Absorica

Name: Absorica

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

What should I discuss with my healthcare provider before taking Absorica (isotretinoin)?

Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. You must have a negative pregnancy test before you start taking isotretinoin. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

  • tubal ligation (tubes tied);

  • vasectomy of the male sexual partner;

  • an IUD (intrauterine device);

  • estrogen-containing birth control pills (not mini-pills); and

  • hormonal birth control patches, implants, injections, or vaginal ring.

Secondary forms of birth control include:

  • a male latex condom with or without spermicide;

  • a diaphragm plus a spermicide;

  • a cervical cap plus a spermicide; and

  • a vaginal sponge containing a spermicide.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.

You should not use isotretinoin if you are allergic to it.

To make sure isotretinoin is safe for you, tell your doctor if you have:

  • a history of depression or mental illness;

  • asthma;

  • liver disease;

  • diabetes;

  • heart disease or high cholesterol;

  • osteoporosis or low bone mineral density;

  • an eating disorder such as anorexia;

  • an intestinal disorder such as inflammatory bowel disease, ulcerative colitis, or Crohn's disease; or

  • a food or drug allergy.

It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

It is not known whether isotretinoin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Isotretinoin is not approved for use by anyone younger than 12 years old.

What happens if I miss a dose?

Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What should I avoid while taking Absorica (isotretinoin)?

Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to a pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.

Do not take a vitamin or mineral supplement that contains vitamin A.

While you are taking isotretinoin and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. Scarring may result.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Isotretinoin can make your skin more sensitive to sunlight and sunburn may result.

Isotretinoin may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.

What do I need to tell my doctor BEFORE I take Absorica?

  • If you have an allergy to this medicine or any part of Absorica.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are able to get pregnant and are not using 2 kinds of birth control.
  • If you are planning to get pregnant within 1 month before care, during care, or within 1 month after care has ended.
  • If you are breast-feeding. Do not breast-feed while you take this medicine or for 1 month after you stop Absorica.
  • If you are taking any of these drugs: Demeclocycline, doxycycline, minocycline, tetracycline, a product that has vitamin A in it, a product that is like vitamin A, or St. John's wort.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Absorica with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Adverse Reactions

The following adverse reactions with Absorica or other isotretinoin products are described in more detail in other sections of the labeling:

• Embryofetal Toxicity [see Warnings and Precautions (5.1)] • Psychiatric Disorders [see Warnings and Precautions (5.4)] • 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)] • Skeletal Abnormalities [see Warnings and Precautions (5.12)] • Ocular Abnormalities [see Warnings and Precautions (5.13)] • Hypersensitivity [see Warnings and Precautions (5.14)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Absorica cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

The adverse reactions listed below reflect both clinical experience with Absorica, and consider other adverse reactions that are known from clinical trials and the post-marketing surveillance with oral isotretinoin. The relationship of some of these events to isotretinoin therapy is unknown. Many of the side effects and adverse events seen in patients receiving isotretinoin are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage, and eyes).

Dose Relationship

Cheilitis and hypertriglyceridemia are adverse reactions that are usually dose related. Most adverse reactions reported in clinical trials with isotretinoin were reversible when therapy was discontinued; however, some persisted after cessation of therapy.

Body as a Whole

The following adverse reactions have been reported in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): fatigue, irritability, pain. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: allergic reactions, including vasculitis, systemic hypersensitivity, edema, lymphadenopathy, weight loss.

Cardiovascular

The following adverse reactions have been reported with isotretinoin: vascular thrombotic disease, stroke, palpitation, tachycardia.

Endocrine/Metabolism and Nutritional

The following adverse reactions have been reported in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): decreased appetite, weight fluctuation, hyperlipidaemia. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: hypertriglyceridemia, alterations in blood sugar.

Gastrointestinal

The following adverse reactions have been reported in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): lip dry, chapped lips, cheilitis, nausea, constipation, diarrhea, abdominal pain, vomiting. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, and other nonspecific gastrointestinal symptoms.

Hematologic

The following adverse reactions have been reported with isotretinoin: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis.

Infections and infestations

The following adverse reactions have been reported in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): nasopharyngitis, hordeolum, upper respiratory tract infection. In addition to the above adverse reactions, the following adverse reaction has been reported with isotretinoin: infections (including disseminated herpes simplex).

