AMZEEQ

Generic Name/API: minocycline

Manufacturer: ASM Aerosol-Service AG

Dosage Forms & Strength & Pack Size:
Foam, 4%, 30g
AMZEEQ®(minocycline) topical foam, 4% is a yellow suspension supplied in a pressurized aluminum aerosol container (can). Each gram of AMZEEQ contains 40 mg of minocycline equivalent to 43 mg of minocycline hydrochloride, and is supplied as follows: NDC 69489-201-30 30 g

Storage:
AMZEEQ must be stored at 2ºC – 8ºC (36ºF – 46ºF) until dispensed to the patient.
Once dispensed, the patient is to store AMZEEQ at room temperature below 25ºC (77ºF) for 90
days. Do not store in the refrigerator.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION

AMZEEQ® (minocycline) topical foam, 4% is a prescription medicine used on the skin (topical) for the treatment of pimples and red bumps (non-nodular inflammatory lesions) of moderate to severe acne in patients 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. AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in your mouth, eyes or vagina.

IMPORTANT SAFETY INFORMATION

Do not use AMZEEQ if you are allergic to AMZEEQ or any tetracycline medicine. Stop using AMZEEQ right away and call your doctor if you get a rash or other allergic symptom.
Before using AMZEEQ, tell your doctor about all of your medical conditions and the medicines you take. Do not use AMZEEQ if you are pregnant, may become pregnant or are nursing. If you become pregnant while using AMZEEQ, talk to your doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.
AMZEEQ is flammable. Avoid fire, flame, and smoking when applying and right after you apply AMZEEQ.
Protect your skin from the sun while using AMZEEQ. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Stop using AMZEEQ if you get a sunburn.
When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. You should not drive or operate dangerous machinery if you have these symptoms.
AMZEEQ is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea which may be caused by an infection and can cause watery or bloody stools; loss of appetite; tiredness; yellowing of your skin or eyes (jaundice); bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of your skin, scars, teeth, or gums. Call your doctor right away if these side effects occur.

The most common side effect of AMZEEQ is headache.

These are not all of the possible side effects with AMZEEQ. Call your doctor for medical advice about side effects.

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