Absorica 25 mg/1
isotretinoin · CAPSULE · Sun Pharmaceutical Industries, Inc.
Absorica is a capsule containing isotretinoin at 25 mg/1, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- Absorica
- Generic Name
- isotretinoin
- NDC Code (Product)
10631-133- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA021951
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 02/17/2015
Recall History
Ranbaxy Inc.
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Sun Pharmaceutical Industries, Inc.
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2) ]. ABSORICA and ABSORICA LD are retinoids 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 or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. (1) Limitations of Use…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • ABSORICA is not substitutable with ABSORICA LD because of different bioavailability and recommended dosage. ( 2.1 , 5.3 ) • Recommended dosage for: o ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) o ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) • Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6 mg/kg/day of ABSORICA LD) in divided doses. ( 2.1 ) • Once daily dosing is not recommended. ( 2.1 ) • If a dose of ABSORICA/ABSORICA LD is missed, just skip that dose. Do not take two doses of ABSORICA/ABSORICA LD at the same time. ( 2.1 ) • Perform pregnancy tests prior to prescribing, each month during therapy, end of therapy, and one month after discontinuation. ( 2.3 , 8.3 ) • Prior to prescribing, perform fasting lipid profile and liver function tests. ( 2.3 ) 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 with…
Contraindications
4 CONTRAINDICATIONS • Pregnancy ( 4.1 , 8.1 ) • Hypersensitivity to this product or any of its components ( 4.2 , 5.14 ) 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 in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions (5.14) ] .
Drug Interactions
7 DRUG INTERACTIONS • Vitamin A: may cause additive adverse reactions (7.1) • Tetracyclines: avoid concomitant use (7.2) 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 treated with ABSORICA/ABSORICA LD should be advised against taking supplements containing Vitamin A to avoid additive toxic effects. 7.2 Tetracyclines Concomitant treatment with ABSORICA/ABSORICA LD and tetracyclines should be avoided because isotretinoin use has been associated with a number of cases of intracranial hypertension (pseudotumor cerebri), some of which involved concomitant use of tetracyclines [see Warnings and Precautions (5.5) ] . 7.3 Phenytoin Phenytoin is known to cause osteomalacia. No formal clinical trials have been conducted to assess if there is an interactive effect on bone loss between phenytoin and isotretinoin. Therefore, caution should be exercised when using these drugs together. 7.4 Systemic Corticosteroids Systemic corticosteroids are known to cause osteoporosis. No formal clinical trials have been conducted to assess if there is a…
Adverse Reactions
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 and Precautions ( 5.1 )] • Psychiatric Disorders [see Warnings and Precautions ( 5.4 )] • Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.5 )] • Serious Skin Reactions [see Warnings and Precautions ( 5.6 )] • Pancreatitis [see Warnings and Precautions ( 5.7 )] • Lipid Abnormalities [see Warnings and Precautions ( 5.8 )] • Hearing Impairment [see Warnings and Precautions ( 5.9 )] • Hepatotoxicity [see Warnings and Precautions ( 5.10 )] • Inflammatory Bowel Disease [see Warnings and Precautions ( 5.11 )] • Musculoskeletal Abnormalities [see Warnings and Precautions ( 5.12 )] • Ocular Abnormalities [see Warnings and Precautions ( 5.13 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain siz…
Frequently Asked Questions
What is Absorica used for?
Absorica contains isotretinoin. It is a capsule taken oral. Consult your doctor for specific uses.
Is Absorica a controlled substance?
Absorica is not classified as a controlled substance by the DEA.
What is the generic name for Absorica?
The generic name for Absorica is isotretinoin. There are 11 other brand versions of isotretinoin.
What is the NDC code for Absorica 25 mg/1?
The NDC (National Drug Code) for Absorica 25 mg/1 is 10631-133, listed by Sun Pharmaceutical Industries, Inc..