What is AMZEEQ and how is it used?
AMZEEQ is a prescription medicine used on the skin (topical) for the treatment of pimples and red bumps (nonnodular inflammatory lesions) that happen with moderate to severe acne vulgaris in adults and children 9 years of age and older.
AMZEEQ should not be used for the treatment of infections. It is not known if AMZEEQ is safe and effective in children under 9 years of age.
What are possible side effects of AMZEEQ?
AMZEEQ contains minocycline, a tetracycline medicine. Tetracyclines, when taken by mouth, may cause serious side effects, including:
- Harm to an unborn baby. See “What should I tell my healthcare provider before using AMZEEQ?”
- 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 AMZEEQ 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 (Clostridium difficile) in your intestines. Call your healthcare provider right away if you get watery or bloody stools while using AMZEEQ.
- Liver problems. Minocycline taken by mouth to treat acne can cause serious liver problems that may lead to death. Stop using AMZEEQ and call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
- loss of appetite
- yellowing of your skin or the white of your eyes (jaundice)
- bleeding more easily than normal
- Central nervous system effects. See “What should I avoid while using AMZEEQ?”
- 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 AMZEEQ 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 orlymph 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). See “What should I avoid while using AMZEEQ?”
- 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 AMZEEQ 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 AMZEEQ is headache.
Your healthcare provider may stop your treatment with AMZEEQ if you develop certain side effects.
These are not all the possible side effects with AMZEEQ.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12atetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below:
Each gram of AMZEEQ contains micronized minocycline 40 mg equivalent to 43 mg minocycline hydrochloride in a yellow suspension foam.
In addition, the 4% AMZEEQ topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. AMZEEQ topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane).