Isotretinoindosage

Evaluations Prior To Prescribing and Use of Isotretinoin Capsules In patients who can get pregnant, only prescribe isotretinoin capsules after verification and documentation that they are not pregnant. See the Full Prescribing Information for the detailed requirements prior to prescribing isotretinoin capsules Complete the following laboratory tests in all patients: fasting lipid profile and liver function tests. Isotretinoin capsules are not substitutable with ABSORICA LD because of different bioavailability and recommended dosage. Recommended dosage for isotretinoin capsules is 0.5 mg/kg/day to 1 mg/kg/day given in two divided doses without regard to meals for 15 weeks to 20 weeks Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of isotretinoin capsules in divided doses. Once daily dosing is not recommended. If a dose of isotretinoin capsules is missed, just skip that dose. Do not take two doses of isotretinoin capsules at the same time.

2.1 Evaluations

Prior To Prescribing and Use of Isotretinoin Capsules In patients who can get pregnant, only prescribe isotretinoin capsules after verification and documentation that they are not pregnant. For the detailed requirements prior to prescribing isotretinoin capsules, see Use in Specific Populations. Prior to isotretinoin capsules use in all patients, complete the following laboratory testing: A fasting lipid profile including triglycerides. Liver function tests.

2.2 Recommended

Dosage Isotretinoin capsules are not substitutable with ABSORICA LD. The recommended dosage of isotretinoin capsules is 0.5 mg/kg/day to 1 mg/kg/day given in two divided doses with or without meals for 15 weeks to 20 weeks (see Table 1). To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid. Swallow capsules whole. Do not split, crush, chew, or suck on the capsules. During treatment, the dosage may be adjusted according to response of the disease and/or adverse reactions, 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 dosage adjustments up to 2 mg/kg/day for isotretinoin capsules in divided doses, as tolerated. The safety and effectiveness of once daily dosing with isotretinoin capsules has not been established and is not recommended. If a dose of isotretinoin capsules is missed, just skip that dose. Do not take two doses of isotretinoin capsules at the same time. Table 1 Isotretinoin Capsules Daily Dosage by Body Weight 1 1 Administer in two divided doses with or without meals Body Weight Total Daily Dosage (mg) 1 0.5 mg/kg 1 mg/kg 2 mg/kg 40 kg 20 40 80 50 kg 25 50 100 60 kg 30 60 120 70 kg 35 70 140 80 kg 40 80 160 90 kg 45 90 180 100 kg 50 100 200

2.3 Recommended

Duration of Use A normal course of treatment is 15 weeks to 20 weeks. If the total nodule count has been reduced by more than 70% prior to completing 15 weeks to 20 weeks of treatment, may discontinue isotretinoin capsules. After a period of 2 months or more off treatment and if warranted by persistent or recurring severe nodular acne, may initiate a second course of isotretinoin capsules in patients who have completed skeletal growth. The use of another course of isotretinoin capsules treatment is not recommended before a 2 month waiting period because the patient's acne may continue to improve after a 15 week to 20 week course of treatment. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of isotretinoin capsules, even in low dosages, has not been studied and is not recommended. The effect of long-term use of isotretinoin capsules on bone loss is unknown.