The first and only minocycline with immediate- and sustained-release delivery
It’s the active ingredient you know — redefined.
Bringing immediate- and sustained-release minocycline together for the first time ever in a single functionally scored tablet with broad dosing options and safety similar to placebo.1
Three dimensions of MinoLira
Unique delivery system
25% immediate release and 75% sustained release of minocycline for a steady-state plasma concentration2
Functionally scored tablets
Broad dosing flexibility with four options to target 1mg/kg/day1
Safety and tolerability
The safety of sustained-release minocycline with an AE profile similar to placebo1
MinoLira is the only minocycline that delivers all three
Why does the unique delivery system matter?
Powered by Multiple Unit Particulate System (MUPS) technology, MinoLira provides a biphasic delivery system of minocycline that features2,3:
25% immediate and 75% sustained release of minocycline hydrochloride2
Steady-state plasma concentration 2
A low risk of irritation and toxicity3
Even distribution of drug on each side of the score line for confident, accurate dosing
A spherical core coated with micronized minocycline hydrochloride3
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.
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