Clindamycin/bpo 1.2-5% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Lincosamide antibiotic (Clindamycin), Oxidizing agent/Antimicrobial (Benzoyl Peroxide)
Pregnancy Category
Category C
FDA Approved
Aug 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
This gel contains two medicines, clindamycin and benzoyl peroxide, that work together to treat acne. Clindamycin is an antibiotic that kills the bacteria causing acne, and benzoyl peroxide helps to kill bacteria, reduce oil, and unclog pores.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply the medication to the vaginal area.
Before and after applying the medication, wash your hands thoroughly.
Gently wash and rinse the affected skin with warm water, then pat it dry. For facial cleansing, use only mild soaps.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Precautions
Do not apply the medication to cuts, scrapes, or damaged skin.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Keep the medication in a dry place, away from bathrooms.
Discard any unused portion of the medication after 2 months.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply the medication to the vaginal area.
Before and after applying the medication, wash your hands thoroughly.
Gently wash and rinse the affected skin with warm water, then pat it dry. For facial cleansing, use only mild soaps.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Precautions
Do not apply the medication to cuts, scrapes, or damaged skin.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Keep the medication in a dry place, away from bathrooms.
Discard any unused portion of the medication after 2 months.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply to clean, dry skin.
- Avoid contact with eyes, mouth, nostrils, and mucous membranes.
- Avoid contact with hair and colored fabrics, as benzoyl peroxide can bleach them.
- Use sunscreen daily, as benzoyl peroxide can increase sun sensitivity.
- Avoid excessive sun exposure and artificial UV light (tanning beds).
- Do not use on broken, irritated, or sunburned skin.
- Avoid using other topical acne treatments that may cause excessive dryness or irritation unless directed by your doctor.
- Be patient; it may take several weeks to see improvement.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to affected areas once daily, after washing the skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age
Adolescent:
Apply a thin layer to affected areas once daily (12 years and older)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clindamycin is a lincosamide antibiotic that binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects. It releases free radicals that oxidize bacterial proteins, and it also reduces the number of P. acnes (now C. acnes) and reduces follicular hyperkeratosis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 5% for clindamycin, less than 2% for benzoyl peroxide)
Tmax:
Not applicable for topical systemic absorption
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable for topical
ProteinBinding:
Not applicable for topical
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable for topical
Clearance:
Not applicable for topical
ExcretionRoute:
Not applicable for topical
Unchanged:
Not applicable for topical
Pharmacodynamics
OnsetOfAction:
Several weeks (typically 2-5 weeks for noticeable improvement)
PeakEffect:
Typically 8-12 weeks
DurationOfAction:
Maintained with continued use
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ 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
Gastrointestinal problems, including:
+ Diarrhea
+ Bloody diarrhea
+ Colitis (a bowel problem that can be severe and potentially life-threatening)
+ Stomach pain or cramps
+ Severe or watery diarrhea
+ Bloody diarrhea
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 not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:
* Local irritation at the site of application, including:
+ Burning
+ Itching
+ Dryness
+ Other forms of irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ 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
Gastrointestinal problems, including:
+ Diarrhea
+ Bloody diarrhea
+ Colitis (a bowel problem that can be severe and potentially life-threatening)
+ Stomach pain or cramps
+ Severe or watery diarrhea
+ Bloody diarrhea
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 not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:
* Local irritation at the site of application, including:
+ Burning
+ Itching
+ Dryness
+ Other forms of irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact 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 burning, stinging, or itching of the skin
- Severe redness or peeling of the skin
- Swelling of the face or lips
- Difficulty breathing
- Severe diarrhea or abdominal cramps (rare, but seek medical attention if occurs)
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
+ 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change 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
+ 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change 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.
If this medication is accidentally swallowed, it can cause harm. In such cases, immediately contact a doctor or a poison control center for assistance.
When using certain acne products that contain benzoyl peroxide or salicylic acid, there is a rare risk of severe and potentially life-threatening allergic reactions or irritation. Before using this medication for the first time, you may need to follow specific steps to ensure you do not have an allergic reaction. Be sure to use this medication exactly as directed by your doctor or as indicated on the package label. If you have any questions or concerns, discuss them with your doctor.
When applying this medication, exercise caution to avoid any potential interactions. It may cause bleaching of hair or colored fabrics, so take necessary precautions to prevent this.
