Clindamycin Phos/tretinoin Gel 60gm
It is used to treat pimples (acne).
Drug Class
Topical Anti-acne Agent
Pharmacologic Class
Lincosamide Antibiotic; Retinoid
Pregnancy Category
C
FDA Approved
Nov 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
This gel combines an antibiotic (clindamycin) to kill acne-causing bacteria and reduce inflammation, with a retinoid (tretinoin) to help unclog pores and prevent new breakouts. It is used to treat acne vulgaris.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication topically, directly to the affected skin area, and avoid ingesting it or applying it to mucous membranes, such as the mouth, nose, or eyes, as it may cause irritation or burning.
Apply the medication at bedtime to minimize potential disruption to your daily activities.
Before applying the medication, wash your hands thoroughly with soap and water to prevent the spread of infection.
Clean the affected skin area before application, ensuring it is dry and free of any debris or impurities.
Gently rub a thin layer of the medication into the affected skin area, taking care not to apply too much pressure or irritate the skin further.
Storage and Disposal
Store this medication at room temperature, away from direct heat sources, light, and freezing temperatures.
Keep the container tightly closed to maintain the medication's potency and prevent contamination.
Protect the medication from excessive heat, light, and moisture to ensure its stability and effectiveness.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember, unless it is close to the time for your next scheduled dose.
If it is near the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply extra doses or double doses to make up for a missed dose, as this may increase the risk of adverse effects.
To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication topically, directly to the affected skin area, and avoid ingesting it or applying it to mucous membranes, such as the mouth, nose, or eyes, as it may cause irritation or burning.
Apply the medication at bedtime to minimize potential disruption to your daily activities.
Before applying the medication, wash your hands thoroughly with soap and water to prevent the spread of infection.
Clean the affected skin area before application, ensuring it is dry and free of any debris or impurities.
Gently rub a thin layer of the medication into the affected skin area, taking care not to apply too much pressure or irritate the skin further.
Storage and Disposal
Store this medication at room temperature, away from direct heat sources, light, and freezing temperatures.
Keep the container tightly closed to maintain the medication's potency and prevent contamination.
Protect the medication from excessive heat, light, and moisture to ensure its stability and effectiveness.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember, unless it is close to the time for your next scheduled dose.
If it is near the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply extra doses or double doses to make up for a missed dose, as this may increase the risk of adverse effects.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily in the evening, after washing your face.
- Use only a pea-sized amount for the entire face; using more will not improve results faster and may increase irritation.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Use sunscreen daily (SPF 30 or higher) and wear protective clothing (hats, long sleeves) when outdoors, as tretinoin increases sun sensitivity.
- Avoid excessive sun exposure, sunlamps, and tanning beds.
- Avoid waxing on treated areas, as skin may be more fragile.
- Be patient; it may take several weeks (typically 2-4 weeks) to see initial improvement, and full results may take 8-12 weeks. Acne may appear to worsen during the first few weeks of treatment ('purging').
- Use a mild, non-comedogenic cleanser and moisturizer to help manage dryness and irritation.
- Do not use other topical acne treatments (especially those containing benzoyl peroxide, salicylic acid, or sulfur) at the same time unless directed by your doctor, as this can cause excessive irritation.
Available Forms & Alternatives
Available Strengths:
- Clindamycin 1% Gel 60gm
- Clindamycin 1% Pledgets 60s
- Clindamycin 300mg Capsules
- Clindamycin 1% Lotion 60ml
- Clindamycin 1% Topical Soln 60ml
- Clindamycin 1% Topical Soln 30ml
- Clindamycin 2% Vaginal Cream 40gm
- Clindamycin 150mg Capsules
- Clindamycin 1% Gel 30gm
- Clindamycin 150mg/ml Inj, 60ml
- Clindamycin 1% Foam 100gm
- Clindamycin 1% Foam 50gm
- Clindamycin 150mg Capsules
- Clindamycin 300mg Capsules
- Clindamycin 900mg Inj, 50ml
- Clindamycin 900mg/6ml Inj, 6ml
- Clindamycin Phos/tretinoin Gel 60gm
- Clindamycin 1% Gel (once Daily)75ml
- Clindamycin 75mg Capsules
- Clindamycin Phos/tretinoin Gel 30gm
- Clindamycin Phos/tretinoin Gel 60gm
- Clindamycin 1% Lotion 60ml
- Clindamycin 1% Gel(once Daily)75ml
- Clindamy/d5w 600mg/50ml Inj, 50ml
- Clindamycin Ped 75mg/5ml Sol 100ml
- Clindamycin 300mg/d5w Inj, 50ml
- Clindamy/d5w 900mg/50ml Inj, 50ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount to the entire affected face once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established for children under 12 years of age)
Adolescent:
Apply a pea-sized amount to the entire affected face once daily in the evening (for patients 12 years and older)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required due to minimal systemic absorption.
