Ziana Gel 60gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Topical antibiotic; Retinoid
Pregnancy Category
Category C
FDA Approved
Oct 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ziana Gel is a topical medication used to treat acne. It contains two active ingredients: clindamycin, an antibiotic that helps kill acne-causing bacteria and reduce inflammation, and tretinoin, a form of vitamin A that helps clear clogged pores and promote healthy skin cell turnover.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. It is essential to use this medication as directed.
Apply this medication only to your skin, avoiding ingestion or contact with your mouth, nose, and 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, ensuring it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing.
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 the missed dose as soon as you remember.
If the next scheduled dose is near, 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 provided information carefully. It is essential to use this medication as directed.
Apply this medication only to your skin, avoiding ingestion or contact with your mouth, nose, and 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, ensuring it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing.
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 the missed dose as soon as you remember.
If the next scheduled dose is near, 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 once daily in the evening.
- Use only a pea-sized amount for the entire face.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a gentle, non-comedogenic cleanser and moisturizer.
- Sun protection is crucial: Use a broad-spectrum sunscreen with SPF 30 or higher daily, wear protective clothing, and limit sun exposure, including tanning beds. Tretinoin increases sensitivity to sunlight.
- Avoid waxing on treated areas as skin may be more fragile.
- Be patient; it may take 8-12 weeks to see significant improvement. Acne may appear worse during the first few weeks of treatment (purging).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount of Ziana Gel to the entire affected area once daily in the evening, before bedtime.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to the entire affected area once daily in the evening.
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 needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations for topical application.
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
Ziana Gel combines two active ingredients: Clindamycin and Tretinoin. Clindamycin is a lincosamide antibiotic that binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. This action reduces the number of Propionibacterium acnes (now Cutibacterium acnes) on the skin and in follicles, and also has anti-inflammatory effects. Tretinoin is a retinoid that modulates abnormal follicular keratinization, reduces the cohesiveness of follicular epithelial cells, and increases cell turnover. This promotes the extrusion of comedones and prevents the formation of new ones. Tretinoin also has anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption for both active ingredients 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.
ProteinBinding:
Clindamycin: Approximately 93% (systemic). Tretinoin: Highly protein bound (systemic). Not clinically relevant for topical application.
CnssPenetration:
Limited/Not clinically relevant for topical application.
Elimination:
HalfLife:
Clindamycin: Approximately 2.4-3 hours (systemic). Tretinoin: Approximately 0.5-0.8 hours (systemic). Not clinically relevant for topical application due to minimal systemic absorption.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Clindamycin: Urine and feces (systemic). Tretinoin: Urine and feces (systemic). Minimal excretion after topical absorption.
Unchanged:
Not clinically relevant for topical application.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed after 2-4 weeks, with optimal results often seen after 8-12 weeks of consistent use.
PeakEffect:
Peak therapeutic effect usually seen after 12 weeks of treatment.
DurationOfAction:
Duration of effect requires continued application for maintenance of acne control.
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
+ 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
As with 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 contact your doctor or seek medical help if you have any symptoms that bother you or do not go away.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor for medical advice. 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
+ 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
As with 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 contact your doctor or seek medical help if you have any symptoms that bother you or do not go away.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor for medical advice. 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 redness, burning, stinging, or peeling that is intolerable.
- Blistering or crusting of the skin.
- Severe itching or swelling at the application site.
- Signs of a severe allergic reaction: rash, hives, difficulty breathing, swelling of the face, lips, tongue, or throat. Seek immediate medical attention.
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. 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, such as:
+ Crohn's disease
+ Other stomach or bowel problems (colitis, 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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have experienced
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor 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.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. 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, such as:
+ Crohn's disease
+ Other stomach or bowel problems (colitis, 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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have experienced
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor 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.
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 may 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.
Using Other Acne Medications
When using other pimple (acne) medications, exercise caution, as this 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 skin irritation, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn, so take precautions to protect your skin from the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.
