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ACCUTANE is a brand name for Isotretinoin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ACCUTANE™ (isotretinoin) is indicated for the treatment of: • Severe Nodular and/or Inflammatory Acne • Acne Conglobata • Recalcitrant Acne Because of significant side effects associated with its use, ACCUTANE should be reserved for patients where the conditions listed above are unresponsive to conventional first line…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Female patients of childbearing potential must not be given ACCUTANE until pregnancy is excluded. 2 Recommended Dose and Dosage Adjustment The therapeutic response to ACCUTANE is dose related and varies between patients.
This necessitates individual adjustment of dosage according to the response of the condition and the patient’s tolerance of the drug. In most cases, complete or near complete suppression of acne is achieved with a single 12 to 16 week course of therapy.
If a second course of therapy is needed, it can be initiated eight or more weeks after completion of the first course, since experience has shown that patients may continue to PrACCUTANE™ (Isotretinoin Capsules) Page 7 of 37 improve while off the drug.
Initial Therapy The initial dose of ACCUTANE should be individualized according to the patient’s weight and severity of the disease. 5 mg/kg body weight daily for a period of two to four weeks, when their responsiveness to the drug will usually be apparent.
It should be noted that transient exacerbation of acne is occasionally seen during this initial period. The daily dosage should be taken with food in the nearest number of whole capsules, either as a single dose or in two divided doses during the day, whichever is more convenient.
1 and 1 mg/kg body weight daily and, in exceptional instances, up to 2 mg/kg body weight daily, depending upon individual patient response and tolerance to the drug. A complete course of therapy consists of 12 to 16 weeks of ACCUTANE administration.
Patients may show additional improvement for up to several months after a course of ACCUTANE has been completed. With effective treatment, appearance of new lesions will not normally be evident for a period of at least three to six months.
4 Administration ACCUTANE is for oral use only. ACCUTANE should only be prescribed by physicians knowledgeable in the use of retinoids systemically, who understand the risk of teratogenicity in females of child bearing age and who are experienced in counselling young adults for whom ACCUTANE is generally indicated (see 1 INDICATIONS and boxed 2 CONTRAINDICATIONS).
5 Missed Dose If a patient misses a dose of ACCUTANE, it may be taken later the same day, but, the patient should be instructed to not take more ACCUTANE in one day than what has been prescribed. The patient should then administer the next dose on the usual scheduled dosing day.
1 Adverse Reaction Overview The adverse reactions listed below reflect the experience from clinical studies of ACCUTANE and the post-marketing experience. The relationship of some of these events to ACCUTANE therapy is unknown. Many of the side effects and adverse reactions seen or expected in patients receiving ACCUTANE are similar to those described in patients taking high doses of vitamin A.
Adverse reactions were generally reversible when therapy was discontinued; however, some have persisted after cessation of therapy. 2 Clinical Trial Adverse Reactions Dose–Relationship and Duration: Cheilitis and hypertriglyceridemia are usually dose related.
The most common side effects are mucocutaneous or dermatologic. The common side effects include: cheilitis (96%), facial erythema/dermatitis (55%), dry nose (51%), desquamation (50%), pruritus (30%), dry skin (22%), conjunctivitis (19%), alopecia (13%), irritation of the eyes (11%), rash (<10%).
Dryness of the nasal mucosa and pharynx may be associated with mild epistaxis and hoarseness, respectively. Mild to moderate conjunctivitis may be alleviated by use of an ophthalmic ointment. In rare cases, hair loss persisted after treatment was completed.
Approximately 13% of patients experience joint pain during treatment. Peeling of palms and soles, skin infections, increased susceptibility to sunburn, non-specific urogenital symptoms, non-specific gastrointestinal symptoms, headache, fatigue occurred in approximately 5% of patients.
Body as a whole: weight loss, anemia, lymphadenopathy, vasculitis including Wegener’s granulomatosis, allergic vasculitis, allergic responses, and systemic hypersensitivity. Cardiovascular: edema, transient pain in the chest, palpitations, tachycardia, vascular thrombotic disease, stroke (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
, Reproductive Health: Female and Male Potential, Function 2025-08 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 2025-08 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 5 Missed Dose ...........................................................................................................
7 5 OVERDOSAGE............................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 8 7 WARNINGS AND PRECAUTIONS .................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The patient should not take a double dose to make up for a missed dose.
