The following text is complete prescribing information based on official labeling in effect June 2000.


CONTRAINDICATIONS AND :    Accutane must not be used by females who are pregnant or who may become pregnant while undergoing treatment. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. Presently, there are no accurate means of determining after Accutane exposure which fetus has been affected and which fetus has not been affected.

Accutane is contraindicated in females of childbearing potential unless the patient meets all of the following conditions :

  • must have severe disfiguring nodular acne that is recalcitrant to standard therapies (see for definition)
  • must be reliable in understanding and carrying out instructions
  • must be capable of complying with the mandatory contraceptive measures required for Accutane therapy and understand behaviors associated with an increased risk of pregnancy
  • must have received both oral and written of the hazards of taking Accutane during pregnancy and exposing a fetus to the drug
  • must have received both oral and written information on the types of contraceptive methods and about the rates of possible contraceptive failure, and of the need to use two separate, effective forms of contraception simultaneously, unless abstinence is the chosen method, or the patient has undergone a hysterectomy and has acknowledged in writing her understanding of the information and and of the need for using two contraceptive methods simultaneously
  • must have had a negative urine or serum pregnancy test with a sensitivity of at least 50 mIU/mL when the patient is qualified for Accutane therapy by the prescriber, and must have had a second negative urine or serum pregnancy test on the second day of the next normal menstrual period or at least 11 days after the last unprotected act of sexual intercourse, whichever is later
  • must understand and agree that her prescriber will issue her a prescription for Accutane only after she has contacted the prescriber to confirm that she has obtained a negative result for the second urine pregnancy test which is to be conducted on the second day of the next normal menstrual period or at least 11 days after the last unprotected act of sexual intercourse, whichever is later
  • must have received instruction to join the Accutane Survey and have watched a videotape, provided by Roche to her prescriber, that provides information about contraceptive methods, possible reasons for contraceptive failure, and importance of using effective contraception when taking teratogenic drugs.

Major human fetal abnormalities related to Accutane administration have been documented: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); skull abnormality; external ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); cardiovascular abnormalities; facial dysmorphia; cleft palate; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. Cases of IQ scores less than 85 with or without obvious CNS abnormalities have also been reported. There is an increased risk of spontaneous abortion. In addition, premature births have been reported.

It is strongly recommended that a prescription for Accutane should not be issued by the prescriber until a female patient has had negative results from two urine or serum pregnancy tests, one of which is performed in the prescriber's office when the patient is qualified for Accutane therapy, the second of which is performed on the second day of the next normal menstrual period or 11 days after the last unprotected act of sexual intercourse, whichever is later. It is also recommended that pregnancy testing and counseling about contraception and behaviors associated with an increased risk of pregnancy be repeated on a monthly basis. To assure compliance, the prescriber should not issue a prescription for a female patient, until after the second negative pregnancy test result is obtained. In addition, the prescriber should prescribe no more than a 1-month supply of the drug for all Accutane patients and no automatic refills should be permitted. Roche will supply urine pregnancy test kits for female Accutane patients for the initial, second, and monthly testing during therapy.

Effective contraception must be used for at least 1 month before beginning Accutane therapy, during therapy, and for 1 month following discontinuation of therapy even where there has been a history of infertility, unless due to hysterectomy. The patient must be counseled about and understand the limitations of any chosen contraceptive method. The patient must also understand the risks associated with not using two contraceptive methods, even when one of the chosen methods is a hormonal contraceptive method.

Any birth control method can fail. Therefore, it is critically important that women of childbearing potential use two effective forms of contraception simultaneously, unless absolute abstinence is the chosen method, even when one of the forms is a hormonal contraceptive method. Although hormonal contraceptives are highly effective, there have been reports of pregnancy from women who have used oral contraceptives, as well as injectable/implantable contraceptive products. These reports are more frequent for women who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Accutane.

If a pregnancy does occur during treatment, the prescriber and patient should discuss the desirability of continuing the pregnancy. Prescribers are encouraged to report all cases of pregnancy with specific information about the contraceptive forms used during Accutane therapy and for 1 month following therapy, either to the Roche Medical Services @ 1-800-526-6367 or to the Food and Drug Administration MedWatch Program @ 1-800-FDA-1088.

Accutane should be prescribed only by prescribers who have special competence in the diagnosis and treatment of severe recalcitrant nodular acne, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity if Accutane is used during pregnancy.

