Clindamycin Phos/tretinoin Gel 30gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Topical lincosamide antibiotic; Topical retinoid
Pregnancy Category
Category C
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
This gel contains two medicines: clindamycin, an antibiotic that helps kill the bacteria that cause acne, and tretinoin, a form of vitamin A that helps clear up pimples and blackheads by promoting healthy skin cell turnover. It's used to treat acne.
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 take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Apply the medication at bedtime.
Before and after use, wash your hands thoroughly.
Clean the affected area before applying the medication, and make sure it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Protect the medication from heat and light sources.
Keep the lid tightly closed when not in use.
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 take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Apply the medication at bedtime.
Before and after use, wash your hands thoroughly.
Clean the affected area before applying the medication, and make sure it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Protect the medication from heat and light sources.
Keep the lid tightly closed when not in use.
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 once daily in the evening to clean, dry skin.
- Use a pea-sized amount for the entire face.
- Avoid contact with eyes, lips, nostrils, and mucous membranes.
- Avoid excessive sun exposure and use sunscreen (SPF 15 or higher) and protective clothing, as tretinoin can increase sun sensitivity.
- Avoid waxing on treated areas, as skin may be more fragile.
- Avoid other topical products that may cause irritation (e.g., abrasive soaps, astringents, products with high alcohol content) unless directed by your doctor.
- Be patient; it may take several weeks to see improvement, and acne may appear worse initially.
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 area once daily in the evening
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to the entire affected area (e.g., face) once daily in the evening after washing gently with a mild cleanser and patting dry.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age
Adolescent:
For patients 12 years of age and older: Apply a pea-sized amount to the entire affected area once daily in the evening.
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; 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 phosphate is a prodrug that is hydrolyzed to clindamycin, which binds to the 50S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis and suppressing the growth of Propionibacterium acnes (now Cutibacterium acnes). Tretinoin is a retinoid that modulates cell differentiation, keratinization, and inflammatory processes. It reduces follicular hyperkeratosis, which contributes to the formation of microcomedones, and promotes the expulsion of comedones. Tretinoin also has anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (Clindamycin: <4%; Tretinoin: <10%)
Tmax:
Not precisely defined for topical systemic levels; local effect is primary.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption.
ProteinBinding:
Clindamycin: ~90% (systemic); Tretinoin: >95% (systemic)
CnssPenetration:
Limited (not clinically significant for topical use)
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic absorption.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Not clinically relevant for topical application.
Unchanged:
Not clinically relevant for topical application.
Pharmacodynamics
OnsetOfAction:
Weeks to months (typically 2-12 weeks for noticeable improvement)
PeakEffect:
Typically 12 weeks or more for maximal effect
DurationOfAction:
Maintained with continued use; effects diminish upon discontinuation.
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 the diarrhea without consulting your doctor first.
Other Possible Side Effects
As with all medications, you may experience side effects. While many people have no 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 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 the diarrhea without consulting your doctor first.
Other Possible Side Effects
As with all medications, you may experience side effects. While many people have no 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 redness, burning, stinging, or peeling of the skin that does not improve or worsens.
- Blistering or crusting of the skin.
- Severe diarrhea or bloody diarrhea (rare, but seek medical attention immediately).
- Signs of an allergic reaction (e.g., rash, hives, itching, swelling of the face/lips/tongue, difficulty breathing).
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 this medication can be taken 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 this medication can be taken 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
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When applying this drug, avoid using it on sunburned skin, cuts, scrapes, or damaged skin, as this may exacerbate skin irritation.
Be aware that your skin may appear worse before it starts to improve, and it may take several weeks to experience the full effects of the treatment.
If you are using other acne medications, exercise caution, as combining these products may increase the risk of skin irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor to minimize potential interactions.
To optimize your skin care routine, practice good hygiene and take measures to avoid excessive sun exposure, as this medication may increase your susceptibility to sunburn. Avoid direct sunlight, sunlamps, and tanning beds, and use sunscreen with protective clothing and eyewear to safeguard your skin.
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist for guidance on protecting your skin in these situations.
Skin irritation is a common side effect of this medication, and reactions may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation, or if the irritation persists or bothers you, contact your doctor for further evaluation.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
When applying this drug, avoid using it on sunburned skin, cuts, scrapes, or damaged skin, as this may exacerbate skin irritation.
