Solodyn Information
Solodyn () Indications And Usage
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 .
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 .
Solodyn () 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.
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.
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 .
Solodyn () Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Solodyn () Warnings And Precautions
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis".
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
Solodyn () Adverse Reactions
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial 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 () .
Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include:
Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis .
Solodyn () Use In Specific Populations
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 .
Solodyn () 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.
Solodyn () Description
Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4-(4α,4aα,5aα,12aα)]-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, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 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 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. 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 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2. 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.
Solodyn () Clinical Pharmacology
Solodyn () Tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, Solodyn () Tablets produce a delayed T at 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 C were 33.32 µg×hr/mL and 2.63 µg/mL for Solodyn () Tablets and 46.35 µg×hr/mL and 2.92 µg/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 Solodyn () Tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, Solodyn () Tablets 55 mg, 80 mg, and 105 mg were shown to be dose-proportional to Solodyn () Tablets 90 mg and 135 mg.
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.
Minocycline is lipid soluble and distributes into the skin and sebum.
Solodyn () Clinical Studies
The safety and efficacy of Solodyn () 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, studies 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%).
In two efficacy and safety trials, a total of 924 subjects with non-nodular moderate to severe acne vulgaris received Solodyn () or placebo for a total of 12 weeks, according to the following dose assignments.
The two primary efficacy endpoints were:
Solodyn () How Supplied/storage And Handling
Solodyn () (minocycline HCl, USP) Extended Release Tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg minocycline, are supplied as follows.
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:
The 55 mg extended release tablets are pink, unscored, coated, and debossed with "DYN-055" on one side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows:
The 65 mg extended release tablets are blue, unscored, coated, and debossed with "DYN-065" on one side. Each tablet contains minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows:
The 80 mg extended release tablets are dark gray, unscored, coated, and debossed with "DYN-080" on one side. Each tablet contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows:
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:
The 105 mg extended release tablets are purple, unscored, coated, and debossed with "DYN-105" on one side. Each tablet contains minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows:
The 115 mg extended release tablets are green, unscored, coated, and debossed with "DYN-115" on one side. Each tablet contains minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows:
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:
Keep out of reach of children.
Protect from light, moisture, and excessive heat.
Dispense in tight, light-resistant container with child-resistant closure.
Solodyn () Patient Counseling Information
Patients taking Solodyn () (minocycline HCl, USP) Extended Release Tablets should receive the following information and instructions:
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