Weather Conditions
Certain weather conditions, such as cold and wind, may irritate your 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, which may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation, or if it persists and bothers you, contact your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of 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 may 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.
Using Other Acne Medications
When using other pimple (acne) medications, exercise caution, as this 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 skin irritation, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn, so take precautions to protect your skin from the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.
Weather Conditions
Certain weather conditions, such as cold and wind, may irritate your 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, which may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation, or if it persists and bothers you, contact your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to severe local irritation, redness, peeling, and discomfort.
What to Do:
If excessive application occurs, wash the area gently with soap and water. Manage local irritation symptomatically. If accidental ingestion occurs, contact a poison control center or seek medical attention. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Major Interactions
- Neuromuscular blocking agents (Clindamycin may enhance the action of these agents)
- Erythromycin (Topical clindamycin and erythromycin are antagonistic in vitro; avoid concomitant use)
Moderate Interactions
- Other topical preparations with strong drying, irritating, or desquamating effects (e.g., sulfur, resorcinol, benzoyl peroxide, salicylic acid) - concomitant use should be avoided or used with caution due to potential for increased irritation.
- Photosensitizing agents (Tretinoin increases sensitivity to UV light; concomitant use with other photosensitizing drugs may increase risk of sunburn).
Monitoring
Baseline Monitoring
Acne severity assessment
Rationale: To establish baseline for evaluating treatment efficacy.
Timing: Prior to initiation of therapy.
Skin integrity and sensitivity
Rationale: To identify pre-existing irritation or conditions that may be exacerbated by treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin reactions (erythema, peeling, dryness, burning, stinging, pruritus)
Frequency: Regularly during treatment, especially during the first few weeks.
Target: Mild to moderate reactions are common and expected; severe reactions warrant re-evaluation.
Action Threshold: Severe or persistent irritation, blistering, crusting, or swelling may require temporary discontinuation or reduction in frequency of application.
Acne lesion count and overall improvement
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 indicate need for alternative therapy.
Symptom Monitoring
- Excessive skin dryness
- Severe peeling or flaking of skin
- Intense redness or erythema
- Burning or stinging sensation that is severe or persistent
- Itching (pruritus)
- Swelling of the face or application site
- Blistering or crusting of the skin
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat - seek immediate medical attention)
Special Patient Groups
Pregnancy
Pregnancy Category C. Ziana Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, tretinoin is a known teratogen when administered systemically. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential risk of teratogenicity, though systemic absorption from topical use is low. Avoid if possible.
Second Trimester:
Potential risk, but generally lower than first trimester. Use only if clearly needed.
Third Trimester:
Potential risk, but generally lower than first trimester. Use only if clearly needed.
Lactation
It is not known whether clindamycin or tretinoin are excreted in human milk after topical application. Due to the potential for serious adverse reactions in nursing infants from clindamycin (e.g., pseudomembranous colitis) and the potential for systemic effects from tretinoin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution is advised.
Infant Risk:
L3 (Moderately safe, but caution advised due to potential for absorption and theoretical risks).
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Use in children under 12 years has not been established.
Geriatric Use
Clinical studies of Ziana Gel 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 topical application in the elderly, but geriatric skin may be more fragile and prone to irritation.
Clinical Information
Clinical Pearls
- Apply Ziana Gel to a clean, dry face. Wait 20-30 minutes after washing your face before applying 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.
- Strict sun protection is essential due to tretinoin's photosensitizing effects. Use sunscreen daily, even on cloudy days, and avoid prolonged sun exposure and tanning beds.
- Avoid using other harsh or irritating topical products (e.g., abrasive cleansers, astringents, other acne treatments like benzoyl peroxide or salicylic acid) concurrently, unless directed by a healthcare provider, to prevent excessive irritation.
- Consistency is key. Use the gel every evening as directed for optimal results, which may take 8-12 weeks to become apparent.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)
- Chemical peels, laser therapy, light therapy
Cost & Coverage
Average Cost:
Varies widely, typically $300-$600+ per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3, may require prior authorization or step therapy depending on insurance plan.
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 medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.