvovaginal candidiasis (yeast infection) as a very common side effect. This is due to the antibiotic action potentially allowing for the overgrowth of non-susceptible organisms, such as Candida. This adverse reaction may occur either during the treatment period or after the regimen has been completed.


Q: Does using Cleocin Vaginal Cream affect birth control pills?

A: Official regulatory documents do not list a specific drug interaction between this vaginal cream formulation and oral contraceptives (birth control pills). Documented interaction warnings focus on latex or rubber products, such as condoms and diaphragms, which are officially stated to be avoided.


Q: Can I use this medicine while breastfeeding?

A: The active ingredient, clindamycin, is known to be excreted into human milk. Official safety notes highlight the potential for adverse effects on the breast-fed infant's intestinal bacteria. Due to this possibility, the official label states a decision is required to either discontinue nursing or discontinue the medication.


Q: Are there any age restrictions for using Cleocin Vaginal Cream?

A: Safety and effectiveness have officially not been established for use in pre-menarchal females (younger patients who have not yet started menstruating). Additionally, clinical trials did not include enough patients aged 65 and older to determine if their response to the treatment is different from that of younger adult women.


Q: How long does the treatment course usually last?

A: The length of the treatment course is determined by the prescribing healthcare professional. For non-pregnant individuals, the regimen is typically described in official documents as either 3 or 7 consecutive days. A 7-day course is standard for pregnant patients in the second and third trimesters.


Q: Can I stop using the cream early if my symptoms improve?

A: Official prescribing information describes the regimen as a fixed duration of consecutive days. Antibiotic treatments are typically prescribed for a fixed duration to ensure the target bacteria are fully addressed.


Q: Is it normal to see some discharge after using the cream?

A: Official safety data lists adverse reactions that include vulvovaginal disorders and changes in discharge. These are common symptoms reported during or after use of the cream, which may also include some leakage of the medication itself.


Q: Can I use Cleocin Vaginal Cream during my period?

A: Regulatory guidance suggests that treatment with the cream may be continued even if the menstrual period starts during the course. However, the use of internal intravaginal products, such as tampons, is officially stated to be avoided during the treatment period.


Q: What ingredients are in Cleocin Vaginal Cream?

A: The cream contains the active ingredient clindamycin phosphate. The full formulation also includes several inactive components, such as benzyl alcohol, cetostearyl alcohol, mineral oil, propylene glycol, and purified water, among others. These inactive ingredients form the cream base.


Q: What if the cream leaks out after I apply it?

A: The official dosing is scheduled to be administered at bedtime, which is intended to promote local retention of the dose. Some patients use a panty liner to protect clothing, and the use of internal products like tampons is officially stated to be avoided.


Q: What does 'clindamycin phosphate' mean?

A: Clindamycin phosphate is the form of the drug found in the cream. It is described as a prodrug, which means it is an inactive chemical compound. Once applied, it is rapidly converted into the pharmacologically active antibiotic, clindamycin, at the site of infection.


Q: Is there a version of this medicine that is a suppository?

A: The active ingredient, clindamycin, is available in other approved vaginal formulations. Regulatory documents indicate that other options exist, including a gel and a vaginal ovule, which is a type of suppository.


Q: How does Cleocin Vaginal Cream get absorbed by the body?

A: Following intravaginal use, only a small amount of the dose is absorbed into the bloodstream, which is referred to as systemic absorption. Official pharmacokinetic studies show that this absorption is minimal, typically ranging from about 2% to 11% of the administered dose.


Q: Does Cleocin Vaginal Cream cause a burning sensation?

A: Official safety data lists local adverse reactions that include vulvovaginitis and vulvar irritation. These conditions may involve discomfort or a burning sensation. Any concerns about local discomfort or irritation should be directed to a healthcare professional.


Q: Why does the cream have a warning about diarrhea?

A: The warning exists because the active ingredient, clindamycin, is associated with the potential development of Pseudomembranous Colitis (C. difficile-associated diarrhea). This is a serious side effect that can range from mild diarrhea to severe colitis and is noted due to the minimal systemic absorption of the antibiotic.


Q: Is it possible to be allergic to the ingredients in this cream?

A: Yes, use of the cream is officially contraindicated (absolutely forbidden) in individuals with a known history of hypersensitivity (allergic reaction) to clindamycin, a related drug called lincomycin, or any other component in the cream formulation.


