Product Description.:
R189
tablet , film-coated , yellow , oval oblong
Debossed
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.
SOLODYN? Tablets for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 65 mg, 90 mg, 115 mg or 135 mg of minocycline. In addition, 45 mg, 65 mg, 90 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 45 mg tablets also contain Opadry II Gray which contains: lactose monohydrate NF, hypromellose type 2910 USP, titanium dioxide USP, triacetin USP, and iron oxide black JPE. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 90 mg tablets also contain Opadry II Yellow which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, iron oxide yellow NF, polyethylene glycol 3350 NF, and triacetin USP. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2. The 135 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, polyethylene glycol 3350 NF, iron oxide red NF, and triacetin USP.
INDICATIONS
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.
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
SIDE EFFECTS
Clinical Trial Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice.