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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.1

The targeted dose for SOLODYN Tablets is 1 mg/kg/day for patients 12 years and older with non-nodular, moderate to severe inflammatory acne. Extended-release SOLODYN Tablets are commercially available in 55 mg, 65 mg, 80 mg, 105 mg, and 
115 mg strengths.1


In combined phase 2 and phase 3 clinical trials of the 45 mg, 90 mg, and 135 mg dosage strengths with 1,038 patients, SOLODYN demonstrated efficacy at a low dose (1 mg/kg/day). There was no evidence of improved efficacy with 2 mg/kg/day and 3 mg/kg/day.2

Higher doses of SOLODYN have not been shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular adverse events.1,3 Clinical studies also showed that SOLODYN Tablets have a favorable tolerability profile.1
  • In a phase 2 dose-response study of 233 subjects, 1 mg/kg/day extended-release SOLODYN Tablets provided statistically significant inflammatory lesion reduction vs. placebo (n=114, 56.8% vs. 39.4%, P=0.015)2
  • In two phase 3 clinical studies with the 45 mg, 90 mg, and 135 mg dosage strengths, the mean percent improvement in inflammatory lesions was greater in patients treated with SOLODYN Tablets than with placebo (Study 1, n=451, 43.1% vs. 31.7%, P=0.001; Study 2, n=473, 45.8% vs. 30.8%, P<0.001, respectively)2
  • There was no evidence of improved efficacy with 2 mg/kg/day and 3 mg/kg/day2

In a dose-ranging study, inflammatory lesion counts fell with a low dose of 1 mg/kg of SOLODYN4




In a phase 2 dose-ranging study of 233 subjects with the 45 mg, 90 mg, and 135 mg dosage strengths, patients receiving extended-release SOLODYN Tablets 1 mg/kg/day experienced a statistically significant (P=0.015) reduction in inflammatory lesions (56.8%) compared with patients receiving placebo (39.4%). Patients entering the phase 2 study had 39 to 47 inflammatory facial lesions; those entering the phase 3 studies were enrolled with 25 to 75.1,2,4

In two phase 3 clinical trials, consistent, significant changes in inflammatory lesions with SOLODYN2




Two phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center studies randomized patients ≥12 years of age with moderate to severe acne to receive placebo or minocycline HCl caplets administered in a 1 mg/kg daily dosing regimen. Patients had 25 to 75 inflammatory lesions at baseline. Data reflect clinical studies of 45 mg, 90 mg, and 135 mg dosage strengths, which are no longer available.1,2 SOLODYN is indicated to treat only inflammatory lesions.1

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*This offer is only valid for patients with commercial insurance. Eligible uninsured patients will pay more. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid in Massachusetts or Minnesota or where otherwise prohibited, taxed or otherwise restricted. Click here for other terms and conditions that apply.

Indication and Usage

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

Please click here for full Prescribing Information.

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