Clinda/benzoyl 1.2-3.75% Gel Pump
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Topical antibiotic; Topical keratolytic/antiseptic
Pregnancy Category
Category C
FDA Approved
Sep 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a gel that you put on your skin to treat acne. It contains two active ingredients: an antibiotic (clindamycin) to kill acne-causing bacteria and reduce inflammation, and benzoyl peroxide to kill bacteria and help 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 the information provided. 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 take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply the medication to the vaginal area.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected skin 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 gently rub it in.
Important Precautions
Do not apply 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 tightly closed.
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 the information provided. 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 take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply the medication to the vaginal area.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected skin 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 gently rub it in.
Important Precautions
Do not apply 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 tightly closed.
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 mucous membranes.
- Benzoyl peroxide can bleach hair and colored fabrics (towels, clothing, bedding), so allow the gel to dry completely before contact.
- Use sunscreen daily and wear protective clothing, as benzoyl peroxide can increase sun sensitivity.
- Avoid excessive sun exposure, tanning beds, and sunlamps.
- Do not use on broken, irritated, or sunburned skin.
- Wash hands thoroughly after application.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily.
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 areas once daily (12 years 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 use.
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 peptide bond formation. It reduces the number of Propionibacterium acnes (now Cutibacterium acnes) and has anti-inflammatory effects. Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects. It releases free-radical oxygen, which oxidizes bacterial proteins, reducing P. acnes. It also has a mild drying and peeling effect, which helps to prevent clogged pores.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% for clindamycin, less than 5% for benzoyl peroxide).
Tmax:
Not applicable for topical systemic Tmax; local concentration peaks within hours.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not available (primarily local action).
ProteinBinding:
Not available (primarily local action).
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable for topical systemic half-life; local elimination.
Clearance:
Not available.
ExcretionRoute:
Not applicable for topical systemic excretion.
Unchanged:
Not available.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-5 weeks.
PeakEffect:
Maximum therapeutic effect may take 8-12 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
Gastrointestinal problems, including:
+ Diarrhea
+ Bloody diarrhea
+ Colitis (a bowel problem that 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:
* Local irritation at the application site, such as:
+ Burning
+ Itching
+ Dryness
+ Other forms of irritation
This is not an exhaustive list of potential 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
Gastrointestinal problems, including:
+ Diarrhea
+ Bloody diarrhea
+ Colitis (a bowel problem that 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:
* Local irritation at the application site, such as:
+ Burning
+ Itching
+ Dryness
+ Other forms of irritation
This is not an exhaustive list of potential 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.
- Signs of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing).
- Severe or persistent diarrhea, especially if bloody (rare, but seek medical attention immediately).
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
A history of certain health conditions, including:
+ Crohn's disease
+ Other 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
If you are currently using any products that contain erythromycin
It is crucial to note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is vital to inform your doctor and pharmacist about all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins
Your doctor and pharmacist will help you determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
A history of certain health conditions, including:
+ Crohn's disease
+ Other 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
If you are currently using any products that contain erythromycin
It is crucial to note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is vital to inform your doctor and pharmacist about all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins
Your doctor and pharmacist will help you determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, 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 using this medication for the first time, you may need to follow specific steps to ensure you do not have an allergic reaction. Be sure to use this medication as directed by your doctor or as indicated on the package label. If you have any questions or concerns, discuss them with your doctor.
When applying this medication, exercise caution to avoid any potential interactions. It may cause bleaching of hair or colored fabrics, so take necessary precautions to prevent this.
If you are using other acne medications, use them with caution, as they 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 medications 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 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, inform your doctor, as you will need to discuss the potential benefits and risks of using this medication 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 significant 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. Be sure to use this medication as directed by your doctor or as indicated on the package label. If you have any questions or concerns, discuss them with your doctor.
When applying this medication, exercise caution to avoid any potential interactions. It may cause bleaching of hair or colored fabrics, so take necessary precautions to prevent this.
If you are using other acne medications, use them with caution, as they 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 medications 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 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, inform your doctor, as you will need to discuss the potential benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (redness, peeling, discomfort) if too much is applied topically.
What to Do:
Topical overdose is unlikely to cause systemic toxicity. If excessive irritation occurs, discontinue use temporarily and apply a moisturizer. If ingested, call a poison control center (1-800-222-1222) immediately. Management is supportive.
Drug Interactions
Major Interactions
- Neuromuscular blocking agents (clindamycin can potentiate their action, though systemic absorption from topical use is minimal, caution is advised).
Moderate Interactions
- Dapsone topical (may cause temporary orange/yellow skin discoloration when applied concomitantly with benzoyl peroxide).
Minor Interactions
- Other topical acne preparations (e.g., tretinoin, tazarotene, adapalene, salicylic acid) - may increase skin irritation, dryness, or peeling if used concurrently. Use with caution or at different times of day.
Monitoring
Baseline Monitoring
Skin condition (severity of acne, presence of irritation)
Rationale: To establish a baseline for treatment efficacy and tolerability.
Timing: Prior to initiation of therapy.
Routine Monitoring
Acne lesion count and severity
Frequency: Every 4-8 weeks or as clinically indicated.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: Lack of improvement after 8-12 weeks, or worsening of condition, may warrant re-evaluation of treatment.
Skin irritation (erythema, dryness, peeling, burning, itching)
Frequency: Regularly during treatment, especially during the initial weeks.
Target: Mild to moderate irritation is common and acceptable; severe irritation is not.
Action Threshold: Severe or persistent irritation may require temporary discontinuation, reduced frequency of application, or discontinuation of therapy.
Symptom Monitoring
- Excessive dryness
- Redness
- Peeling
- Burning sensation
- Itching
- Stinging
- Contact dermatitis
- Diarrhea (rare, but a potential systemic effect of clindamycin, even topical)
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, but systemic absorption is minimal. Risk considered low but caution advised.
Second Trimester:
Limited data, but systemic absorption is minimal. Risk considered low but caution advised.
Third Trimester:
Limited data, but systemic absorption is minimal. Risk considered low but caution advised.
Lactation
Caution should be exercised when administered to a nursing woman. It is not known whether clindamycin or benzoyl peroxide are excreted in human milk following topical application. Due to the minimal systemic absorption, risk to the infant is generally considered low (L3). Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
Low to Moderate (L3)
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 similar to adults.
Geriatric Use
No specific dosage adjustments are necessary. However, geriatric patients may have more fragile or sensitive skin, so monitor for increased irritation.
Clinical Information
Clinical Pearls
- This product is a combination of an antibiotic and a keratolytic/antiseptic, providing dual action against acne.
- The '10-Week Storage' refers to the stability of the mixed product after dispensing; patients should be instructed to discard any unused product after this period.
- Patients should be advised that initial irritation (redness, dryness, peeling) is common and usually subsides with continued use. If severe, reduce frequency or temporarily stop.
- Emphasize the importance of consistent daily application for optimal results.
- Remind patients about the bleaching potential of benzoyl peroxide on fabrics and hair.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide (monotherapy)
- Topical salicylic acid
- Topical dapsone
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Hormonal therapies (e.g., oral contraceptives for females)
Cost & Coverage
Average Cost:
Varies widely by brand and pharmacy, typically $200-$600+ per 50g pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 for more information. If you have any questions or concerns about this 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and appropriate care.