Laboratory Abnormalities

The following changes in laboratory tests have been noted in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): blood creatine phosphokinase (CPK) increased, blood triglycerides increased, alanine aminotransferase (SGPT) increased, aspartate aminotransferase (SGOT) increased, gamma-glutamyltransferase (GGTP) increased, blood cholesterol increased, low density lipoprotein (LDL) increased, white blood cell count decreased, blood alkaline phosphatase increased, blood bilirubin increased, blood glucose increased, high density lipopoprotein (HDL) decreased, bone mineral density decreased. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: increased LDH, elevation of fasting blood sugar, hyperuricemia, decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis), elevated sedimentation rates, elevated platelet counts, thrombocytopenia, white cells in the urine, proteinuria, microscopic or gross hematuria.

Musculoskeletal and Connective Tissue

The following adverse reactions have been reported in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, athralgia, musculoskeletal discomfort, musculoskeletal pain, neck pain, pain in extremity, myalgia, musculoskeletal stiffness [see Warnings and Precautions (5.12)]. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient pain in the chest, and rare reports of rhabdomyolysis.

Neurological

The following adverse reactions have been reported in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): headache, syncope. In addition to the above adverse reactions, other adverse reactions reported with isotretinoin include: pseudotumor cerebri, dizziness, drowsiness, lethargy, malaise, nervousness, paresthesias, seizures, stroke, weakness.

Psychiatric

The following adverse reactions have been reported in clinical trials conducted with Absorica and a generic product of Accutane® (isotretinoin): suicidal ideation, insomnia, anxiety, depression, irritability, panic attack, anger, euphoria, violent behaviors, emotional instability. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: suicide attempts, suicide, aggression, psychosis and hallucination auditory. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

Reproductive System

The following adverse reaction has been reported with isotretinoin: abnormal menses.

Respiratory

The following adverse reactions have been reported in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): epistaxis, nasal dryness. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: bronchospasms (with or without a history of asthma), respiratory infection, voice alteration.

Skin and Subcutaneous Tissue

The following adverse reactions have been reported in a clinical trial conducted with Absorica and a generic product of Accutane® (isotretinoin): dry skin, dermatitis, eczema, rash, dermatitis contact, alopecia, pruritus, sunburn, erythema. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: acne fulminans, alopecia (which in some cases persists), bruising, dry nose, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener's granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).

Special Senses

Hearing: The following adverse reactions have been reported with isotretinoin: tinnitus and hearing impairment.

Ocular: The following adverse reactions have been reported in clinical trials conducted with Absorica and a generic product of Accutane® (isotretinoin): dry eye, visual acuity reduced, vision blurred, eye pruritis, eye irritation, asthenopia, decreased night vision, ocular hyperemia, increased lacrimation, and conjunctivitis. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, eyelid inflammation, keratitis, optic neuritis, photobia, visual disturbances.

Renal and Urinary

The following adverse reactions have been reported in clinical trials conducted with isotretinoin: glomerulonephritis, nonspecific urogenital findings.

Absorica - Clinical Pharmacology

Mechanism of Action

Absorica is a retinoid, which when administered in pharmacologic dosages of 0.5 to 1 mg/kg/day, inhibits sebaceous gland function and keratinization. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and is related to the dose and duration of treatment with isotretinoin and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation. The exact mechanism of action of Absorica is unknown.

Pharmacodynamics

The pharmacodynamics of Absorica are unknown.

Pharmacokinetics

Absorption

Due to its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal. Absorica is bioequivalent to Accutane® (isotretinoin) capsule when both drugs are taken with a high-fat meal. Absorica is more bioavailable than Accutane® (isotretinoin) capsules when both drugs are taken fasted; the AUC0-t of Absorica is approximately 83% greater than that of Accutane®. Absorica is therefore not interchangeable with generic products of Accutane®.

A single dose two-way crossover pharmacokinetic trial was conducted in 14 healthy adult male subjects comparing Absorica 40 mg (1 x 40 mg capsules), dosed under fasted and fed conditions. Under fed conditions after a high-fat meal, it was observed that the mean AUC0-t and Cmax were approximately 50% and 26% higher, than that observed under fasting conditions (Table 2). The observed elimination half-life (T1/2) was slightly lower in the fed state versus fasted. The time to peak concentration (Tmax) increased with food and this may be related to a longer absorption phase.

