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Sotret

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Sotret

Indications
Dosage
How Supplied

INDICATIONS

Severe Recalcitrant Nodular Acne

Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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 (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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 isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin 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 PATIENT INFORMATION).

The recommended dosage range for Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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/day8, 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 (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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 (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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 (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) , even in low doses, has not been studied, and is not recommended. It is important that Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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 (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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 88 20 40 80
50 110 25 50 100
60 132 30 60 120
70 154 35 70 140
80 176 40 80 160
90 198 45 90 180
100 220 50 100 200
*See DOSAGE AND ADMINISTRATION: the recommended dosage range is 0.5 to 1.0 mg/kg/ day.

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 (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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 (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) is dispensed, as required by law. This Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 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.

REFERENCES

1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 13-cis-retinoic acid. N Engl J Med 300:329-333, 1979.

2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991.

3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980.

4. Jones H, Blanc D, Cunliffe WJ. 13-cis-retinoic acid and acne. Lancet 2:1048-1049, 1980.

8. Strauss JS, Rapini RP, Shalita AR, et al. Isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.

Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA. Manufactured by: Ranbaxy Laboratories Limited New Delhi -110 019, India. Distributed by: Ranbaxy Laboratories Inc.

Last reviewed on RxList: 9/27/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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