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Sotret (Isotretinoin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Severe Recalcitrant Nodular Acne

Sotret 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, Sotret should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Sotret is indicated only for those female patients who are not pregnant, because Sotret 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 isotretinoin capsules. 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

Sotret should be administered with a meal (see PRECAUTIONS: Information for Patients).

The recommended dosage range for Sotret is 0.5 to 1.0 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 2.0 mg/kg/day, as tolerated. Failure to take Sotret 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 Sotret 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 Sotret, even in low doses, has not been studied, and is not recommended. It is important that Sotret be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Sotret 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 3 Sotret Dosing by Body Weight (Based on Administration With Food)

Body Weight Total mg/day

*See DOSAGE AND ADMINISTRATION: the recommended dosage range is 0.5 to 1.0 mg/kg/day.

kilograms pounds 0.5 mg/kg 1 mg/kg 2 mg/kg*
4088204080
501102550100
601323060120
701543570140
801764080160
901984590180
10022050100200

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. Sotret 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.

A Sotret Medication Guide must be given to the patient each time Sotret is dispensed, as required by law. This Sotret Medication Guide is an important part of the risk management program for the patient.

HOW SUPPLIED

Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.

Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)

Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)

Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.

Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)

Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)

Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.

Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)

Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)

Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.

Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)

Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)

Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.

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