References

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

2. Data on file.

3. Solid Dosage – MUPS (Multiple Unit Pellet System) Production. https://www.gea.com/en/applications/pharma/solid-dosage/solid-dosage_mups.jsp. Last accessed 9/17/2018.

4. Anthropometric Reference Data for Children and Adults: United States, 2011–2014. https://www.cdc.gov/nchs/data/series/sr_03/sr03_039.pdf. Last accessed 9/17/2018.

5. Del Rosso JQ. J Clin Aesthet Dermatol. 2015;8(5):19-26.

Indication and Usage

MINOLIRA is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

MINOLIRA did not demonstrate any effect on non-inflammatory acne lesions. Safety of MINOLIRA has not been established beyond 12 weeks 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, MINOLIRA should be used only as indicated.

Important Safety Information

  • This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
  • Minocycline, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman.
  • The use of MINOLIRA 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.
  • If pseudomembranous colitis occurs, discontinue MINOLIRA.
  • If renal impairment exists, MINOLIRA doses may need to be adjusted to avoid accumulations of the drug and possible liver toxicity.
  • Minocycline may cause central nervous system side effects, including light-headedness, dizziness, or vertigo.
  • Minocycline may cause intracranial hypertension and autoimmune disorders in adults and adolescents. Discontinue MINOLIRA if symptoms occur.
  • Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and DRESS syndrome. Discontinue MINOLIRA immediately if symptoms occur.
  • The most commonly observed adverse reactions are headache, fatigue, dizziness, and pruritus.

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