Clindesse

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Clindesse

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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 Clindesse

Quick Facts

Property Description
Active ingredient Clindamycin Phosphate
Form Vaginal cream
Pharmacological class Lincosamide Antibiotic
Common use Addressing localized bacterial infections
Origin Semi-synthetic

What is Clindesse and Its Pharmacological Classification?

Clindesse is a specialized, single-dose, prescription-only medication containing the active ingredient Clindamycin Phosphate, and it is classified as an antibiotic. This medication belongs specifically to the lincosamide antibiotic class. This classification is widely accepted in pharmacological studies, confirming its intended role in managing infections caused by susceptible pathogens.

The active compound, Clindamycin, is a semi-synthetic derivative of the parent antibiotic lincomycin. This semi-synthetic nature allows for optimized stability and efficacy compared to the original molecule.

Composition, Form, and Origin

Clindesse is formulated as a white, semi-solid vaginal cream, which serves as the dosage form designed for topical (vaginal) route of administration. The preparation is a single-ingredient product, with the Clindamycin Phosphate incorporated into an emollient/aqueous vehicle base. The formulation is particularly distinctive due to its single-dose regimen, an approach clinically recognized for promoting patient adherence to treatment protocols.

Clindamycin Phosphate itself is a prodrug, which means it is an inactive form that is rapidly converted into the active Clindamycin compound after application. The use of a cream base ensures that the active agent is delivered directly to the target area, optimizing its localized effect.

General Purpose of the Clindamycin Active Agent

The primary role of the active agent, Clindamycin, is to act as a bacteriostatic agent by stopping bacterial growth. This effect is achieved because the substance interferes with the bacteria’s ability to manufacture essential proteins required for replication. The general purpose of administering this antibacterial agent is therefore to reduce the concentration of the pathogenic bacterial population, which is key to resolving the underlying imbalance and facilitating recovery in cases of localized bacterial overgrowth.

What side effects are possible with Clindesse?

Possible Side Effects and Safety Information

Clindesse (clindamycin phosphate vaginal cream) is an antibiotic used to treat bacterial vaginosis. Like all medications, it can cause side effects. Patients should be aware of important safety information before use.


Common Adverse Reactions

The most commonly reported side effects in clinical trials (occurring in 2% or more of patients treated with Clindesse and at a higher rate than placebo) primarily involved the reproductive and nervous systems. These include:

Adverse Reaction Rate in Clindesse Group
Vaginal Fungal Infection 14%
Headache 7%
Back Pain 5%
Constipation 2%
Urinary Tract Infection (UTI) 2%

Because clindamycin can cause an overgrowth of non-susceptible organisms, a new vaginal infection, such as a fungal infection, may require separate antifungal treatment.


Serious Warnings

Clostridioides difficile-Associated Diarrhea (CDAD): Clindamycin, the active ingredient in Clindesse, is associated with CDAD, which can range from mild diarrhea to fatal colitis. This serious side effect may occur during or even weeks to months after antibiotic treatment. Contact a healthcare provider immediately if you experience severe diarrhea, abdominal pain, or bloody stools.

Hypersensitivity: Clindesse is contraindicated for individuals with a history of hypersensitivity or allergic reaction to clindamycin or other lincosamide antibiotics. Signs of a severe allergic reaction (e.g., rash, hives, swelling of the face/throat, difficulty breathing) require immediate medical attention.


Drug Interaction and Usage Precautions

Barrier Contraceptives: The cream contains mineral oil that can weaken the latex or rubber in products like condoms and vaginal contraceptive diaphragms. Do not rely on these barrier methods for contraception or protection against sexually transmitted diseases during treatment and for at least 5 days following treatment.

Bowel Disease: Clindesse is contraindicated for patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis/CDAD.

Vaginal Products and Intercourse: Patients are generally advised to avoid vaginal intercourse, douches, and tampons while using Clindesse.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information regarding Clindesse (clindamycin phosphate vaginal cream 2%) indicates that overdosage is unlikely with this product. This determination is based on the minimal systemic exposure achieved when the drug is applied vaginally. The vaginal route of administration results in significantly lower peak serum levels and overall systemic absorption of clindamycin compared to the levels attained with oral or intravenous dosing.

Because the systemic exposure is minimal, the official overdose documentation for Clindesse does not specify distinct dose levels or circumstances associated with a high overdose risk, nor does it list specific clinical manifestations or symptom clusters for an overdose event. Furthermore, governmental labeling does not explicitly detail emergency procedural instructions required in the event of an overdose.

