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SORIATANE is a brand name for Acitretin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SORIATANE (acitretin) is indicated for: • Severe psoriasis (includes erythrodermic and pustular types) • Other disorders of keratinization Severe psoriasis is a condition that involves more than 10% of body surface area or is physically, occupationally or psychologically disabling. Because of significant adverse…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations SORIATANE should only be prescribed by qualified physicians experienced in the use of systemic retinoids who understand the risk of teratogenicity associated with SORIATANE treatment. When SORIATANE (acitretin capsules) Page 7 of 48 prescribing this drug, physicians must use the SORIATANE Pregnancy Prevention Program.
Full patient information about the teratogenic risk and the strict pregnancy prevention measures should be given by the physician to all patients, male and female. See 2 CONTRAINDICATIONS and 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with SORIATANE.
Individualization of dosage is required to achieve maximum therapeutic response while minimizing side effects. 2 Recommended Dose and Dosage Adjustment The capsules should preferably be taken once daily with a meal or following a meal.
The following serves a guideline:
Initial Treatment SORIATANE treatment should be initiated at 25 mg per day, given as a single dose with the main meal. If by four weeks the response is unsatisfactory, and in the absence of toxicity, the daily dose may be gradually increased to a maximum of 75 mg per day.
The dose may be reduced if necessary to minimize side effects.
Maintenance Treatment Psoriasis:
Maintenance doses of 25 mg to 50 mg per day may be given after initial response to treatment. The maintenance dose should be based on clinical efficacy and tolerability. It may be necessary in some cases to increase the dose to a maximum of 75 mg per day.
In general, treatment should be terminated when lesions have resolved sufficiently. Relapses may be treated as outlined for initial treatment.
Other Keratinization Disorders:
Maintenance doses of 10 mg to a maximum of 50 mg per day may be given for disorders of keratinization. 4 Administration SORIATANE capsules should preferably be taken once daily with a meal or following a meal. 5 Missed Dose A missed dose should be taken as soon as the patient remembers.
However, if it is almost time for the next dose, the patient should skip the missed dose and continue with the regular dosing schedule. Doses should not be doubled up on the following day.
If, despite these measures, hypertriglyceridemia and low HDL levels persist, the discontinuation of SORIATANE should be considered. An associated risk of atherogenesis cannot be ruled out if these conditions persist. There have been post-marketing reports of acute myocardial infarction, thromboembolism and stroke in patients treated with SORIATANE.
See 8 ADVERSE REACTIONS. Post-marketing cases of capillary leak syndrome/retinoic acid syndrome have been reported with acitretin treatment. Driving and Operating Machinery Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
Decreased night vision and blurring of vision has been reported with acitretin treatment (see 7 WARNINGS AND PRECAUTIONS, Ophthalmologic). Patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.
Ear/Nose/Throat Impaired hearing and tinnitus have been reported in some patients treated with SORIATANE. Patients SORIATANE (acitretin capsules) Page 10 of 48 who experience tinnitus or hearing impairment should discontinue SORIATANE treatment and be referred for specialized care for further evaluation.
Endocrine and Metabolism • Glucose Tolerance:
In diabetics or patients with risk factors/family history of diabetes, retinoids may affect glucose tolerance. Blood-sugar levels must therefore be checked more frequently than usual in the early stages of treatment. Elevated fasting blood glucose levels have been reported and new cases of diabetes have been diagnosed during SORIATANE treatment.
See 2 CONTRAINDICATIONS, 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, 9 DRUG-DRUG INTERACTIONS, Table 4- Sulfonylurea (glyburide), and 8 ADVERSE REACTIONS. Gastrointestinal Other retinoids have been temporally associated with inflammatory bowel disease (including regional ileitis, colitis and hemorrhage) in patients without a prior history of intestinal disorders.
, Psychiatric 04/2025 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 ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 5 OVERDOSAGE..............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 16 8 ADVERSE REACTIONS ................................................................................................
