References

1. MinoLira Tablets [Package Insert]. Charleston, SC: EPI Health, LLC; 2018.

2. Del Rosso JQ. Oral doxycycline in the management of acne vulgaris: current perspectives on clinical use and recent findings with a new double-scored small tablet formulation. J Clin Aesthet Dermatol. 2015;8(5):19–26.

3. American Academy of Dermatology. Acne: Who gets and causes.
https://www.aad.org/public/diseases/acne-and-rosacea/acne#causes. Accessed 12/18/2018.

4. National Institute of Arthritis and Musculoskeletal and Skin Diseases. https://www.niams.nih.gov/healthtopics/
acne. Accessed 11/30/2018.

5. American Osteopathic College of Dermatology. https://www.aocd.org/page/Minocycline. Accessed 11/30/2018.

6. PK Data, contained in NDA 209269.
MINOLIRA is indicated to treat only the pimples and red bumps (inflammatory lesions of non-nodular acne) of moderate to severe acne in patients 12 years of age and older.

MINOLIRA is not effective on acne that does not look red or swollen (non-inflammatory acne). The safety of MINOLIRA is not known after using it for 12 weeks. MINOLIRA has not been tested for the treatment of infections.
  • Do not use MINOLIRA if you are allergic to any of the tetracycline class of drugs. Ask your doctor or pharmacist for a list of these drugs if you are not sure. Stop taking MINOLIRA right away if a rash or other allergic symptoms appear.
  • Do not use MINOLIRA if you are pregnant, may become pregnant or are nursing. If you become pregnant while taking MINOLIRA, stop taking it and call your doctor. Taking MINOLIRA during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and slow the growth of bones.
  • Severe irritation and bleeding in the colon (called pseudomembranous colitis) can happen while taking most antibiotics and can range from mild to life-threatening. Talk to your doctor if you have watery diarrhea, diarrhea that doesn’t go away or bloody stools.
  • Before taking MINOLIRA, tell your doctor if you have kidney or liver problems.
  • Protect your skin from the sun while taking MINOLIRA. Avoid sunlight, sunlamps, and tanning beds as you are more likely to get a severe sunburn. Avoid driving or operating dangerous machinery until you know whether MINOLIRA causes you to feel dizzy or light-headed, or a spinning feeling (vertigo).
  • Minocycline may cause severe headaches and autoimmune disorders. Stop taking MINOLIRA if symptoms occur.
  • The most commonly observed side effects are headache, tiredness, dizziness and itching.


To report SUSPECTED ADVERSE REACTIONS contact EPI Health, LLC at 800-499-4468
or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.