Prescribers who prescribe Accutane should use the Pregnancy Prevention Program sm kit provided by Roche for the counseling of patients, should instruct the patient to participate in the Accutane Survey, and should receive medical education sponsored by Roche about effective contraception, the limitations of contraceptive methods and behaviors associated with an increased risk of contraceptive failure and pregnancy.

Isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg soft gelatin capsules for oral administration. Each capsule also contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg -- iron oxide (red) and titanium dioxide; 20 mg -- C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg -- FD&C Yellow No. 6, D&C Yellow No. 10, 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-orange to orange crystalline powder with a molecular weight of 300.44. The structural formula is:


Isotretinoin is a retinoid, which when administered in pharmacologic dosages of 0.5 to 2.0 mg/kg/day, inhibits sebaceous gland function and keratinization. The exact mechanism of action of Accutane is unknown.

Nodular Acne:   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 Accutane, and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation. 1

   Absorption Oral absorption of isotretinoin is optimal when taken with food or milk. After administration of a single 80-mg oral dose (two 40-mg capsules) of isotretinoin to 15 healthy male subjects, maximum blood concentrations ranged from 167 to 459 ng/mL (mean 256 ng/mL) and were achieved in 1 to 6 hours (mean 3.2 hours). The oral absorption of isotretinoin is consistent with first-order kinetics and can be described with a linear two-compartment model. Nodular acne does not alter the absorption of the drug: In a 27-day study of isotretinoin in 10 male patients with nodular acne treated with an oral dose of 40 mg bid, the mean peak concentration ranged from 98 ng/mL to 535 ng/mL (mean 262 ng/mL) and occurred at 2 to 4 hours after administration (mean 2.9 hours). In these patients, the mean ± SD minimum steady-state blood concentration of isotretinoin was 160 ± 19 ng/mL. The terminal elimination half-life was consistent with that observed in normal subjects.

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

Metabolism:   After oral administration of isotretinoin, 4- oxo -isotretinoin is the major metabolite identified in the blood. Maximum concentrations of 4- oxo -isotretinoin (87 to 399 ng/mL) were achieved at 6 to 20 hours after oral administration of two 40-mg capsules; the blood concentration of the major metabolite generally exceeded that of isotretinoin after 6 hours. Isotretinoin also undergoes isomerization to the all-trans-isomer, tretinoin, which is then metabolized to its corresponding 4- oxo -metabolite; both have been detected. Both parent compound and metabolites are further metabolized into conjugates which are excreted.

Elimination   Following administration of an 80-mg liquid suspension oral dose of 14 C-isotretinoin, 14 C-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%). The terminal elimination half-life of isotretinoin ranges from 10 to 20 hours. The mean elimination half-life of 4- oxo -isotretinoin is 25 hours (range 17 to 50 hours). After both single and multiple doses, the accumulation ratio of 4- oxo -isotretinoin to parent compound is 3 to 3.5.

Severe recalcitrant nodular acne:   Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, for female patients of childbearing potential, Accutane is indicated only for those females who are not pregnant (see boxed CONTRAINDICATIONS AND ).

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. 1,3,4 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 has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see : Skeletal : Hyperostosis and Premature Epiphyseal Closure ).


Pregnancy:    Category X. See boxed CONTRAINDICATIONS AND .

Allergic Reactions:   Accutane is contraindicated in patients who are hypersensitive to this medication or to any of its components. Accutane should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule (see PRECAUTIONS : Hypersensitivity ).

Psychiatric Disorders:    Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events (see ADVERSE REACTIONS : Psychiatric ).

Pseudotumor Cerebri:    Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, they should be told to discontinue Accutane immediately and be referred to a neurologist for further diagnosis and care (see ADVERSE REACTIONS : Neurological ).

Pancreatitis    Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported. Accutane should be stopped if hypertriglyceridemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur.

