Zilxi 1.5% Topical Foam 30gm
It is used to treat rosacea.
Drug Class
Anti-rosacea agent, Tetracycline antibiotic
Pharmacologic Class
Tetracycline antibiotic
Pregnancy Category
D
FDA Approved
May 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zilxi is a foam applied to the skin to help reduce the redness and bumps (inflammatory lesions) associated with rosacea. It contains an antibiotic called minocycline, which works by reducing inflammation in the skin.
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 as directed.
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.
Do not apply the medication to the vaginal area.
Apply the medication at the same time every day, at least 1 hour before bedtime.
Before using the medication, shake the container well.
If the medication is cold, allow it to warm up to room temperature before use. Do not heat the medication.
Gently rub the medication onto the affected area.
Wash your hands after applying the medication.
Wait at least 1 hour after applying the medication before bathing, showering, or swimming.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not refrigerate or freeze the medication.
Discard any unused medication after 3 months.
Protect the medication from heat and open flames.
Do not puncture or burn the container, even if it appears empty.
Missed Dose
If you miss a dose:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
* Do not apply two doses at the same time or use 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 as directed.
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.
Do not apply the medication to the vaginal area.
Apply the medication at the same time every day, at least 1 hour before bedtime.
Before using the medication, shake the container well.
If the medication is cold, allow it to warm up to room temperature before use. Do not heat the medication.
Gently rub the medication onto the affected area.
Wash your hands after applying the medication.
Wait at least 1 hour after applying the medication before bathing, showering, or swimming.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not refrigerate or freeze the medication.
Discard any unused medication after 3 months.
Protect the medication from heat and open flames.
Do not puncture or burn the container, even if it appears empty.
Missed Dose
If you miss a dose:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Avoid triggers that can worsen rosacea, such as sun exposure, hot beverages, spicy foods, alcohol, and stress.
- Use a broad-spectrum sunscreen with an SPF of 30 or higher daily, as minocycline can increase sensitivity to sunlight.
- Use gentle skin care products and avoid harsh cleansers or exfoliants.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected facial areas once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
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 (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
Minocycline is a tetracycline-class antibiotic. While its exact mechanism in the treatment of rosacea is unknown, it is believed to exert anti-inflammatory effects by inhibiting pro-inflammatory mediators (e.g., nitric oxide synthase, matrix metalloproteinases) and reducing reactive oxygen species. It also possesses antimicrobial activity, but its efficacy in rosacea is primarily attributed to its anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (mean Cmax 1.0 Âą 0.7 ng/mL)
Tmax:
Not precisely defined for topical, but systemic concentrations are very low
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not applicable for topical formulation (minimal systemic distribution)
ProteinBinding:
Not applicable for topical formulation (minimal systemic protein binding)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely defined for topical (minimal systemic elimination)
Clearance:
Not precisely defined for topical (minimal systemic clearance)
ExcretionRoute:
Not precisely defined for topical (minimal systemic excretion)
Unchanged:
Not precisely defined for topical
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within several weeks
PeakEffect:
Not precisely defined for topical
DurationOfAction:
Once daily application
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Feeling tired or weak
Abnormal heartbeat
Swelling
Changes in nail, skin, eye, scar, tooth, or gum color to a darker shade
Sunburn
Diarrhea, especially if it is severe, bloody, or watery (note: diarrhea is common with antibiotics, but a rare and severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems)
Stomach pain, cramps, or very loose, watery, or bloody stools (if you experience these symptoms, contact your doctor before treating diarrhea)
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Raised pressure in the brain, which can cause:
+ Headache
+ Eyesight problems, such as blurred vision, double vision, or loss of vision
Severe skin reactions, including Stevens-Johnson syndrome (SJS) or other severe skin reactions, which can cause:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms or if they bother you or do not go away, contact your doctor:
Dry skin
Redness
Burning or stinging
Flushing
Itching
* Mild spider veins
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Feeling tired or weak
Abnormal heartbeat
Swelling
Changes in nail, skin, eye, scar, tooth, or gum color to a darker shade
Sunburn
Diarrhea, especially if it is severe, bloody, or watery (note: diarrhea is common with antibiotics, but a rare and severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems)
Stomach pain, cramps, or very loose, watery, or bloody stools (if you experience these symptoms, contact your doctor before treating diarrhea)
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Raised pressure in the brain, which can cause:
+ Headache
+ Eyesight problems, such as blurred vision, double vision, or loss of vision
Severe skin reactions, including Stevens-Johnson syndrome (SJS) or other severe skin reactions, which can cause:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms or if they bother you or do not go away, contact your doctor:
Dry skin
Redness
Burning or stinging
Flushing
Itching
* Mild spider veins
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. 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 or persistent skin irritation (e.g., burning, stinging, itching, dryness)
- Signs of an allergic reaction (e.g., rash, hives, swelling of the face, lips, or tongue, difficulty breathing)
- Unusual skin discoloration (e.g., yellow, brown, or gray areas on the skin)
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 taking any of the following medications: Acitretin, isotretinoin, or a penicillin.
