Clindamycin/benzoy 1/5% Gel 25g Jar
It is used to treat pimples (acne).
Drug Class
Topical anti-acne agent
Pharmacologic Class
Lincosamide antibiotic; Oxidizing agent/Keratolytic
Pregnancy Category
Category C
FDA Approved
Aug 2000
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 reduces inflammation, and benzoyl peroxide, which also kills bacteria and helps to 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 this 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 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.
Discard any unused portion of the medication after 3 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 this 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 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.
Discard any unused portion of the medication after 3 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
- Wash and dry the affected skin area thoroughly before applying the gel.
- Apply a thin layer of the gel to the entire affected area, not just individual pimples.
- Avoid contact with eyes, mouth, nostrils, and other mucous membranes, as it may cause irritation.
- Avoid applying to cuts, scrapes, or irritated skin.
- This product may bleach hair or colored fabrics (e.g., clothing, bedding, towels). Allow the gel to dry completely before contact with fabrics.
- Use sunscreen and wear protective clothing when outdoors, as benzoyl peroxide can increase sensitivity to the sun.
- Avoid using other topical acne products that may cause excessive dryness or irritation (e.g., strong astringents, abrasive soaps, alcohol-containing products) unless directed by your doctor.
- Do not share this medication with others.
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, typically in the evening, after washing the skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age. Safety and efficacy not established.
Adolescent:
For adolescents 12 years 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 (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 inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting the initiation of peptide chains. It reduces the number of Propionibacterium acnes (P. acnes) on the skin and has anti-inflammatory effects. Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic properties. It releases free radicals that oxidize bacterial proteins, effectively killing P. acnes. It also helps to reduce follicular hyperkeratosis and comedone formation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (Clindamycin: ~4% of applied dose; Benzoyl Peroxide: converted to benzoic acid, absorbed systemically)
Tmax:
Not applicable for topical effect; systemic Tmax not clinically relevant for topical application
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Not clinically relevant for topical application
CnssPenetration:
Limited (not clinically relevant for topical application)
Elimination:
HalfLife:
Not clinically relevant for topical application
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Clindamycin: Urine and feces; Benzoyl Peroxide (as benzoic acid): Urine
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Several weeks (typically 2-5 weeks for noticeable improvement)
PeakEffect:
Up to 12 weeks
DurationOfAction:
Maintained with continued use
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help 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 attention 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 persist, contact your doctor or seek medical attention:
* 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 attention 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 persist, contact your doctor or seek medical attention:
* 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., excessive redness, burning, itching, peeling, or swelling)
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Severe diarrhea or bloody stools (rare, but seek immediate medical attention if this 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
+ 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 modify 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 modify 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. Always use this medication as directed by your doctor or as indicated on the package label. If you have any questions or concerns, consult with your doctor.
When applying this medication, exercise caution to avoid any potential interactions. It may cause bleaching of hair or colored fabrics, so be mindful of this when using the product.
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 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 experience any concerns, consult with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of using this medication with your doctor to ensure the best outcome for 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. Always use this medication as directed by your doctor or as indicated on the package label. If you have any questions or concerns, consult with your doctor.
When applying this medication, exercise caution to avoid any potential interactions. It may cause bleaching of hair or colored fabrics, so be mindful of this when using the product.
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 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 experience any concerns, consult with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of using this medication with your doctor to ensure the best outcome for 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 a soothing moisturizer. If accidentally ingested, seek medical attention. For severe symptoms or concerns, call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Topical dapsone (may cause temporary yellow/orange skin discoloration)
- Other topical acne preparations (e.g., retinoids, salicylic acid, sulfur, resorcinol) (may increase skin irritation, dryness, or peeling)
Confidence Interactions
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To establish baseline severity of acne and identify any pre-existing skin irritation or conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in acne lesions)
Frequency: Monthly or as clinically indicated
Target: Reduction in inflammatory and non-inflammatory lesions
Action Threshold: If no improvement after 12 weeks, reassess treatment plan.
Local skin reactions (erythema, peeling, dryness, burning, itching)
Frequency: Regularly, especially during initial weeks of therapy
Target: Mild to moderate irritation is expected; severe irritation is not.
Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue use. Consult healthcare provider.
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness
- Burning
- Itching
- Stinging
- Contact dermatitis
- Diarrhea (rare, but systemic absorption of clindamycin can occur)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, clindamycin has been shown to cross the placenta in animal studies.
Trimester-Specific Risks:
First Trimester:
Limited data; potential risk cannot be excluded.
Second Trimester:
Limited data; potential risk cannot be excluded.
Third Trimester:
Limited data; potential risk cannot be excluded.
Lactation
L2 (Clindamycin) / L3 (Benzoyl Peroxide). Clindamycin is excreted in human milk after oral or parenteral administration. It is not known if topical clindamycin is excreted in human milk. Benzoyl peroxide is rapidly metabolized to benzoic acid, which is a normal component of human milk. Due to minimal systemic absorption, topical use is generally considered low risk for the infant. Avoid applying to areas where the infant may ingest the medication (e.g., breast area).
Infant Risk:
Low risk (for topical application)
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 12 years of age. Use in adolescents 12 years and older is common and generally well-tolerated.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. However, older patients may have more fragile or sensitive skin, which could increase the likelihood of local irritation. Monitor for skin dryness and irritation.
Clinical Information
Clinical Pearls
- This combination product is more effective than either clindamycin or benzoyl peroxide used alone for acne vulgaris.
- The benzoyl peroxide component helps to reduce the development of antibiotic resistance to clindamycin.
- Patients should be advised that initial dryness, redness, and peeling are common and usually subside with continued use. If severe, reduce frequency of application (e.g., every other day) or temporarily discontinue.
- Emphasize the importance of consistent, daily application for optimal results.
- Remind patients about the bleaching potential of benzoyl peroxide on fabrics and hair.
- The '90-Day Storage' indicates the stability period after the product is dispensed or mixed (if it comes as a kit that needs mixing). Patients should be instructed to discard any unused portion after this period.
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
- Azelaic acid
Cost & Coverage
Average Cost:
$100 - $500+ per 25g jar
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'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.