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Minocycline hydrochloride

Brand and Other Names: EMROSI
Mechanism of Action:

The mechanism of action of EMROSI for the treatment of rosacea is unknown.

Indications:

EMROSI is a tetracycline-class drug indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults.

Limitations of Use

This formulation of minocycline has not been evaluated in the treatment or prevention of infections. To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, use EMROSI only as indicated.

Route: Oral
Dose:

The recommended dosage of EMROSI is 40 mg orally, once daily.

Adverse Reactions:

The most commonly observed adverse reaction (incidence ≥1%) is dyspepsia.

Contraindication:

Known hypersensitivity to any of the tetracyclines.

Warnings and Precautions:
  • Serious Skin/Hypersensitivity Reactions: Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Discontinue EMROSI immediately if symptoms occur.
  • Tooth Discoloration and Enamel Hypoplasia: The use of EMROSI during tooth development (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).
  • Inhibition of Bone Growth: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
  • Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis): Discontinue if Clostridioides difficile-associated diarrhea (antibiotic-associated colitis) occurs.
  • Hepatotoxicity: Discontinue EMROSI if liver injury is suspected.
  • Central Nervous System Effects: May cause central nervous system side effects including light-headedness, dizziness, or vertigo.
  • Idiopathic Intracranial Hypertension: May cause idiopathic intracranial hypertension in adults and adolescents. Discontinue EMROSI if symptoms occur.
  • Autoimmune Syndromes: Minocycline has been associated with autoimmune syndromes; discontinue EMROSI immediately if symptoms occur.
  • Metabolic Effects: If renal impairment exists, monitor serum levels of EMROSI during treatment, discontinue EMROSI if necessary.
See package insert for full prescribing information.