Lipids:   Elevations of serum triglycerides have been reported in patients treated with Accutane. Marked elevations of serum triglycerides in excess of 800 mg/dL were reported in approximately 25% of patients receiving Accutane in clinical trials. In addition, approximately 15% developed a decrease in high-density lipoproteins and about 7% showed an increase in cholesterol levels. In clinical trials, the effects on triglycerides, HDL, and cholesterol were reversible upon cessation of Accutane therapy. Some patients have been able to reverse triglyceride elevation by reduction in weight, restriction of dietary fat and alcohol, and reduction in dose while continuing Accutane. 5

Blood lipid determinations should be performed before Accutane is given and then at intervals until the lipid response to Accutane is established, which usually occurs within 4 weeks. Especially careful consideration must be given to risk/benefit for patients who may be at high risk during Accutane therapy (patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder). If Accutane therapy is instituted, more frequent checks of serum values for lipids and/or blood sugar are recommended (see PRECAUTIONS : Laboratory Tests ).

The cardiovascular consequences of hypertriglyceridemia associated with Accutane are unknown. Animal Studies: In rats given 8 or 32 mg/kg/day of isotretinoin (0.7 or 2.7 times the maximum clinical dose after normalization for total body surface area) for 18 months or longer, the incidences of focal calcification, fibrosis and inflammation of the myocardium, calcification of coronary, pulmonary and mesenteric arteries, and metastatic calcification of the gastric mucosa were greater than in control rats of similar age. Focal endocardial and myocardial calcifications associated with calcification of the coronary arteries were observed in two dogs after approximately 6 to 7 months of treatment with isotretinoin at a dosage of 60 to 120 mg/kg/day (15 to 30 times the maximum clinical dose, respectively, after normalization for total body surface area).

Hearing Impairment:   Impaired hearing has been reported in patients taking Accutane; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Mechanism(s) and causality for this event have not been established. Patients who experience tinnitus or hearing impairment should discontinue Accutane treatment and be referred to specialized care for further evaluation (see ADVERSE REACTIONS : Special Senses ).

Hepatotoxicity   Clinical hepatitis considered to be possibly or probably related to Accutane therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or continued administration of the drug. If normalization does not readily occur or if hepatitis is suspected during treatment with Accutane, the drug should be discontinued and the etiology further investigated.

Inflammatory Bowel Disease:   Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Accutane treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately (see ADVERSE REACTIONS : Gastrointestinal ).

Skeletal   Hyperostosis: A high prevalence of skeletal hyperostosis was noted in clinical trials for disorders of keratinization with a mean dose of 2.24 mg/kg/day. Additionally, skeletal hyperostosis was noted in 6 of 8 patients in a prospective study of disorders of keratinization. 6 Minimal skeletal hyperostosis and calcification of ligaments and tendons have also been observed by x-ray in prospective studies of nodular acne patients treated with a single course of therapy at recommended doses. The skeletal effects of multiple Accutane treatment courses for acne are unknown.

Premature Epiphyseal Closure:   There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses, but it is not known if there is a causal relationship with Accutane. In clinical trials for disorders of keratinization with a mean dose of 2.24 mg/kg/day, two children showed x-ray findings suggestive of premature epiphyseal closure. The skeletal effects of multiple Accutane treatment courses for acne are unknown.

Vision Impairment:   Visual problems should be carefully monitored. All Accutane patients experiencing visual difficulties should discontinue Accutane treatment and have an ophthalmological examination (see ADVERSE REACTIONS : Special Senses ).

Corneal Opacities:   Corneal opacities have occurred in patients receiving Accutane for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization. The corneal opacities that have been observed in clinical trial patients treated with Accutane have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug (see ADVERSE REACTIONS : Special Senses ).

Decreased Night Vision:    Decreased night vision has been reported during Accutane therapy and in some instances the event has persisted after therapy was discontinued. Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.


Information for Patients and Prescribers:    Females of childbearing potential should be instructed that they must not be pregnant when Accutane therapy is initiated, and that they should use effective contraception while taking Accutane and for 1 month after Accutane has been stopped. They should also sign a consent form prior to beginning Accutane therapy. They should be instructed to join the Accutane Survey and to review the patient videotape provided by Roche to the prescriber that provides information about contraception, the most common reasons that contraception fails, and the importance of using effective contraception when taking teratogenic drugs. Female patients should also be seen monthly and have a urine or serum pregnancy test performed each month during treatment to confirm negative pregnancy status (see boxed CONTRAINDICATIONS AND ).

Hypersensitivity   Anaphylactic reactions and other allergic reactions have been reported. Cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura (bruises and red patches) of the extremities and extracutaneous involvement (including renal) have been reported. Severe allergic reaction necessitates discontinuation of therapy and appropriate medical management.

