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Absorica

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Uses

ABSORICA is a retinoid indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, means “many” as opposed to “few or several” nodules. Because of significant adverse reactions associated with its use, ABSORICA should be reserved for patients with multiple severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, ABSORICA is indicated only for those female patients who are not pregnant, because ABSORICA can cause severe birth defects [see Contraindications (4.1)].

Limitations of Use

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. 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 with isotretinoin has shown that patients may continue to improve following treatment with isotretinoin. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth [seeWarnings and Precautions (5.12)].

As a part of the iPLEDGE program, ABSORICA may only be administered to patients enrolled in the program [seeWarnings and Precautions (5.2)].

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Other Information

ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems:

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10 mg – iron oxide (yellow) and titanium dioxide;
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20 mg – iron oxide (red), and titanium dioxide;
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25 mg – FD&C Blue #1, FD&C Yellow #5, FD&C Yellow #6 and titanium dioxide;
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30 mg – iron oxide (black, red and yellow) and titanium dioxide;
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35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide;
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40 mg – iron oxide (black, red and yellow) and titanium dioxide.

Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44.  It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is:

structural formula

Meets USP Dissolution Test 3.

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  • Ranbaxy Laboratories Inc.
    Absorica | Ranbaxy Laboratories Inc.
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    Absorica | Ranbaxy Laboratories Inc.

    Absorica | Ranbaxy Laboratories Inc.

    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 [seeUse in Specific Populations (8.6)].

    2.1 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 [seePatient 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

    2.2 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.

    2.3 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 [seeWarnings and Precautions (5.12)].

    2.4 Laboratory Testing

    Pregnancy Testing

    [SeeUse in Specific Populations (8.6)]

    Lipid Profile

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

    Liver Function Test

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

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