Clindamycin/benzoy 1/5% Gel 35g Pmp
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
Aug 2002
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: clindamycin, an antibiotic that kills acne-causing bacteria, and benzoyl peroxide, which also kills bacteria and helps to unclog pores.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected skin area. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Do not apply the medication to the vaginal area.
Before applying the medication, wash your hands thoroughly. Gently wash the affected skin area 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 rub it in gently. Avoid applying the medication to cuts, scrapes, or damaged skin.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from freezing temperatures. Keep it in a dry place, avoiding storage in a bathroom. Discard any unused medication after 3 months.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, 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 one.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected skin area. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Do not apply the medication to the vaginal area.
Before applying the medication, wash your hands thoroughly. Gently wash the affected skin area 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 rub it in gently. Avoid applying the medication to cuts, scrapes, or damaged skin.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from freezing temperatures. Keep it in a dry place, avoiding storage in a bathroom. Discard any unused medication after 3 months.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, 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 one.
Lifestyle & Tips
- Wash hands before and after applying the gel.
- Apply a thin layer to clean, dry skin once daily, usually in the evening.
- Avoid contact with eyes, mouth, nostrils, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Avoid contact with hair and colored fabrics, as benzoyl peroxide can bleach them.
- Use a mild cleanser and moisturizer. Avoid harsh or abrasive skin products.
- Sun sensitivity may increase; use sunscreen and protective clothing when outdoors.
- Be patient; it may take several weeks to see improvement.
Available Forms & Alternatives
Available Strengths:
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 the entire affected facial area (or other affected areas) once daily after washing the skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 12 years of age)
Adolescent:
Apply a thin layer to affected areas once daily (for patients 12 years of age 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 adjustment needed (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 bacterial protein synthesis. Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects. It releases free radicals that oxidize bacterial proteins, reducing Propionibacterium acnes (now Cutibacterium acnes) on the skin and in follicles. It also has a mild keratolytic effect, which helps to prevent the formation of comedones.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (Clindamycin: <4% systemically absorbed; Benzoyl Peroxide: ~5% systemically absorbed)
Tmax:
Not applicable for topical therapeutic effect; systemic Tmax not clinically relevant due to minimal absorption.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not clinically relevant (primarily local action)
ProteinBinding:
Not clinically relevant (primarily local action)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant (primarily local action)
Clearance:
Not clinically relevant (primarily local action)
ExcretionRoute:
Not clinically relevant (minimal systemic absorption)
Unchanged:
Not clinically relevant (minimal systemic absorption)
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 or seek medical attention immediately:
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. While many people may not experience any side effects or only minor ones, it is essential to contact your doctor or seek medical help if you are bothered by or experience any of the following:
* Burning, itching, dryness, or other irritation at the site where the medication was applied
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 attention immediately:
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. While many people may not experience any side effects or only minor ones, it is essential to contact your doctor or seek medical help if you are bothered by or experience any of the following:
* Burning, itching, dryness, or other irritation at the site where the medication was applied
Reporting Side Effects
This list is not exhaustive, and you may experience other 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, burning, or peeling that does not improve or worsens.
- Swelling of the face, lips, or tongue (signs of allergic reaction).
- Severe or persistent diarrhea (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 allergic reaction and its 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 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 needs to assess the safety of taking this medication with your existing medications and health conditions. Do not initiate, stop, or modify the dose of any medication without consulting your doctor first.
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 and its 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 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 needs to assess the safety of taking this medication with your existing medications and health conditions. Do not initiate, stop, or modify the dose of any medication without consulting your doctor first.
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 irritation. Before initial use, it may be necessary to follow specific steps 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 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, using dapsone on the skin simultaneously 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 minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a sunscreen with adequate sun protection factor (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, inform your doctor to discuss the potential benefits and risks to you and 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 irritation. Before initial use, it may be necessary to follow specific steps 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 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, using dapsone on the skin simultaneously 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 minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a sunscreen with adequate sun protection factor (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, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation, redness, dryness, or peeling (with topical overuse)
- Systemic overdose is highly unlikely due to minimal absorption.
What to Do:
Discontinue use and wash affected area. For severe irritation, consult a healthcare professional. For accidental ingestion, call Poison Control at 1-800-222-1222.
Drug Interactions
Major Interactions
- Dapsone topical (may cause temporary yellow/orange skin discoloration when applied concomitantly with benzoyl peroxide)
Moderate Interactions
- Other topical acne preparations (e.g., retinoids, salicylic acid, sulfur, resorcinol) - may increase skin irritation, dryness, or peeling.
- Neuromuscular blocking agents (theoretical potentiation of neuromuscular blockade by clindamycin, though unlikely with minimal topical absorption)
Monitoring
Baseline Monitoring
Skin condition (severity of acne, presence of inflammation, dryness)
Rationale: To establish baseline for treatment efficacy assessment and identify potential for irritation.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, dryness, peeling, burning, itching)
Frequency: Daily, especially during initial weeks of therapy
Target: Mild to moderate irritation is common and acceptable; severe irritation requires dose adjustment or discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency of application, temporarily discontinue, or switch to alternative therapy.
Acne lesion count and severity
Frequency: Monthly or as clinically indicated
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: No improvement after 8-12 weeks: re-evaluate diagnosis or consider alternative/adjunctive therapy.
Symptom Monitoring
- Excessive skin dryness
- Peeling
- Redness
- Burning or stinging sensation
- Itching
- Swelling
- Severe irritation or rash
- Diarrhea (rare, but systemic clindamycin can cause C. difficile-associated diarrhea)
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 due to benzoyl peroxide.
Trimester-Specific Risks:
First Trimester:
Limited data; use with caution.
Second Trimester:
Limited data; use with caution.
Third Trimester:
Limited data; use with caution.
Lactation
Clindamycin is excreted in breast milk after oral/parenteral administration; it is unknown if topical clindamycin is. Benzoyl peroxide is minimally absorbed. Use with caution. Consider applying after breastfeeding or avoiding application to areas where the infant may come into contact.
Infant Risk:
Low risk for topical application due to minimal systemic absorption, but monitor infant for potential adverse effects (e.g., diarrhea).
Pediatric Use
Safety and efficacy not established in pediatric patients under 12 years of age. Use in adolescents (12 years and older) is similar to adults.
Geriatric Use
No specific dosage adjustments or precautions are generally required for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are unlikely to affect safety.
Clinical Information
Clinical Pearls
- This product is a combination of an antibiotic and an oxidizing agent, providing dual mechanisms of action against acne.
- Patients should be advised that initial irritation (redness, dryness, peeling) is common, especially during the first few weeks of treatment, but 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, towels, and hair.
- The '90-Day Storage' refers to the stability of the *reconstituted* product at room temperature (typically below 25°C or 77°F). Unreconstituted product may require refrigeration before dispensing.
- Sun protection is crucial due to potential increased photosensitivity.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide (monotherapy)
- Topical salicylic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Hormonal therapies (e.g., oral contraceptives for females)
- Dermatological procedures (e.g., chemical peels, laser therapy)
Cost & Coverage
Average Cost:
$100 - $500+ per 35g tube/pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generics often Tier 1 or 2, brands Tier 3)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.