If you are using other acne medications, use them with caution, as they may increase the risk of skin irritation. Additionally, using dapsone on the skin simultaneously may cause temporary yellowing or orange discoloration of the skin or facial hair.
Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.
This medication may increase your susceptibility to sunburn. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a sunscreen with adequate protection and wear protective clothing and eyewear when going outside.
Do not use this medication for an extended period beyond the recommended duration, as this may lead to a secondary infection. If you become pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of using this medication to you and your baby.
If this medication is accidentally swallowed, it can cause harm. In such cases, immediately contact a doctor or a poison control center for assistance.
When using certain acne products that contain benzoyl peroxide or salicylic acid, there is a rare risk of severe and potentially life-threatening allergic reactions or irritation. Before using this medication for the first time, you may need to follow specific steps to ensure you do not have an allergic reaction. Be sure to use this medication exactly as directed by your doctor or as indicated on the package label. If you have any questions or concerns, discuss them with your doctor.
When applying this medication, exercise caution to avoid any potential interactions. It may cause bleaching of hair or colored fabrics, so take necessary precautions to prevent this.
If you are using other acne medications, use them with caution, as they may increase the risk of skin irritation. Additionally, using dapsone on the skin simultaneously may cause temporary yellowing or orange discoloration of the skin or facial hair.
Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.
This medication may increase your susceptibility to sunburn. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a sunscreen with adequate protection and wear protective clothing and eyewear when going outside.
Do not use this medication for an extended period beyond the recommended duration, as this may lead to a secondary infection. If you become pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (redness, peeling, burning)
What to Do:
Topical overdose is unlikely to cause systemic toxicity. If excessive irritation occurs, discontinue use and apply cool compresses. If accidentally ingested, call a poison control center (1-800-222-1222) or seek medical attention immediately.
Drug Interactions
Moderate Interactions
- Dapsone topical gel (can cause temporary yellow/orange skin discoloration)
Minor Interactions
- Other topical acne preparations (e.g., retinoids, salicylic acid, sulfur) - may increase skin irritation, dryness, or peeling.
- Abrasive soaps or cleansers, alcohol-containing products, astringents, medicated cosmetics (may increase irritation).
Monitoring
Baseline Monitoring
Skin condition (severity of acne, presence of irritation)
Rationale: To establish a baseline for treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, dryness, peeling, burning, itching)
Frequency: Regularly during treatment (e.g., weekly for first few weeks, then as needed)
Target: Minimal to mild irritation
Action Threshold: Moderate to severe irritation may require temporary discontinuation or reduced frequency of application.
Acne lesion count and severity
Frequency: Monthly or as clinically indicated
Target: Reduction in inflammatory and non-inflammatory lesions
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment.
Symptom Monitoring
- Severe skin irritation
- Excessive dryness
- Peeling
- Redness
- Burning
- Itching
- Diarrhea (rare, but possible with systemic absorption of clindamycin)
- Abdominal pain (rare)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clindamycin is Category B, Benzoyl Peroxide is Category C. The combination is generally considered Category C.
Trimester-Specific Risks:
First Trimester:
Limited data, potential risk cannot be ruled out.
Second Trimester:
Limited data, potential risk cannot be ruled out.
Third Trimester:
Limited data, potential risk cannot be ruled out.
Lactation
Use with caution. It is not known if clindamycin or benzoyl peroxide are excreted in human milk after topical application. Due to minimal systemic absorption, risk to the infant is considered low, but caution is advised. Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
Low risk, but potential for gastrointestinal effects in infant if significant exposure occurs.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 12 years of age. Generally used for adolescents 12 years and older.
Geriatric Use
No specific dose adjustments or precautions are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are unlikely to significantly impact drug exposure.
Clinical Information
Clinical Pearls
- This combination product helps reduce bacterial resistance to clindamycin when used alone.
- Patients should be advised that bleaching of hair or colored fabrics may occur with benzoyl peroxide.
- Initial dryness and irritation are common; advise patients to start with a small amount and gradually increase as tolerated.
- Sun protection is crucial due to increased photosensitivity caused by benzoyl peroxide.
- Results are not immediate; consistent use for several weeks (typically 8-12) is necessary to see significant improvement.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., erythromycin, dapsone)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Salicylic acid topical
- Azelaic acid topical
Cost & Coverage
Average Cost:
Varies, typically $100-$500+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 1 or 2)
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 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 overdose, including the medication taken, the amount, and the time it occurred.