* If you are breastfeeding. Please note that you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage 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.
If you are currently taking any of the following medications: Acitretin, isotretinoin, or a penicillin.
* If you are breastfeeding. Please note that you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage 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 taking the oral form of this medication, you may experience dizziness. If this occurs, do not engage in activities that require alertness, such as driving, until the dizziness subsides.
You may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when going outside.
Do not use this medication for a longer duration than prescribed, as this may increase the risk of a second infection.
This medication may interfere with certain laboratory tests. Be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication.
The medication may cause staining on clothing and fabrics, so take precautions to protect them.
Be cautious when using this medication, as it may be flammable. Avoid exposure to open flames, sparks, or smoking during and immediately after application.
In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If you notice any changes in tooth color, consult your doctor.
Note that this medication is not approved for use in children. If you have any concerns or questions, discuss them with your doctor.
Additionally, if you are pregnant or become pregnant while taking this medication, you should contact your doctor immediately, as it may pose a risk to the unborn baby.
When taking the oral form of this medication, you may experience dizziness. If this occurs, do not engage in activities that require alertness, such as driving, until the dizziness subsides.
You may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when going outside.
Do not use this medication for a longer duration than prescribed, as this may increase the risk of a second infection.
This medication may interfere with certain laboratory tests. Be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication.
The medication may cause staining on clothing and fabrics, so take precautions to protect them.
Be cautious when using this medication, as it may be flammable. Avoid exposure to open flames, sparks, or smoking during and immediately after application.
In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If you notice any changes in tooth color, consult your doctor.
Note that this medication is not approved for use in children. If you have any concerns or questions, discuss them with your doctor.
Additionally, if you are pregnant or become pregnant while taking this medication, you should contact your doctor immediately, as it may pose a risk to the unborn baby.
Overdose Information
Overdose Symptoms:
- Overdose with topical application is unlikely due to minimal systemic absorption.
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (Call 1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To establish baseline severity of inflammatory lesions of rosacea and overall skin condition.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy assessment
Frequency: Periodically (e.g., at follow-up visits)
Target: Reduction in inflammatory lesions
Action Threshold: Lack of improvement or worsening of condition may warrant re-evaluation of therapy.
Local adverse reactions
Frequency: At each follow-up visit and patient self-monitoring
Target: Absence or mildness of erythema, dryness, stinging, burning, or discoloration
Action Threshold: Persistent or severe local reactions may require dose reduction or discontinuation.
Symptom Monitoring
- Worsening of rosacea symptoms
- Severe skin irritation (e.g., burning, stinging, itching, dryness)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Skin discoloration (yellow/brown/gray)
Special Patient Groups
Pregnancy
Minocycline is a tetracycline, which is classified as Pregnancy Category D. While systemic absorption from topical application is minimal, caution is advised. Tetracyclines can cause permanent tooth discoloration and inhibition of bone growth when administered systemically during pregnancy. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though systemic exposure from topical use is low.
Second Trimester:
Potential for fetal harm, including tooth discoloration and inhibition of bone growth, though systemic exposure from topical use is low.
Third Trimester:
Potential for fetal harm, including tooth discoloration and inhibition of bone growth, though systemic exposure from topical use is low.
Lactation
Minocycline is excreted in breast milk following systemic administration (Lactation Risk L3). While systemic absorption from topical application is minimal, caution is advised. The potential for infant exposure is low, but monitor the infant for potential adverse effects such as tooth discoloration (unlikely with low exposure), diarrhea, or candidiasis.
Infant Risk:
Low risk, but monitor for potential adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Zilxi is not indicated for use in children.
Geriatric Use
No specific dose adjustments are needed for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, no overall differences in safety or effectiveness were observed.
Clinical Information
Clinical Pearls
- Zilxi is for topical use only and should not be ingested or used in the eyes, mouth, or other mucous membranes.
- Apply the foam to clean, dry skin. Wash hands thoroughly after application.
- Patients should be advised that improvement may take several weeks of consistent use.
- Due to the potential for photosensitivity with tetracyclines, even with minimal systemic absorption, patients should be advised to use sunscreen and protective clothing when exposed to sunlight.
- Store the foam at room temperature, away from heat and open flame, as it is flammable.
Alternative Therapies
- Topical metronidazole (e.g., Metrogel, Noritate)
- Topical azelaic acid (e.g., Finacea, Azelex)
- Topical ivermectin (e.g., Soolantra)
- Oral doxycycline (e.g., Oracea, low-dose doxycycline)
- Oral minocycline (systemic formulations)
- Topical brimonidine (e.g., Mirvaso) for erythema
- Topical oxymetazoline (e.g., Rhofade) for erythema
Cost & Coverage
Insurance Coverage:
Tier 3 or higher, may require prior authorization
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your 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 name of the medication taken, the amount, and the time it occurred.