Zilxi (minocycline)

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

Zilxi should not be used for the treatment of infections.

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

Zilxi contains minocycline, a tetracycline medicine. Tetracyclines, when taken by mouth, may cause serious side effects, including:

• Harm to an unborn baby. 
• Permanent tooth discoloration. Tetracycline medicine when taken by mouth may permanently turn a baby or child's teeth yellow-gray-brown during tooth development. You should not use Zilxi during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth up to 8 years of age.
• Slow bone growth. Tetracycline medicine taken by mouth may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment.
• Diarrhea. Diarrhea can happen with most antibiotics, including minocycline taken by mouth. This diarrhea may be caused by an infection (Clostridioides difficile) in your intestines. Call your healthcare provider right away if you get watery or bloody stools while using Zilxi.
• Liver problems. Minocycline taken by mouth can cause serious liver problems that may lead to death. Stop using Zilxi and call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
  • loss of appetite
  • tiredness
  • diarrhea
  • yellowing of your skin or the white of your eyes (jaundice)
  • bleeding more easily than normal
  • confusion
  • sleepiness
• Central nervous system effects.
• Increased pressure in the brain (intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female of childbearing potential and are overweight or have a history of intracranial hypertension. Stop using Zilxi and tell your healthcare provider right away if you have blurred vision, double vision, vision loss, or unusual headaches.
• Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis) have happened during treatment with minocycline taken by mouth. Call your healthcare provider right away if you get a fever, rash, joint pain, or body weakness.
• Sensitivity to sunlight (photosensitivity).
• Serious skin or allergic reactions have happened during treatment with minocycline taken by mouth that may affect parts of your body such as your liver, lungs, kidneys and heart. Sometimes these can lead to death. Stop using Zilxi and go to the nearest hospital emergency room right away if you have any of the following signs or symptoms:
  • skin rash, hives, sores in your mouth, or your skin blisters and peels
  • swelling of your face, eyes, lips, tongue, or throat
  • trouble swallowing or breathing
  • blood in your urine
  • fever, yellowing of the skin or the whites of your eyes (jaundice), dark-colored urine
  • pain on the right side of the stomach area (abdominal pain)
  • chest pain or abnormal heartbeats
  • swelling in your legs, ankles, and feet
• Discoloration (hyperpigmentation). Minocycline taken by mouth may cause darkening of your skin, scars, teeth, or gums.

The most common side effect of Zilxi is diarrhea.

Your healthcare provider may stop your treatment with Zilxi if you develop certain side effects.

These are not all the possible side effects with Zilxi.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• For topical use only, not for oral, ophthalmic or intravaginal use.
• After shaking the can well, a small amount of topical foam (e.g. a cherry-sized amount) should be expressed from the can onto the fingertips of the hand and then applied as a thin layer over all areas of the face.
• Additional Zilxi foam may be used as needed to ensure the entire face is treated.
• The topical foam should be applied at approximately the same time each day at least 1 hour before bedtime.
• The patient should not bathe, shower or swim for at least 1 hour after application of the product.

Anticoagulants

• Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Penicillin

• Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Drug/Laboratory Test Interactions

• False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Do not use Zilxi if you are allergic to any tetracycline medicines or to any of the ingredients in Zilxi. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Before using Zilxi, tell your healthcare provider about all of your medical conditions, including if you:

• have diarrhea or watery stools
• have liver problems
• have kidney problems
• are pregnant or plan to become pregnant. Taking tetracycline medicines by mouth during pregnancy may cause serious side effects on the growth of bone and teeth of your baby. Zilxi topical foam is used on your skin and it is not known if it will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with Zilxi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements, and skin products you use. Tetracycline medicines taken by mouth may affect the way other medicines work and may increase your chance of developing certain side effects.

Especially tell your healthcare provider if you take:

• a blood thinner medicine
• a penicillin antibiotic medicine
• isotretinoin

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.