Clindamycin/bpo 1.2-2.5%gel 50gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Lincosamide antibiotic; Keratolytic/Oxidizing agent
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a topical gel used to treat acne. It contains two active ingredients: an antibiotic (clindamycin) that kills acne-causing bacteria, and benzoyl peroxide, which helps to reduce oil, unclog pores, and also kills bacteria.
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 this medication to the vaginal area.
Before and after applying the medication, wash your hands thoroughly.
Cleanse the affected skin with warm water and 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 this medication to cuts, scrapes, or damaged skin.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Keep it in a dry place, avoiding storage in a bathroom.
Store the medication upright with the cap securely closed.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose 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 application.
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 this medication to the vaginal area.
Before and after applying the medication, wash your hands thoroughly.
Cleanse the affected skin with warm water and 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 this medication to cuts, scrapes, or damaged skin.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Keep it in a dry place, avoiding storage in a bathroom.
Store the medication upright with the cap securely closed.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose 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 application.
Lifestyle & Tips
- Apply to clean, dry skin.
- Avoid contact with eyes, mouth, nostrils, and mucous membranes.
- May cause increased sensitivity to sunlight; use sunscreen and wear protective clothing.
- May bleach hair or colored fabrics (towels, pillowcases, clothing).
- Avoid using other topical acne medications 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 area once daily
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to affected area once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children under 12 years)
Adolescent:
Apply a thin layer to affected area once daily (12 years and older)
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 (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
Mechanism of Action
Clindamycin: Binds to the 50S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis. Benzoyl Peroxide: Releases free radicals that oxidize bacterial proteins, leading to a bactericidal effect against Propionibacterium acnes. It also has keratolytic and comedolytic properties, reducing follicular hyperkeratosis.
Pharmacokinetics
Absorption:
Bioavailability:
Clindamycin: <4% systemic absorption; Benzoyl Peroxide: <5% systemic absorption (converted to benzoic acid)
Tmax:
Not applicable (topical, minimal systemic absorption)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (primarily local action)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Weeks (typically 2-5 weeks for noticeable improvement)
PeakEffect:
Weeks (typically 8-12 weeks)
DurationOfAction:
Continues with consistent 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 many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
* Local irritation at the application site, including:
+ Burning
+ Itching
+ Dryness
+ Other forms of irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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, 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 many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
* Local irritation at the application site, including:
+ Burning
+ Itching
+ Dryness
+ Other forms of irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 skin irritation (redness, dryness, peeling, burning)
- Swelling or blistering of the skin
- Signs of a severe allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Severe diarrhea or stomach cramps (rare, but report immediately)
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 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
Current use of products containing erythromycin
This list is not exhaustive, and it is crucial to discuss all of your medications, health problems, and concerns with your doctor and pharmacist. This includes:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never 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 allergic reaction you experienced, including any 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
Current use of products containing erythromycin
This list is not exhaustive, and it is crucial to discuss all of your medications, health problems, and concerns with your doctor and pharmacist. This includes:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never 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 significant 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.
To use this medication correctly, follow the instructions provided by your doctor or as outlined on the package label. If you have any questions or concerns, discuss them with your doctor.
When applying this medication, exercise caution to avoid accidental contact with hair or colored fabrics, as it may cause bleaching.
If you are using other acne medications, be aware that combining them with this drug 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 appropriate SPF 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 experience any concerns, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these situations to ensure the best outcome for both 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 significant 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.
To use this medication correctly, follow the instructions provided by your doctor or as outlined on the package label. If you have any questions or concerns, discuss them with your doctor.
When applying this medication, exercise caution to avoid accidental contact with hair or colored fabrics, as it may cause bleaching.
If you are using other acne medications, be aware that combining them with this drug 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 appropriate SPF 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 experience any concerns, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these situations to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (redness, dryness, peeling)
- Burning sensation
What to Do:
Wash the area thoroughly with water. Discontinue use and contact a healthcare professional if symptoms persist or are severe. For accidental ingestion, call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Dapsone topical gel (potential for temporary yellow/orange skin discoloration)
Monitoring
Baseline Monitoring
Skin condition and acne severity
Rationale: To establish baseline for efficacy assessment
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in acne lesions)
Frequency: Monthly or as clinically indicated
Target: Improvement in lesion count
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation
Local skin reactions (erythema, dryness, peeling, burning, itching)
Frequency: At each follow-up visit
Target: Mild to moderate, tolerable
Action Threshold: Severe or persistent irritation may require temporary discontinuation or reduced frequency
Symptom Monitoring
- Severe skin irritation
- Excessive dryness or peeling
- Burning or stinging sensation
- Swelling
- Blistering
- Signs of allergic reaction (rash, itching, hives, difficulty breathing)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected, but data are limited.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk.
Second Trimester:
Limited data, theoretical risk.
Third Trimester:
Limited data, theoretical risk.
Lactation
Use with caution. Clindamycin is excreted in breast milk after oral/parenteral administration; it is unknown if topical application results in sufficient systemic absorption to be detectable in breast milk. Benzoyl peroxide is minimally absorbed. Consider applying to areas not in contact with the infant.
Infant Risk:
Low risk due to minimal systemic absorption, but monitor infant for potential adverse effects (e.g., diarrhea).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients younger than 12 years of age.
Geriatric Use
No specific dose adjustments are necessary. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Clinical Information
Clinical Pearls
- This combination product is more effective than either ingredient alone for acne vulgaris.
- Advise patients that skin irritation (dryness, redness, peeling) is common, especially during the first few weeks of treatment, and usually subsides with continued use.
- Emphasize the importance of consistent, once-daily application for optimal results.
- Remind patients about the bleaching potential of benzoyl peroxide on clothing, bedding, and hair.
- Instruct patients to apply a pea-sized amount to the entire affected area, not just individual lesions.
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:
$50 - $200 per 50gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (varies by plan)
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 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.