Indication and Usage and Important Safety Information
SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN 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, SOLODYN should be used only as indicated.
Important Safety Information for SOLODYN Tablets
- 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. Should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.
- TETRACYCLINE DRUGS SHOULD NOT BE USED DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY AND UP TO 8 YEARS OF AGE) AS THEY MAY CAUSE PERMANENT DISCOLORATION OF TEETH.
- Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening; therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents
- Dose adjustments may be necessary in patients with renal impairment to avoid liver toxicity
- Central nervous system side effects, including light-headedness, dizziness, and vertigo, have been reported with minocycline therapy
- Pseudotumor cerebri (benign intracranial hypertension) and autoimmune syndromes have been associated with the use of tetracyclines
- Cases of anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms have been reported postmarketing with minocycline use. Discontinue SOLODYN immediately if symptoms occur. In rare cases, photosensitivity has been reported.
- The most commonly observed adverse reactions are headache, fatigue, dizziness, and pruritus
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Reference: 1. SOLODYN Tablets Package Insert. Valeant Pharmaceuticals North America LLC.
SOLODYN is a trademark of Ortho Dermatologics’ affiliated entities. ® All Rights Reserved. SDN.0056.USA.17