Clindamycin 2% Vaginal Cream 40gm
It is used to treat vaginal infections. If this drug has been given for some other reason, talk with the doctor for more information.
Drug Class
Anti-infective, Vaginal
Pharmacologic Class
Lincosamide antibiotic
Pregnancy Category
Category B
FDA Approved
Sep 1992
DEA Schedule
Not Controlled
Overview
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. It is applied directly into the vagina.
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. Use this medication only as directed, and do not take it by mouth. It is for vaginal use only, and you should avoid getting it in your mouth, nose, or eyes, as it may cause burning. Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly.
Some products are designed to be used at bedtime, while others can be used at any time. If you are unsure about when to use your medication, consult with your pharmacist.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, avoiding freezing temperatures. Protect the medication from heat sources and keep it in a dry place. Do not store it in a bathroom.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is 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.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and do not take it by mouth. It is for vaginal use only, and you should avoid getting it in your mouth, nose, or eyes, as it may cause burning. Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly.
Some products are designed to be used at bedtime, while others can be used at any time. If you are unsure about when to use your medication, consult with your pharmacist.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, avoiding freezing temperatures. Protect the medication from heat sources and keep it in a dry place. Do not store it in a bathroom.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is 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.
Lifestyle & Tips
- Apply the cream at bedtime to allow it to stay in place while lying down.
- Avoid douching or using other vaginal products (e.g., tampons, spermicides) during treatment, as they may interfere with the medication.
- Avoid sexual intercourse during treatment, or use barrier contraception (condoms, diaphragms) carefully, as the cream's oil base can weaken latex or rubber products.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence of the infection.
Available Forms & Alternatives
Available Strengths:
- Clindamycin 1% Gel 60gm
- Clindamycin 1% Pledgets 60s
- Clindamycin 300mg Capsules
- Clindamycin 1% Lotion 60ml
- Clindamycin 1% Topical Soln 60ml
- Clindamycin 1% Topical Soln 30ml
- Clindamycin 2% Vaginal Cream 40gm
- Clindamycin 150mg Capsules
- Clindamycin 1% Gel 30gm
- Clindamycin 150mg/ml Inj, 60ml
- Clindamycin 1% Foam 100gm
- Clindamycin 1% Foam 50gm
- Clindamycin 150mg Capsules
- Clindamycin 300mg Capsules
- Clindamycin 900mg Inj, 50ml
- Clindamycin 900mg/6ml Inj, 6ml
- Clindamycin Phos/tretinoin Gel 60gm
- Clindamycin 1% Gel (once Daily)75ml
- Clindamycin 75mg Capsules
- Clindamycin Phos/tretinoin Gel 30gm
- Clindamycin Phos/tretinoin Gel 60gm
- Clindamycin 1% Lotion 60ml
- Clindamycin 1% Gel(once Daily)75ml
- Clindamy/d5w 600mg/50ml Inj, 50ml
- Clindamycin Ped 75mg/5ml Sol 100ml
- Clindamycin 300mg/d5w Inj, 50ml
- Clindamy/d5w 900mg/50ml Inj, 50ml
Dosing & Administration
Adult Dosing
Standard Dose:
One applicatorful (approx. 5 grams containing 100 mg clindamycin phosphate) intravaginally, once daily, preferably at bedtime, for 3 or 7 consecutive days.
Dose Range:
3 - 7 mg
Condition-Specific Dosing:
bacterialVaginosis:
One applicatorful intravaginally, once daily, preferably at bedtime, for 3 or 7 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy not established in premenarchal females. For postmenarchal adolescents, dosing is generally similar to adults if indicated and appropriate.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment necessary due to minimal systemic absorption.
Severe:
No dosage adjustment necessary due to minimal systemic absorption.
Dialysis:
No dosage adjustment necessary due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No dosage adjustment necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment necessary due to minimal systemic absorption.
Severe:
No dosage adjustment necessary due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clindamycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit and preventing peptide bond formation. It is primarily bacteriostatic but may be bactericidal in high concentrations or against highly susceptible organisms.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 3% to 10% of the administered dose is absorbed systemically following intravaginal administration.
Tmax:
Systemic peak plasma concentrations occur approximately 10 hours (range 4-24 hours) after intravaginal administration.
FoodEffect:
Not applicable for vaginal cream.
Distribution:
Vd:
Not specifically quantified for vaginal cream due to minimal systemic absorption; primarily local action.
ProteinBinding:
Systemically absorbed clindamycin is approximately 93% bound to plasma proteins.
CnssPenetration:
Limited (systemic clindamycin does not readily penetrate the CNS, and absorption from vaginal cream is minimal).
Elimination:
HalfLife:
Systemic elimination half-life is approximately 1.5 to 2.6 hours (for systemically absorbed portion).
Clearance:
Not specifically quantified for vaginal cream due to minimal systemic absorption.
ExcretionRoute:
Systemically absorbed clindamycin and its metabolites are primarily excreted in urine and feces.
Unchanged:
Less than 4% of the systemically absorbed dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Local therapeutic effect begins shortly after application.
PeakEffect:
Clinical improvement typically seen within a few days of starting treatment.
DurationOfAction:
Therapeutic levels maintained locally for the duration of treatment.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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. Although many people experience no side effects or only mild 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 do not go away, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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. Although many people experience no side effects or only mild 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 do not go away, 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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea
- Abdominal pain or cramping
- Bloody or mucus-containing stools
- New or worsening vaginal irritation, itching, or discharge
- Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing)
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 the symptoms that occurred.
A history of certain health conditions, including:
+ Crohn's disease
+ Other stomach or bowel problems, such as colitis or enteritis
+ Severe bowel problems that have occurred while taking an antibiotic, including severe diarrhea, bowel swelling, or stomach pain
* If you are currently using any products that contain erythromycin
This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without first consulting 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 the symptoms that occurred.
A history of certain health conditions, including:
+ Crohn's disease
+ Other stomach or bowel problems, such as colitis or enteritis
+ Severe bowel problems that have occurred while taking an antibiotic, including severe diarrhea, bowel swelling, or stomach pain
* If you are currently using any products that contain erythromycin
This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without first consulting your doctor.
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 avoid sexual intercourse. You may also need to refrain from sex for a certain period after your last dose. Consult your doctor to determine if you need to avoid sex after completing the treatment.
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. Make sure you understand how long you need to continue using this alternative birth control method.
During treatment with this drug, do not use vaginal products such as douches or tampons. You may also need to avoid these products for some time after your last dose. If you have any questions or concerns, discuss them with your doctor.
Do not use this medication for longer than prescribed, as this may increase the risk of a second infection.
In case of accidental ingestion, this drug can be harmful. If you or someone else swallows this medication, immediately contact a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
While using this drug, it is crucial to avoid sexual intercourse. You may also need to refrain from sex for a certain period after your last dose. Consult your doctor to determine if you need to avoid sex after completing the treatment.
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. Make sure you understand how long you need to continue using this alternative birth control method.
During treatment with this drug, do not use vaginal products such as douches or tampons. You may also need to avoid these products for some time after your last dose. If you have any questions or concerns, discuss them with your doctor.
Do not use this medication for longer than prescribed, as this may increase the risk of a second infection.
In case of accidental ingestion, this drug can be harmful. If you or someone else swallows this medication, immediately contact a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with vaginal cream due to minimal systemic absorption. In case of accidental oral ingestion, symptoms might include gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
For accidental oral ingestion, contact a poison control center or emergency medical services. Call 1-800-222-1222. Treatment is generally supportive.
Drug Interactions
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.
Monitoring
Baseline Monitoring
Diagnosis of Bacterial Vaginosis (BV)
Rationale: To confirm the indication for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of symptoms (e.g., vaginal discharge, odor, irritation)
Frequency: Daily during treatment, and at follow-up visit if clinically indicated.
Target: Absence or significant reduction of symptoms.
Action Threshold: Persistent or worsening symptoms may indicate treatment failure or alternative diagnosis.
Symptom Monitoring
- Vaginal discharge (amount, color, odor)
- Vaginal itching or irritation
- Abdominal pain
- Diarrhea (especially severe or persistent)
- Fever
Special Patient Groups
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 acceptable for use during pregnancy, particularly in the second and third trimesters, when indicated for bacterial vaginosis.
Trimester-Specific Risks:
First Trimester:
Limited data, but no evidence of increased risk. Use only if clearly needed.
Second Trimester:
Generally considered safe and effective.
Third Trimester:
Generally considered safe and effective.
Lactation
Clindamycin is excreted in breast milk following systemic administration. While systemic absorption from vaginal cream is minimal, caution should be exercised when administering to a nursing mother. The amount transferred to breast milk is likely very small, and adverse effects in breastfed infants are unlikely but theoretical (e.g., changes in gut flora, diarrhea).
Infant Risk:
L3 (Moderate risk, limited data). Monitor infant for diarrhea or candidiasis.
Pediatric Use
Safety and efficacy have not been established in premenarchal females. For postmenarchal adolescents, dosing is generally similar to adults if indicated and appropriate.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Systemic absorption is minimal, and age-related changes in renal or hepatic function are unlikely to significantly impact the drug's safety or efficacy when administered vaginally.
Clinical Information
Clinical Pearls
- Although systemic absorption is minimal, clindamycin vaginal cream carries a warning for pseudomembranous colitis, a potentially life-threatening condition. Patients should be instructed to discontinue the drug and contact their healthcare provider if significant diarrhea or abdominal pain occurs.
- The oil-based formulation of clindamycin vaginal cream can weaken latex or rubber condoms and diaphragms, potentially reducing their effectiveness as contraception or protection against STIs. Patients should be advised to use alternative or abstain from sexual activity during treatment and for at least 72 hours after the last dose.
- Patients should be advised to complete the entire course of therapy, even if symptoms improve, to ensure eradication of the infection and prevent recurrence.
- This medication is for vaginal use only and should not be taken orally or applied to other areas.
Alternative Therapies
- Metronidazole vaginal gel (0.75% or 1.3%)
- Metronidazole oral (500 mg twice daily for 7 days)
- Tinidazole oral (2 gm single dose or 1 gm daily for 5 days)
- Secnidazole oral (single 2 gm dose)
Cost & Coverage
Average Cost:
$30 - $70 per 40gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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. 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.