Zilxi is an aerosol foam medicine that contains minocycline, a tetracycline antibiotic.

Zilxi foam is a prescription medicine used on the skin to treat adults with pimples and bumps caused by a condition called rosacea.

Zilxi is not for use in treating a skin infections.

Zilxi foam is only to be used on the skin only (topical use). Zilxi is not for use in your mouth, eyes, or vagina.

It is not known if Zilxi foam is safe and effective in children.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Zilxi foam if you are allergic to minocycline or to similar antibiotics such as demeclocycline, doxycycline, or tetracycline.

To make sure Zilxi is safe for you, tell your doctor if you have ever had::

• liver disease;

• kidney disease;

• increased pressure inside your skull; or

• if you are currently having diarrhea or watery stools.

Tell your doctor if you are pregnant. Although it is not known whether minocycline applied to the skin is harmful to an unborn baby, taking minocycline by mouth during the second or third trimester of pregnancy may cause bone growth problems in the unborn baby, or permanent tooth discoloration later in life.

You should not breastfeed while using Zilxi.

Use Zilxi foam exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Shake the Zilxi foam canister well just before each use.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Zilxi foam is usually applied once per day, at least 1 hour before bedtime. Apply only a small amount of topical foam to affected skin areas.

Try to use the medicine at the same time each day.

Do not bathe or shower or swim for at least 1 hour after you have applied Zilxi.

Store at room temperature away from moisture and heat. Do not keep this medicine in a refrigerator.

Zilxi foam is refrigerated at the pharmacy before you receive it. You may be instructed to continue storing the canister in a refrigerator at home, until you first start using the medicine. When you begin using a canister for the first time, allow it to reach room temperature before you apply the medicine. Once you start using a canister, keep storing it at room temperature for up to 90 days and then throw it away, even if there is still medicine left inside.

Zilxi foam is flammable. Do not use near high heat or open flame. Do not smoke until the medicine has completely dried on your skin.

You should not use Zilxi foam if you are allergic to minocycline or to similar antibiotics such as demeclocycline, doxycycline, or tetracycline.

To make sure Zilxi is safe for you, tell your doctor if you have ever had::

• liver disease;

• kidney disease;

• increased pressure inside your skull; or

• if you are currently having diarrhea or watery stools.

Tell your doctor if you are pregnant. Although it is not known whether minocycline applied to the skin is harmful to an unborn baby, taking minocycline by mouth during the second or third trimester of pregnancy may cause bone growth problems in the unborn baby, or permanent tooth discoloration later in life.

You should not breastfeed while using Zilxi.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

An overdose of Zilxi is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Minocycline topical could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid getting Zilxi foam in your eyes, mouth, or vagina.

Get emergency medical help if you have signs of an allergic reaction to Zilxi (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Serious side effects are unlikely when Zilxi foam is applied to the skin, but can occur if the medicine is absorbed into your bloodstream.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• severe dizziness;

• confusion, headache, vision problems, pain behind your eyes;

• fever, swollen glands, itching, joint pain, or not feeling well;

• discoloration of your skin, nails, eyes, mouth, gums, or teeth.

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• lupus-like symptoms - muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight.

Minocycline can affect growth in children, especially if used long term.

Common Zilxi side effects may include:

• diarrhea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• isotretinoin;

• a blood thinner - warfarin, Coumadin, Jantoven; or

• a penicillin antibiotic - amoxicillin, ampicillin, nafcillin, oxacillin, Augmentin, Prevpac, and others.

This list is not complete. Other drugs may interact with minocycline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.