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Absorica Dosage

Generic name: ISOTRETINOIN 10mg
Dosage form: capsule

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Healthcare professionals who prescribe ABSORICA must be certified in the iPLEDGE program and must comply with the required monitoring to ensure safe use of ABSORICA [see Warnings and Precautions (5.2)].

The required laboratory testing must be completed prior to dosing ABSORICA [see Dosage and Administration (2.4)].

Pregnancy Testing, and Contraceptive measures must be followed prior to dosing ABSORICA [see Use in Specific Populations (8.6)].

Recommended Dosage

The recommended dosage range for ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks (see Table 1). To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of liquid [see Patient Counseling Information (17)].

The safety of once daily dosing with ABSORICA has not been established. Once daily dosing is not recommended.

Table 1: ABSORICA Dosing by Body Weight (Based on Administration With or Without Food)

Body Weight

Total Daily (mg)

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

Dosage Range

In trials comparing 0.1, 0.5, and 1 mg/kg/day, 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.

Duration of Use

A normal course of treatment is 15 – 20 weeks. 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 ABSORICA, even in low doses, has not been studied, and is not recommended. It is important that ABSORICA be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of ABSORICA on bone loss is unknown [see Warnings and Precautions (5.12)].

Laboratory Testing

Pregnancy Testing

[See Use in Specific Populations (8.6)]

Lipid Profile

Perform a fasting lipid profile including triglycerides prior to use of ABSORICA [see Warnings and Precautions (5.8, 5.15)].

Liver Function Test

Perform liver function tests prior to use of ABSORICA [see Warnings and Precautions (5.10, 5.15)].

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