DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Amnesteem (Isotretinoin) - Indications and Dosage

 
 



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).  

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.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015