Drug Catalog - Product Detail
AMNESTEEM-ISOTRETINOIN CAP 40 MG 30 EA UOU
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
00378-6614-93 | MYLAN | 30 | 40MG | CAPSULE |
PACKAGE FILES
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![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0018861f-1b9b-431b-84ee-9d34aab615c3&name=f6d66b0a-7f01-4905-875d-706e2d3a6363-05.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0018861f-1b9b-431b-84ee-9d34aab615c3&name=f6d66b0a-7f01-4905-875d-706e2d3a6363-05.jpg)
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Description
DESCRIPTION Isotretinoin, USP a retinoid, is available as Amnesteem (isotretinoin capsules, USP) in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil and soybean oil. Gelatin capsules contain glycerin, with the following dye systems: 10 mg – red iron oxide paste and black ink; 20 mg – red iron oxide paste, yellow iron oxide paste, titanium dioxide and black ink; 40 mg – red iron oxide paste, yellow iron oxide paste, titanium dioxide and black ink. USP Dissolution Test Pending. Chemically, isotretinoin is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is: Isotretinoin Structure Formula
How Supplied
HOW SUPPLIED Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP. The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows: NDC 54868-5039-0 Cartons of 30 containing 3 Prescription Packs of 10 capsules The 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows: NDC 54868-5041-0 Cartons of 30 containing 3 Prescription Packs of 10 capsules The 40 mg capsules are orange-brown and imprinted with I40. They are available as follows: NDC 54868-5043-0 Cartons of 30 containing 3 Prescription Packs of 10 capsules Storage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.] Protect from light.
Indications & Usage
INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Amnesteem is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Amnesteem should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics . In addition, Amnesteem is indicated only for those female patients who are not pregnant, because Amnesteem can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Amnesteem. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density , Hyperostosis , and Premature Epiphyseal Closure ).
Dosage and Administration
DOSAGE AND ADMINISTRATION Amnesteem should be administered with a meal (see PRECAUTIONS: Information for Patients ). The recommended dosage range for Amnesteem is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5 and 1 mg/kg/day, 8 it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated. Failure to take Amnesteem with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions. The safety of once daily dosing with Amnesteem has not been established. Once daily dosing is not recommended. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Amnesteem, even in low doses, has not been studied, and is not recommended. It is important that Amnesteem be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Amnesteem on bone loss is unknown (see WARNINGS: Skeletal: Bone Mineral Density , Hyperostosis , and Premature Epiphyseal Closure ). Contraceptive measures must be followed for any subsequent course of therapy (see PRECAUTIONS ). Table 4. Amnesteem Dosing by Body Weight (Based on Administration with Food) Body Weight Total mg/day kilograms pounds 0.5 mg/kg 1 mg/kg 2 mg/kg 40 50 60 70 80 90 100 88 110 132 154 176 198 220 20 25 30 35 40 45 50 40 50 60 70 80 90 100 80 100 120 140 160 180 200 INFORMATION FOR PHARMACISTS Access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to obtain an authorization and the “do not dispense to patient after” date. Amnesteem must only be dispensed in no more than a 30 day supply. REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM. An Amnesteem Medication Guide must be given to the patient each time Amnesteem is dispensed, as required by law. This Amnesteem Medication Guide is an important part of the risk management program for the patient.