While an overdose is considered unlikely, patients should always monitor for any unusual systemic symptoms or signs of hypersensitivity reactions. For any suspected adverse reaction or concerning symptoms experienced while using the medication, immediate contact with a healthcare professional is appropriate. Questions concerning exposure should be directed to the prescribing physician or pharmacist, or a certified poison control center.

Therapeutic Uses of Clindesse

The primary therapeutic role of Clindesse is in the management of Bacterial Vaginosis (BV), a condition commonly associated with non-pregnant women of reproductive age. As an antibacterial, it is applied when susceptible bacteria drive this condition.

Clindesse is applied as a localized therapeutic intervention for BV, which is a condition marked by the overgrowth of certain susceptible anaerobic bacteria. This treatment is relevant in clinical settings to address the established infection and contributes to the resolution of the clinical signs. It is commonly used to help with managing symptoms related to physical discomfort and systemic imbalance.

The medication helps address symptom clusters that may become intense or disruptive that interfere with daily functioning. This includes helping in easing the highly distinctive and unpleasant foul/fishy vaginal odor and the management of the abnormal vaginal discharge. This topical approach is generally considered relevant when supportive symptom management is appropriate, as it supports the overall therapeutic context.

It is relevant in conditions characterized by periods of heightened symptoms, and it may assist with stabilizing acute symptoms like localized irritation and pain during sexual activity. This contributes to improved day-to-day comfort during symptomatic periods.


Quick Fact: Support for Localized Symptoms
Primary Indication Bacterial Vaginosis (BV)
Symptom Management Foul odor, abnormal discharge, localized discomfort
Patient Benefit Supports comfort and helps ease the overall symptom load

Eligibility and Restrictions for Use

Who Can and Cannot Use Clindesse?

The population eligibility for Clindesse (clindamycin phosphate vaginal cream) is strictly defined by regulatory guidance, limiting its use and establishing conditions for exclusion.

Clindesse is indicated for the treatment of Bacterial Vaginosis in non-pregnant women who are post-menarchal. The safety and effectiveness of the medication have not been established in pre-menarchal females (children).


Absolute Exclusions (Contraindications)

Individuals who fall into the following categories must not use Clindesse, as this constitutes a formal contraindication:

  • Hypersensitivity: Patients with a known allergy to clindamycin or any other antibiotic in the lincosamide class.
  • Gastrointestinal History: Patients with a history of regional enteritis, ulcerative colitis, or Clostridioides difficile-associated diarrhea (CDAD).

Conditional Use

  • Pregnancy and Lactation: Use during pregnancy is restricted to situations where it is considered clearly needed. For nursing mothers, a careful assessment is required to decide whether to discontinue the drug or discontinue breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Clindesse (clindamycin phosphate vaginal cream) has a strictly limited interaction profile based on official regulatory documentation. The product's prescribing information notes that no formal drug interaction studies have been conducted specifically for this formulation.


Documented Pharmacodynamic Interaction

The active ingredient, clindamycin, has been shown to possess neuromuscular blocking properties. Therefore, co-administration with other Neuromuscular Blocking Agents (NMBAs) may enhance the action of these agents, a clinically relevant interaction requiring caution.


Restriction with Barrier Contraceptives

The cream formulation contains mineral oil as an excipient. This component may weaken latex or rubber products, including condoms and vaginal contraceptive diaphragms.

Interaction-Related Constraint: The use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. This constraint is in place to ensure the integrity of the contraceptive product is maintained.

Mechanism of Action

Targeted Blockade of Bacterial Protein Synthesis

The drug's action is mediated by the active agent, clindamycin, which targets the core machinery of susceptible bacteria. Clindamycin works by binding with high affinity to the 23S ribosomal RNA within the bacteria's 50S ribosomal subunit. This binding event physically obstructs the mechanism of protein manufacturing, specifically arresting the process of peptide chain elongation that is essential for bacterial function and replication.


Rebalancing the Local Microbial Flora

The molecular inhibition of protein synthesis produces a bacteriostatic effect on susceptible anaerobic organisms. This consequence translates into a system-level effect: by reducing the concentration of susceptible pathogens, the drug supports the natural proliferation of protective, non-susceptible bacteria, thereby influencing the local microbial population dynamics toward a re-established equilibrium.


Mechanistic Constraints and Target Modification

The efficacy of this mechanism is constrained by bacterial ability to alter the drug's target site. Resistance often involves methylation of the 23S rRNA component of the ribosome. This modification directly lowers clindamycin's binding affinity, which functionally prevents the arrest of protein synthesis.

Dosage and Administration Information

How to Use Clindesse: Administration Guidelines

Clindesse (clindamycin phosphate) Vaginal Cream, 2%, is administered as a single-dose, localized treatment. The primary principle of use is adherence to the intravaginal route of administration, which is the indicated method for this formulation.

