Clindamycin/benzoy 1/5% Gel 50g Jar
It is used to treat pimples (acne).
Drug Class
Anti-acne agent, topical
Pharmacologic Class
Topical antibiotic (Clindamycin); Keratolytic, Antimicrobial (Benzoyl Peroxide)
Pregnancy Category
Category C
FDA Approved
May 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
This gel is a topical medication used to treat acne. It contains two active ingredients: clindamycin, an antibiotic that kills the bacteria causing acne, and benzoyl peroxide, which also kills bacteria and helps to unclog pores by shedding dead skin cells.
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, eyes, or vagina, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Before and after applying the medication, wash your hands with soap and water.
Gently wash the affected skin with warm water and pat it dry before applying the medication. 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.
If you accidentally get the medication in your eyes, nose, mouth, or vagina, rinse the area with water immediately.
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.
Discard any unused 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, eyes, or vagina, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Before and after applying the medication, wash your hands with soap and water.
Gently wash the affected skin with warm water and pat it dry before applying the medication. 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.
If you accidentally get the medication in your eyes, nose, mouth, or vagina, rinse the area with water immediately.
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.
Discard any unused 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
- Apply to clean, dry skin. Wash hands before and after application.
- Avoid contact with eyes, mouth, nostrils, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Benzoyl peroxide may bleach hair or colored fabrics (towels, clothing, bedding). Allow the gel to dry completely before contact with fabrics.
- Use sunscreen and wear protective clothing when outdoors, as this medication may increase sensitivity to sunlight.
- Avoid using other topical acne treatments or products that may cause skin irritation (e.g., abrasive soaps, alcohol-containing products, astringents) unless directed by your doctor.
- Do not apply to cuts, scrapes, or irritated skin.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily after washing and drying the skin.
Condition-Specific Dosing:
acne_vulgaris:
Apply once daily to the entire affected facial and/or truncal areas.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children under 12 years of age)
Adolescent:
Apply a thin layer to affected areas once daily after washing and drying the skin (typically for patients 12 years and older).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required 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. It is active against Propionibacterium acnes (now Cutibacterium acnes). Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects. It releases free oxygen radicals that are toxic to bacteria, including C. acnes, and also helps to shed dead skin cells and reduce sebum production.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically < 5% for clindamycin, < 2% for benzoyl peroxide)
Tmax:
Not applicable for topical systemic effects; local skin concentration peaks within hours.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic distribution)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Clindamycin: Urine and feces (if systemically absorbed). Benzoyl Peroxide: Benzoic acid excreted in urine.
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-5 weeks.
PeakEffect:
Maximum therapeutic effect may take 8-12 weeks.
DurationOfAction:
Continuous application required for sustained effect.
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
Gastrointestinal problems, including:
+ Diarrhea
+ Bloody diarrhea
+ A certain bowel problem (colitis), which 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
* Burning, itching, dryness, or other irritation at the site where the medication was applied
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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
Gastrointestinal problems, including:
+ Diarrhea
+ Bloody diarrhea
+ A certain bowel problem (colitis), which 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
* Burning, itching, dryness, or other irritation at the site where the medication was applied
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 (excessive redness, dryness, peeling, burning, stinging) â contact your doctor.
- Signs of an allergic reaction (hives, rash, itching, swelling of face/lips/tongue, difficulty breathing) â seek immediate medical attention.
- Severe or persistent diarrhea, abdominal pain, or bloody stools (rare, but serious side effect of clindamycin) â seek immediate medical attention.
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 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. 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 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, so it is crucial to contact a doctor or a poison control center immediately.
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.
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. Therefore, use these products with caution.
Using dapsone on the skin simultaneously may cause temporary 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. Additionally, use sunscreen 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 are breastfeeding, it is essential to discuss the potential benefits and risks of using this medication with your doctor to make an informed decision regarding your health and the health of your baby.
If this medication is accidentally swallowed, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately.
