MINOCYCLINE HYDROCHLORIDE_- minocycline hydrochloride_tablet, film coated, extended release

The mechanism of action of minocycline hydrochloride extended-release tablets for the treatment of acne is unknown. The pharmacodynamics of minocycline hydrochloride extended-release tablets for the treatment of acne are unknown. Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, minocycline hydrochloride extended-release tablets produce a delayed T max max (0en dash24) max Susceptibility Testing.

Minocycline hydrochloride 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) Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 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 [see CLINICAL STUDIES (14) WARNINGS AND PRECAUTIONS (5.

The recommended dosage of minocycline hydrochloride extended-release tablets 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. Table 1: Dosing Table for Minocycline Hydrochloride Extended-Release Tablets Patient’s Patient’s Tablet Actual mg/kg 99 to 109 45 to 49 45 1 to 0. 92 110 to 131 50 to 59 55 1. 93 132 to 157 60 to 71 65 1. 92 158 to 186 72 to 84 80 1. 95 187 to 212 85 to 96 90 1. 94 213 to 243 97 to 110 105 1. 95 244 to 276 111 to 125 115 1. 92 277 to 300 126 to 136 135 1. 99 Minocycline hydrochloride extended-release tablets may be taken with or without food [see CLINICAL PHARMACOLOGY (12. 3) WARNINGS AND PRECAUTIONS (5. 4) The recommended dosage of minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks.

The most commonly observed adverse reactions (incidence >=5%) are headache, fatigue, dizziness, and pruritus. 1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www. gov/medwatch. 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. Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects Adverse Reactions Minocycline Hydrochloride Placebo 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) Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include: WARNINGS AND PRECAUTIONS (5. 9) NONCLINICAL TOXICOLOGY (13.

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

Minocycline like other tetracycline-class drugs can cause fetal harm when administered to a pregnant woman. 1) The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of teeth. 4) Teratogenic Effects: Pregnancy Category D WARNINGS AND PRECAUTIONS (5. 1) Tetracycline-class antibiotics are excreted in human milk. Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother [see WARNINGS AND PRECAUTIONS (5. Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established. WARNINGS AND PRECAUTIONS (5. 1) Clinical studies of minocycline hydrochloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 1) The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. 3) To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline. 5) Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations. In a multi-center study to evaluate the effect of minocycline hydrochloride extended-release tablets on low dose oral contraceptives, hormone levels over one menstrual cycle with and without minocycline hydrochloride extended-release tablets 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, cannot be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline. False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