Standard Dosing and Duration

Usage Component Instruction
Route of Administration Intravaginal use only; not intended for oral or dermal application.
Dosing Regimen The complete contents of a single pre-filled applicator are used once.
Dose Delivered Approximately 5 g of cream, equivalent to 100 mg of clindamycin.
Treatment Course Defined as a one-day treatment

Administration Conditions and Restrictions

The medication is to be administered once, at any time of the day. The complete, pre-measured dose must be inserted and dispensed using the disposable applicator.

There is a constraint regarding potential material incompatibility: the cream contains mineral oil, which may weaken latex or rubber products, such as condoms and vaginal contraceptive diaphragms. Consequently, the use of these barrier contraceptives is not recommended concurrently or for a period of 5 days following treatment. The medication is indicated for use in non-pregnant women, and safety has not been established for females under 12 years of age. This protocol ensures that the single-dose is administered correctly and that the required post-treatment restrictions are observed.

Recent Clinical Evidence

Clindesse: Recent Clinical Evidence

The active ingredient in Clindesse is clindamycin phosphate, a lincosamide antibiotic. Its clinical development and trial data focus primarily on its use as a single-dose treatment for bacterial vaginosis (BV) in non-pregnant women.

Efficacy Studies

The key clinical evidence for Clindesse (clindamycin phosphate 2% vaginal cream) comes from a multi-center, randomized, single-blind, active-controlled study. The primary objective of this trial was to compare the effectiveness and safety of a single dose of Clindesse to a standard, multi-dose (seven-day) regimen of clindamycin vaginal cream (Cleocin).

  • Study Design: The trial involved over 500 non-pregnant patients diagnosed with BV using Amsel's criteria and Nugent scoring.
  • Primary Findings: The study results indicated that the single-dose regimen of Clindesse was equivalent in efficacy to the seven-day regimen of the comparator cream. The cure rates—measured by Investigator Cure, Clinical Cure, Nugent Cure, and Therapeutic Cure—showed no significant statistical difference between the two treatment groups.

Safety and Tolerability Profile

Clindesse was monitored for adverse events during clinical development and showed a generally comparable safety profile to the multi-dose clindamycin cream and placebo.

  • Common Events: The most frequently reported adverse reactions that occurred at a higher rate than in the placebo group included vaginal fungal infections (candidiasis), headache, back pain, and constipation.
  • Systemic Absorption: Studies on the pharmacokinetics of the cream showed that the systemic exposure (absorption into the bloodstream) of clindamycin after intravaginal application is substantially lower than when the drug is administered orally or intravenously.

Key Studies & References

  1. Amsel's criteria and Nugent score for the diagnosis of bacterial vaginosis

Frequently Asked Questions (FAQ)

Common questions about Clindesse (FAQ)


Q: How long do the effects of Clindesse last?

Clindesse is administered as a single-dose treatment. Official studies show that the active medication, clindamycin, remains detectable at the application site for at least 24 hours, and in some cases, for up to several days after application. Once absorbed into the bloodstream, the medication has a relatively short systemic half-life of less than three hours.


Q: Is it normal to see some white discharge after using Clindesse?

Clindesse is formulated as a white, semi-solid cream, and physical leakage or discharge of this cream base may occur after application. However, regulatory documents also list vaginal fungal infection (candidiasis), which can cause discharge, as the most commonly reported side effect in clinical trials.


Q: What happens if Clindesse is used more than once?

The official product instructions define Clindesse as a single-dose, one-time application. The single, one-time application regimen is defined in official instructions. Clindamycin, the active ingredient, has been associated with the potential for severe diarrhea (CDAD).


Q: Can Clindesse interact with birth control pills?

Official product information states that formal studies specifically testing drug interactions with this vaginal cream, including oral contraceptives (pills), have not been conducted. However, the cream formulation contains mineral oil, which is known to weaken latex or rubber barrier methods, such as condoms and diaphragms.


Q: Why is Clindesse often prescribed over other treatments?

Clinical studies summarized in the official labeling indicate that a single-day dose of Clindesse was equivalent in effectiveness to a standard seven-day regimen using a different clindamycin cream. This single-dose approach is a key feature described in the product’s administration.


Q: What are the ingredients in Clindesse besides the active drug?

In addition to the active drug, clindamycin phosphate, the cream contains several inactive ingredients to create the vehicle base. These excipients, listed in the official product description, include mineral oil, cetostearyl alcohol, propylene glycol, and benzyl alcohol.


Q: Can Clindesse cause a rash or itching?

