Clinical Information
Gen. Code and Des.
80360 minocycline HCl TOPICAL FOAM 4 %
Strength
4 %
Dose Form
FOAM (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84040400 ANTIBACTERIALS (SKIN, MUCOUS MEMBRANE)
Active Ingredients
2754 minocycline HCl 13614987
Inactive Ingredients
13405 soy
16176 coconut
9290 cremophor el (polyethoxlated castor oil) These highlights do not include all the information needed to use AMZEEQ safely and effectively. See full prescribing information for AMZEEQ.
AMZEEQTM (minocycline) topical foam
Initial U.S. Approval: 1971
INDICATIONS AND USAGE
AMZEEQ is a tetracycline-class drug indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. (1)
Limitations of Use
This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated. (5.14)
DOSAGE AND ADMINISTRATION
Apply AMZEEQ to affected areas once daily. AMZEEQ should be gently rubbed into the skin. (2)
DOSAGE FORMS AND STRENGTHS
Foam, 4% (3)
CONTRAINDICATIONS
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the ingredients within AMZEEQ. (4)
WARNINGS AND PRECAUTIONS
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The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. (5.1)
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The use of tetracycline-class of drugs orally during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. (5.2, 5.3, 5.4, 8.1, 8.4)
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If Clostridium difficile associated diarrhea occurs, discontinue AMZEEQ. (5.5)
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If liver injury is suspected, discontinue AMZEEQ. (5.6)
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If renal impairment exists, oral minocycline doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. (5.7)
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Oral minocycline may cause central nervous system side effects including lightheadedness, dizziness, or vertigo. (5.8)
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Oral minocycline may cause intracranial hypertension in adults and adolescents. Discontinue AMZEEQ if symptoms occur. (5.9)
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Oral minocycline has been associated with autoimmune syndromes; discontinue AMZEEQ immediately if symptoms occur. (5.10)
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Photosensitivity can occur with oral tetracycline. Patients should minimize or avoid exposure to natural or artificial sunlight. (5.11)
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Oral minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and DRESS syndrome. Discontinue AMZEEQ immediately if symptoms occur. (5.12)
ADVERSE REACTIONS
The most commonly observed adverse reaction is headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Foamix Pharmaceuticals Inc. at 1-844-375-3673 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. (7.1)
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Penicillin: avoid coadministration. (7.2)
USE IN SPECIFIC POPULATIONS
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Minocycline like other tetracycline-class drugs can cause fetal harm when administered orally to a pregnant woman. (5.2, 8.1)
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The use of drugs of the tetracycline class orally during tooth development may cause permanent discoloration of teeth. (5.3, 8.2, 8.4)
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Lactation: Breastfeeding not recommended. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