Table 2: Pharmacokinetic parameters of Absorica mean (%CV) following administration of 40 mg strength, N=14


Absorica¶ (1 x 40 mg capsules)

AUC0-t
(ng x hr/mL)

Cmax
(ng/mL)

Tmax
(hr)

T1/2
(hr)

Fed

6095 (26 %)

395 (39 %)

6.4 (47 %)

22 (25 %)

Fasted

4055 (20 %)

314 (26 %)

2.9 (34 %)

24 (28 %)

Published clinical literature has shown that there is no difference in the pharmacokinetics of isotretinoin between patients with nodular acne and healthy subjects with normal skin.

Distribution

Isotretinoin is more than 99.9% bound to plasma proteins, primarily albumin.

Metabolism

Following oral administration of isotretinoin, at least three metabolites have been identified in human plasma: 4-oxo-isotretinoin, retinoic acid (tretinoin), and 4-oxo-retinoic acid (4-oxo-tretinoin). Retinoic acid and 13-cis-retinoic acid are geometric isomers and show reversible interconversion. The administration of one isomer will give rise to the other. Isotretinoin is also irreversibly oxidized to 4-oxo-isotretinoin, which forms its geometric isomer 4-oxo-tretinoin.

After a single 40 mg oral dose of Absorica to 57 healthy adult subjects, concurrent administration of food increased the extent of formation of all metabolites in plasma when compared to the extent of formation under fasted conditions.

All of these metabolites possess retinoid activity that is in some in vitro models more than that of the parent isotretinoin. However, the clinical significance of these models is unknown.

In vitro studies indicate that the primary P450 isoforms involved in isotretinoin metabolism are 2C8, 2C9, 3A4, and 2B6. Isotretinoin and its metabolites are further metabolized into conjugates, which are then excreted in urine and feces.

Elimination

Following oral administration of an 80 mg dose of 14C-isotretinoin as a liquid suspension, 14C-activity in blood declined with a half-life of 90 hours. The metabolites of isotretinoin and any conjugates are ultimately excreted in the feces and urine in relatively equal amounts (total of 65% to 83%).

After a single 40 mg (2 x 20 mg) oral dose of Absorica to 57 healthy adult subjects under fed conditions, the mean ± SD elimination half-lives (T1/2) of isotretinoin and 4-oxo-isotretinoin under fed states were 18 hours and 38 hours, respectively.

Special Patient Populations

The pharmacokinetics of isotretinoin were evaluated after single and multiple doses in 38 pediatric patients (12 to 15 years) and 19 adult patients (≥18 years) who received isotretinoin for the treatment of severe recalcitrant nodular acne. In both age groups, 4-oxo-isotretinoin was the major metabolite; tretinoin and 4-oxo-tretinoin were also observed. There were no statistically significant differences in the pharmacokinetics of isotretinoin between pediatric and adult patients.

Package/Label Display Panel

Attention Pharmacist: Dispense with enclosed Medication Guide.

NDC 10631-115-69

Absorica® (isotretinoin) Capsules

10 mg

Each capsule contains 10 mg Isotretinoin, USP

10 Capsules

Prescription Pack

PATIENT: READ INFORMATION CAREFULLY

Rx only

What side effects can this medication cause?

Isotretinoin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • red, cracked, and sore lips
  • dry skin, eyes, mouth, or nose
  • nosebleeds
  • changes in skin color
  • peeling skin on the palms of the hands and soles of the feet
  • changes in the nails
  • slowed healing of cuts or sores
  • bleeding or swollen gums
  • hair loss or unwanted hair growth
  • sweating
  • flushing
  • voice changes
  • tiredness
  • cold symptoms

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, stop taking isotretinoin and call your doctor or get emergency medical treatment immediately:

  • headache
  • blurred vision
  • dizziness
  • nausea
  • vomiting
  • seizures
  • slow or difficult speech
  • weakness or numbness of one part or side of the body
  • stomach pain
  • chest pain
  • difficulty swallowing or pain when swallowing
  • new or worsening heartburn
  • diarrhea
  • rectal bleeding
  • yellowing of the skin or eyes
  • dark colored urine
  • back, bone, joint or muscle pain
  • muscle weakness
  • difficulty hearing
  • ringing in the ears
  • vision problems
  • painful or constant dryness of the eyes
  • unusual thirst
  • frequent urination
  • trouble breathing
  • fainting
  • fast or pounding heartbeat
  • red, swollen, itchy, or teary eyes
  • fever
  • rash
  • peeling or blistering skin, especially on the legs, arms, or face
  • sores in the mouth, throat, nose, or eyes
  • red patches or bruises on the legs
  • swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
  • difficulty swallowing or pain when swallowing

Isotretinoin may cause the bones to stop growing too soon in teenagers. Talk to your child's doctor about the risks of giving this medication to your child.

