Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/428
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SOLODYN (Tablet, Extended Release)
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SOLODYN���is a once-daily tablet to be prescribed based on the patient's weight to achieve approximately a 1 mg/kg dosage without any loading dose. The following table shows tablet strength and body weight to achieve approximately 1 mg/kg. SOLODYN���tablets may be taken with or without food . Ingestion of food along with SOLODYN���may help reduce the risk of esophageal irritation and ulceration. The recommended dosage of SOLODYN���per clinical trials is 1 mg/kg 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. 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.
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| dailymed-instance:descripti... |
Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4��,4a��,5a��,12a��)]-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: SOLODYN���tablets for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 90 mg or 135 mg of minocycline. In addition, 45 mg, 90 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 45 mg tablets also contain opadry II gray which contains: lactose monohydrate NF, hypromellose type 2910 USP, titanium dioxide USP, triacetin USP, and iron oxide black JPE. The 90 mg tablets also contain opadry II yellow which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, iron oxide yellow NF, polyethylene glycol 3350 NF, and triacetin USP. The 135 mg tablets also contain opadry II pink which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, polyethylene glycol 3350 NF, iron oxide red NF, and triacetin USP.
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Pharmacokinetics: SOLODYN���tablets are not bioequivalent to minocycline products. Based on pharmacokinetic studies in healthy adults, SOLODYN���tablets produce a delayed Tat 3.5���4.0 hours as compared to a non-modified release reference minocycline product (Tat 2.25���3 hours). At steady-state (Day 6), the mean AUC(0���24) and Cwere 33.32��g��hr/mL and 2.63��g/mL for SOLODYN���tablets and 46.35��g��hr/mL and 2.92��g/mL for Minocin capsules, respectively. These parameters are based on dose adjusted to 135 mg per day for both products. A single-dose, four-way crossover study demonstrated that all strengths of SOLODYN���tablets (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. When SOLODYN���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.<br/>Microbiology: Minocycline is bacteriostatic exerting its antimicrobial effect by the inhibition of bacterial protein synthesis. Minocycline is lipid soluble and distributes in to the skin and sebum. Minocycline has been shown to have in vitro activity against Propionibacterium acnes, an organism associated with acne vulgaris, however, the clinical significance of this activity against P. acnes in patients with acne vulgaris is not known.
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This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
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| dailymed-instance:supply |
SOLODYN���(MINOCYCLINE HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 45 mg, 90 mg or 135 mg minocycline. The 45 mg extended release tablets are gray, unscored, coated, and debossed with "DYN-045" on one side. Each tablet contains minocycline hydrochloride equivalent to 45 mg minocycline, supplied as follows: NDC 99207-460-30 Bottle of 30NDC 99207-460-90 Bottle of 90NDC 99207-460-10 Bottle of 100 The 90 mg extended release tablets are yellow, unscored, coated, and debossed with "DYN-090" on one side. Each tablet contains minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows: NDC 99207-461-30 Bottle of 30NDC 99207-461-90 Bottle of 90NDC 99207-461-10 Bottle of 100 The 135 mg extended release tablets are pink (orange-brown), unscored, coated, and debossed with "DYN-135" on one side. Each tablet contains minocycline hydrochloride equivalent to 135 mg minocycline, supplied as follows: NDC 99207-462-30 Bottle of 30NDC 99207-462-90 Bottle of 90NDC 99207-462-10 Bottle of 100 Store at 25��C (77��F); excursions are permitted to 15�����30��C (59�����86��F)[See USP Controlled Room Temperature]. Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.
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dailymed-ingredient:carnauba_wax,
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:hypromellose_type_2910,
dailymed-ingredient:iron_oxide_black_JPE,
dailymed-ingredient:lactose_monohydrate,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:opadry_II_gray,
dailymed-ingredient:titanium_dioxide,
dailymed-ingredient:triacetin
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| dailymed-instance:precautio... |
General: Safety of SOLODYN���beyond 12 weeks of use has not been established. As with other antibiotic preparations, use of SOLODYN���may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted. Bacterial resistance to the tetracyclines may develop in patients using SOLODYN���, therefore the susceptibility of bacteria associated with infection should be considered in selecting antimicrobial therapy. Because of the potential for drug-resistant bacteria to develop during the use of SOLODYN���, it should be used only as indicated.<br/>Autoimmune Syndromes: Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.<br/>Serious Skin/Hypersensitivity Reaction: Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with minocycline use in treatment of acne.<br/>Tissue Hyperpigmentation: Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.<br/>Information for Patients: (See Patient Package Insert that accompanies this Package Insert for additional information to give patients)<br/>Laboratory Tests: Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.<br/>Drug Interactions: 1. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 2. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. 3. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. 4. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations. 5. In a multi-center study to evaluate the effect of SOLODYN���on low dose oral contraceptives, hormone levels over one menstrual cycle with and without SOLODYN���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, can not be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline.<br/>Drug/Laboratory Test Interactions: False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.<br/>Carcinogenesis, Mutagenesis&Impairment of Fertility:<br/>Carcinogenesis: Long-term animal studies have not been performed to evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.<br/>Mutagenesis: Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.<br/>Impairment of Fertility: Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN���). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of SOLODYN���) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis. SOLODYN���should not be used by individuals of either gender who are attempting to conceive a child.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>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 .<br/>Pediatric Use: SOLODYN���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 .<br/>Geriatric Use: Clinical studies of SOLODYN���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.
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| dailymed-instance:overdosag... |
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.
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minocycline hydrochloride
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SOLODYN (Tablet, Extended Release)
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| dailymed-instance:adverseRe... |
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. However, adverse reaction information from clinical trials provides a basis for identifying the adverse events that appear to be related to drug use. Adverse events reported in clinical trials for SOLODYN���are described below in Table 2. Adverse reactions not observed in the clinical trials, but 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. 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: thyroid discoloration, abnormal thyroid function. Oncology: papillary 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 Carcinogenesis, Mutagenesis, Impairment of Fertility section).
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| dailymed-instance:indicatio... |
SOLODYN���is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN���did not demonstrate any effect on non-inflammatory lesions. Safety of SOLODYN���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, SOLODYN���should be used only as indicated.
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SOLODYN
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