Cleocin 2% Vaginal Cream 40gm
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
- Cleocin 150mg Capsules
- Cleocin 75mg Capsules
- Cleocin 75mg/5ml Granules100ml
- Cleocin T 1% Topical Solution 30ml
- Cleocin T 1% Topical Solution 60ml
- Cleocin T 1% Lotion 60ml
- Cleocin 300mg Capsules
- Cleocin 2% Vaginal Cream 40gm
- Cleocin T 1% Pledgete 60s
- Cleocin 100mg Vaginal Ovule 3s
- Cleocin Phos 9gm Inj, 60ml
- Cleocin Phos 600mg/4ml Inj, 4ml
- Cleocin Phos 900mg/6ml Inj, 6ml
- Cleocin 300mg/2ml Inj, 2ml
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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.
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
Baseline Monitoring
Rationale: To confirm appropriate indication for treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
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.
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.
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 safe for use during pregnancy when clearly needed, especially for bacterial vaginosis which can be associated with adverse pregnancy outcomes.
Trimester-Specific Risks:
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.
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.
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
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.
Alternative Therapies
- Metronidazole (oral or vaginal gel/cream)
- Tinidazole (oral)
- Secnidazole (oral)