Isotretinoin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Side effects

The following adverse reactions with ABSORICA or other isotretinoin products are described in more detail in other sections of the labeling:

  • Embryofetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Disorders [see WARNINGS AND PRECAUTIONS]
  • Pseudotumor Cerebri [see WARNINGS AND PRECAUTIONS]
  • Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
  • Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Lipid Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Hearing Impairment [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Inflammatory Bowel Disease [see WARNINGS AND PRECAUTIONS]
  • Skeletal Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Ocular Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of ABSORICA cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

The adverse reactions listed below reflect both clinical experience with ABSORICA, and consider other adverse reactions that are known from clinical trials and the post-marketing surveillance with oral isotretinoin. The relationship of some of these events to isotretinoin therapy is unknown. Many of the side effects and adverse events seen in patients receiving isotretinoin are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage, and eyes).

Dose Relationship

Cheilitis and hypertriglyceridemia are adverse reactions that are usually dose related. Most adverse reactions reported in clinical trials with isotretinoin were reversible when therapy was discontinued; however, some persisted after cessation of therapy.

Body as a Whole

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): fatigue, irritability, pain. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: allergic reactions, including vasculitis, systemic hypersensitivity, edema, lymphadenopathy, weight loss.

Cardiovascular

The following adverse reactions have been reported with isotretinoin: vascular thrombotic disease, stroke, palpitation, tachycardia.

Endocrine/Metabolism and Nutritional

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): decreased appetite, weight fluctuation, hyperlipidaemia. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: hypertriglyceridemia, alterations in blood sugar.

Gastrointestinal

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): lip dry, chapped lips, cheilitis, nausea, constipation, diarrhea, abdominal pain, vomiting. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, and other nonspecific gastrointestinal symptoms.

Hematologic

The following adverse reactions have been reported with isotretinoin: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis.

Infections and infestations

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): nasopharyngitis, hordeolum, upper respiratory tract infection. In addition to the above adverse reactions, the following adverse reaction has been reported with isotretinoin: infections (including disseminated herpes simplex).

Laboratory Abnormalities

The following changes in laboratory tests have been noted in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): blood creatine phosphokinase (CPK) increased, blood triglycerides increased, alanine aminotransferase (SGPT) increased, aspartate aminotransferase (SGOT) increased, gamma-glutamyltransferase (GGTP) increased, blood cholesterol increased, low density lipoprotein (LDL) increased, white blood cell count decreased, blood alkaline phosphatase increased, blood bilirubin increased, blood glucose increased, high density lipopoprotein (HDL) decreased, bone mineral density decreased. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: increased LDH, elevation of fasting blood sugar, hyperuricemia, decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis), elevated sedimentation rates, elevated platelet counts, thrombocytopenia, white cells in the urine, proteinuria, microscopic or gross hematuria.

Musculoskeletal and Connective Tissue

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, athralgia, musculoskeletal discomfort, musculoskeletal pain, neck pain, pain in extremity, myalgia, musculoskeletal stiffness [see WARNINGS AND PRECAUTIONS]. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient pain in the chest, and rare reports of rhabdomyolysis.

Neurological

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): headache, syncope. In addition to the above adverse reactions, other adverse reactions reported with isotretinoin include: pseudotumor cerebri, dizziness, drowsiness, lethargy, malaise, nervousness, paresthesias, seizures, stroke, weakness.

Psychiatric

The following adverse reactions have been reported in clinical trials conducted with ABSORICA and a generic product of Accutane® (isotretinoin): suicidal ideation, insomnia, anxiety, depression, irritability, panic attack, anger, euphoria, violent behaviors, emotional instability. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: suicide attempts, suicide, aggression, psychosis and hallucination auditory. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

Reproductive System

The following adverse reaction has been reported with isotretinoin: abnormal menses.

Respiratory

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): epistaxis, nasal dryness. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: bronchospasms (with or without a history of asthma), respiratory infection, voice alteration.

Skin and Subcutaneous Tissue

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): dry skin, dermatitis, eczema, rash, dermatitis contact, alopecia, pruritus, sunburn, erythema. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: acne fulminans, alopecia (which in some cases persists), bruising, dry nose, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener's granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).

Special Senses

Hearing: The following adverse reactions have been reported with isotretinoin: tinnitus and hearing impairment.

