ABSORICA Capsule (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Sun Pharmaceutical Industries, Inc.

Λέξεις κλειδιά

10631-115 10631-116 10631-117 10631-118 10631-133 10631-134 10631-002 10631-003 10631-004 10631-005 10631-006 10631-007

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BOXED WARNING SECTION

WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY ABSORICA/ABSORICA LD can cause severe life-threatening birth defects and is contraindicated in pregnancy. There is an extremely ...

1. Indications and Usage

ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm ...

2. Dosage and Administration

2.1 Recommended Dosage ABSORICA is not substitutable with ABSORICA LD [see Warnings and Precautions (5.3)]. The recommended dosage of: ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses ...

3. Dosage Forms and Strengths

ABSORICA and ABSORICA LD have different dosage regimens [see Dosage and Administration (2.1)]. Although ABSORICA and ABSORICA LD have a 20 mg strength, these strengths have different bioavailability ...

4. Contraindications

4.1 Pregnancy ABSORICA/ABSORICA LD is contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. 4.2 Hypersensitivity ABSORICA/ABSORICA LD is contraindicated ...

5. Warnings and Precautions

5.1 Embryo-Fetal Toxicity ABSORICA/ABSORICA LD is contraindicated in pregnancy [see Contraindications (4.1)]. Based on human data, ABSORICA/ABSORICA LD can cause fetal harm when administered to ...

6. Adverse Reactions

The following adverse reactions with ABSORICA/ABSORICA LD or other isotretinoin capsule products are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings ...

7. Drug Interactions

7.1 Vitamin A ABSORICA/ABSORICA LD is closely related to vitamin A. Therefore, the use of both vitamin A and ABSORICA/ABSORICA LD at the same time may lead to vitamin A related adverse reactions. Patients ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 ...

8.2. Lactation

Risk Summary There are no data on the presence of isotretinoin in either animal or human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious ...

8.3. Females and Males of Reproductive Potential

All patients who can become pregnant must comply with the iPLEDGE program requirements [see Warnings and Precautions (5.2)]. Pregnancy Testing ABSORICA/ABSORICA LD must only be prescribed to patients ...

8.4. Pediatric Use

The safety and effectiveness of ABSORICA/ABSORICA LD for the treatment of severe recalcitrant nodular acne have been established in pediatric subjects ages 12 to 17 years. Use of ABSORICA/ABSORICA LD in ...

8.5. Geriatric Use

Clinical studies of ABSORICA/ABSORICA LD did not include sufficient numbers of geriatric subjects (subjects aged 65 years of age and older) to determine whether they respond differently from younger adults. ...

10. Overdosage

In humans, isotretinoin overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolved without apparent residual ...

11. Description

ABSORICA 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, ...

12.1. Mechanism of Action

ABSORICA/ABSORICA LD is a retinoid, which when administered at the recommended dosage [see Dosage and Administration (2.1)], inhibits sebaceous gland function and keratinization. Clinical improvement ...

12.2. Pharmacodynamics

The pharmacodynamics of ABSORICA/ABSORICA LD are unknown.

12.3. Pharmacokinetics

No clinically significant differences in the pharmacokinetics of isotretinoin between patients with nodular acne and healthy subjects without acne were reported in published literature. Absorption Following ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In male and female Fischer 344 rats given oral isotretinoin at dosages of 8 or 32 mg/kg/day (1.3 or 5.3 times the recommended clinical ABSORICA dosage of 1 mg/kg/day or the recommended clinical ABSORICA ...

13.2. Animal Toxicology and/or Pharmacology

In rats given 8 or 32 mg/kg/day of isotretinoin (1.3 or 5.3 times the recommended clinical ABSORICA dosage of 1 mg/kg/day or the recommended clinical ABSORICA LD dosage of 0.8 mg/kg/day, respectively, ...

14. Clinical Studies

The effectiveness of ABSORICA/ABSORICA LD for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older has been established and is based on a double-blind, randomized, parallel ...

15. References

1. Cinar SL, Kartal D, Aksoy H, et al. Long-term effect of systemic isotretinoin on female fertility. Cutan Ocul Toxicol. 2017;36(2):132-134.

16.1. How Supplied

ABSORICA and ABSORICA LD have different dosage regimens. Although ABSORICA and ABSORICA LD have a 20 mg strength, these strengths have different bioavailability and are not substitutable [see Dosage ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Protect from light.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity There is an extremely high risk of severe birth defects when ABSORICA/ABSORICA LD is used in pregnancy ...