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Brand Name(s): Amzeeq^®, Zilxi^®

WHY is this medicine prescribed?

Minocycline topical (Amzeeq) is used to treat certain types of acne in adults and children 9 years of age and older. Minocyclinetopical (Zilxi) is used to treat inflammatory lesions of rosacea in adults. Minocycline is in a class of medications called tetracycline antibiotics. It works to treat acne by killing the bacteria that infects pores and decreasing a certain natural oily substance that causes acne.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Minocycline topical comes as a foam to apply to the skin. It is usually used once daily, at least 1 hour before bedtime. Use minocycline at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use minocycline exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Minocycline foam may catch fire. Stay away from open fire, flames, and do not smoke while you are applying minocycline foam, and for a short time afterward.

To use the minocycline foam, follow these steps:

1. Shake the minocycline foam well before use. Allow the can to warm to room temperature before first use.
2. Wash the affected skin with water and a mild cleanser and pat dry with a soft towel.
3. Apply a thin layer onto the fingertips of the hand and apply it to the affected acne on the face. Be careful not to get minocycline in your eyes, nose, or mouth.
4. If acne is on the neck, shoulders, arms, back or chest, apply the minocycline foam to these parts. Do not let minocycline get into your eyes, mouth, corners along your nose, or vaginal area.
5. Do not bathe, shower or swim for at least 1 hour after applying the medication.
6. Wash your hands after applying minocycline to the affected skin.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using minocycline,

• tell your doctor and pharmacist if you are allergic to minocycline, sarecycline, doxycycline, omadacycline, tetracycline, demeclocycline, any other medications, or any of the ingredients in minocycline foam. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking minocycline topical. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have diarrhea or watery stools. Also, tell your doctor if you have or have ever had asthma, lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys), intracranial hypertension (pseudotumor cerebri; high pressure in the skull that may cause headaches, blurry or double vision, vision loss, and other symptoms), or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using minocycline, call your doctor immediately. Minocycline can harm the fetus.

• you should know that minocycline may make you lightheaded or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Minocycline may make your skin sensitive to sunlight.

• you should know that when minocycline is used during pregnancy or in babies or children up to age 8, it can cause the teeth to become permanently stained or temporarily affect bone growth. Minocycline should not be used in pregnant women or in children 8 years of age or younger.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra foam to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Minocycline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness
• darkening of skin, scars, teeth, or gums
• redness, dryness, itching, or skin peeling
• flushing of face or blushing appearance

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fever, rash, joint pain, or extreme tiredness
• yellowing of skin or eyes, itching, dark-colored urine, light colored bowel movements, loss of appetite, stomach pain, extreme tiredness, nausea, vomiting, or confusion
• blurred vision, double vision, vision loss, or unusual headaches
• rash, hives, mouth sores, skin blisters and peeling, swelling of your face, eyes, lips, tongue, or throat
• difficulty swallowing or breathing
• blood in urine
• swelling in your legs, ankles, and feet
• watery or bloody stools, stomach cramps, or fever during treatment or for up to 2 or more months after stopping treatment

Minocycline may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not store it in the refrigerator.

Minocycline foam is flammable, keep it away from flames and extreme heat. Do not puncture or incinerate the container.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

If someone swallows topical minocycline, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using topical minocycline.

Minocycline topical may stain fabric.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: December 15, 2022.