Important Safety Information
Indications and Usage
XIMINO is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, XIMINO should be used only as indicated.
Limitations of Use
XIMINO did not demonstrate any effect on non-inflammatory acne lesions. Safety of XIMINO has not been
established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections.
Important Safety Information
Contraindications
XIMINO is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Warning and Precautions
Teratogenic: Minocycline, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during
pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. XIMINO should not be used during pregnancy
or by individuals of either gender who are attempting to conceive a child.
The use of XIMINO during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
Pseudomembranous Colitis: Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may
range in severity from mild diarrhea to fatal colitis. If pseudomembranous colitis occurs, discontinue XIMINO.
Hepatotoxicity: Postmarketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have
been reported with minocycline use in the treatment of acne. If liver injury is suspected, discontinue XIMINO.
Metabolic Effects: The anti-anabolic action of the tetracyclines may cause an increase in BUN. If renal impairment exists, XIMINO doses may need to be adjusted
to avoid excessive systemic accumulations of the drug and possible liver toxicity.
Central Nervous System Effects: Minocycline may cause central nervous system side effects including light-headedness, dizziness, or vertigo. Patients who experience
these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear
when the drug is discontinued.
Benign Intracranial Hypertension: Minocycline may cause pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents. Discontinue XIMINO
if symptoms occur.
Autoimmune Syndromes: Minocycline has been associated with autoimmune syndromes; discontinue XIMINO immediately if symptoms occur.
Serious Skin/Hypersensitivity Reaction: Minocycline has been associated with anaphylaxis, serious skin reactions,(e.g, Stevens Johnson syndrome) erythema
multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Discontinue XIMINO immediately if symptoms occur.
Superinfection: XIMINO may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, XIMINO should be discontinued and
appropriate therapy instituted.
Adverse Reactions
The most commonly observed adverse reactions (incidence ≤ 5%) are headache, fatigue, dizziness, and pruritus
Use in Specific Populations
Pregnancy: Minocycline like other tetracycline-class drugs can cause fetal harm when administered to a pregnant woman.
Pediatric Use: Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration.
Please see Full Prescribing information and Medication Guide.
