Clindamycin/bpo 1.2-2.5% Gel 50gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Lincosamide antibiotic; Oxidizing agent/Keratolytic
Pregnancy Category
Category C
FDA Approved
May 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a gel applied to the skin to treat acne. It contains two active ingredients: an antibiotic (clindamycin) that kills the bacteria causing acne, and benzoyl peroxide, which also kills bacteria and helps to unclog pores and reduce oiliness.
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.
Preparation and Application
Before applying the medication, wash your hands thoroughly.
Gently wash and rinse the affected skin area with warm water, then pat it dry.
Use only mild soaps for cleansing the facial area.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to cuts, scrapes, or damaged skin.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the medication 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 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 this medication to the vaginal area.
Preparation and Application
Before applying the medication, wash your hands thoroughly.
Gently wash and rinse the affected skin area with warm water, then pat it dry.
Use only mild soaps for cleansing the facial area.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to cuts, scrapes, or damaged skin.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the medication 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 dose.
Lifestyle & Tips
- Wash and dry the affected skin area before applying the gel.
- Apply a thin layer to the entire affected area, not just individual pimples.
- Avoid contact with eyes, mouth, nostrils, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Benzoyl peroxide can bleach hair and colored fabrics (towels, clothing, bedding). Allow the gel to dry completely before contact with fabrics.
- Use sunscreen and protective clothing, as benzoyl peroxide can increase sun sensitivity.
- Avoid excessive exposure to sunlight, sunlamps, or tanning beds.
- Do not use on broken, irritated, or sunburned skin.
- Moisturize regularly to counteract dryness, but choose a non-comedogenic moisturizer.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily after washing the skin.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to the entire affected facial area (or other affected areas) once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For patients 12 years of age and older: Apply a thin layer to affected areas once daily.
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 for topical use due to 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 is a lincosamide antibiotic that binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. It is primarily bacteriostatic against Propionibacterium acnes (now Cutibacterium acnes). Benzoyl peroxide is an oxidizing agent with bactericidal activity against P. acnes and also possesses keratolytic and comedolytic properties. The combination provides synergistic effects by reducing P. acnes and promoting exfoliation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% for clindamycin, benzoyl peroxide is metabolized to benzoic acid which is absorbed).
Tmax:
Not well-defined for systemic levels from topical application; local effect is gradual.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical formulation due to minimal systemic absorption.
ProteinBinding:
Not applicable for topical formulation due to minimal systemic absorption.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for topical formulation due to minimal systemic absorption.
Clearance:
Not applicable for topical formulation due to minimal systemic absorption.
ExcretionRoute:
Not applicable for topical formulation due to minimal systemic absorption.
Unchanged:
Not applicable for topical formulation due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Noticeable improvement typically within 2-5 weeks.
PeakEffect:
Optimal results usually seen after 8-12 weeks of continuous use.
DurationOfAction:
Effects persist with continued application; acne may recur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
Diarrhea, bloody diarrhea, or a bowel problem (colitis), which can be severe and potentially life-threatening. If you experience:
+ 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 do not go away, contact your doctor or seek medical help:
* Burning, itching, dryness, or other irritation at the site where the medication was applied
Note: 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 or seek medical help right away:
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
Diarrhea, bloody diarrhea, or a bowel problem (colitis), which can be severe and potentially life-threatening. If you experience:
+ 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 do not go away, contact your doctor or seek medical help:
* Burning, itching, dryness, or other irritation at the site where the medication was applied
Note: 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 (e.g., extreme redness, burning, itching, peeling, swelling)
- Signs of an allergic reaction (e.g., rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing)
- Severe or persistent diarrhea (rare with topical use, but report immediately as it could indicate Clostridium difficile-associated diarrhea)
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. 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
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 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. 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
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 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 be harmful. 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. To minimize this risk, it is crucial to follow specific steps before the initial application to ensure you do not have an allergic reaction. Always use this medication as directed by your doctor or as indicated on the package label, and consult with your doctor if you have any questions.
When applying this medication, exercise caution to avoid accidental contact with other areas. It may cause bleaching of hair or discoloration of colored fabrics.
