Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 24 October 2017

Indication(s)

1 INDICATIONS AND USAGE SOLODYN 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) 1.1 Indication SOLODYN 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 SOLODYN did not demonstrate any effect on non-inflammatory acne 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 [see Clinical Studies (14)]. 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 [see Warnings and Precautions (5.11)].

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Advisory information

contraindications
4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. (4)
Adverse reactions
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 Valeant Pharmaceuticals North America LLC at 1-800-321-4576 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 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 SOLODYN. Table 2: Selected Treatment-Emergent Adverse Reactions in at Least 1% of Clinical Trial Subjects Adverse Reactions SOLODYN (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)].

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of SOLODYN 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 SOLODYN Patient's Weight (lbs) Patient's Weight (kg) Tablet Strength (mg) Actual Dose mg/kg 99 – 109 45 – 49 45No longer distributed or sold by Valeant. 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 SOLODYN Tablets may be taken with or without food [see Clinical Pharmacology (12.3)]. Ingestion of food along with SOLODYN 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)]. The recommended dosage of SOLODYN is approximately 1 mg/kg once daily for 12 weeks. (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS • Minocycline like other tetracycline-class drugs can cause fetal harm when administered to a pregnant woman. (5.1, 8.1) • The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of teeth. (5.1, 8.4) 8.1 Pregnancy Teratogenic Effects: Pregnancy Category D [see Warnings and Precautions (5.1)] SOLODYN 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. Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in postmarketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. Minocycline- induced skeletal malformations (i.e., bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of SOLODYN. Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day, which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN. Minocycline was assessed for effects on peri- and postnatal development of rats in a study that involved oral administration to pregnant rats from Day 6 of gestation through the period of lactation (postpartum Day 20) at dosages of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day, resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients as a result of use of SOLODYN. No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals). 8.3 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 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 (5.1)]. 8.4 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 [see Warnings and Precautions (5.1)]. 8.5 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.
Pregnancy and lactation
8.3 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 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 (5.1)].

Interactions

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 advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. 7.3 Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. 7.4 Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium and iron-containing preparations. 7.5 Low-Dose Oral Contraceptives In a multicenter 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, cannot be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline. 7.6 Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

More information

Category Value
Authorisation number NDA050808
Agency product number 0020414E5U
Orphan designation No
Product NDC 99207-463,99207-462,99207-461,99207-460,99207-467,99207-466,99207-465,99207-464
Date Last Revised 12-09-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 629699
Storage and handling 16.2 Storage Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Marketing authorisation holder Valeant Pharmaceuticals North America LLC