Minocycline Hydrochloride

1 INDICATIONS AND USAGE Minocycline hydrochloride extended-release tablets USP are 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 hydrochloride extended-release tablets USP are 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 USP did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets USP have 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 USP should be used only as indicated [see WARNINGS AND PRECAUTIONS ( 5.11 )]

2 DOSAGE AND ADMINISTRATION The recommended dosage of minocycline hydrochloride extended-release tablets USP are approximately 1 mg/kg once daily for 12 weeks. ( 2 ) The recommended dosage of minocycline hydrochloride extended-release tablet USP are 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 Hydrochloride Extended-release Tablets USP Patient's Weight ( lbs .) Patient's Weight ( kg ) Tablet Strength ( mg ) Actual mg / kg Dose 99 - 109 45 - 49 45 1 - 0.92 110 - 131 50 - 59 55 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 hydrochloride extended-release tablets USP may be taken with or without food [see CLINICAL PHARMACOLOGY (12.3) ]. Ingestion of food along with minocycline hydrochloride extended-release tablets USP 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) ] .

4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 ) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Not available.

6 ADVERSE REACTIONS The most commonly observed adverse reactions (incidence ≥ 5%) are headache, fatigue, dizziness, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended-release tablets. Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects Adverse Reactions Minocycline hydrochloride extended - release tablets ( 1 mg / kg ) N = 674 (%) Placebo N = 364 (%) At least one treatment-emergent event 379 (56) 197 (54) Headache 152 (23) 83 (23) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Mood alteration 17 (3) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) Arthralgia 9 (1) 2 (0) Vertigo 8 (1) 3 (1) Dry mouth 7 (1) 5 (1) Myalgia 7 (1) 4 (1) 6.2 Postmarketing Experience Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include: Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis, DRESS syndrome [see WARNINGS AND PRECAUTIONS ( 5.9 ) ]. Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome. Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing. Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function. Oncology: thyroid cancer. Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure. Renal: reversible acute renal failure. Hematology: hemolytic anemia, thrombocytopenia, eosinophilia. Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis [see NONCLINICAL TOXICOLOGY ( 13.1 ) ].