Solodyn (Minocycline Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Indication

SOLODYN 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 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 [see Clinical Studies].

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 [see Warnings and Precautions].

DOSAGE AND ADMINISTRATION

The recommended dosage of SOLODYN 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

Patient's Weight (lbs.)	Patient's Weight (kg)	Tablet Strength (mg)	Actual mg/kg Dose
99 – 109	45 – 49	45	1 – 0.92
110 – 131	50 – 59	55	1.10 – 0.93
132 – 157	60 – 71	65	1.08 – 0.92
158 – 186	72 – 84	80	1.11 – 0.95
187 – 212	85 – 96	90	1.06 – 0.94
213 – 243	97 – 110	105	1.08 – 0.95
244 – 276	111 – 125	115	1.04 – 0.92
277 – 300	126 – 136	135	1.07 – 0.99

SOLODYN Tablets may be taken with or without food [see Clinical Pharmacology]. Ingestion of food along with SOLODYN may help reduce the risk of esophageal irritation and ulceration.

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

DOSAGE FORMS AND STRENGTHS

• •45 mg extended release tablets: gray, unscored, coated, and debossed with "DYN-045" on one side. [No longer distributed or sold by Medicis.]
• •55 mg extended release tablets: pink, unscored, coated, and debossed with "DYN-055" on one side.
• •65 mg extended release tablets: blue, unscored, coated, and debossed with "DYN-065" on one side.
• •80 mg extended release tablets: dark gray, unscored, coated, and debossed with "DYN-080" on one side.
• •90 mg extended release tablets: yellow, unscored, coated, and debossed with "DYN-090" on one side.
• •105 mg extended release tablets: purple, unscored, coated, and debossed with "DYN-105" 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.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

SOLODYN (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg minocycline, are supplied as follows.

The 55 mg extended release tablets are pink, unscored, coated, and debossed with "DYN-055" on one side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows:

NDC 99207-465-30

Bottle of 30

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:

NDC 99207-463-30

Bottle of 30

The 80 mg extended release tablets are dark gray, unscored, coated, and debossed with "DYN-080" on one side. Each tablet contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows:

NDC 99207-466-30

Bottle of 30

The 105 mg extended release tablets are purple, unscored, coated, and debossed with "DYN-105" on one side. Each tablet contains minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows:

NDC 99207-467-30

Bottle of 30

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:

NDC 99207-464-30

Bottle of 30

Storage

Store at 25°C (77°F); excursions are permitted to 15°–30°C (59°–86°F) [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.