Endocrine and Metabolism: new cases of diabetes (see 7 WARNINGS AND PRECAUTIONS, Endocrine PrACCUTANE™ (Isotretinoin Capsules) Page 19 of 37 and Metabolism) Gastrointestinal: nausea, severe diarrhea, mild gastrointestinal bleeding, rectal bleeding, abdominal pain, inflammatory bowel disease (including regional ileitis, colitis and hemorrhage) (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).
Hearing Disorders: tinnitus, impaired hearing at certain frequencies.
Hepatic/Biliary/Pancreatic:
Patients treated with ACCUTANE especially those with high triglyceride levels are at risk of developing pancreatitis. Rare cases of fatal pancreatitis and several cases of clinical hepatitis have been reported (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Mucocutaneous and Dermatologic: flushing, changes in skin pigment, urticaria, bruising, disseminated herpes simplex, hair problems (other than thinning), hirsutism, erythema nodosum, paronychia, nail dystrophy, pyogenic granuloma, bleeding and inflammation of the gums, acne fulminans, exanthema, sweating, increased formation of granulation tissue, photoallergic/photosensitizing reactions, skin fragility.
5 Post-Market Adverse Reactions). 5 Post-Market Adverse Reactions). Neurologic: seizures, dizziness, nervousness, drowsiness, malaise, weakness, insomnia, lethargy, paresthesia, benign intracranial hypertension (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Neurologic).
Ophthalmologic: optic neuritis, photophobia, eye lid inflammation, lenticular cataracts, keratitis, blurred vision, blepharitis, conjunctivitis, decreased night vision, papilledema as sign of benign intracranial hypertension and colour vision disturbances.
Dry eyes and/or decreased tolerance to contact lenses have also been reported during therapy. In some instances, these conditions have persisted after cessation of therapy. Of 72 patients who had normal pre-treatment ophthalmological examinations, five developed corneal opacities while taking ACCUTANE (all five patients had a disorder of keratinization).
Corneal opacities have also been reported in nodular and/or inflammatory acne patients treated with ACCUTANE (see 7 WARNINGS AND PRECAUTIONS, Ophthalmologic). Decrease in night vision has been reported and in rare instances has persisted (see 7 WARNINGS AND PRECAUTIONS, Ophthalmologic).
Cataracts and visual disturbances have also been reported.
Psychiatric Disorders:
Depression, psychotic symptoms and, rarely, suicide attempts, suicide, and aggressive and/or violent behaviours (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Psychiatric and 7 WARNINGS AND PRECAUTIONS, Psychiatric). Depression has been reported during and after therapy.
In some of these patients, depression has subsided with discontinuation of therapy and recurred when ACCUTANE therapy was reintroduced. Emotional instability has been reported with ACCUTANE. Respiratory: respiratory infections, bronchospasm has been rarely reported; sometimes in patients PrACCUTANE™ (Isotretinoin Capsules) Page 20 of 37 with pre-history of asthma.
Reproductive system: abnormal menses, erectile dysfunction. 4.
Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry, and Other Quantitative Data ACCUTANE therapy induces changes in serum lipids in a significant number of treated subjects. These changes consisted of: elevation of serum triglycerides (25% of patients), mild to moderate decrease in serum high density lipoprotein (HDL) (16% of patients), and minimal elevations of serum cholesterol (7% of patients).
Abnormalities of serum triglycerides, HDL and cholesterol were reversible upon cessation of ACCUTANE therapy. A rise in serum levels of liver enzymes may occur, especially with higher dosages. Although the […]
1 Special Populations .............................................................................................. 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
18 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................
4.
Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry, and Other Quantitative Data............................................................................................................. 5 Post-Market Adverse Reactions...........................................................................
20 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions .............................................................................
4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................ 6 Drug-Herb Interactions ........................................................................................
7 Drug-Laboratory Test Interactions....................................................................... 22 10 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 1 Mechanism of Action ...........................................................................................
2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics ................................................................................................. 22 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
24 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 24 PART II: SCIENTIFIC INFORMATION ..................................................................................... 25 13 PHARMACEUTICAL INFORMATION ..........................................................................
25 14 CLINICAL TRIALS ...................................................................................................... 25 15 MICROBIOLOGY ......................................................................................................
25 16 NON-CLINICAL TOXICOLOGY .................................................................................... 25 PATIENT MEDICATION INFORMATION ................................................................................ 29 PrACCUTANE™ (Isotretinoin Capsules) Page 4 of 37 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ACCUTANE™ (isotretinoin) is indicated for the treatment of: • Severe Nodular and/or Inflammatory Acne • Acne Conglobata • Recalcitrant Acne Because of significant side effects associated with its use, ACCUTANE should be reserved for patients where the […]