Ziana Gel 30gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent, topical
Pharmacologic Class
Lincosamide antibiotic (topical), Retinoid
Pregnancy Category
Category C
FDA Approved
Nov 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 retinoid that helps to unclog pores and prevent new acne from forming.
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, avoiding 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, avoiding 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 a thin layer to clean, dry skin once daily in the evening.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Do not apply to cuts, abrasions, or eczematous skin.
- Use a mild cleanser and moisturizer. Avoid harsh or abrasive skin products.
- Sun sensitivity: Tretinoin can increase sensitivity to sunlight. Use sunscreen (SPF 30 or higher) daily, wear protective clothing, and limit sun exposure, even on cloudy days.
- Initial worsening of acne (purging) may occur during the first few weeks of treatment; this is normal and usually resolves with continued use.
- Be patient; it may take 8-12 weeks to see significant improvement.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount to the entire affected face once daily in the evening.
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to the entire affected area once daily in the evening after washing the skin.
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 face once daily in the evening.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed due to minimal systemic absorption.
Moderate:
No adjustment typically needed due to minimal systemic absorption.
Severe:
No adjustment typically needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically needed due to minimal systemic absorption.
Moderate:
No adjustment typically needed due to minimal systemic absorption.
Severe:
No adjustment typically needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clindamycin: A lincosamide antibiotic that binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting bacterial protein synthesis. It reduces the number of Propionibacterium acnes (now Cutibacterium acnes) on the skin and in follicles, and also has anti-inflammatory effects. Tretinoin: A retinoid that binds to specific retinoic acid receptors (RARs) in the nucleus. It modulates epithelial cell differentiation, proliferation, and inflammation. Tretinoin reduces follicular hyperkeratosis, promoting the shedding of comedones and preventing the formation of new lesions.
Pharmacokinetics
Absorption:
Bioavailability:
Clindamycin: Approximately 4% of the applied dose is systemically absorbed. Tretinoin: Approximately 1-2% of the applied dose is systemically absorbed.
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:
Not clinically relevant for topical application.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically relevant for topical application.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Not clinically relevant for topical application.
Unchanged:
Not clinically relevant for topical application.
Pharmacodynamics
OnsetOfAction:
Weeks (typically 2-4 weeks for initial improvement)
PeakEffect:
Months (typically 8-12 weeks for maximal effect)
DurationOfAction:
Maintained with continued use
Confidence:
High
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 immediate medical attention:
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 condition (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 contact your doctor if you have any symptoms that bother you or persist. This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.
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 immediate medical attention:
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 condition (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 contact your doctor if you have any symptoms that bother you or persist. This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation, redness, burning, or peeling that does not improve or worsens significantly.
- Swelling or blistering of the skin.
- Severe or persistent diarrhea (rare, but seek medical attention if it occurs, as it could be a sign of 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 symptoms you experienced.
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 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 or have had
Before starting, stopping, or changing the dose of any medication, including this one, 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
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 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 or have had
Before starting, stopping, or changing the dose of any medication, including this one, 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 to Share with Your Healthcare Providers
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Precautions for Application
Do not apply this medication to sunburned skin, cuts, scrapes, or damaged skin, as this may increase the risk of adverse reactions.
Expected Treatment Outcomes
It's essential to note that your skin may appear worse before it starts to improve. Be patient, as it may take several weeks to experience the full effects of this 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 potential side effects, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn, so take necessary precautions, such as avoiding sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to shield your skin from the sun.
Weather-Related Skin Irritation
Certain weather conditions, like cold and wind, may irritate your skin. Discuss with your doctor or pharmacist ways to protect your skin from these environmental factors.
Common Side Effects
Skin irritation is a common side effect of this medication, which may manifest as burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation, or if it persists and bothers you, contact your doctor for guidance.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It's crucial to discuss the benefits and risks of this medication to both you and your baby.
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Precautions for Application
Do not apply this medication to sunburned skin, cuts, scrapes, or damaged skin, as this may increase the risk of adverse reactions.
Expected Treatment Outcomes
It's essential to note that your skin may appear worse before it starts to improve. Be patient, as it may take several weeks to experience the full effects of this 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 potential side effects, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn, so take necessary precautions, such as avoiding sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to shield your skin from the sun.
Weather-Related Skin Irritation
Certain weather conditions, like cold and wind, may irritate your skin. Discuss with your doctor or pharmacist ways to protect your skin from these environmental factors.
Common Side Effects
Skin irritation is a common side effect of this medication, which may manifest as burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation, or if it persists and bothers you, contact your doctor for guidance.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It's crucial to discuss the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation, redness, peeling, or discomfort if applied in large amounts or too frequently.
- Systemic overdose is highly unlikely with topical application due to minimal absorption.
What to Do:
If excessive application occurs, wash the area with mild soap and water. Symptomatic and supportive care for local irritation. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention immediately, though systemic toxicity from ingestion of a small amount of topical gel is generally low.
Drug Interactions
Moderate 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 other neuromuscular blocking agents (though systemic absorption from topical use is minimal, caution is advised).
- Other topical acne preparations (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol): Concomitant use may increase skin irritation, dryness, or peeling. If necessary, apply at different times of day.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of acne, presence of irritation)
Rationale: To establish baseline for efficacy and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in acne lesions)
Frequency: Monthly or as clinically indicated
Target: Improvement in lesion count and overall skin appearance.
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment.
Local skin reactions (erythema, peeling, dryness, burning, itching)
Frequency: Regularly, especially during initial weeks of therapy
Target: Mild to moderate irritation is common and expected. Severe or persistent irritation is not.
Action Threshold: Severe or persistent irritation may require temporary discontinuation, reduction in frequency, or discontinuation of therapy.
Symptom Monitoring
- Excessive dryness or peeling of skin
- Severe redness or burning sensation
- Itching or stinging
- Swelling or blistering
- Diarrhea (rare, but possible with systemic absorption of clindamycin, especially if severe or persistent, could indicate C. difficile-associated diarrhea)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to the tretinoin component (Category C). While systemic absorption from topical application is minimal, oral retinoids are known teratogens. The decision to use should be made only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk of teratogenicity, especially during organogenesis. Avoid if possible.
Second Trimester:
Risk likely lower than first trimester, but still generally avoided.
Third Trimester:
Risk likely lower than first trimester, but still generally avoided.
Lactation
Use with caution. Both clindamycin and tretinoin are minimally absorbed systemically from topical application. It is unknown if clindamycin or tretinoin 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. Avoid applying to areas where the infant may ingest the medication (e.g., breast area).
Infant Risk:
Low risk due to minimal systemic absorption, but caution advised.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Not recommended for use in children under 12 years of age.
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 typically needed, but older patients may have more fragile or sensitive skin and may be more prone to irritation.
Clinical Information
Clinical Pearls
- Apply to the entire affected area, not just individual lesions, to prevent new breakouts.
- A 'pea-sized' amount is usually sufficient for the entire face. Using more will not improve results faster and may increase irritation.
- Always apply to clean, dry skin. Wait 20-30 minutes after washing your face before applying to minimize irritation.
- Consistency is key; results take time (weeks to months).
- Emphasize strict sun protection due to tretinoin's photosensitizing effects.
- Patients may experience initial worsening of acne (purging) and increased dryness/irritation during the first few weeks; this is often a sign the medication is working and usually subsides.
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:
Varies widely, typically $100-$500+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), 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 check with your pharmacist for more information. If you have any questions or concerns about this medication, consult 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.