Ocular: The following adverse reactions have been reported in clinical trials conducted with ABSORICA and a generic product of Accutane® (isotretinoin): dry eye, visual acuity reduced, vision blurred, eye pruritis, eye irritation, asthenopia, decreased night vision, ocular hyperemia, increased lacrimation, and conjunctivitis. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, eyelid inflammation, keratitis, optic neuritis, photobia, visual disturbances.

Renal and Urinary

The following adverse reactions have been reported in clinical trials conducted with isotretinoin: glomerulonephritis, nonspecific urogenital findings.

Absorica Drug Class

Absorica is part of the drug class:

  • Retinoids for topical use in acne

Inform MD

Tell your doctor if you have any of the following health conditions:

  • mental problems
  • asthma
  • liver disease
  • diabetes
  • heart disease
  • bone loss (osteoporosis) or weak bones
  • an eating problem called anorexia nervosa (where people eat too little)
  • food or medicine allergies

Tell your doctor if you are pregnant or breastfeeding. Absorica must not be used by women who are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Absorica and certain other medicines can interact with each other, sometimes causing serious side effects.

For Healthcare Professionals

Applies to isotretinoin: compounding powder, oral capsule

General

The most commonly reported side effects include dryness of the skin and mucous membranes (e.g., cheilitis, epistaxis, conjunctivitis).[Ref]

Gastrointestinal

Very common (10% or more): Cheilitis/dry lips (up to 90%)
Very rare (less than 0.01%): Colitis, ileitis, gastrointestinal hemorrhage, nausea, pancreatitis/fatal pancreatitis, hemorrhagic diarrhea and inflammatory bowel disease
Frequency not reported: Esophagitis/esophageal ulceration, chapped lips, constipation, diarrhea/severe diarrhea, abdominal pain, vomiting, other nonspecific gastrointestinal symptoms, bleeding and inflammation of the gums[Ref]

Hematologic

Very common (10% or more): Increased red blood cell sedimentation rate (up to 40%)
Common (1% to 10%): Neutropenia/severe neutropenia, anemia, thrombocytopenia/decreased platelet counts, thrombocytosis
Rare (0.01% to 0.1%): Agranulocytosis
Very rare (less than 0.01%): Lymphadenopathy
Frequency not reported: Decreased red blood cell parameters, decreased red blood cell counts/hematocrit, decreased white blood cell counts, increased platelet counts[Ref]

Metabolic

Very common (10% or more): Increased blood triglycerides/hypertriglyceridemia (up to 30%)
Common (1% to 10%): Increased blood cholesterol/hyperlipidemia, increased blood glucose/alterations in blood sugar levels, decreased high density lipoprotein
Very rare (less than 0.01%): Diabetes mellitus, hyperuricemia
Frequency not reported: Weight loss/fluctuations in weight, decreased appetite, increased low density lipoprotein
Postmarketing reports: Increased fasting blood glucose levels[Ref]

Respiratory

Bronchospasm occurred in patients receiving treatment, especially in those with asthma.[Ref]

Very common (10% or more): Epistaxis (Up to 30%)
Common (1% to 10%): Hoarseness, nasal dryness, nasopharyngitis
Very rare (less than 0.01%): Bronchospasm, dry throat
Frequency not reported: Respiratory infection/upper respiratory tract infection, voice alteration[Ref]

Dermatologic

In some cases, acne flares occurred during the initial stages of treatment and persisted for several weeks[Ref]

Common (1% to 10%): Dermatitis, dry skin, localized exfoliation, pruritus, rash erythematous, skin fragility/risk of frictional trauma
Rare (0.01% to 0.1%): Allergic skin reaction, alopecia/persistent or resistant alopecia
Very rare (less than 0.01%): Mucocutaneous/gram positive bacterial infection, allergic vasculitis, acne fulminans, acne aggravated/acne flare, facial erythema, exanthema, hair disorders/persistent hair thinning, hirsutism, nail dystrophy, paronychia, photosensitivity/photoallergic reaction, pyogenic granuloma, skin hyperpigmentation, sweating/increased sweating, increased formation of granulation tissue
Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eruptive xanthoma, hypopigmentation, increased sunburn susceptibility, urticaria, eczema, contact dermatitis, sunburn, peeling of the palms and soles
Postmarketing reports: Bruising, seborrhea[Ref]

Ocular

Papilledema occurred as a sign of benign intracranial hypertension.[Ref]

