Cleocin 2% Vaginal Cream 40gm

Manufacturer PFIZER Active Ingredient Clindamycin Vaginal Cream(klin da MYE sin) Pronunciation KLIN-da-MYE-sin
It is used to treat vaginal infections. If this drug has been given for some other reason, talk with the doctor for more information.
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Drug Class
Anti-infective, Vaginal
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Pharmacologic Class
Lincosamide Antibiotic
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Pregnancy Category
Category B
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FDA Approved
Sep 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin vaginal cream is an antibiotic medication used to treat bacterial vaginosis, a common vaginal infection. It works by stopping the growth of bacteria that cause the infection. You insert the cream into your vagina using a special applicator, usually once a day at bedtime, for several days.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Do not take this medication by mouth; it is for vaginal use only. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Continue using the medication as directed, even if your symptoms improve. Wash your hands before and after applying the medication.

Some products are designed to be used at bedtime, while others can be used at any time. If you're unsure about the best time to use your medication, consult with your pharmacist.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from heat sources. Do not freeze the medication. Keep it in a dry place, avoiding storage in a bathroom.

Missing a Dose

If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
  • Avoid sexual intercourse or use of tampons during treatment, as they may interfere with the medication's effectiveness and could cause irritation.
  • Clindamycin vaginal cream may weaken latex condoms and diaphragms for up to 72 hours after treatment, increasing the risk of pregnancy or sexually transmitted infections. Use alternative birth control methods during and for at least 3 days after treatment.
  • Wear a sanitary pad to protect clothing from leakage.
  • Avoid douching, as it can disrupt the natural balance of bacteria in the vagina.

Dosing & Administration

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Adult Dosing

Standard Dose: One applicator full (approximately 5 grams containing 100 mg clindamycin phosphate) intravaginally, once daily, preferably at bedtime, for 7 consecutive days.

Condition-Specific Dosing:

bacterialVaginosis: One applicator full (approximately 5 grams containing 100 mg clindamycin phosphate) intravaginally, once daily, preferably at bedtime, for 7 consecutive days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established in pre-pubertal females)
Adolescent: Safety and efficacy in post-menarchal adolescents are expected to be similar to adult women. Dosing is typically the same as adults if indicated.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations due to minimal systemic absorption

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacteria. This binding interferes with the initiation of peptide chains and inhibits peptidyl transferase activity, leading to bacteriostatic effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 3-10% (systemic absorption from vaginal administration)
Tmax: Systemic peak concentrations occur 8-10 hours post-dose (vaginal administration)
FoodEffect: Not applicable (vaginal administration)

Distribution:

Vd: Not available (minimal systemic distribution from vaginal administration)
ProteinBinding: Approximately 93% (for systemically absorbed clindamycin)
CnssPenetration: Limited (for systemically absorbed clindamycin)

Elimination:

HalfLife: Approximately 1.5-2.6 hours (for systemically absorbed clindamycin)
Clearance: Not available (minimal systemic clearance from vaginal administration)
ExcretionRoute: Urine and feces (for systemically absorbed clindamycin)
Unchanged: Minimal (for systemically absorbed clindamycin)
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Pharmacodynamics

OnsetOfAction: Within 24-48 hours (symptomatic improvement)
PeakEffect: Within 3-7 days (completion of treatment course)
DurationOfAction: Sustained effect throughout the 7-day treatment period

Safety & Warnings

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BLACK BOX WARNING

Clindamycin can cause severe colitis, which may result in death. It has been shown to be associated with the production of toxins by Clostridioides difficile. Because clindamycin therapy has been associated with severe colitis, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin. Although pseudomembranous colitis has been reported rarely with the vaginal administration of clindamycin, it is an important consideration.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Vaginal itching or discharge
Symptoms of C diff-associated diarrhea (CDAD), a severe form of diarrhea that can be life-threatening:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools
Do not attempt to treat diarrhea without consulting your doctor first.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Irritation at the site of application
Back pain
Constipation
Headache

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea (especially if bloody or watery)
  • Severe abdominal pain or cramping
  • Fever
  • New vaginal yeast infection symptoms (e.g., severe itching, thick white discharge)
  • Worsening of original symptoms or no improvement after completing the course
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms.
A history of certain health conditions, including:
+ Crohn's disease
+ Other stomach or bowel problems, such as colitis or enteritis
+ Severe bowel problems that occurred while taking an antibiotic, including severe diarrhea, bowel swelling, or stomach pain
Current use of products containing erythromycin

This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and supplements with your doctor and pharmacist. This includes:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

Your doctor needs to assess the safety of taking this medication with your existing health conditions and medications. Do not initiate, stop, or adjust the dose of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

While using this drug, it is crucial to abstain from sexual intercourse. Additionally, you may need to continue avoiding sex for a certain period after your last dose. Consult your doctor to determine the specific duration for which you should avoid sex after stopping the medication.