OVERDOSAGE
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.
NONCLINICAL TOXICOLOGY
Mutagenesis in vitro in vitro in vivo
CLINICAL STUDIES
The safety and efficacy of minocycline hydrochloride extended-release tablets in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris was assessed in two 12-week, multi-center, randomized, double-blind, placebo-controlled, trials in subjects >=12 years. The mean age of subjects was 20 years and subjects were from the following racial groups: White (73%), Hispanic (13%), Black (11%), Asian/Pacific Islander (2%), and Other (2%). Table 3: Clinical Studies Dosing Table Subject’s Subject’s Weight (kg) Available Tablet Actual mg/kg Dose 99 to 131 45 to 59 45 1 to 0.76 132 to 199 60 to 90 90 1.5 to 1 200 to 300 91 to 136 135 1.48 to 0.99 The two primary efficacy endpoints were: Table 4: Efficacy Results at Week 12 *Evaluator’s Global Severity Assessment Trial 1 Trial 2 Minocycline Hydrochloride Extended-Release Tablets (1 mg/kg) N = 300 Placebo N = 151 Minocycline Hydrochloride Extended-Release Tablets (1 mg/kg) N = 315 Placebo N = 158 Mean Percent Improvement in 43.1% 31.7% 45.8% 30.8% No. (%) of Subjects Clear or 52 12 50 15 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).
PATIENT INFORMATION
Minocycline Hydrochloride (min'''' oh sye'' kleen hye'''' droe klor'' ide) Extended-Release Tablets, USP Read this Patient Information leaflet that comes with minocycline hydrochloride extended-release tablets before you start taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment. What are minocycline hydrochloride extended-release tablets? Minocycline hydrochloride is a tetracycline-class drug. Minocycline hydrochloride extended-release tablets are prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years and older. Minocycline hydrochloride extended-release tablets are not effective for acne that is not red-looking (this means acne that is not inflammatory). It is not known if minocycline hydrochloride extended-release tablets are: safe for use longer than 12 weeks. safe and effective for the treatment of infections. safe and effective in children under the age of 12 years. Who should not take minocycline hydrochloride extended-release tablets? Do not take minocycline hydrochloride extended-release tablets if you are allergic to tetracycline-class drugs. Ask your doctor or pharmacist for a list of these medicines if you are not sure. What should I tell my doctor before taking minocycline hydrochloride extended-release tablets? Before you take minocycline hydrochloride extended-release tablets, tell your doctor if you: have kidney problems. Your doctor may prescribe a lower dose of medicine for you. have liver problems. have diarrhea or watery stools. have vision problems. plan to have surgery with general anesthesia. have any other medical conditions. are a male, and you and your female partner are trying to conceive a baby. You should not take minocycline hydrochloride extended-release tablets. are pregnant or plan to become pregnant. Minocycline hydrochloride extended-release tablets may harm your unborn baby. Taking minocycline hydrochloride extended-release tablets while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking minocycline hydrochloride extended-release tablets if you plan to become pregnant, or are breastfeeding or plan to breastfeed. Minocycline hydrochloride passes into your milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride extended-release tablets or breastfeed. You should not do both. Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take: birth control pills. a blood thinner medicine. a penicillin antibiotic medicine. antacids that contain aluminum, calcium, or magnesium or iron-containing products. an acne medicine that contains isotretinoin Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist. How should I take minocycline hydrochloride extended-release tablets? Take minocycline hydrochloride extended-release tablets exactly as your doctor tells you. Skipping doses or not taking all doses of minocycline hydrochloride extended-release tablets may: make the treatment not work as well. increase the chance that the bacteria will become resistant to minocycline hydrochloride extended-release tablets. Minocycline hydrochloride extended-release tablets can be taken with or without food. Swallow minocycline hydrochloride extended-release tablets whole. Do not chew, crush, or split the tablets. If you take too much minocycline hydrochloride extended-release tablets, call your doctor or poison control center right away. What should I avoid while taking minocycline hydrochloride extended-release tablets? Avoid sunlight, sunlamps, and tanning beds. Minocycline hydrochloride extended-release tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn. Protect your skin while out in sunlight. You should not drive or operate dangerous machinery until you know how minocycline hydrochloride extended-release tablets affect you. Minocycline hydrochloride extended-release tablets may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo). What are possible side effects of minocycline hydrochloride extended-release tablets? Minocycline hydrochloride extended-release tablets may cause serious side effects, including: Harm to an unborn baby. “What should I tell my doctor before taking minocycline hydrochloride extended-release tablets?” Permanent teeth discoloration. “What should I tell my doctor before taking minocycline hydrochloride extended-release tablets?” Intestine infection Serious liver problems. loss of appetite tiredness diarrhea yellowing of your skin or the whites of your eyes unexplained bleeding confusion sleepiness Central nervous system effects. “What should I avoid while taking minocycline hydrochloride extended-release tablets?” Benign intracranial hypertension, also called pseudotumor cerebri. Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis). Serious rash and allergic reactions. Stop taking minocycline hydrochloride extended-release tablets and get medical help right away if you have any of these symptoms: skin rash, hives, sores in your mouth, or your skin blisters and peels swelling of your face, eyes, lips, tongue, or throat trouble swallowing or breathing blood in your urine fever, yellowing of the skin or the whites of your eyes, dark colored urine pain on the right side of the stomach area (abdominal pain) chest pain or abnormal heartbeats swelling in your legs, ankles, and feet darkening of your nails, skin, eyes, scars, teeth, and gums The most common side effects of minocycline hydrochloride extended-release tablets include: headache tiredness dizziness or spinning feeling itching Call your doctor if you have a side effect that bothers you or that does not go away. Your doctor may do tests to check you for side effects during treatment with minocycline hydrochloride extended-release tablets . These are not all the side effects with minocycline hydrochloride extended-release tablets. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Aurobindo Pharma USA, Inc. at 1-866-850-2876. How should I store minocycline hydrochloride extended-release tablets? Store minocycline hydrochloride extended-release tablets between 20° to 25°C (68° to 77°F). Keep minocycline hydrochloride extended-release tablets in the container that they come in and keep the container tightly closed. Keep minocycline hydrochloride extended-release tablets dry. Keep minocycline hydrochloride extended-release tablets and all medicines out of the reach of children. General information about minocycline hydrochloride extended-release tablets Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use minocycline hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give minocycline hydrochloride extended-release tablets to other people, even if they have the same symptoms you have. They may harm them. This Patient Information leaflet summarizes the most important information about minocycline hydrochloride extended-release tablets. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride extended-release tablets that is written for health professionals. For more information, call 1-866-850-2876. What are the ingredients in minocycline hydrochloride extended-release tablets? Active Ingredient: Inactive Ingredients: This Patient Information has been approved by the U.S. Food and Drug Administration. All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. Distributed by: Aurobindo Pharma USA, Inc. Aurobindo Pharma Limited

Aurobindo Pharma Limited

• Founded in:

  2001-11-23 00:00:00

• Address:

  Ares Block, South Ruislip, Odyssey Business Park, HA4 6QD

MINOCYCLINE HYDROCHLORIDE_- minocycline hydrochloride_tablet, film coated, extended release Product manual source documgent