Cleocin 100mg Vaginal Ovule 3s
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
Pharmacologic Class
Lincosamide antibiotic
Pregnancy Category
Category B
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clindamycin vaginal ovules are a type of antibiotic medication inserted into the vagina to treat bacterial vaginosis, a common vaginal infection caused by an overgrowth of certain bacteria. It works by stopping the growth of these bacteria.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Administration
This medication is for vaginal use only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after using the medication.
Apply the medication at bedtime for best results.
Using the Suppository
Remove the foil wrapper from the suppository before use.
Do not use the medication if the pouch is torn, open, or not sealed properly.
Storage and Disposal
Store the medication at room temperature, away from heat sources.
Keep the medication in a dry place, avoiding storage in a bathroom.
Do not freeze the medication.
Missed Dose
If you miss a dose, use it as soon as you remember.
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 correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Administration
This medication is for vaginal use only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after using the medication.
Apply the medication at bedtime for best results.
Using the Suppository
Remove the foil wrapper from the suppository before use.
Do not use the medication if the pouch is torn, open, or not sealed properly.
Storage and Disposal
Store the medication at room temperature, away from heat sources.
Keep the medication in a dry place, avoiding storage in a bathroom.
Do not freeze the medication.
Missed Dose
If you miss a dose, use it as soon as you remember.
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
- Insert one ovule into the vagina at bedtime for 3 consecutive nights, even if symptoms improve sooner.
- Do not use tampons, douches, or other vaginal products during treatment.
- Avoid sexual intercourse during treatment.
- This medication may weaken latex condoms and diaphragms for up to 72 hours after treatment, reducing their effectiveness in preventing pregnancy or STIs. Use alternative birth control methods during and for 3 days after treatment.
- Complete the entire course of medication as prescribed, even if you feel better, to prevent the infection from returning.
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
Dosing & Administration
Adult Dosing
Standard Dose:
One 100 mg ovule intravaginally once daily at bedtime for 3 consecutive days.
Dose Range:
100 - 100 mg
Condition-Specific Dosing:
bacterialVaginosis:
One 100 mg ovule intravaginally once daily at bedtime for 3 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy not established in pre-menarcheal females. For post-menarcheal adolescents, adult dosing may apply if 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 specific considerations for dialysis patients 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 depending on drug concentration, infection site, and organism susceptibility.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 5% of the administered clindamycin dose is absorbed systemically from the vaginal ovule.
Tmax:
Systemic Tmax is variable, typically ranging from 1 to 5 hours after vaginal administration.
FoodEffect:
Not applicable for vaginal administration.
Distribution:
Vd:
Not applicable for vaginal administration due to minimal systemic absorption. Systemically, clindamycin distributes widely into body fluids and tissues.
ProteinBinding:
Systemically, approximately 93% protein bound.
CnssPenetration:
Limited systemic CNS penetration.
Elimination:
HalfLife:
Systemic elimination half-life is approximately 1.5 to 2.6 hours.
Clearance:
Not specifically quantified for vaginal administration due to minimal systemic absorption.
ExcretionRoute:
Systemically absorbed clindamycin is primarily excreted in urine and feces.
Unchanged:
Less than 10% of systemically absorbed clindamycin is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Local therapeutic effect begins shortly after administration.
PeakEffect:
Clinical improvement typically seen within days of starting treatment.
DurationOfAction:
Therapeutic concentrations are maintained locally for the duration of the 3-day treatment course.
Safety & Warnings
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 do not go away, contact your doctor:
Irritation at the site of application
Back pain
Constipation
Headache
This is not an exhaustive list of possible 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.
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 do not go away, contact your doctor:
Irritation at the site of application
Back pain
Constipation
Headache
This is not an exhaustive list of possible 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, with or without fever and abdominal cramps) - seek immediate medical attention as this could be a sign of *Clostridium difficile*-associated diarrhea (CDAD).
- Signs of an allergic reaction: rash, itching, hives, swelling of the face/lips/tongue/throat, severe dizziness, trouble breathing.
- New or worsening vaginal irritation, itching, or discharge (may indicate a yeast infection or treatment failure).
