Cleocin Vaginal Cream

Cleocin Vaginal Cream is a topical antibiotic formulation primarily prescribed for the treatment of bacterial vaginosis. It contains clindamycin phosphate, a potent lincosamide antibiotic, which targets and eradicates pathogenic bacteria within the vaginal environment. Delivered in a cream base, this therapy offers a localized effect with minimal systemic absorption.

Cleocin Vaginal Cream is FDA-approved for intravaginal use. It is classified as an Rx-only (prescription-only) medication under the antimicrobial category, specifically indicated for bacterial vaginosis in women of reproductive age. Regulatory clearance underscores its safety and efficacy within defined therapeutic boundaries.

Belonging to the lincosamide class of antibiotics, Cleocin exhibits bacteriostatic and, at higher concentrations, bactericidal activity. It works by inhibiting bacterial protein synthesis via binding to the 50S ribosomal subunit. Its pharmacokinetic profile ensures high local concentrations in the vaginal mucosa, with limited systemic distribution.

The primary bioactive component is clindamycin phosphate (equivalent to 20 mg of clindamycin per gram of cream). It exhibits a broad spectrum of activity against anaerobic bacteria associated with bacterial vaginosis.

Inactive components may include:

- Purified water

- Cetostearyl alcohol

- Mineral oil

- Glycerol monostearate

- Propylene glycol

These agents aid in emulsification, consistency, and mucosal adherence.

Cleocin is supplied as a 1% concentration vaginal cream in pre-filled applicators or tubes. Each full applicator (approximately 5 grams) contains 100 mg of clindamycin phosphate.

Clindamycin targets and eliminates obligate anaerobic bacteria responsible for dysbiosis in the vaginal microbiome.

It is particularly active against Gardnerella vaginalis, Mobiluncus spp., and Mycoplasma hominis.

The antibiotic binds to the 50S subunit of bacterial ribosomes, blocking peptide chain elongation. This action halts protein synthesis, suppressing bacterial proliferation and virulence.

• Strong inhibition of anaerobes
• Moderate activity against gram-positive aerobes
• Ineffective against gram-negative aerobes and fungi

Clindamycin reduces overgrowth of pathogenic anaerobes while potentially disrupting protective Lactobacillus species, which may lead to secondary fungal overgrowth in some users.

Cleocin is a first-line treatment for bacterial vaginosis (BV) in adult, non-pregnant women. It alleviates symptoms such as abnormal discharge, odor, and irritation.

Approved for use in pregnant women during the second and third trimesters when oral therapy is contraindicated. Clinical trials have demonstrated relative safety in later pregnancy.

Cleocin targets a broad range of anaerobic vaginal pathogens, making it suitable for mixed or undefined anaerobic infections.

Though not officially approved, Cleocin is occasionally used alongside metronidazole to enhance eradication of Trichomonas vaginalis in resistant cases.

Effective as part of combination regimens for polymicrobial infections involving Candida albicans, Gardnerella, and anaerobes.

Utilized when clinical symptoms suggest vaginitis but lab confirmation is pending or inconclusive.

Intermittent use under physician supervision may help reduce recurrence in chronic BV sufferers.

- 1 applicator (5 grams) intravaginally once daily at bedtime

- Typical duration: 3 to 7 days depending on patient response

- Wash hands thoroughly before application

- Fill applicator fully and insert gently into the vaginal canal

- Depress plunger to release cream

If a dose is missed, apply as soon as remembered unless near the time of the next dose. Avoid double application.

Repeat courses should not be initiated without reassessment. Overuse may promote resistance and adverse effects.

- Vaginal pruritus or burning sensation

- Thin, white discharge

- Vulvovaginal candidiasis

- Mild gastrointestinal cramping

- Hypersensitivity reactions (rash, urticaria, rare anaphylaxis)

- Clostridioides difficile-associated colitis

- Post-treatment vaginal bleeding

- Emergence of antibiotic-resistant strains

• Concurrent oral clindamycin may amplify systemic effects
• May degrade latex, compromising condoms and diaphragms
• Caution with other intravaginal products due to antagonistic pH or excipient interactions
• Seizure medications, such as carbamazepine, phenobarbital, and phenytoin 
• Antibiotics like rifampin.
• Dietary supplements like St. John's wort.

- Known hypersensitivity to clindamycin or related compounds

- Prior history of antibiotic-induced colitis

-Use during the first trimester of pregnancy without specialist oversight

Rare but serious risk of C. difficile infection necessitates discontinuation if persistent diarrhea develops.

