Drug Catalog - Product Detail
MINOCYCLINE HCL ER 55mg TAB 30's
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0467-30 | OCEANSIDE PHARMACEUTICALS | 30 | 55MG | TABLET |
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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: C23H27N3O7•HCl M. W. 493.95 Minocycline HCl Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 80 mg, or 105 mg of minocycline. In addition, 55 mg, 80 mg, and 105 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 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Minocycline HCl, USP Extended Release Tablets are supplied as aqueous film-coated tablets containing minocycline hydrochloride equivalent to 55 mg, 80 mg, or 105 mg minocycline, 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 68682-467-30 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 68682-466-30 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 68682-468-30 Bottle of 30 16.2 Storage Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°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.
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 1.10 – 0.93 132 – 157 60 – 71 65 Not distributed by Oceanside Pharmaceuticals. 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 )