21 9 DRUG INTERACTIONS ................................................................................................ 24 10 CLINICAL PHARMACOLOGY .......................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 26 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 27 PART II: SCIENTIFIC INFORMATION .......................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Acitretin in Canada.
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Therefore, it is expected that some patients taking SORIATANE could develop inflammatory bowel disease. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue SORIATANE immediately.
Hepatic/Biliary/Pancreatic • Hepatotoxicity:
Hepatic function should be checked before starting treatment with SORIATANE, every 4 weeks for the first 2 months after commencement, and then at least every 3 months during treatment. If abnormal results are obtained, weekly checks should be instituted.
If hepatic function fails to return to normal or deteriorates further, SORIATANE must be withdrawn. In such cases it is advisable to continue monitoring hepatic function for at least 3 months. Elevations of AST (SGOT), ALT (SGPT) or LDH have occurred in 20-28% of patients treated with SORIATANE.
One of the 329 patients treated in clinical trials had clinical jaundice with elevated serum bilirubin and transaminases considered possibly related to SORIATANE treatment. Liver function test results in this patient returned to normal after SORIATANE was discontinued.
If hepatotoxicity is suspected during treatment with SORIATANE, the drug should be discontinued and the etiology further investigated. Ten of 652 patients treated in clinical trials of etretinate, (acitretin is the active metabolite), had clinical or histologic hepatitis considered to be possibly or probably related to etretinate treatment.
There have been four reports of hepatitis-related deaths worldwide; two of these patients had received etretinate for a month or less before presenting with hepatic symptoms. See 2 CONTRAINDICATIONS, 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, and 8 ADVERSE REACTIONS.
• Pancreatitis: There have been some reports of fatal fulminant pancreatitis with SORIATANE and other retinoids. This is sometimes associated with elevation of serum triglycerides in excess of 800 mg/dL or 9 mmol/L. See 8 ADVERSE REACTIONS.
Therefore, every attempt should be made to control significant triglyceride elevation, see 7 WARNINGS AND PRECAUTIONS, Cardiovascular. SORIATANE treatment should be discontinued if uncontrolled hypertriglyceridemia or if symptoms of pancreatitis occur.
SORIATANE (acitretin capsules) Page 11 of 48 Immune Anaphylactic reactions have been very rarely reported. In individuals treated with systemic retinoids, these reactions were more serious after prior exposure to topical retinoids. Severe allergic reactions, including hypersensitivity to acitretin necessitate interruption of treatment and careful monitoring.
Monitoring and Laboratory Tests • Pregnancy Tests:
At the start of SORIATANE treatment, two pregnancy tests must be obtained from a licensed laboratory (minimum sensitivity 25 mIU/mL). The first test (with a negative result) is obtained at screening when SORIATANE treatment is under consideration and the second (confirmatory) test (with a negative result) must be obtained up to 3 days before the first dose is given.
During treatment, pregnancy tests should be arranged at 28 day-intervals. A negative pregnancy test not older than 3 days is mandatory before a renewal prescription is provided at monthly follow-up visits with the physician. After stopping treatment, pregnancy tests should be performed at 1-3 monthly intervals for a period of 3 years after the last dose was given.
See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and 7 WARNINGS AND PRECAUTIONS, Reproductive Health, Teratogenic Risk. • Lipid Monitoring: Serum cholesterol and serum triglycerides (fasting values) should be performed before starting treatment with acitretin and again at intervals of 4 weeks until the lipid response to the drug is established, which is usually within four to eight weeks and thereafter every three months during treatment.
See 7 WARNINGS AND PRECAUTIONS, Cardiovascular. In patients with diabetes, alcoholism, obesity, cardiovascular risk factors or a lipid metabolism disorder […]
28 13 PHARMACEUTICAL INFORMATION ............................................................................ 28 14 CLINICAL TRIALS ........................................................................................................
28 15 MICROBIOLOGY ........................................................................................................ 28 16 NON-CLINICAL TOXICOLOGY .....................................................................................
28 PATIENT MEDICATION INFORMATION .................................................................................. 40 SORIATANE (acitretin capsules) Page 4 of 48 PART I: […]