Minocycline HCL 105 mg ER tab#30

1 INDICATIONS & USAGE

1.1 Indication

Minocycline hydrochloride extended-release tablets is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

1.2 Limitations of Use

Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline hydrochloride extended-release tablets 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 (14)].
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Minocycline hydrochloride extended-release tablets should be used only as indicated [see Warnings and Precautions (5.11)].

11 DESCRIPTION

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα, 12aα)] - 4,7 – Bis (dimethylamino) -1,4,4a,5,5a,6,11,12a - octahydro-3,10,12,12a -tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride.
The structural formula is represented below:

C23H27N3O7•HCl M. W. 493.95

Minocycline hydrochloride extended-release tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin.

The 45 mg tablets also contain iron oxide black.

The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake,

polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake.

The 55 mg tablets also contain macrogol, FD&C RED #40.

The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow

#6.

The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350.

The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1.

The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake.

The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red.

The USP Dissolution Test is pending

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied
Minocycline hydrochloride extended-release tablets, USP are supplied as aqueous film coated tablets containing Minocycline hydrochloride equivalent to 105 mg minocycline, are supplied as follows.

The 105 mg extended release tablets are Purple colored capsule shaped film coated tablets, debossed with "105'' on one side, plain on other side.Each tablet contains Minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows:

16.2 Storage

Store at 20˚ to 25˚C (68˚ to 77˚ F) [See USP Controlled Room Temperature].

16.3 Handling

Keep out of reach of children.
Protect from light, moisture, and excessive heat.
Dispense in tight, light-resistant container with child-resistant closure.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504