Minocycline Hydrochloride Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Minocycline Hydrochloride is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication 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.
What should I know before taking it?
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS The use of Minocycline hydrochloride extended-release tablets during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). (5.1) If pseudomembranous colitis occurs, discontinue Minocycline hydrochloride extended-release tablets. (5.2) If liver injury is suspected, discontinue Minocycline hydrochloride extended-release tablets. (5.3) If renal impairment exists, Minocycline hydrochloride extended-release tablets doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. (5.4) Minocycline may cause central.
How is this medication usually taken?
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. 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 Patient's Weight (lbs.) Patient's Weight (kg) Tablet Strength (mg) Actual mg/kg Dose 99 to 109 45 to 49 45 1 to 0.92 110 to 131 50 to 59 55 1.10 to 0.93 132 to 157 60 to 71 65 1.08 to 0.92 158 to 186 72 to 84 80 1.11 to 0.95 187 to.
What side effects are listed?
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 Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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.
What interactions are listed?
7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. (7.1) The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. (7.3) To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline. (7.5) 7.1 Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 7.2 Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=084fb405-fcb9-4db9-8d95-5a9c1d89f3b6
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.