Indication

SOLODYN® (minocycline hydrochloride) is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

Limitations of Use

SOLODYN® (minocycline hydrochloride) did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN® (minocycline hydrochloride) has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies].

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN® (minocycline hydrochloride) should be used only as indicated [see WARNINGS AND PRECAUTIONS].

The recommended dosage of SOLODYN® (minocycline hydrochloride) is approximately 1 mg/kg once daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects.

The following table shows tablet strength and body weight to achieve approximately 1 mg/kg.

Table 1: Dosing Table for SOLODYN® (minocycline hydrochloride)

SOLODYN (minocycline hydrochloride) ® Tablets may be taken with or without food [see CLINICAL PHARMACOLOGY]. Ingestion of food along with SOLODYN® (minocycline hydrochloride) may help reduce the risk of esophageal irritation and ulceration.

In patients with renal impairment [see WARNINGS AND PRECAUTIONS], the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses.

Dosage Forms And Strengths

• 45 mg extended release tablets: gray, unscored, coated, and debossed with “DYN-045" on one side.
• 65 mg extended release tablets: blue, unscored, coated, and debossed with “DYN-065" on one side.
• 90 mg extended release tablets: yellow, unscored, coated, and debossed with “DYN-090" on one side.
• 115 mg extended release tablets: green, unscored, coated, and debossed with “DYN-115" on one side.
• 135 mg extended release tablets: pink (orange-brown), unscored, coated, and debossed with “DYN-135" on one side.

SOLODYN® (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 45 mg, 65 mg, 90 mg, 115 mg or 135 mg minocycline, are supplied as follows.

The 45 mg extended release tablets are gray, unscored, coated, and debossed with “DYN-045” on one side. Each tablet contains minocycline hydrochloride equivalent to 45 mg minocycline, supplied as follows:

The 65 mg extended release tablets are blue, unscored, coated, and debossed with “DYN-065” on one side. Each tablet contains minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows:

The 90 mg extended release tablets are yellow, unscored, coated, and debossed with “DYN-090” on one side. Each tablet contains minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows:

The 115 mg extended release tablets are green, unscored, coated, and debossed with “DYN-115” on one side. Each tablet contains minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows:

The 135 mg extended release tablets are pink (orange-brown), unscored, coated, and debossed with “DYN-135” on one side. Each tablet contains minocycline hydrochloride equivalent to 135 mg minocycline, supplied as follows:

Storage

Store at 25ºC (77ºF); excursions are permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].

Handling

Keep out of reach of children.

Protect from light, moisture, and excessive heat.

Dispense in tight, light-resistant container with child-resistant closure.

Manufactured for: Medicis, The Dermatology Company, Scottsdale, AZ 85256. Manufactured by: WellSpring Pharmaceutical Canada Corp. Oakville, Ontario, CANADA L6H 1M5

Last reviewed on RxList: 1/27/2010
This monograph has been modified to include the generic and brand name in many instances.