Minocyclinedrug info
24 HR minocycline 45 MG Extended Release Oral Tablet
What it is used for
1 INDICATIONS & USAGE Minocycline hydrochloride extended-release tablets 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 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. 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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 3, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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 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
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 3, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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