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MINT-ACITRETIN 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: MINT-ACITRETIN is also contraindicated in the following conditions: • Patients who are hypersensitive to MINT-ACITRETIN (acitretin) or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND…
Verbatim from this product's HC label. Tap a section to expand.
If, despite these measures, hypertriglyceridemia and low HDL levels persist, the discontinuation of MINT- ACITRETIN 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 acitretin.
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.
MINT-ACITRETIN (acitretin capsules) Page 10 of 48 Ear/Nose/Throat Impaired hearing and tinnitus have been reported in some patients treated with acitretin. Patients who experience tinnitus or hearing impairment should discontinue MINT-ACITRETIN 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 acitretin 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.
Therefore, it is expected that some patients taking MINT-ACITRETIN could develop inflammatory bowel disease. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue MINT-ACITRETIN immediately.
, Psychiatric 05/2026 Table of Contents Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. Recent Major Label Changes....................................................................................................
2 Table of Contents .................................................................................................................... 2 PART I: HEALTHCARE PROFESSIONAL INFORMATION ..............................................................
4 1. INDICATIONS .................................................................................................................... 1. Pediatrics (<18 years of age) .....................................................................................
2. Geriatrics (≥ 65 years of age) ..................................................................................... 4 2. CONTRAINDICATIONS .......................................................................................................
4 3. SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................. 6 4. DOSAGE AND ADMINISTRATION ....................................................................................... 1. Dosing Considerations ...............................................................................................
2. Recommended Dose and Dosage Adjustment .......................................................... 4. Administration........................................................................................................... 5. Missed Dose ..............................................................................................................
7 5. OVERDOSE........................................................................................................................ 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.
Other brands of Acitretin in Canada.
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Hepatic/Biliary/Pancreatic • Hepatotoxicity:
Hepatic function should be checked before starting treatment with MINT-ACITRETIN, 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, MINT-ACITRETIN 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 acitretin.
One of the 329 patients treated in clinical trials had clinical jaundice with elevated serum bilirubin and transaminases considered possibly related to acitretin treatment. Liver function test results in this patient returned to normal after acitretin was discontinued.
If hepatotoxicity is suspected during treatment with MINT-ACITRETIN, 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 acitretin 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, MINT-ACITRETIN (acitretin capsules) Page 11 of 48 see 7 WARNINGS AND PRECAUTIONS, Cardiovascular. MINT-ACITRETIN treatment should be discontinued if uncontrolled hypertriglyceridemia or if symptoms of pancreatitis occur.
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 MINT-ACITRETIN 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 MINT-ACITRETIN 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, […]
1. Special Populations ................................................................................................. 15 8. ADVERSE REACTIONS ......................................................................................................
1. Adverse Reaction Overview ..................................................................................... 2. Clinical Trial Adverse Reactions ............................................................................... 3. 0%) ..........................................
4.
Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings ................................................................................................... 5. Post-Market Adverse Reactions ..............................................................................
21 9. DRUG INTERACTIONS ..................................................................................................... 1. Serious 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 .......................................................................... 24 10. CLINICAL PHARMACOLOGY .............................................................................................
1. Mechanism of Action............................................................................................... 2. Pharmacodynamics .................................................................................................
3. Pharmacokinetics .................................................................................................... 24 11. STORAGE AND STABILITY ................................................................................................
26 12. SPECIAL HANDLING INSTRUCTIONS ................................................................................ 26 PART II: SCIENTIFIC INFORMATION ........................................................................................
27 13. PHARMACEUTICAL INFORMATION ................................................................................. 27 14. CLINICAL TRIALS .............................................................................................................
1. Clinical Trial by Indication ........................................................................................ 2. Comparative Bioavailability Studies ........................................................................ 28 15.
MICROBIOLOGY .............................................................................................................. 29 16. NON-CLINICAL TOXICOLOGY ...........................................................................................
29 17. SUPPORTING PRODUCT MONOGRAPHS ......................................................................... 39 Patient Medication Information ............................................................................................
40 MINT-ACITRETIN (acitretin capsules) Page 4 of 48 […]