Duac 1.2% / 5% Topical Gel 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent, topical
Pharmacologic Class
Topical antibiotic (Clindamycin), Keratolytic/Antimicrobial (Benzoyl Peroxide)
Pregnancy Category
Category C
FDA Approved
Aug 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Duac Gel is a topical medication used to treat acne. It contains two active ingredients: clindamycin, an antibiotic that kills acne-causing bacteria, 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 the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin. 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 area thoroughly with water.
Do not apply the medication to the vagina.
Preparation and Application
Wash your hands before and after using the medication.
Gently wash and rinse the affected skin with warm water, then pat it dry.
Use mild soaps for facial cleansing to avoid irritating the skin.
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.
Discard any unused medication after 2 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 dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin. 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 area thoroughly with water.
Do not apply the medication to the vagina.
Preparation and Application
Wash your hands before and after using the medication.
Gently wash and rinse the affected skin with warm water, then pat it dry.
Use mild soaps for facial cleansing to avoid irritating the skin.
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.
Discard any unused medication after 2 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 dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly after applying the gel.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- May bleach hair or colored fabric; allow gel to dry completely before contact with clothing or bedding.
- Sun sensitivity may increase; advise use of sunscreen and protective clothing when outdoors.
- Use a gentle, non-comedogenic cleanser and moisturizer.
- Do not use other topical acne treatments unless directed by a healthcare professional, as this may increase skin irritation.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily after washing the skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness established for patients 12 years of age and older)
Adolescent:
Apply a thin layer to affected areas once daily after washing the skin (for patients 12 years of age and older).
Dose Adjustments
Renal Impairment:
Mild:
Not applicable for topical administration due to minimal systemic absorption.
Moderate:
Not applicable for topical administration due to minimal systemic absorption.
Severe:
Not applicable for topical administration due to minimal systemic absorption.
Dialysis:
Not applicable for topical administration due to minimal systemic absorption.
Hepatic Impairment:
Mild:
Not applicable for topical administration due to minimal systemic absorption.
Moderate:
Not applicable for topical administration due to minimal systemic absorption.
Severe:
Not applicable for topical administration due to 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 the translation process. It has bacteriostatic activity against Propionibacterium acnes (now Cutibacterium acnes). Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic properties. It releases free radicals that oxidize bacterial proteins, reducing P. acnes, and also causes desquamation of the stratum corneum, preventing follicular occlusion.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption. Less than 4% of clindamycin is absorbed systemically after topical application. Benzoyl peroxide is absorbed into the skin and converted to benzoic acid.
Tmax:
Not clinically relevant for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not clinically relevant for topical application.
ProteinBinding:
Not clinically relevant for topical application.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic absorption.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Clindamycin: Minimal systemic excretion. Benzoic acid (from benzoyl peroxide) is excreted in urine.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 2-5 weeks.
PeakEffect:
Maximal effect seen after 8-12 weeks of continuous use.
DurationOfAction:
Maintained with continued daily application.
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
+ Stomach pain or cramps
+ Severe or watery diarrhea
+ Colitis (a bowel problem that can be life-threatening if left untreated)
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, such as:
+ Burning
+ Itching
+ Dryness
+ Other irritation at the site of application
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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
+ Stomach pain or cramps
+ Severe or watery diarrhea
+ Colitis (a bowel problem that can be life-threatening if left untreated)
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, such as:
+ Burning
+ Itching
+ Dryness
+ Other irritation at the site of application
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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 (excessive redness, dryness, peeling, burning, or itching) that does not improve or worsens.
- Persistent or severe diarrhea, especially if accompanied by abdominal pain or fever (though very rare with topical use, seek medical attention immediately).
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 symptoms you experienced.
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 (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe 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 symptoms you experienced.
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 (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe 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 this medication is accidentally swallowed, it can cause harm. 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 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.
To use this medication correctly, follow the instructions provided 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 risks. 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 yellowing 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 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, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, it is crucial to discuss the potential benefits and risks of using this medication with your doctor to ensure the best outcome for you and your baby.
If this medication is accidentally swallowed, it can cause harm. 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 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.
To use this medication correctly, follow the instructions provided 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 risks. 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 yellowing 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 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, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, it is crucial to discuss the potential benefits and risks of using this medication with your doctor to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose may result in excessive redness, peeling, or discomfort.
- Ingestion is unlikely to cause systemic toxicity but may lead to gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
Discontinue use and apply symptomatic and supportive care for skin irritation. For accidental ingestion, contact a poison control center (1-800-222-1222) or seek medical attention.
Drug Interactions
Moderate Interactions
- Dapsone topical (potential for temporary yellow/orange skin discoloration when used concurrently with benzoyl peroxide)
- Other topical acne preparations (may increase skin irritation, dryness, or peeling if used concurrently)
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To evaluate baseline acne severity and identify any pre-existing skin irritation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, dryness, peeling, burning, itching)
Frequency: Daily during initial treatment, then as needed.
Target: Tolerable irritation.
Action Threshold: Reduce frequency or temporarily discontinue if severe irritation occurs.
Acne lesion count/severity
Frequency: Monthly or as clinically indicated.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: Re-evaluate treatment if no improvement after 8-12 weeks.
Symptom Monitoring
- Severe skin irritation (redness, dryness, peeling, burning, itching)
- Persistent or severe diarrhea (rare, but indicates potential for Clostridioides difficile-associated diarrhea, though very rare with topical clindamycin)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected, but animal studies with clindamycin have shown some adverse effects at high doses.
Trimester-Specific Risks:
First Trimester:
Limited data, minimal systemic absorption expected.
Second Trimester:
Limited data, minimal systemic absorption expected.
Third Trimester:
Limited data, minimal systemic absorption expected.
Lactation
L3 (Moderately safe). Use with caution. It is not known if clindamycin or benzoyl peroxide are excreted in human milk after topical application. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
Low, due to minimal systemic absorption, but theoretical risk of gastrointestinal effects in infant if ingested.
Pediatric Use
Safety and effectiveness established in pediatric patients 12 years of age and older. Not established in patients younger than 12 years.
Geriatric Use
No specific dosage adjustments are recommended. Acne vulgaris is less common in geriatric patients, but efficacy and safety are expected to be similar to younger adults.
Clinical Information
Clinical Pearls
- Instruct patients to apply Duac Gel to clean, dry skin. A pea-sized amount is usually sufficient for the entire face.
- Patients should be advised that initial worsening of acne or skin irritation (redness, dryness, peeling) is common and usually subsides with continued use.
- Emphasize the importance of consistent daily application for optimal results, which may take 8-12 weeks.
- The product must be stored in a refrigerator (2°C-8°C / 36°F-46°F) until dispensed. After dispensing, it can be stored at room temperature (20°C-25°C / 68°F-77°F) for up to 60 days.
- Remind patients about the potential for bleaching fabrics and hair.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Other topical antimicrobials (e.g., erythromycin, azelaic acid)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (for female patients)
- Chemical peels, laser therapy, light therapy
Cost & Coverage
Average Cost:
Varies widely, typically $200-$500 for a 45gm tube (brand name Duac). per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (Brand name), 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.