Drug Catalog - Product Detail
Minocycline Hydrochloride Extended Release 65mg Tablet 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00115-9935-08 | AMNEAL PHARMACEUTICALS | 30 | 65MG | TABLET |
PACKAGE FILES
Generic Name
MINOCYCLINE HYDROCHLORIDE
Substance Name
MINOCYCLINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA050808
Description
11 DESCRIPTION Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4 S -(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 monohydrochloride. The structural formula is represented below: Minocycline HCl Tablets for oral administration contain minocycline hydrochloride USP equivalent to 65 mg or 115 mg of minocycline. In addition, 65 mg and 115 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 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 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. chem.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Minocycline HCl, USP Extended Release Tablets are supplied as aqueous film-coated tablets containing minocycline hydrochloride equivalent to 65 mg or 115 mg minocycline, 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: NDC 0115-9935-08 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 0115-9936-08 Bottle of 30 Storage Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 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.
Indications & Usage
1 INDICATIONS AND USAGE Minocycline HCl is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) 1.1 Indication Minocycline HCl 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 HCl did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline HCl 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 HCl should be used only as indicated [see Warnings and Precautions (5.11) ] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of Minocycline HCl 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 Minocycline HCl Patient's Weight (lbs) Patient's Weight (kg) Tablet Strength (mg) Actual Dose (mg/kg) 99 – 109 45 – 49 45 No longer distributed or sold. 1 – 0.92 110 – 131 50 – 59 55 Not distributed by Amneal. 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 Minocycline HCl Tablets may be taken with or without food [see Clinical Pharmacology (12.3) ] . Ingestion of food along with Minocycline HCl 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 (5.4) ] . The recommended dosage of Minocycline HCl is approximately 1 mg/kg once daily for 12 weeks. ( 2 )