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 symptoms you experienced.
A history of certain health conditions, including:
+ Crohn's disease
+ 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 all your other medications and health conditions. Do not initiate, stop, or adjust the dose 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 symptoms you experienced.
A history of certain health conditions, including:
+ Crohn's disease
+ 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 all your other medications and health conditions. Do not initiate, stop, or adjust the dose 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 period after your last dose. Make sure you understand how long you need to continue using this alternative birth control method.
Additionally, do not use douches or other vaginal products, such as tampons, while you are taking this medication. 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 breast-feeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to 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 period after your last dose. Make sure you understand how long you need to continue using this alternative birth control method.
Additionally, do not use douches or other vaginal products, such as tampons, while you are taking this medication. 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 breast-feeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with vaginal clindamycin is unlikely due to minimal systemic absorption. However, excessive local application might lead to increased local irritation.
What to Do:
In case of suspected overdose or accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Major Interactions
- Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin has neuromuscular blocking properties and may enhance the action of these agents, leading to increased or prolonged muscle weakness/paralysis. Use with caution.
Moderate Interactions
- Erythromycin: In vitro antagonism between clindamycin and erythromycin has been demonstrated; concurrent use is not recommended.
- Warfarin and other vitamin K antagonists: Potentiation of anticoagulant effects (increased INR/bleeding) has been reported with systemic clindamycin. While systemic absorption from vaginal ovules is minimal, monitor INR if co-administered.
Monitoring
Routine Monitoring
Resolution of symptoms of bacterial vaginosis (e.g., discharge, odor, itching)
Frequency: Daily during treatment and post-treatment
Target: Complete resolution
Action Threshold: Persistent or worsening symptoms may indicate treatment failure or alternative diagnosis; re-evaluation by healthcare provider.
Symptom Monitoring
- Vaginal discharge (amount, color, odor)
- Vaginal itching or irritation
- Abdominal pain
- Diarrhea (especially severe or persistent)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Clindamycin vaginal ovules are generally considered safe for use during pregnancy (Category B), particularly in the second and third trimesters, when treatment for bacterial vaginosis is indicated.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk. Use only if clearly needed.
Second Trimester:
Commonly used and generally considered safe for bacterial vaginosis treatment.
Third Trimester:
Commonly used and generally considered safe for bacterial vaginosis treatment.
Lactation
Clindamycin is excreted in breast milk in small amounts following systemic administration. However, due to minimal systemic absorption from vaginal administration, the amount transferred to breast milk is expected to be very low and unlikely to cause adverse effects in a breastfed infant. Considered compatible with breastfeeding (L2).
Infant Risk:
Low risk. Monitor infant for diarrhea or candidiasis (thrush).
Pediatric Use
Safety and efficacy have not been established in pediatric patients, particularly pre-menarcheal females. Bacterial vaginosis is rare in this population. Use in post-menarcheal adolescents should be based on clinical judgment and may follow adult dosing.
Geriatric Use
No specific dosage adjustment is necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related changes in renal or hepatic function are unlikely to significantly impact drug exposure.
Clinical Information
Clinical Pearls
- Advise patients that this medication is for vaginal use only and should not be taken orally.
- Instruct patients to insert the ovule high into the vagina at bedtime to minimize leakage.
- Patients should be aware that some discharge may occur as the ovule dissolves.
- Emphasize the importance of completing the full 3-day course of treatment, even if symptoms improve, to ensure eradication of the infection and prevent recurrence.
- Inform patients that alcohol consumption is not contraindicated with vaginal clindamycin, unlike oral metronidazole.
- If a patient develops severe diarrhea during or after treatment, they should contact their healthcare provider immediately due to the risk of *Clostridium difficile*-associated diarrhea (CDAD).
Alternative Therapies
- Metronidazole (oral or vaginal gel/cream)
- Tinidazole (oral)
- Secnidazole (oral)
Cost & Coverage
Average Cost:
Varies, typically $50-$150 per 3 ovules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic or non-preferred brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 medication taken, the amount, and the time it happened.