If you are using other acne medications, be aware that combining them with this drug may increase the risk of skin irritation. Additionally, concurrent use of dapsone on the skin may temporarily cause yellow 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 protect yourself, 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 become pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of using this medication with your doctor to make an informed decision regarding your treatment and the well-being of your baby.
If this medication is accidentally swallowed, it can be harmful. 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. To minimize this risk, it is crucial to follow specific steps before the initial application to ensure you do not have an allergic reaction. Always use this medication as directed by your doctor or as indicated on the package label, and consult with your doctor if you have any questions.
When applying this medication, exercise caution to avoid accidental contact with other areas. It may cause bleaching of hair or discoloration of colored fabrics.
If you are using other acne medications, be aware that combining them with this drug may increase the risk of skin irritation. Additionally, concurrent use of dapsone on the skin may temporarily cause yellow 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 protect yourself, 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 become pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of using this medication with your doctor to make an informed decision regarding your treatment and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (redness, peeling, burning)
- Unlikely to cause systemic toxicity due to minimal absorption.
What to Do:
If excessive application occurs, wash the area thoroughly with water. If irritation is severe, discontinue use temporarily. In case of accidental ingestion or severe systemic symptoms, contact a poison control center (Call 1-800-222-1222 in the US) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Dapsone topical (may cause temporary yellow/orange skin discoloration)
Moderate Interactions
- Other topical acne preparations (e.g., salicylic acid, retinoids, sulfur) - may increase skin irritation, dryness, or peeling if used concurrently.
- Neuromuscular blocking agents (clindamycin has neuromuscular blocking properties, though systemic absorption from topical is minimal, caution with systemic NMBs is advised).
Monitoring
Baseline Monitoring
Clinical assessment of acne severity
Rationale: To establish baseline for treatment efficacy evaluation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical assessment of acne improvement
Frequency: Every 4-8 weeks or as clinically indicated.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: If no improvement after 8-12 weeks, consider alternative therapy. If severe irritation occurs, reduce frequency or discontinue.
Skin tolerance (erythema, dryness, peeling, burning, itching)
Frequency: Daily, or at each follow-up visit.
Target: Mild to moderate and tolerable.
Action Threshold: If severe or persistent irritation, reduce frequency of application, use a moisturizer, or temporarily discontinue use.
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness (erythema)
- Burning sensation
- Itching
- Stinging
- Swelling (especially face, lips, tongue, throat - signs of allergic reaction)
- Difficulty breathing or swallowing (signs of allergic reaction)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with topical use.
Trimester-Specific Risks:
First Trimester:
Limited data. Risk considered low due to minimal systemic absorption.
Second Trimester:
Limited data. Risk considered low due to minimal systemic absorption.
Third Trimester:
Limited data. Risk considered low due to minimal systemic absorption.
Lactation
Caution advised. It is not known if clindamycin or benzoyl peroxide are excreted in human milk after topical application. However, systemic absorption is minimal. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.
Infant Risk:
Low risk due to minimal systemic absorption, but monitor infant for potential gastrointestinal upset (e.g., diarrhea, candidiasis).
Pediatric Use
Safety and efficacy have been established in pediatric patients 12 years of age and older. Use in children younger than 12 years has not been established.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profiles are expected to be similar to those in younger adults.
Clinical Information
Clinical Pearls
- This product may bleach hair or colored fabrics. Advise patients to apply carefully and allow to dry completely before contact with clothing or bedding.
- Patients should be advised to use a non-comedogenic moisturizer and sunscreen daily, as the product can cause dryness and increase sun sensitivity.
- Consistency is key for effective treatment; patients should be encouraged to use the product daily as prescribed, even if immediate results are not seen.
- While rare with topical use, patients should be educated on the signs of Clostridium difficile-associated diarrhea (persistent, severe diarrhea) and advised to seek medical attention if it occurs.
- Store the gel at room temperature, away from excessive heat or cold, as per manufacturer instructions (e.g., 10-week storage after mixing for some formulations).
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Other topical antibiotics (e.g., erythromycin, dapsone)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Azelaic acid
- Salicylic acid
Cost & Coverage
Average Cost:
Highly variable, typically $100-$500+ per 50gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.