Q: Are there specific types of clothing to wear after application?

A: Because the cream is administered at bedtime and some leakage may occur, some patients opt to wear protective undergarments or a panty liner due to the possibility of leakage. Official regulatory documents do not specify particular types of clothing.


Q: Is Cleocin Vaginal Cream used for anything other than bacterial vaginosis (BV)?

A: The official regulatory documents provide an indication for only one condition: the treatment of bacterial vaginosis (BV). Use for any other condition is not described in the official product labeling.


Q: Can Cleocin Vaginal Cream interact with over-the-counter pain relievers?

A: Official regulatory documents do not list any specific interactions between the vaginal cream formulation and commonly used over-the-counter pain relievers. The documented interactions are limited to other neuromuscular blocking agents and specific constraints with latex/rubber products.


Q: Does using alcohol affect Cleocin Vaginal Cream?

A: Official regulatory documents and product labeling do not list an interaction between the vaginal cream formulation and the consumption of alcohol. No specific warnings or restrictions regarding alcohol are documented.


Q: What if I accidentally swallow a small amount of the cream?

A: Regulatory documents state that even though it is applied vaginally, the clindamycin phosphate vaginal cream could be absorbed in amounts sufficient to potentially produce systemic effects, such as those seen with oral use. This possibility is noted in the Overdosage section of the prescribing information.


Q: What does it mean if the original symptoms return shortly after finishing the cream?

A: The return of symptoms is referred to as relapse or re-occurrence. Studies monitoring this treatment, similar to other antibiotic monotherapies for BV, have observed a pattern where the symptoms and microbial imbalance may return in the months following the initial treatment interval.


Q: Is the cream a generic or a brand name drug?

A: Cleocin Vaginal Cream is the brand-name product. The active ingredient, clindamycin phosphate, is also available from other manufacturers as a chemically equivalent, FDA-approved generic product.


Q: Are there foods I need to avoid while using this medicine?

A: Official regulatory documents do not list any specific interactions or required restrictions between the vaginal cream formulation and food products. No warnings regarding food or dietary changes are documented.


Q: Can I use other vaginal products, like douches, during treatment?

A: The official patient information instructs that the use of other intravaginal products, such as douches or tampons, is to be avoided during the entire treatment period. This is intended to ensure the effectiveness and integrity of the medication.


Q: Is it normal to feel a change in taste or have a metallic taste while using this medicine?

A: While uncommon with the vaginal cream due to its low absorption, a metallic taste in the mouth has been a reported systemic side effect associated with oral forms of clindamycin. This is a recognized adverse reaction linked to the antibiotic itself.


Q: What should I look for on the applicator before I use it?

A: Official patient directions describe preparing the applicator by removing it from its packaging. Before use, it is described that one should check to ensure the plunger is fully extended and the applicator is properly ready to administer the required dose.


Q: Is there a possibility of developing resistance to the antibiotic?

A: Yes, regulatory information confirms that bacteria can develop resistance to clindamycin. This often happens when the bacteria change the structure of their internal machinery. Cross resistance has also been demonstrated, meaning bacteria resistant to clindamycin may also be resistant to related antibiotics.


Q: Does the cream work for men who have BV?

A: The official regulatory indication for this cream is strictly for the treatment of bacterial vaginosis (BV) in non-pregnant women and pregnant women. The medication is not indicated for use in men.


Q: What is the difference between this cream and an oral antibiotic for the same condition?

A: The primary difference is the delivery method. The cream is a topical, localized treatment with only minimal amounts absorbed into the body. Oral antibiotics are systemic treatments that lead to much higher levels of the drug circulating throughout the entire body.

How should Cleocin Vaginal Cream be stored and disposed of?

Official Storage and Disposal Requirements

Cleocin Vaginal Cream must be stored at Controlled Room Temperature, which is defined as 20 to 25 C (68 to 77 F). The medication must be protected from freezing and stored away from excess heat, moisture, and direct light. It should be kept in its tightly closed container and stored out of the reach of children.

Disposal

Do not keep outdated medicine. Unused or expired cream should be disposed of through an official drug take-back program. If a take-back program is unavailable, the cream may be mixed with an undesirable substance (e.g., dirt) and placed in a sealed bag for household trash disposal. The empty disposable applicator should be thrown into the trash after use.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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