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.
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. Therefore, use these products with caution.
Using dapsone on the skin simultaneously may cause temporary 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. Additionally, use sunscreen 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 are breastfeeding, it is essential to discuss the potential benefits and risks of using this medication with your doctor to make an informed decision regarding your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (redness, peeling, burning)
- Dryness
What to Do:
Topical overdose is unlikely to cause systemic toxicity. If excessive irritation occurs, wash the area thoroughly with water and discontinue use temporarily. If accidentally ingested, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention immediately.
Drug Interactions
Major Interactions
- Neuromuscular blocking agents (Clindamycin can potentiate the action of neuromuscular blocking agents, though systemic absorption from topical use is minimal, caution is advised.)
Moderate Interactions
- Erythromycin (Topical or oral erythromycin may antagonize the antibacterial effect of clindamycin if used concomitantly.)
- Dapsone topical (Concomitant use with benzoyl peroxide may cause temporary yellow or orange discoloration of the skin and facial hair.)
- Other topical acne preparations (e.g., retinoids, salicylic acid, sulfur) (May increase skin irritation, dryness, or peeling. Use with caution and consider alternating application times.)
Minor Interactions
- Abrasive soaps or cleansers
- Alcohol-containing products
- Medicated cosmetics
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To evaluate the type and severity of acne, and identify any pre-existing skin irritation or sensitivity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in acne lesions)
Frequency: Every 4-8 weeks during initial treatment, then as needed.
Target: Progressive reduction in inflammatory and non-inflammatory lesions.
Action Threshold: If no improvement after 8-12 weeks, or worsening of condition, re-evaluate treatment plan.
Local skin reactions (erythema, dryness, peeling, burning, itching)
Frequency: At each follow-up visit and as reported by patient.
Target: Mild to moderate and tolerable.
Action Threshold: If severe or intolerable irritation occurs, reduce frequency of application, temporarily discontinue, or discontinue permanently.
Symptom Monitoring
- Excessive dryness
- Redness
- Peeling or flaking of skin
- Burning or stinging sensation
- Itching
- Photosensitivity (increased sensitivity to sunlight)
- Diarrhea (rare, but report immediately if severe or persistent, as it could indicate pseudomembranous colitis from systemic clindamycin absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but clindamycin crosses the placenta.
Trimester-Specific Risks:
First Trimester:
Potential risk, but minimal systemic absorption limits exposure.
Second Trimester:
Potential risk, but minimal systemic absorption limits exposure.
Third Trimester:
Potential risk, but minimal systemic absorption limits exposure.
Lactation
Use with caution. It is not known if clindamycin or benzoyl peroxide are excreted in human milk after topical application. However, clindamycin is excreted in human milk after oral or parenteral administration. Due to minimal systemic absorption, risk to infant is likely low. Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
L3 (Moderately safe; possible risk, but studies are limited or data are conflicting. Weigh benefits vs. risks.)
Pediatric Use
Safety and effectiveness have not been established in pediatric patients younger than 12 years of age. Use in adolescents (12 years and older) is generally consistent with adult dosing.
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 product is for external use only. Do not ingest.
- The 90-day storage indicates the stability of the product after dispensing or reconstitution. Ensure proper storage as directed (often refrigeration for reconstituted products, but check specific product instructions).
- Patients should be advised that improvement may not be seen for several weeks and that consistent daily application is crucial.
- Warn patients about potential bleaching of hair and fabrics due to benzoyl peroxide.
- Emphasize the importance of sun protection due to increased photosensitivity.
- Although rare with topical use, advise patients to report any severe or persistent diarrhea immediately, as it could indicate pseudomembranous colitis.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Other topical antibiotics (e.g., dapsone, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Salicylic acid topical
- Azelaic acid topical
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $500+ per 50g jar
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic); Tier 3 or 4 (for brand)
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. If you have any questions or concerns about your medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.