Drug Interactions:

Laboratory Tests:

Carcinogenesis, Mutagenesis and Impairment of Fertility:   In male and female Fischer 344 rats given oral isotretinoin at dosages of 8 or 32 mg/kg/day (0.7 or 2.7 times the maximum clinical dose, respectively, after normalization for total body surface area) for greater than 18 months, there was a dose-related increased incidence of pheochromocytoma relative to controls. The incidence of adrenal medullary hyperplasia was also increased at the higher dosage in both sexes. The relatively high level of spontaneous pheochromocytomas occurring in the male Fischer 344 rat makes it an equivocal model for study of this tumor; therefore, the relevance of this tumor to the human population is uncertain.

The Ames test was conducted with isotretinoin in two laboratories. The results of the tests in one laboratory were negative while in the second laboratory a weakly positive response (less than 1.6 x background) was noted in S. typhimurium TA100 when the assay was conducted with metabolic activation. No dose-response effect was seen and all other strains were negative. Additionally, other tests designed to assess genotoxicity (Chinese hamster cell assay, mouse micronucleus test, S. cerevisiae D7 assay, in vitro clastogenesis assay with human-derived lymphocytes, and unscheduled DNA synthesis assay) were all negative.

In rats, no adverse effects on gonadal function, fertility, conception rate, gestation or parturition were observed at oral dosages of isotretinoin of 2, 8, or 32 mg/kg/day (0.2, 0.7, or 2.7 times the maximum clinical dose, respectively, after normalization for total body surface area).

In dogs, testicular atrophy was noted after treatment with oral isotretinoin for approximately 30 weeks at dosages of 20 or 60 mg/kg/day (5 or 15 times the maximum clinical dose, respectively, after normalization for total body surface area). In general, there was microscopic evidence for appreciable depression of spermatogenesis but some sperm were observed in all testes examined and in no instance were completely atrophic tubules seen. In studies of 66 men, 30 of whom were patients with nodular acne under treatment with oral isotretinoin, no significant changes were noted in the count or motility of spermatozoa in the ejaculate. In a study of 50 men (ages 17 to 32 years) receiving Accutane (isotretinoin) therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.

Pregnancy:    Category X. See boxed CONTRAINDICATIONS AND .

Nursing Mothers:   It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Accutane.


Clinical Trials and Postmarketing Surveillance:   The adverse reactions listed below reflect the experience from investigational studies of Accutane, and the postmarketing experience. The relationship of some of these events to Accutane therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Accutane are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, eg, of the lips, nasal passage, and eyes).

Dose Relationship:   Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy (see and ADVERSE REACTIONS ).

Body as a Whole:   allergic reactions, including vasculitis, systemic hypersensitivity (see PRECAUTIONS : Hypersensitivity ), edema, fatigue, lymphadenopathy, weight loss

Cardiovascular   palpitation, tachycardia, vascular thrombotic disease, stroke

Endocrine/Metabolic:   hypertriglyceridemia (see : Lipids ), alterations in blood sugar levels (see PRECAUTIONS : Laboratory Tests )

Gastrointestinal:   inflammatory bowel disease (see : Inflammatory Bowel Disease ), hepatitis (see : Hepatotoxicity ), pancreatitis (see : Lipids ), bleeding and inflammation of the gums, colitis, ileitis, nausea, other nonspecific gastrointestinal symptoms

Hematologic:   allergic reactions (see PRECAUTIONS : Hypersensitivity ), anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis (see PRECAUTIONS : Information for Patients and Prescribers ). See PRECAUTIONS : Laboratory for other hematological parameters.

Musculoskeletal   skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure (see : Skeletal ), mild to moderate musculoskeletal symptoms including arthralgia (see PRECAUTIONS : Information for Patients and Prescribers ), transient pain in the chest (see PRECAUTIONS : Information for Patients and Prescribers ), elevations of CPK (see PRECAUTIONS : Laboratory Tests ), arthritis, tendonitis, other types of bone abnormalities

Neurological:   pseudotumor cerebri (see : Pseudotumor Cerebri ), dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness

Psychiatric   suicidal ideation, suicide attempts, suicide, depression, psychosis (see : Psychiatric Disorders ), emotional instability

Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

Reproductive System:    abnormal menses

Respiratory:   bronchospasms (with or without a history of asthma), respiratory infection, voice alteration

Skin and Appendages:   acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas, 7 flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), sunburn susceptibility increased, sweating, urticaria, vasculitis (including Wegener's granulomastosis; see PRECAUTIONS : Hypersensitivity ), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see PRECAUTIONS : Information for Patients and Prescribers )

Special Senses:   Hearing: hearing impairment (see : Hearing Impairment ), tinnitus. Vision: corneal opacities (see : Corneal Opacities ), decreased night vision which may persist (see : Decreased Night Vision ), cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances

Urinary System:   glomerulonephritis (see PRECAUTIONS : Hypersensitivity ), nonspecific urogenital findings (see PRECAUTIONS : Laboratory for other urological parameters)

Laboratory   Elevation of plasma triglycerides (see : Lipids ), decrease in serum high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment

Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH (see : Hepatotoxicity )

Elevation of fasting blood sugar, elevations of CPK (see PRECAUTIONS : Laboratory Tests ), hyperuricemia

Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis; see PRECAUTIONS : Information for Patients and Prescribers ), elevated sedimentation rates, elevated platelet counts, thrombocytopenia

White cells in the urine, proteinuria, microscopic or gross hematuria


The oral LD 50 of isotretinoin is greater than 4000 mg/kg in rats and mice (>300 times the maximum clinical dose after normalization of the rat dose for total body surface area and >150 times the maximum clinical dose after normalization of the mouse dose for total body surface area) and is approximately 1960 mg/kg in rabbits (327 times the maximum clinical dose after normalization for total body surface area). In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. All symptoms quickly resolved without apparent residual effects.


The recommended dosage range for Accutane is 0.5 to 2 mg/kg given in 2 divided doses daily for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1 mg/kg/day, 8 it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages.

It is recommended that for most patients the initial dosage of Accutane be 0.5 to 1 mg/kg/day. Patients whose disease is very severe or is primarily manifested on the trunk may require up to the maximum recommended dosage, 2 mg/kg/day. 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.

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 (see : Skeletal: Hyperostosis and Premature Epiphyseal Closure ).

Contraceptive measures must be followed for any subsequent course of therapy (see boxed CONTRAINDICATIONS AND ).

Accutane should be administered with food.

Body Weight  Total Mg/Day 
kilograms pounds 0.5 mg/kg 1 mg/kg 2 mg/kg
 40 88 20 40 80
 50 110 25 50 100
 60 132 30 60 120
 70 154 35 70 140
 80 176 40 80 160
 90 198 45 90 180
100 220 50 100 200


Soft gelatin capsules, 10 mg (light pink), imprinted ACCUTANE 10 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0155-49).

Soft gelatin capsules, 20 mg (maroon), imprinted ACCUTANE 20 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0169-49).

Soft gelatin capsules, 40 mg (yellow), imprinted ACCUTANE 40 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0156-49).

Store at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light.


NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.



  1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 13- cis -retinoic acid. N Engl J Med 300:329-333, 1979. 
  2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 
  3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13- cis -retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 
  4. Jones H, Blanc D, Cunliffe WJ. 13- cis -retinoic acid and acne. Lancet 2:1048-1049, 1980. 
  5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 
  6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 
  7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin (13- cis -retinoic acid). Arch Dermatol 116:951-952, 1980. 
  8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.


To be completed by the patient, her parent/guardian * and signed by her prescriber.

Please read each item below and initial in the space provided to indicate that you understand each item and agree to follow your prescriber's instructions. DO NOT SIGN THIS CONSENT AND DO NOT TAKE ACCUTANE IF THERE IS ANYTHING THAT YOU DO NOT UNDERSTAND. A parent or guardian of a minor patient must also read and understand each item before signing the consent.

