Minonil ER

Dosage in Special Population

The recommended dosage of Minocycline ER 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 Pregnancy: Teratogenic Effects: Pregnancy Category D; Minocycline ER should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman Nursing Mothers: 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 Pediatric Use: Minocycline ER is 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. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration Geriatric Use: Clinical studies of Minocycline ER 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

Indications

Minonil ER is indicated for the treatment of Acne Vulgaris

Adverse Effects

Adverse effects with Minonil ER may include Headache, Fatigue, Dizziness , Pruritus, Malaise, Mood alteration , Somnolence , Urticaria , Tinnitus , Arthalgia , Vertigo , Dry mouth, Myalgia.

Drug Interactions

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 Penicillin: Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin Methoxyflurane: The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity Antacids and Iron Preparations: Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations Low Dose Oral Contraceptives: To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline

Mechanism of Action

Minocycline passes directly through the lipid bilayer or passively diffuses through porin channels in the bacterial membrane Tetracyclines like minocycline bind to the 30S ribosomal subunit, preventing the binding of tRNA to the mRNA-ribosome complex and interfering with protein synthesis

Pharmacokinetics

Based on pharmacokinetic studies in healthy adults, Minocycline ER tablets produce a delayed Tmax at 3.5-4.0 hours as compared to a non-modified release reference minocycline product (Tmax at 2.25-3 hours). When Minocycline ER tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions. Minocycline is lipid soluble and distributes into the skin and sebum Half life of Minoxidil in Minonil ER is 4 hours

Drug Use in Pregnancy

Pregnancy: Teratogenic Effects: Pregnancy Category D; Minocycline ER should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman Nursing Mothers: 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

Drug Use in Pediatric Population

Pediatric Use: Minocycline ER is 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. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration