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IMPORTANT SAFETY INFORMATION
+ - -

Contraindications: Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ.

Warnings and Precautions

Flammability: The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:

  • Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use 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.
  • Clostridioides difficile associated diarrhea (CDAD): If CDAD occurs, discontinue AMZEEQ.
  • Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue AMZEEQ.
  • Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery.
  • Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue AMZEEQ immediately if symptoms occur.
  • Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue AMZEEQ immediately if symptoms occur.
  • Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using AMZEEQ. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn.
  • Hypersensitivity reactions: Discontinue AMZEEQ immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
  • Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
  • Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue AMZEEQ and institute appropriate therapy.
Adverse Reactions: The most common adverse reaction reported during clinical trials of AMZEEQ was headache.
INDICATIONS AND USAGE

AMZEEQ is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.

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.

Please see full Prescribing Information.
References
  1. AMZEEQ® (minocycline) topical foam, 4% Prescribing Information. Bridgewater, NJ: VYNE Pharmaceuticals Inc; Jan 2021.
  2. Sutcliffe J et al. Anaerobe. 2020;62:102169. doi:10.1016/j.anaerobe.2020.102169
  3. Physicians' Desk Reference. 27th ed. Medical Economics; 1973.
  4. Sapadin AN et al. J Am Acad Dermatol. 2006;54(2):258-265.
  5. Jones TM et al. J Drugs Dermatol. 2017;16(10):1022-1028.
  6. Kircik L et al. J Clin Aesthet Dermatol. 2020;13(4):14–21.
  7. Lin TK et al. Int J Mol Sci. 2017;19(1):70. doi:10.3390/ijms19010070
  8. Stein Gold L et al. J Clin Aesthet Dermatol. 2019;12(10):16-23.
  9. Data on file. VYNE Pharmaceuticals Inc.
  10. Data on file. Integrated Summary of Safety. VYNE Pharmaceuticals Inc.

IMPORTANT SAFETY INFORMATION

Contraindications: Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ.

Warnings and Precautions

Flammability: The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:

  • Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use 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.
  • Clostridioides difficile associated diarrhea (CDAD): If CDAD occurs, discontinue AMZEEQ.
  • Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue AMZEEQ.
  • Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery.
  • Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue AMZEEQ immediately if symptoms occur.
  • Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue AMZEEQ immediately if symptoms occur.
  • Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using AMZEEQ. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn.
  • Hypersensitivity reactions: Discontinue AMZEEQ immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
  • Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
  • Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue AMZEEQ and institute appropriate therapy.
Adverse Reactions: The most common adverse reaction reported during clinical trials of AMZEEQ was headache.
INDICATIONS AND USAGE

AMZEEQ is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.

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.

Please see full Prescribing Information.
References
  1. AMZEEQ® (minocycline) topical foam, 4% Prescribing Information. Bridgewater, NJ: VYNE Pharmaceuticals Inc; Jan 2021.
  2. Sutcliffe J et al. Anaerobe. 2020;62:102169. doi:10.1016/j.anaerobe.2020.102169
  3. Physicians' Desk Reference. 27th ed. Medical Economics; 1973.
  4. Sapadin AN et al. J Am Acad Dermatol. 2006;54(2):258-265.
  5. Jones TM et al. J Drugs Dermatol. 2017;16(10):1022-1028.
  6. Kircik L et al. J Clin Aesthet Dermatol. 2020;13(4):14–21.
  7. Lin TK et al. Int J Mol Sci. 2017;19(1):70. doi:10.3390/ijms19010070
  8. Stein Gold L et al. J Clin Aesthet Dermatol. 2019;12(10):16-23.
  9. Data on file. VYNE Pharmaceuticals Inc.
  10. Data on file. Integrated Summary of Safety. VYNE Pharmaceuticals Inc.
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© 2021 VYNE Therapeutics Inc. All rights reserved. COM-AMZ-US-210050 04/2021

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