Moderate:
No specific adjustment required due to minimal systemic absorption.
Severe:
No specific adjustment required due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment required due to minimal systemic absorption.
Moderate:
No specific adjustment required due to minimal systemic absorption.
Severe:
No specific adjustment required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clindamycin: Binds to the 50S ribosomal subunit of susceptible bacteria (e.g., Cutibacterium acnes), thereby inhibiting bacterial protein synthesis. It also exhibits anti-inflammatory properties. Tretinoin: Modifies abnormal follicular keratinization, reduces the cohesiveness of follicular epithelial cells, and stimulates mitotic activity and increased turnover of follicular epithelial cells. This promotes the expulsion of comedones and prevents new ones. It also has anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<4% for clindamycin, <2% for tretinoin) after topical application.
Tmax:
Not clinically relevant for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption.
ProteinBinding:
Not clinically relevant for topical application due to minimal systemic absorption.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic absorption.
Clearance:
Not clinically relevant for topical application due to minimal systemic absorption.
ExcretionRoute:
Primarily via urine and feces for systemically absorbed drug, but topical absorption is negligible.
Unchanged:
Not clinically relevant for topical application due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-4 weeks.
PeakEffect:
Full therapeutic effect may take 8-12 weeks.
DurationOfAction:
Maintained with continued use.
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, including:
+ 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's essential to discuss any concerns with your doctor. If you experience side effects that bother you or persist, contact your doctor for advice.
Reporting Side Effects
If you have questions or concerns about side effects, you can:
Contact your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
* Submit a report 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, including:
+ 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's essential to discuss any concerns with your doctor. If you experience side effects that bother you or persist, contact your doctor for advice.
Reporting Side Effects
If you have questions or concerns about side effects, you can:
Contact your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (excessive redness, swelling, blistering, crusting, severe burning or stinging)
- Signs of an allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
- Severe diarrhea or abdominal pain (rare, but clindamycin can cause C. difficile-associated diarrhea)
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.
If you are currently using any products that contain erythromycin.
If you have 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
This list is not exhaustive, and it is crucial to discuss all your medications and health problems with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Any existing health problems
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Do not 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.
If you are currently using any products that contain erythromycin.
If you have 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
This list is not exhaustive, and it is crucial to discuss all your medications and health problems with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Any existing health problems
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Applying the Medication
Do not apply this medication to sunburned skin, cuts, scrapes, or damaged skin, as this can exacerbate skin irritation.
What to Expect
Your skin may appear worse before it starts to improve. It may take several weeks to experience the full effects of the medication. Be patient and continue using the medication as directed.
Using Other Acne Medications
If you are using other pimple (acne) medications, use them with caution, as they may increase the risk of skin irritation. Consult with your doctor before using any other drugs or products on your skin, including soaps.
Skin Care and Sun Protection
To minimize the risk of skin irritation and other adverse effects, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn while using this medication. To protect your skin, avoid direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when going outside.
Weather Conditions
Certain weather conditions, such as cold and wind, can irritate the skin. Consult with your doctor or pharmacist for guidance on how to protect your skin in these conditions.
Common Side Effects
Skin irritation is a common side effect of this medication. Reactions may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation, or if the irritation bothers you or persists, contact your doctor for advice.
Pregnancy and Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to you and your baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Applying the Medication
Do not apply this medication to sunburned skin, cuts, scrapes, or damaged skin, as this can exacerbate skin irritation.
What to Expect
Your skin may appear worse before it starts to improve. It may take several weeks to experience the full effects of the medication. Be patient and continue using the medication as directed.
