Acanya 1.2-2.5% Gel 50gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Topical antibiotic; Topical antimicrobial/keratolytic
Pregnancy Category
Category C
FDA Approved
Oct 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acanya Gel is a topical medication used to treat acne. It contains two active ingredients: clindamycin, an antibiotic that helps kill the bacteria causing acne, and benzoyl peroxide, which also kills bacteria and helps to 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 accompanying information carefully. It is essential to use this medication as directed to ensure safe and effective treatment.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it or apply it to mucous membranes.
Avoid getting this medication in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply this medication to the vagina or any other sensitive areas.
Before and after applying the medication, wash your hands thoroughly to prevent cross-contamination.
Gently wash and rinse the affected skin with warm water, then 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.
Avoid applying this medication to cuts, scrapes, or damaged skin, as it may exacerbate the condition.
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 other humid environment.
Store the medication upright with the cap securely closed.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose 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 application.
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 to ensure safe and effective treatment.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it or apply it to mucous membranes.
Avoid getting this medication in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply this medication to the vagina or any other sensitive areas.
Before and after applying the medication, wash your hands thoroughly to prevent cross-contamination.
Gently wash and rinse the affected skin with warm water, then 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.
Avoid applying this medication to cuts, scrapes, or damaged skin, as it may exacerbate the condition.
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 other humid environment.
Store the medication upright with the cap securely closed.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose 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 application.
Lifestyle & Tips
- Apply to clean, dry skin.
- Avoid contact with eyes, mouth, nostrils, and other mucous membranes.
- Wash hands thoroughly after application.
- This product may bleach hair or colored fabrics (towels, clothing, bedding).
- Use sunscreen and wear protective clothing when outdoors, as this medication can increase sensitivity to the sun.
- Avoid excessive sun exposure, including tanning beds and sunlamps.
- Do not use on broken, irritated, or sunburned skin.
- Avoid using other topical acne products that may cause excessive dryness or irritation unless directed by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic 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 adjustment needed (minimal systemic absorption)
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, a lincosamide antibiotic, binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. It exhibits in vitro activity against Propionibacterium acnes (now Cutibacterium acnes). Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects. It releases free oxygen radicals that oxidize bacterial proteins, leading to bactericidal action against C. acnes. It also has mild keratolytic and comedolytic effects, reducing the number of comedones.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (Clindamycin <1%, Benzoyl Peroxide <5%)
Tmax:
Not well-defined for topical systemic absorption
FoodEffect:
Not applicable
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:
Benzoic acid (from benzoyl peroxide) is primarily excreted renally. Clindamycin has minimal systemic excretion after topical use.
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Improvement typically seen within 2-5 weeks
PeakEffect:
Optimal therapeutic effect usually observed after 8-12 weeks of continuous use
DurationOfAction:
Sustained with continued daily application
Safety & Warnings
Side Effects
Serious 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 is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Local irritation, such as:
+ Burning
+ Itching
+ Dryness
+ Other irritation at the site of application
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website 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 is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Local irritation, such as:
+ Burning
+ Itching
+ Dryness
+ Other irritation at the site of application
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (e.g., excessive redness, peeling, burning, itching, swelling)
- Signs of an allergic reaction (e.g., rash, hives, itching, swelling of the face/tongue/throat, severe dizziness, trouble breathing)
- Severe diarrhea, abdominal pain, or bloody stools (rare, but seek immediate medical attention if these occur, as they could indicate pseudomembranous colitis)
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.
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
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 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.
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
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 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 you accidentally swallow this drug, seek medical attention immediately by calling a doctor or a poison control center.
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 your first use, 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.
Exercise caution when applying this medication to avoid any potential skin or fabric damage. 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 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. Use a sunscreen with adequate sun protection factor (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 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 outcome for you and your baby.
If you accidentally swallow this drug, seek medical attention immediately by calling a doctor or a poison control center.
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 your first use, 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.
Exercise caution when applying this medication to avoid any potential skin or fabric damage. 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 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. Use a sunscreen with adequate sun protection factor (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 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 outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (redness, peeling, burning)
What to Do:
Overdose with topical application is unlikely. If excessive application occurs, wash the area thoroughly with water. In case of accidental ingestion, seek medical attention. For general poison control, call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Dapsone topical (potential for temporary yellow/orange skin discoloration when applied concomitantly)
- Other topical acne preparations (e.g., retinoids, salicylic acid, sulfur) due to potential for additive irritant or drying effects
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
Skin assessment for efficacy
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 may warrant re-evaluation of treatment plan
Skin assessment for adverse reactions
Frequency: At each follow-up visit and as needed
Target: Absence of excessive dryness, peeling, erythema, burning, or stinging
Action Threshold: Significant or persistent irritation may require temporary discontinuation, reduced frequency, or discontinuation of therapy
Symptom Monitoring
- Dryness
- Peeling
- Erythema (redness)
- Burning sensation
- Stinging sensation
- Itching
- Photosensitivity
- Contact dermatitis
- Diarrhea (rare, but severe diarrhea/colitis is a known risk with clindamycin, even topical)
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, clindamycin has been shown to cross the placenta in animal studies. 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). Clindamycin is excreted in human milk following oral and parenteral administration. It is not known whether clindamycin is excreted in human milk following topical application. Benzoyl peroxide is minimally absorbed. Use with caution. Avoid applying to areas that may come into direct contact with the infant during breastfeeding.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption, but monitor infant for potential gastrointestinal effects (e.g., diarrhea) if significant exposure occurs.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Safety and effectiveness in pediatric patients under 12 years of age have not been established.
Geriatric Use
Clinical studies of Acanya did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustments are generally needed for geriatric patients due to minimal systemic absorption.
Clinical Information
Clinical Pearls
- Instruct patients to apply a pea-sized amount to the entire affected area, not just individual lesions.
- Remind patients that full therapeutic effect may take several weeks (typically 8-12 weeks), and consistent use is key.
- Advise patients about the potential for skin irritation (dryness, redness, peeling) especially during the first few weeks of treatment, and to contact their provider if irritation is severe or persistent.
- Emphasize the importance of sunscreen use due to increased photosensitivity caused by benzoyl peroxide.
- Warn patients about the bleaching potential of benzoyl peroxide on hair, clothing, and bedding.
- Although rare with topical use, educate patients on the signs and symptoms of pseudomembranous colitis (severe diarrhea, abdominal pain, fever) and to seek immediate medical attention if they occur.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Other topical antibiotics (e.g., erythromycin, dapsone)
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin)
- Oral retinoids (e.g., isotretinoin)
- Hormonal therapies (e.g., oral contraceptives, spironolactone)
- Salicylic acid
- Azelaic acid
- Chemical peels
- Laser/light therapies
Cost & Coverage
Average Cost:
Varies, typically $300-$600+ per 50gm 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 this 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 overdose, including the medication taken, the amount, and the time it occurred.