Click here to see Important Safety Information for SOLODYN Tablets.

References

  1. Wolters Kluwer, National TRx Data, January – December 2012, Data on file, Medicis, a division of Valeant Pharmaceutical
  2. SOLODYN Tablets Package Insert. Scottsdale, AZ: Medicis, The Dermatology Company; February 2012.
  3. AcneNet: A comprehensive online acne information resource. http://www.skincarephysicians.com/acnenet/index.html.
  4. Thiboutot E, Gollnick H, et al. New Insights into the Management of Acne: An Update from the Global Alliance to Improve Outcomes in Acne Group. J Am Acad Dermatol. 2009;60:S1-50.
  5. NDA 50-808 for SOLODYN Tablets; MP-0104-01; Table 14.2.1.1. 2004. Data on file, Medicis Pharmaceutical Corporation.
  6. NDA 50-808 for SOLODYN Tablets; MP-0104-01 and MP-0104-05; Table 2.7.3.3.4. 2004. Data on file, Medicis Pharmaceutical Corporation.
  7. Fleischer Jr A, Dinehart S, et al. Safety and Efficacy of a New Extended Release Formulation of Minocycline. Cutaneous Medicine for the Practitioner. 2006; 78: 21-31.
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Indication and Usage

SOLODYN is an oral antibiotic approved to treat only the red, pus-filled pimples of moderate to severe acne in patients 12 years of age and older. SOLODYN won't improve infected acne cysts (nodules) under the skin. In clinical studies, SOLODYN did not work on blackheads or whiteheads. The safety of using SOLODYN longer than 12 weeks has not been studied and is not known. It is not known whether this kind of minocycline will be effective in treating infections. You should use SOLODYN only as directed by your doctor to reduce the chance that bacteria will become resistant to this antibacterial drug and similar drugs.

Important Safety Information for SOLODYN Tablets
  • The most common side effects were headache, tiredness, dizziness, and itching.
  • SOLODYN contains minocycline. Like other antibiotics based on tetracycline, minocycline can harm an unborn child when taken by a pregnant woman.
  • Tetracycline drugs should not be used when a child's teeth are forming (during the last half of pregnancy and up to 8 years of age) because they may cause permanent darkening of teeth.
  • Severe irritation and bleeding in the colon (pseudomembranous colitis) have been reported with nearly all antibiotics and may range from mild to life-threatening. Talk to your doctor if you have severe diarrhea.
  • Light-headedness, dizziness, and a spinning feeling have been reported by patients taking minocycline.
  • In rare cases, patients can develop an increased sensitivity to sunlight (photosensitivity).
  • Don't use SOLODYN if you are pregnant. Men and women who are trying to conceive a child should not take SOLODYN. SOLODYN may make an oral contraceptive less effective.
  • This drug should not be used by anyone who has had allergic reactions to any of the tetracycline drugs.
  • The safety of using SOLODYN for longer than 12 weeks has not been studied and is not known.
  • SOLODYN may cause a serious rash and allergic reactions that may affect parts of your body. Discontinue SOLODYN immediately if symptoms occur.