Using Other Acne Medications
If you are using other pimple (acne) medications, use them with caution, as they may increase the risk of skin irritation. Consult with your doctor before using any other drugs or products on your skin, including soaps.
Skin Care and Sun Protection
To minimize the risk of skin irritation and other adverse effects, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn while using this medication. To protect your skin, avoid direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when going outside.
Weather Conditions
Certain weather conditions, such as cold and wind, can irritate the skin. Consult with your doctor or pharmacist for guidance on how to protect your skin in these conditions.
Common Side Effects
Skin irritation is a common side effect of this medication. Reactions may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation, or if the irritation bothers you or persists, contact your doctor for advice.
Pregnancy and Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical use. If accidentally swallowed, symptoms may include gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
If swallowed, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. For topical overdose, discontinue use and manage symptoms of irritation.
Drug Interactions
Moderate Interactions
- Other topical acne preparations (e.g., benzoyl peroxide, salicylic acid, sulfur): May cause excessive irritation, dryness, or peeling. Benzoyl peroxide can inactivate clindamycin; apply at different times of day.
- Topical products containing alcohol, astringents, spices, or lime: May cause excessive irritation.
- Neuromuscular blocking agents: Theoretical potentiation of neuromuscular blockade with clindamycin (due to systemic absorption, though minimal).
Minor Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): May increase risk of sunburn with tretinoin.
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To evaluate acne severity, skin type, and identify any pre-existing irritation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging, pruritus)
Frequency: At follow-up visits (e.g., every 4-8 weeks) and as needed.
Target: Mild to moderate, manageable irritation.
Action Threshold: Severe or persistent irritation may require temporary discontinuation or reduction in frequency of application.
Acne lesion count and severity
Frequency: At follow-up visits (e.g., every 4-8 weeks).
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Redness
- Peeling
- Dryness
- Burning sensation
- Stinging sensation
- Itching
- Photosensitivity (increased sensitivity to sunlight)
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Advise women of childbearing potential to use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Potential risk to fetus; animal studies show adverse effects, but human data are limited. Systemic absorption is minimal.
Second Trimester:
Potential risk to fetus; animal studies show adverse effects, but human data are limited. Systemic absorption is minimal.
Third Trimester:
Potential risk to fetus; animal studies show adverse effects, but human data are limited. Systemic absorption is minimal.
Lactation
Caution advised. Clindamycin is excreted in breast milk following oral/IV administration, but systemic absorption from topical application is minimal. Tretinoin topical absorption is also minimal. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
Low to Moderate (L3). Monitor infant for gastrointestinal upset (diarrhea, candidiasis) if significant absorption occurs. Avoid applying to areas where the infant may ingest the medication.
Pediatric Use
Safety and efficacy established for patients 12 years and older. Not recommended for children under 12 years of age as safety and efficacy have not been established in this age group.
Geriatric Use
Acne vulgaris is less common in the elderly. No specific dosage adjustments are needed. Use with caution in patients with fragile or excessively dry skin.
Clinical Information
Clinical Pearls
- This combination product is designed to address multiple factors contributing to acne: bacterial overgrowth, inflammation, and abnormal keratinization.
- Patients should be advised that an initial 'purging' or worsening of acne may occur during the first few weeks of treatment due to the tretinoin component, which is a normal part of the process.
- Emphasize the importance of consistent, once-daily evening application to the entire affected area, not just individual lesions.
- Strict adherence to sun protection measures (sunscreen, protective clothing) is crucial due to the photosensitizing effects of tretinoin.
- Using a gentle, non-comedogenic moisturizer can help mitigate dryness and irritation, especially during the initial phase of treatment.
Alternative Therapies
- Topical Retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical Antibiotics (e.g., clindamycin, erythromycin)
- Oral Antibiotics (e.g., doxycycline, minocycline, sarecycline)
- Oral Retinoids (e.g., isotretinoin - for severe acne)
- Hormonal Therapies (e.g., oral contraceptives, spironolactone - for hormonal acne)
- Topical Benzoyl Peroxide
- Topical Salicylic Acid
- Azelaic Acid
Cost & Coverage
Average Cost:
Varies widely (e.g., $100 - $800+) per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Varies by insurance plan (often Tier 2 or 3 for brand, Tier 1 for generic)
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 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 effective treatment.