Please note that condoms and diaphragms may not be effective in preventing pregnancy or stopping the spread of sexually transmitted diseases while you are taking this medication and for a period of time after you stop. Therefore, you will need to use an alternative form of birth control for a certain duration after your last dose. It is vital to understand how long you need to continue using this alternative birth control method.

During the treatment period and possibly for some time after your last dose, refrain from douching or using other vaginal products, such as tampons. If you have any questions or concerns, discuss them with your doctor.

Do not use this medication for an extended period beyond the recommended duration, as this may increase the risk of a second infection.

In case of accidental ingestion, this drug can be harmful. If swallowed, immediately contact a doctor or a poison control center.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with vaginal administration due to minimal systemic absorption. However, if accidentally ingested, symptoms could include gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

If accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek medical attention. Treatment is generally supportive.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., succinylcholine, vecuronium): Clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents, leading to increased or prolonged respiratory depression.
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Moderate Interactions

  • Erythromycin: In vitro antagonism between clindamycin and erythromycin has been demonstrated. Avoid concomitant use.
  • Warfarin and other vitamin K antagonists: Potentiation of anticoagulant effects (increased INR/bleeding) has been reported with systemic clindamycin. While systemic absorption from vaginal cream is low, caution is advised.

Monitoring

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Baseline Monitoring

Diagnosis of Bacterial Vaginosis

Rationale: To confirm appropriate indication for treatment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Resolution of symptoms (vaginal discharge, odor, itching)

Frequency: Daily during treatment, and at follow-up visit if symptoms persist

Target: Complete resolution or significant improvement

Action Threshold: If symptoms worsen or do not improve after 7 days, re-evaluate diagnosis and consider alternative treatment.

Development of new symptoms (e.g., severe diarrhea, abdominal pain, fever)

Frequency: Daily during and after treatment

Target: Absence of new symptoms

Action Threshold: Promptly discontinue treatment and investigate for Clostridioides difficile-associated diarrhea (CDAD) if severe diarrhea occurs.

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Symptom Monitoring

  • Vaginal discharge (amount, color, odor)
  • Vaginal itching or irritation
  • Abdominal pain
  • Diarrhea (especially severe or persistent)
  • Fever

Special Patient Groups

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Pregnancy

Clindamycin vaginal cream is classified as Pregnancy Category B. Studies in pregnant women have not shown an increased risk of fetal abnormalities. It is generally considered safe for use during pregnancy when clearly needed, especially for bacterial vaginosis which can be associated with adverse pregnancy outcomes.

Trimester-Specific Risks:

First Trimester: No increased risk of fetal abnormalities observed in human studies.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Clindamycin is excreted in breast milk following systemic administration. However, systemic absorption from vaginal cream is minimal, leading to very low levels in breast milk. It is generally considered compatible with breastfeeding, but caution is advised. Monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low risk (L3 - Moderately Safe)
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Pediatric Use

Safety and efficacy have not been established in pre-pubertal females. In post-menarchal adolescents, dosing is typically the same as adults if indicated for bacterial vaginosis.

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Geriatric Use

No specific dose adjustments are necessary for elderly patients. Systemic absorption is minimal, and age-related changes in renal or hepatic function are unlikely to significantly impact drug exposure or safety with vaginal administration.

Clinical Information

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Clinical Pearls

  • Advise patients that this medication is for vaginal use only and should not be taken orally.
  • Emphasize the importance of completing the full 7-day course of treatment, even if symptoms improve earlier, to prevent recurrence and resistance.
  • Inform patients about the potential for the cream to weaken latex condoms and diaphragms, and advise alternative contraception for at least 3 days after treatment.
  • Counsel patients on proper application technique using the provided applicator, preferably at bedtime to minimize leakage.
  • Be aware that vaginal clindamycin can sometimes lead to vulvovaginal candidiasis (yeast infection) as a side effect, which may require separate treatment.
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Alternative Therapies

  • Metronidazole (oral or vaginal gel/cream)
  • Tinidazole (oral)
  • Secnidazole (oral)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 for generic, higher for brand per 40gm tube
Generic Available: Yes
Insurance Coverage: Tier 1-3 (depending on generic vs. brand and specific insurance plan)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.