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TARO-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: Taro-Acitretin (acitretin capsules) 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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Taro-Acitretin should only be prescribed by qualified physicians experienced in the use of systemic retinoids who understand the risk of teratogenicity associated with Taro-Acitretin treatment. When prescribing this drug, physicians must use the Taro-Acitretin 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 Taro-Acitretin.
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 Taro-Acitretin 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 Taro-Acitretin 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. 5 OVERDOSE To date, there has been no experience with acute overdose of Acitretin.
If, despite these measures, hypertriglyceridemia and low HDL levels persist, the discontinuation of Taro-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 Protected B / Protégé B Taro-Acitretin (acitretin capsules) Page 11 of 49 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 acitretin. Patients who experience tinnitus or hearing impairment should discontinue Taro-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.
, Psychiatric 12/2025 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 1 INDICATIONS ....................................................................................................................
1 Pediatrics (< 18 years of age) ........................................................................................... 2 Geriatrics (≥ 65 years of age) ...........................................................................................
5 2 CONTRAINDICATIONS ....................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.........................................................................
7 4 DOSAGE AND ADMINISTRATION ....................................................................................... 1 Dosing Considerations .....................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................. 4 Administration .................................................................................................................
5 Missed Dose..................................................................................................................... 8 5 OVERDOSE ................................................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In the event of acute overdosage, acitretin must be withdrawn at once. Evacuation of the stomach should be considered Protected B / Protégé B Taro-Acitretin (acitretin capsules) Page 9 of 49 during the first few hours after overdose.
, severe headache, nausea or vomiting, drowsiness, irritability, and pruritus. Specific treatment is unnecessary because of the low acute toxicity of the preparation. Elevated intracranial pressure has been reported with both acute and chronic vitamin A overdoses as well as in patients treated with therapeutic doses of Acitretin.
Patients with a Taro- Acitretin overdose should be monitored closely for signs of increased intracranial pressure. If overdosage occurs in patients already receiving therapeutic doses of Taro-Acitretin, the drug must be discontinued immediately.
All female patients of childbearing potential who have taken an overdose of Taro-Acitretin must: • Have a pregnancy test at the time of the overdose. • Use an effective form of contraception for at least 3 years duration after the overdose.
If the pregnancy test is positive, the patient should be fully counselled on the serious risk to the fetus from exposure to Taro-Acitretin and the physician and patient should discuss the desirability of continuing the pregnancy. See 2 CONTRAINDICATIONS, 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and).
7 WARNINGS AND PRECAUTIONS, Reproductive Health, Teratogenic Risk.
Therefore, it is expected that some patients taking Taro-Acitretin could develop inflammatory bowel disease. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Taro-Acitretin immediately.
Hepatic/Biliary/Pancreatic • Hepatotoxicity:
Hepatic function should be checked before starting treatment with Taro-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, Taro-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 Taro-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, Monitoringand 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 Protected B / Protégé B Taro-Acitretin (acitretin capsules) Page 12 of 49 ADVERSE REACTIONS.
Therefore, every attempt should be made to control significant triglyceride elevation, see 7 WARNINGS AND PRECAUTIONS, Cardiovascular. Taro-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 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 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 […]
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................................... 9 7 WARNINGS AND PRECAUTIONS. ............................................................................................... 9 General..........................................................................................................................................................
9 Cardiovascular ............................................................................................................................................. 10 Driving and Operating Machinery ...............................................................................................................
10 Ear/Nose/Throat ......................................................................................................................................... 11 Endocrine and Metabolism .........................................................................................................................
11 Hepatic/Biliary/Pancreatic........................................................................................................................... 11 Pancreatitis: ................................................................................................................................................
11 Immune ....................................................................................................................................................... 12 Monitoring and Laboratory Tests ...............................................................................................................
12 Musculoskeletal .......................................................................................................................................... 13 Neurologic ...................................................................................................................................................
13 Protected B / Protégé B Taro-Acitretin (acitretin capsules) Page 3 of 49 Ophthalmologic ........................................................................................................................................... 14 Psychiatric ...................................................................................................................................................
14 Reproductive Health ................................................................................................................................... 1 Pregnancy...........................................................................................................................................
2 Breast-feeding .................................................................................................................................... 3 Pediatrics ............................................................................................................................................
4 Geriatrics (≥ 65 years of age):............................................................................................................. 17 8 ADVERSE REACTIONS ..............................................................................................................
22 9 DRUG […]