Yes, official safety information indicates that allergic reactions to clindamycin, which may include a rash, are possible. Furthermore, itching is a common symptom of a vaginal fungal infection (candidiasis), which was the most frequent side effect reported in clinical trials.


Q: Is it true that Clindesse can cause stomach upset?

Gastrointestinal side effects have been reported with this medication. Clinical trial data includes constipation as an adverse reaction. Additionally, the drug carries a serious warning regarding the potential for severe diarrhea and colitis (CDAD).


Q: How long after using Clindesse is it safe to resume sexual activity?

Product literature notes that vaginal intercourse, douches, and tampons are generally avoided while using the treatment. Furthermore, the use of latex or rubber barrier contraceptives is not recommended during treatment and for a period of five days following administration.


Q: Can I use other vaginal products (like lubricants) while using Clindesse?

Regulatory usage precautions advise avoiding the use of douches and tampons while receiving treatment. The product also contains mineral oil that can physically damage latex or rubber barrier contraceptives, making them ineffective.


Q: Does Clindesse treat sexually transmitted infections (STIs)?

The official indications state that Clindesse is approved specifically for the treatment of bacterial vaginosis (BV), a condition caused by an overgrowth of certain bacteria. The product labeling does not list any sexually transmitted infections (STIs) as an approved treatment indication.


Q: What is the purpose of the oil-based ingredients in Clindesse?

The ingredients, including mineral oil, are part of the excipient base used to create the vaginal cream formulation. This base is essential for the product’s consistency and localized delivery. The official label notes that this component can physically weaken latex or rubber products.


Q: Can I travel while using Clindesse?

Official labeling requires Clindesse to be stored at Controlled Room Temperature, which is generally 20 C to 25 C. When traveling, temporary temperature excursions are permitted, but care must be taken to avoid excessive heat or freezing, as defined in the product's storage instructions.


Q: What is the difference in how Clindesse and oral antibiotics work?

Both Clindesse and oral clindamycin work by blocking bacterial protein synthesis. However, the vaginal cream is applied locally, resulting in a substantially lower systemic exposure—meaning less of the drug is absorbed into the general bloodstream—compared to taking the medication orally.


Q: Is Clindesse the same type of medication as Flagyl (metronidazole)?

No. Clindesse is classified as a lincosamide antibiotic. Metronidazole, which is sold under the brand name Flagyl, is classified as a nitroimidazole antibiotic. While both medications are used to address bacterial vaginosis, they belong to different pharmacological classes.


Q: How quickly does Clindesse start to work?

The active compound, clindamycin phosphate, is rapidly converted into its active form upon application. The medication’s mechanism of action, which involves inhibiting bacterial protein synthesis, is initiated upon the active compound reaching the target site.


Q: Can I use Clindesse if I am currently menstruating?

The official product labeling for Clindesse does not provide specific instructions for use during menstruation. Information from similar vaginal products suggests that treatment may be avoided immediately prior to or during a woman's menstrual cycle.


Q: Are there any known interactions between Clindesse and common pain relievers?

According to the official product information, no formal drug interaction studies have been conducted specifically using the Clindesse formulation.


Q: Does Clindesse affect fertility or trying to conceive?

Official product labeling does not contain information regarding a direct impact on human fertility or the ability to conceive.


Q: Is there a generic version of Clindesse available?

Regulatory records indicate that a generic version of the specific single-dose Clindesse brand formulation is not currently available in the United States. However, other generic clindamycin vaginal cream products are available that follow different dosing schedules.


Q: Does Clindesse contain hormones?

No. Clindesse is classified as an antibiotic. The single active ingredient listed in the official labeling is clindamycin phosphate, which is not a hormone.


Q: What are the expectations regarding follow-up after using Clindesse?

Clindesse is an abbreviated one-day treatment. Clinical studies summarized in regulatory documents assessed treatment effectiveness at a specific follow-up time point. The appropriate follow-up schedule to confirm successful treatment is determined by the prescribing healthcare provider.

How should Clindesse be stored and disposed of?

How to Store and Dispose of Clindesse?

The storage and handling of Clindesse (clindamycin phosphate) vaginal cream are strictly defined by official regulatory labeling to ensure product quality and safety.


Storage Requirements

  • Temperature: Clindesse must be stored at Controlled Room Temperature, which is defined as 20 C to 25 C (68 F to 77 F). Temporary excursions outside of this range are permitted between 15 C and 30 C (59 F and 86 F), but storage must avoid excessive heat. The product should not be frozen.
  • Child Safety: The medication must be kept out of the reach of children.

Disposal Instructions

Clindesse is a single-dose product supplied in a pre-filled, disposable applicator. After the cream has been administered, the empty applicator must be discarded by being thrown away in the trash.

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

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