Amzeeq

Amzeeq is a prescription drug used to treat acne vulgaris in adults and children 9 years of age and older.

Minocycline, the active ingredient in Amzeeq, belongs to a group of drugs 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.

This medication comes as a foam to apply to the skin. It is usually used once daily, at least 1 hour before bedtime. Use Amzeeq at around the same time every day.

The most common side effect of Amzeeq is headache. Minocycline taken by mouth may cause feelings of light-headedness, dizziness, or spinning (vertigo). You should not drive or operate dangerous machinery if you have these symptoms during treatment with Amzeeq.

Amzeeq is a prescription medicine used on the skin (topical) for the treatment of pimples and red bumps (non-nodular 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.

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

Serious side effects have been reported with Amzeeq. See the "Amzeeq Precautions" section.

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.

Tell your healthcare provider about all the other medicines you take, including prescription and over-the- counter medicines, vitamins and herbal supplements. Tetracycline medicines taken by mouth may affect the way other medicines work, and may increase your risk of 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.

Amzeeq 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 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 
  • 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 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 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). Limit your time in sunlight. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using Amzeeq if you get sunburn.

• 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.

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

• Amzeeq is flammable. Avoid fire, flame, and smoking when applying and right after you apply Amzeeq.

• Minocycline taken by mouth may cause feelings of light-headedness, dizziness, or spinning (vertigo). You should not drive or operate dangerous machinery if you have these symptoms during treatment with Amzeeq.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Amzeeq, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Amzeeq, 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. Amzeeq 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 Amzeeq.

Tell your healthcare provider about all the other medicines you take, including prescription and over-the- counter medicines, vitamins and herbal supplements.

Tell your healthcare provider if you 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. There are no well-done studies that have been done in humans with Amzeeq TOPICAL foam. In animal studies, pregnant animals were given ORAL formulations of minocycline and some babies did show medical issues related to minocycline.

Amzeeq topical foam is used on your skin and it is not known if it will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Amzeeq topical foam crosses into human milk. Because many medications can cross into human milk and because the possibility for serious adverse reactions in nursing infants with use of this medication, breastfeeding is not recommended during treatment with Amzeeq.

• See the detailed “Instructions for Use” that comes with this medication for directions about how to apply Amzeeq the right way.
• Use Amzeeq exactly as your healthcare provider tells you.
• Apply Amzeeq to the affected skin area(s) at about the same time each day, at least 1 hour before bedtime.
• Do not bathe, shower, or swim for at least 1 hour after applying Amzeeq.
• Wash your hands after applying Amzeeq.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully.

Recommended Dosage: After shaking the can well, press the top of the can to dispense only a small amount of AMZEEQ onto your fingertips. You only need enough to cover the affected areas of the skin, so start small and use more if needed. Apply and gently rub into the affected areas. If you have acne on your neck, shoulders, arms, back, or chest, additional amounts of foam may be applied to these areas, too.

If you have applied too much Amzeeq or if someone has swallowed this medication, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Amzeeq at room temperature below 77ºF (25ºC) for 90 days. 
• Do not store Amzeeq in the refrigerator.
• Do not puncture or burn the Amzeeq can.
• Do not expose to heat or temperatures above 120ºF (49ºC) 

Keep Amzeeq and all medicines out of the reach of children.