Absorica (Page 8 of 11)

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 HOW SUPPLIED/STORAGE AND HANDLING

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 and Administration (2.1)].

ABSORICA

ABSORICA (isotretinoin) Capsules (opaque) are supplied as follows:

10 mg: Dark yellow, capsule imprinted with black ink “G 240” on cap and “10” on the body
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-115-31
20 mg: Red, capsule imprinted with black ink “G 241” on cap and “20” on the body
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-116-31
25 mg: Green, capsule imprinted with white ink “G 342” on cap and “25” on the body
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-133-31
30 mg: Brown, capsule imprinted with white ink “G 242” on cap and “30” on the body
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-117-31
35 mg: Dark blue, capsule imprinted with white ink “G 343” on cap and “35” on the body
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-134-31
40 mg: Brown and red, capsule imprinted with white ink “G 325” on cap and “40” on the body
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-118-31

ABSORICA LD

ABSORICA LD (isotretinoin) Capsules (opaque-printed, hard-gelatin) are supplied as follows:

8 mg: A size 3, light green, capsules banded with a colorless band. The cap is printed in white with “RL29” and the body is printed in white with “RL29”.
Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-002-31
16 mg: A size 2, dark blue, capsules banded with a colorless band. The cap is printed in white with “RL30” and the body is printed in white with “RL30”.
Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-003-31
20 mg: A size 1, dark pink, capsules banded with a colorless band. The cap is printed in black with “RL33”and the body is printed in black with “RL33”.
Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-004-31
24 mg: A size 1, yellow, capsules banded with a colorless band. The cap is printed in white with “RL31” and the body is printed in white with “RL31”.
Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-005-31
28 mg: A size 0, light blue, capsules banded with a colorless band. The cap is printed in black with “RL34” and the body is printed in black with “RL34”.
Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-006-31
32 mg: A size 0, caramel, capsules banded with a colorless band. The cap is printed in white with “RL32” and the body is printed in white with “RL32”.
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-007-31

Storage and Handling of ABSORICA and ABSORICA LD

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 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Instruct patients who can become pregnant that they must not be pregnant during or up to one month after ABSORICA/ABSORICA LD therapy. Instruct patients to not donate blood during ABSORICA/ABSORICA LD therapy and for 1 month following discontinuation to avoid blood donation to a pregnant patient.

iPLEDGE

ABSORICA and ABSORICA LD are available only through a restricted program called iPLEDGE [see Warnings and Precautions (5.2)]. Inform patients who can become pregnant of the following notable requirements. These patients must:

Sign an informed consent form to be enrolled in the program
Comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.3)]
Demonstrate comprehension of the safe-use conditions of the program every month
Obtain the prescription within 7 days of the pregnancy test collection

Inform patients who cannot become pregnant of the following notable requirements. These patients must sign an informed consent form to enroll in the program and they must obtain the prescription within 30 days of the office visit. ABSORICA/ABSORICA LD is available only from certified pharmacies participating in the program. Therefore, provide patients with the telephone number and website for information on how to obtain ABSORICA/ABSORICA LD [see Warnings and Precautions (5.2)].

Lactation

Because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with ABSORICA/ABSORICA LD, and for at least 8 days after the last dose of ABSORICA/ABSORICA LD [see Use in Specific Populations (8.2)].

Psychiatric Disorders

Instruct patients and/or their caregivers/families that ABSORICA/ABSORICA LD may cause depression, psychosis, suicidal ideation, suicide attempts, and aggressive or violent behavior. Instruct patients to read the Recognizing Psychiatric Disorders in Adolescents and Young Adults brochure prior to taking ABSORICA/ABSORICA LD. Instruct patients to stop ABSORICA/ABSORICA LD and to contact a healthcare provider if they develop any of these signs or symptoms [see Warnings and Precautions (5.4)].

Important Administration Instructions

To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid [see

Dosage and Administration (2.1)].

Intracranial Hypertension (Pseudotumor Cerebri)

Advise patients that intracranial hypertension (pseudotumor cerebri) has occurred with ABSORICA/ABSORICA LD use including concomitant use with tetracyclines. Thus, advise patients to avoid concomitant use with tetracyclines and to discontinue ABSORICA/ABSORICA LD immediately if they have symptoms of intracranial hypertension [see Warningsand Precautions (5.5)].

Serious Skin Reactions

Advise patients that severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in patients treated with isotretinoin and to discontinue ABSORICA/ABSORICA LD if clinically significant skin reactions occur [see Warnings and Precautions (5.6)].

Inflammatory Bowel Disease

Advise patients that inflammatory bowel disease (including regional ileitis) have occurred with isotretinoin use including those without a prior history of IBD and if they experience IBD symptoms, they should discontinue

ABSORICA/ABSORICA LD immediately [see Warnings and Precautions (5.11)].

Musculoskeletal Abnormalities

Inform patients that:

There have been reports of osteoporosis and fractures and that isotretinoin may have a negative effect on bone mineral density [see Warnings and Precautions (5.12)].
Isotretinoin use has been associated with musculoskeletal abnormalities (e.g., arthralgia, back pain) [see Warnings and Precautions (5.12)].

Inform adolescents and their families that isotretinoin use in adolescents who participated in sports with repetitive impact increase their risk of spondylolisthesis or hip growth plate injuries [see Warnings and Precautions (5.12)]. Inform pediatric patients and their caregivers that pediatric patients treated with isotretinoin capsules developed back pain including severe back pain, and arthralgias including severe arthralgias [see Use in Specific Populations (8.4)].

Ocular Abnormalities

Inform patients that they may experience dry eyes, corneal opacities, and decreased night vision and contact lens wearers may experience decreased tolerance to contact lenses during and after therapy [see Warnings and Precautions (5.13)].

Rhabdomyolysis

Inform patients there have been rare postmarketing reports of rhabdomyolysis in patients treated with isotretinoin capsules, some associated with strenuous physical activity [see Warnings and Precautions (5.15)].

Hypersensitivity Reactions

Given that anaphylactic reactions and other allergic reactions have been reported in patients treated with isotretinoin capsules, instruct the patient to discontinue ABSORICA/ABSORICA LD and contact their healthcare provider if they have a severe allergic reaction [see Warnings and Precautions (5.14)].

Lipid Abnormalities

Instruct patients that hypertriglyceridemia, decreased HDL, and increased cholesterol levels were reported in patients treated with isotretinoin capsules [see Warnings and Precautions (5.8)].

Additional Instructions

Inform patients:

To not share ABSORICA/ABSORICA LD with anyone else because of the risk of birth defects and other serious adverse reactions.
That transient exacerbation (flare) of acne has been seen, generally during the initial period of therapy.
That wax epilation and skin resurfacing procedures (such as dermabrasion, laser) should be avoided during ABSORICA/ABSORICA LD therapy and for at least 6 months thereafter due to the possibility of scarring.
To avoid prolonged exposure to UV rays or sunlight.

Distributed by:
Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512

ABSORICA and ABSORICA LD are trademarks of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

ABSORICA LD 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg is protected by US Patent No. US 9,700,535 and US 9,750,711.

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