Extended use may promote fungal overgrowth or colonization with resistant bacteria.

Patients experiencing burning, rash, or swelling should stop treatment and consult a healthcare provider immediately.

Intercourse and intravaginal devices should be avoided during the course of therapy to ensure effectiveness and minimize irritation.

In geriatric populations, pharmacokinetics can be altered due to age-related physiological changes such as reduced hepatic metabolism, diminished renal clearance, and decreased mucosal perfusion. Although Cleocin Vaginal Cream is intended for local administration with minimal systemic absorption, caution is still warranted.

- The vaginal mucosa may become thinner and more fragile in postmenopausal women, increasing sensitivity to topical agents.

- A longer duration of cream retention may occur due to decreased vaginal discharge in older adults. However, there is limited clinical data specifically evaluating the efficacy and safety of clindamycin vaginal cream in women over 65 years of age. As a result, individualized assessment based on patient health status, comorbidities, and concurrent medications is essential.

Clindamycin vaginal cream is classified as a Pregnancy Category B drug by the FDA, indicating that animal studies have not demonstrated a risk to the fetus, but adequate and well-controlled studies in pregnant women are lacking.

- Clinical trials support its safe use during the second and third trimesters when administered intravaginally.

- Use in the first trimester is not recommended unless clearly necessary and prescribed under specialist supervision.

- Intravaginal administration limits systemic exposure, which reduces the theoretical risk to fetal development.

During lactation, while systemic absorption is low, trace amounts may still be excreted into breast milk. Although adverse effects in nursing infants are unlikely, monitoring for signs of gastrointestinal disturbance (e.g., diarrhea or candidiasis) is advised if exposure is suspected.

Cleocin Vaginal Cream has not been extensively studied in children and is not recommended for use in premenarchal individuals due to a lack of safety and efficacy data.

- Adolescents who are post-menarcheal may use the cream under medical supervision if a diagnosis of bacterial vaginosis is confirmed.

- In younger patients, alternative treatment options should be considered.

- Long-term effects of clindamycin on developing reproductive tissues remain unexplored.

Overdose via vaginal administration is rare due to the low systemic absorption. However, inappropriate or excessive use may lead to:

- Increased local irritation, burning, or mucosal inflammation

- Possible systemic symptoms such as nausea, diarrhea, or abdominal discomfort if absorbed

While designed for localized application, repeated or high-volume use, particularly in patients with compromised vaginal mucosa, can increase the risk of systemic absorption. Systemic toxicity may present as gastrointestinal distress or, in severe cases, pseudomembranous colitis.

- Discontinue use immediately if overdose is suspected.

- Supportive care includes hydration, symptomatic treatment, and monitoring for signs of colitis.

- In cases of severe systemic effects, hospitalization and specialist consultation may be required.

Cleocin Vaginal Cream should be stored at controlled room temperature, ideally between 20°C and 25°C (68°F to 77°F). Protect from excessive heat and freezing.

- Always check the expiration date before use.

- Do not use beyond the indicated shelf life, as degradation of the active ingredient may occur.

- Discoloration, separation, or an unusual odor indicates possible spoilage.

Unused or expired cream should not be flushed or poured down the drain. Return to a pharmacy take-back program or follow local regulations for safe disposal of medical products.

- Single-use applicators should be discarded after use.

- If reusable applicators are used (in rare formulations), they must be cleaned thoroughly with warm water and mild soap.

- Ensure full drying before reuse to prevent bacterial contamination.

Strict hand hygiene is essential to prevent contamination of the medication and reduce the risk of secondary infection.

- Wash hands thoroughly before opening the tube or handling the applicator.

- After application, wash hands again to avoid unintentional transfer to the eyes or other sensitive areas.

Cleocin Vaginal Cream is for vaginal use only.

- Accidental contact with eyes or oral mucosa may cause irritation.

- In case of exposure, rinse thoroughly with clean water and seek medical attention if symptoms persist.

- Store the cream in its original container to avoid contamination.

- Keep away from pets and children.

- Do not expose to sunlight or extreme temperatures, which may degrade the product.

- Refrain from using tampons, douches, or other vaginal products during treatment.

- Avoid sexual intercourse to allow full therapeutic effect and prevent transmission.

- Wear breathable cotton underwear and avoid tight clothing to reduce moisture buildup and irritation.