Clindamycin/benzoy 1/5% Gel 50g Pmp
It is used to treat pimples (acne).
Drug Class
Anti-acne agent, topical antibiotic
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 topical gel 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 shed dead skin cells, preventing clogged 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. Do not ingest it or apply it to mucous membranes, including your mouth, nose, and eyes, as it may cause irritation or burning.
Avoid applying this medication to the vaginal area.
If you accidentally get the medication in your mouth, nose, eyes, or vagina, 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 this medication to cuts, scrapes, or damaged skin, as it may exacerbate the condition or delay healing.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Keep the medication in a dry place, avoiding storage in a bathroom or humid environment.
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. Do not ingest it or apply it to mucous membranes, including your mouth, nose, and eyes, as it may cause irritation or burning.
Avoid applying this medication to the vaginal area.
If you accidentally get the medication in your mouth, nose, eyes, or vagina, 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 this medication to cuts, scrapes, or damaged skin, as it may exacerbate the condition or delay healing.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Keep the medication in a dry place, avoiding storage in a bathroom or humid environment.
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
- Apply a thin layer to clean, dry skin once daily, usually in the evening.
- Avoid contact with eyes, mouth, nostrils, and other mucous membranes.
- Benzoyl peroxide can bleach hair and colored fabrics (towels, pillowcases, clothing). Allow the gel to dry completely before contact with fabrics.
- Use sunscreen and wear protective clothing when outdoors, as this medication may increase sun sensitivity.
- Wash hands thoroughly after applying the gel.
- Do not use on broken, irritated, or sunburned skin.
Available Forms & Alternatives
Available Strengths:
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 after washing the skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
Apply a thin layer to affected area 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 specific considerations for topical application.
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 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 bactericidal against P. acnes and also reduces follicular hyperkeratosis and comedone formation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1% for clindamycin, <5% for benzoyl peroxide)
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
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:
Typically 2-5 weeks for noticeable improvement in acne
PeakEffect:
Up to 12 weeks
DurationOfAction:
Maintained with continued use
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 first consulting your doctor.
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. If you experience any of the following side effects or any other unusual symptoms that bother you or 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.
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 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 first consulting your doctor.
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. If you experience any of the following side effects or any other unusual symptoms that bother you or 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.
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 (e.g., excessive redness, dryness, peeling, burning, stinging) that does not improve or worsens.
- Signs of an allergic reaction, such as rash, itching, hives, swelling of the face/lips/tongue, or difficulty breathing. Seek immediate medical attention.
- Severe diarrhea, abdominal pain, or bloody stools (though rare with topical use, this can be a sign of C. difficile-associated diarrhea and requires 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
+ 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 in conjunction with your other medications and health conditions. Do not initiate, stop, or modify the dosage 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
+ 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 in conjunction with your other medications and health conditions. Do not initiate, stop, or modify the dosage 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. Before initial use, it may be necessary 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 other areas, as 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 the skin or facial hair to turn yellow or orange.
Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe and effective 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 or have questions, consult your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for 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 significant irritation. Before initial use, it may be necessary 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 other areas, as 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 the skin or facial hair to turn yellow or orange.
Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe and effective 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 or have questions, consult your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (redness, peeling, burning)
- Unlikely to cause systemic overdose due to minimal absorption.
What to Do:
If excessive application occurs, wash the area thoroughly with water. If accidental ingestion occurs, contact a poison control center immediately. Call 1-800-222-1222.
Drug Interactions
Major Interactions
- Dapsone topical (e.g., Aczone): Concomitant use with benzoyl peroxide-containing products can cause temporary yellow or orange discoloration of the skin and facial hair.
Moderate Interactions
- Other topical acne preparations (e.g., tretinoin, adapalene, tazarotene, salicylic acid, sulfur, resorcinol): Concomitant use may increase skin irritation (dryness, peeling, redness). Use with caution and consider alternating application times.
- Neuromuscular blocking agents: Clindamycin has neuromuscular blocking properties and should be used with caution in patients receiving neuromuscular blocking agents due to potential for enhanced blockade (though systemic absorption from topical application is minimal, this is a theoretical concern).
Monitoring
Baseline Monitoring
Skin condition and acne severity
Rationale: To establish baseline for assessing treatment efficacy and adverse reactions.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin reactions (erythema, peeling, dryness, burning, itching)
Frequency: Regularly during treatment, especially during the first few weeks
Target: Mild to moderate reactions are common and often tolerable; severe reactions warrant re-evaluation.
Action Threshold: Discontinue if severe irritation, burning, or allergic reaction occurs.
Efficacy (reduction in acne lesions)
Frequency: Monthly or as clinically indicated
Target: Progressive reduction in inflammatory and non-inflammatory lesions.
Action Threshold: Re-evaluate treatment if no significant improvement after 8-12 weeks.
Symptom Monitoring
- Severe skin irritation (e.g., excessive redness, peeling, burning, stinging)
- Signs of allergic reaction (e.g., hives, itching, swelling of face/lips/tongue, difficulty breathing)
- Severe diarrhea or abdominal pain (rare, but clindamycin can cause C. difficile-associated diarrhea, even with topical use, though risk is very low)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, animal studies have shown some adverse effects with clindamycin. Consult with a healthcare provider.
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
L3 (Moderately Safe). It is not known whether clindamycin or benzoyl peroxide are excreted in human milk after topical application. Due to minimal systemic absorption, risk to the infant is considered low. However, caution should be exercised. Avoid applying to areas where the infant may ingest the medication (e.g., breast area).
Infant Risk:
Low risk due to minimal systemic absorption, but monitor for adverse effects.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients younger than 12 years of age. For adolescents 12 years and older, dosing is similar to adults.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is expected to be similar to that in younger adults.
Clinical Information
Clinical Pearls
- This combination product is more effective than either clindamycin or benzoyl peroxide used alone for acne vulgaris.
- Patients should be advised that initial irritation (redness, dryness, peeling) is common and usually subsides with continued use or by reducing frequency of application.
- Emphasize the importance of sun protection due to increased photosensitivity.
- Remind patients about the bleaching potential of benzoyl peroxide on fabrics and hair.
- Results are not immediate; consistent use for several weeks is necessary to see significant improvement.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics alone (e.g., clindamycin solution/lotion)
- Topical benzoyl peroxide alone
- Topical salicylic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (for female patients)
Cost & Coverage
Average Cost:
$100 - $500+ per 50g tube (brand)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (varies by insurance plan)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.