  1. I, __________________________________________________________,
    (Patient's Name)
    understand that Accutane is a very powerful medicine with the potential for serious Adverse Effects that is used to treat severe nodular acne that did not get better with other treatments including oral antibiotics.
                                                                       INITIALS: _________________
  2. I understand that I must not take Accutane (isotretinoin) if I am pregnant. I understand that I must not take Accutane if I am able to become pregnant and I am not using the required two separate forms of effective methods of birth control.
                                                                       INITIALS: _________________
  3. I understand from my prescriber that although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that my unborn baby could have severe birth defects if I am pregnant or become pregnant while taking Accutane in any amount even for short periods of time. Potentially any fetus exposed during pregnancy can be affected.
                                                                       INITIALS: _________________
  4. I understand that I must avoid pregnancy during the entire time of my treatment and for 1 month after the end of my treatment with Accutane.
                                                                       INITIALS: _________________
  5. I understand that if I am able to become pregnant and unless I absolutely and consistently abstain from sexual intercourse, I must use two separate, effective forms of birth control (contraception) AT THE SAME TIME.
                                                                       INITIALS: _________________
  6. I understand from discussions with my prescriber that birth control pills and injectable/implantable birth control products are the most effective forms of birth control. I understand that there have been reports of pregnancy from women who have used birth control pills, as well as women who have used injectable/implantable birth control products and I understand that pregnancies occur more often when only a single method of birth control is used. Therefore, I understand that it is essential that I use two different methods, even if one of the methods I choose is birth control pills or injectable/implantable birth control products.
                                                                       INITIALS: _________________
  7. I understand that the following are considered effective forms of contraception:
    Primary: ligation, partner's vasectomy, birth control pills, injectable/implantable birth control products, and an IUD
    Secondary:Diaphragms, latex condoms, and cervical caps; each must be used with a spermicide.
    I understand that at least one of my two chosen methods of birth control must be a primary method, and that any birth control method can fail, even when two forms are used at the same time.
                                                                       INITIALS: _________________
  8. I understand that I may receive free initial contraceptive counseling and pregnancy testing from a consulting physician or family planning center. I understand that my Accutane prescriber can provide me with an Accutane Patient Referral Form for this consultation.
                                                                       INITIALS: _________________
  9. I understand that I must begin actively avoiding pregnancy as described above at least 1 month before taking the first dose of Accutane, throughout treatment with Accutane and for 1 month after I have completed Accutane treatment.
                                                                       INITIALS: _________________
  10. I understand that I cannot receive a prescription for Accutane unless I have 2 negative pregnancy test results. The first pregnancy test should be during the office visit when my prescriber decides to prescribe Accutane. The second test should be on the second day of my next menstrual cycle or 11 days after the last time I had unprotected sexual intercourse, whichever is later. I understand that I will have additional pregnancy testing, monthly, throughout my Accutane therapy.
                                                                       INITIALS: _________________
  11. I understand that I should not start Accutane until I am sure that I am not pregnant and have negative results from 2 pregnancy tests.
                                                                       INITIALS: _________________
  12. I have read and understand the materials my prescriber has given to me, including the brochure Important Information Concerning Your Treatment with Accutane® (isotretinoin) . I have watched and understand the Roche video provided to me by my prescriber about contraception. I have also been told about a confidential counseling line that I may call for additional information about birth control and I have received information on emergency contraception.
                                                                       INITIALS: _________________
  13. I understand that I must not share my medication with anyone else and that I should not give blood until 1 month after taking my last dose of Accutane, because if I do, someone else's unborn baby may be exposed to Accutane.
                                                                       INITIALS: _________________
  14. I understand that I must immediately stop taking Accutane and inform my prescriber if I become pregnant, miss my menstrual period, or stop using birth control.
                                                                       INITIALS: _________________
  15. I have been given information about the confidential Accutane Survey by my prescriber and he/she has explained to me how important it is to join the Accutane Survey.
    My prescriber has answered all my questions about Accutane and the Accutane information provided to me. I understand all the information I have received and that avoiding pregnancy during Accutane treatment is my responsibility.
                                                                       INITIALS: _________________
    I now authorize my prescriber  ____________________________________ to begin my treatment with Accutane.
    Patient signature                                                                                  Date
    Parent/guardian signature                                                                     Date
    Please print:   Patient name and address
    Telephone (area code) __________________________________________
    I have fully explained to the patient, __________________________, the nature and purpose of the treatment described above and the risks to females of childbearing potential. I have asked the patient if she has any questions regarding her treatment with Accutane and have answered those questions to the best of my ability.
    Prescriber signature                                                                           Date

*if patient is a minor under the age of 18.

Roche Pharmaceuticals
Roche Laboratories Inc., 340 Kingsland Street, Nutley, New Jersey 07110-1199
Revised: May 2000