Be aware that your skin may appear worse before it starts to improve, and it may take several weeks to experience the full effects of the treatment.
If you are using other acne medications, exercise caution, as combining these products may increase the risk of skin irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor to minimize potential interactions.
To optimize your skin care routine, practice good hygiene and take measures to avoid excessive sun exposure, as this medication may increase your susceptibility to sunburn. Avoid direct sunlight, sunlamps, and tanning beds, and use sunscreen with protective clothing and eyewear to safeguard your skin.
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist for guidance on protecting your skin in these situations.
Skin irritation is a common side effect of this medication, and reactions may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation, or if the irritation persists or bothers you, contact your doctor for further evaluation.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Severe peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity. If excessive application occurs, discontinue use temporarily and allow skin to recover. If ingested, seek medical attention. For general overdose concerns, call a poison control center (1-800-222-1222 in the US).
Drug Interactions
Major Interactions
- Erythromycin (topical or systemic): May antagonize the antibacterial effect of clindamycin.
- Neuromuscular blocking agents: Clindamycin has neuromuscular blocking properties and may enhance the action of these agents.
Moderate Interactions
- Other topical acne preparations (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol): May cause cumulative irritant or drying effects.
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): May increase risk of photosensitivity with tretinoin.
Minor Interactions
- Abrasive soaps and cleansers, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime: May increase irritation.
Monitoring
Baseline Monitoring
Skin condition (acne severity, presence of lesions)
Rationale: To establish baseline for treatment efficacy assessment.
Timing: Prior to initiation of therapy.
Skin sensitivity/irritation
Rationale: To assess potential for adverse reactions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical assessment of acne lesions
Frequency: Every 4-8 weeks initially, then as needed.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: If no improvement after 12 weeks, reassess treatment plan. If worsening irritation, adjust frequency or discontinue.
Skin irritation (erythema, peeling, dryness, burning, itching)
Frequency: At each follow-up visit and patient self-monitoring.
Target: Mild to moderate irritation is common and expected; severe irritation should be addressed.
Action Threshold: Severe or persistent irritation may require temporary discontinuation, reduced frequency of application, or use of moisturizers.
Symptom Monitoring
- Skin redness
- Peeling or flaking of skin
- Dryness
- Burning or stinging sensation
- Itching
- Swelling
- Blistering or crusting (rare, severe irritation)
- Diarrhea (rare, if significant systemic absorption of clindamycin occurs)
Special Patient Groups
Pregnancy
Use is generally not recommended during pregnancy due to the tretinoin component. While systemic absorption of topical tretinoin is minimal, there is a theoretical risk of teratogenicity. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity (Category C). Avoid use.
Second Trimester:
Potential for teratogenicity (Category C). Avoid use.
Third Trimester:
Potential for teratogenicity (Category C). Avoid use.
Lactation
Clindamycin is generally considered compatible with breastfeeding (L2), but tretinoin topical is L3 (moderately safe, but caution). Use with caution. Avoid applying to areas where the infant may come into direct contact with the medication, especially the breast area.
Infant Risk:
Low to moderate risk. Monitor infant for gastrointestinal upset (diarrhea) or skin irritation.
Pediatric Use
Approved for use in patients 12 years of age and older. Safety and effectiveness in children younger than 12 years have not been established.
Geriatric Use
No specific dosage adjustments are required. Elderly patients may have more sensitive skin and may experience increased irritation; monitor closely.
Clinical Information
Clinical Pearls
- Apply to dry skin, typically 20-30 minutes after washing the face, to minimize irritation.
- A 'pea-sized' amount is usually sufficient for the entire face; using more will not speed up results and may increase irritation.
- Initial worsening of acne (purging) is common during the first few weeks of tretinoin use; this is usually temporary.
- Consistent daily use is key for efficacy. Skipping applications can reduce effectiveness.
- Emphasize strict sun protection due to tretinoin's photosensitizing effects.
- Moisturizers can be used to help manage dryness and irritation, but apply them after the gel has fully absorbed.
Alternative Therapies
- Topical retinoids (e.g., adapalene, tazarotene)
- Topical antibiotics (e.g., erythromycin, dapsone)
- Topical benzoyl peroxide
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral retinoids (e.g., isotretinoin - for severe acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone)
- Chemical peels, laser therapy, light therapy
Cost & Coverage
Average Cost:
$100 - $500+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization or step therapy)
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 occurred.