Common (1% to 10%): Blepharitis, conjunctivitis, dry eye, eye irritation
Very rare (less than 0.01%): Blurred vision, cataract/lenticular cataracts, color blindness/color vision deficiencies, contact lens intolerance, corneal opacity/reversible corneal opacities, decreased night vision/persistently decreased night vision, keratitis, papilledema, photophobia, visual disturbances, optic neuritis, hordeolum
Frequency not reported: Eyelid inflammation, decreased visual acuity, eye pruritus, asthenopia, ocular hyperemia, increased lacrimation[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia/severe arthralgia, back pain/severe back pain, myalgia/severe myalgia with or without elevated creatine phosphokinase (CPK) levels
Very rare (less than 0.01%): Arthritis, premature epiphyses fusion, exostosis, skeletal hyperostosis/hyperostosis, reduced bone density/decreased bone mineral density, tendonitis, rhabdomyolysis, increased blood CPK, rhabdomyolysis, other types of bone abnormalities, calcinosis/calcification of ligaments and tendons
Frequency not reported: Neck pain, musculoskeletal pain/discomfort/stiffness, extremity pain[Ref]

Back pain occurred more frequently in children and adolescent patients.

Rhabdomyolysis, sometimes leading to hospitalization or death, has occurred, especially in patients undertaking vigorous physical activity.[Ref]

Genitourinary

Common (1% to 10%): Proteinuria, microscopic or gross hematuria
Frequency not reported: Abnormal menses, nonspecific urogenital findings, white cells in the urine[Ref]

Nervous system

Common (1% to 10%): Headache
Very rare (less than 0.01%): Benign intracranial hypertension, convulsions, drowsiness, dizziness
Frequency not reported: Stroke, pseudotumor cerebri/increased intracranial pressure, lethargy, paresthesia, seizures, syncope[Ref]

Hepatic

Common (1% to 10%): Transient and reversible increased transaminase levels
Very rare (less than 0.01%): Hepatitis
Frequency not reported: Increased alkaline phosphatase/lactate dehydrogenase/blood bilirubin[Ref]

Psychiatric

Depression symptoms have been reported to disappear after discontinuation of the drug and reappear when treatment is resumed.[Ref]

Rare (0.01% to 0.1%): Depression, aggravated depression, aggression/aggressive tendencies, anxiety, mood alterations
Very rare (less than 0.01%): Abnormal behavior, psychosis/psychotic disorder, suicidal ideation/attempt, suicide
Frequency not reported: Nervousness, insomnia, violent behavior, emotional instability, irritability, panic attack, anger, euphoria, behavioral disorders
Postmarketing reports: Auditory hallucinations[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reaction, hypersensitivity/systemic hypersensitivity
Frequency not reported: Allergic reactions[Ref]

Other

Very rare (less than 0.01%): Impaired hearing/impaired hearing at certain frequencies, malaise
Frequency not reported: Fatigue, pain, tinnitus, weakness, disseminated herpes simplex, delayed wound healing, exuberant granulation tissue with crusting, local or systemic infections due to gram positive bacteria (Staphylococcus aureus)
Postmarketing reports: Infection[Ref]

Cardiovascular

Very rare (less than 0.01%): Vasculitis, Wegener's granulomatosis
Frequency not reported: Edema, palpitations, tachycardia, vascular thrombotic disease, transient chest pain, flushing[Ref]

Renal

Very rare (less than 0.01%): Glomerulonephritis[Ref]

Some side effects of Absorica may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Isotretinoin Levels and Effects while Breastfeeding

Summary of Use during Lactation

No information is available on the use of isotretinoin during breastfeeding. Various topical agents that are less likely to be absorbed by the mother may be preferred during breastfeeding, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

A woman who had weaned her infant 18 months previously developed a nipple discharge from her right breast after 5.5 months of therapy with isotretinoin. Microbiological, hormonal (including prolactin), radiologic, and physical examinations were otherwise normal. One month after discontinuing isotretinoin, the discharge ceased. After isotretinoin was reinstituted at the same dose, the discharge reappeared within 10 days.[1] The galactorrhea was probably caused by isotretinoin.

Alternate Drugs to Consider

(Acne) Azelaic Acid, Benzoyl Peroxide, Clindamycin, Erythromycin, Tretinoin

References

Larsen GK. Iatrogenic breast discharge with isotretinoin. Arch Dermatol. 1985;121:450-1. PMID: 3856419

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