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PROPYLTHIOURACIL is a brand name for Propylthiouracil, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PROPYLTHIOURACIL TABLETS (propylthiouracil tablets) is indicated: For the medical management of hyperthyroidism. In conjunction with radioiodine to hasten recovery while awaiting the effects of radiation. For the control of thyrotoxicosis prior to surgery. In the management of a thyroid storm in addition to…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Treatment with PROPYLTHIOURACIL TABLETS should be individualized, according to the severity of symptoms and signs of hyperthyroidism and response to therapy. Usually after one or 2 weeks, but certainly after 3 weeks of therapy, objective signs of clinical improvement should be seen.
Delayed responses are sometimes noted when the thyroid is unusually large and when iodine in any form has previously been given. The course of therapy may last from 6 months to 3 years. Usually within 1 to 2 years, a prolonged remission in 50% of the cases can be expected.
When remission is observed, PROPYLTHIOURACIL TABLETS should be withdrawn over a period of 1- 2 months under close supervision. 2 Recommended Dose and Dosage Adjustment Adults (≥18 years of age): The recommended initial dose is 50-100 mg (1 to 2 tablets of PROPYLTHIOURACIL TABLETS) every 8 hours, with increases as necessary up to a maximum of 500 mg/day.
In some cases, initial doses as high as 900 mg/day may be required. When doses larger than 300 mg/day of PROPYLTHIOURACIL TABLETS are needed, the drug should be administered every 4 to 6 hours. The patient should be examined regularly by the physician and the dose of PROPYLTHIOURACIL TABLETS adjusted until the patient is euthyroid (usually after 6-8 weeks).
At this stage, the dose should be reduced by 1/3 every 4-6 weeks to a maintenance dosage of one tablet of PROPYLTHIOURACIL TABLETS 2 or 3 times daily, administered at regular intervals.
Geriatric (>65 years of age):
No data are available to determine whether subjects aged 65 or over respond differently from younger subjects. Dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Pediatric (<18 years of age):
Health Canada has not authorized an indication for pediatric use.
Hepatic impairment:
No clinical studies have been performed with PROPYLTHIOURACIL TABLETS in patients with hepatic insufficiency. Since liver toxicity is associated with the use of PROPYLTHIOURACIL TABLETS, caution is warranted in patients with hepatic impairment.
Peri-Operative Considerations When PROPYLTHIOURACIL TABLETS is administered pre-operatively, iodine, in the form of a strong iodine solution (Lugol’s solution or potassium iodide solution) should be given concomitantly for 7-10 days prior to surgery.
The rationale for this is to reduce the vascularity and fragility of the thyroid gland. Renal PROPYLTHIOURACIL TABLETS should be used with caution in patients with renal impairment. Respiratory In view of the fact that hypothyroid patients seem to have poor adrenergic nervous function, PROPYLTHIOURACIL TABLETS should be used with caution in patients with asthma.
Skin PROPYLTHIOURACIL TABLETS should be discontinued immediately at the appearance of a skin rash, as the rash may be, in some instances, followed by dermatological reactions/hypersensitivity syndrome (including Stevens Johnson Syndrome or, toxic epidermal necrolysis).
1 Pregnant Women Hyperthyroidism in pregnant women should be adequately treated to prevent serious maternal and fetal complications. Individual benefit/risk assessment is necessary before treatment with PROPYLTHIOURACIL TABLETS during pregnancy.
If PROPYLTHIOURACIL TABLETS is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard of the rare potential hazard to the mother and fetus of liver damage.
PROPYLTHIOURACIL TABLETS is suggested for use prior to conception and in the first trimester of pregnancy where clinically appropriate due to the higher risk of congenital abnormalities with methimazole during fetal organogenesis in the first trimester.
After the first trimester of pregnancy, the use of an alternative antithyroid medication may be advisable given the potential for maternal hepatotoxicity from PROPYLTHIOURACIL TABLETS. PROPYLTHIOURACIL TABLETS should be administered during pregnancy at the lowest effective dose, without additional administration of thyroid hormones.
Severe liver injury and acute liver failure, in some cases fatal, have been reported in patients treated with PROPYLTHIOURACIL TABLETS. These reports of hepatic reactions include cases requiring liver transplantation in adult and pediatric patients.
1 Dosing Considerations Treatment with PROPYLTHIOURACIL TABLETS should be individualized, according to the severity of symptoms and signs of hyperthyroidism and response to therapy. Usually after one or 2 weeks, but certainly after 3 weeks of therapy, objective signs of clinical improvement should be seen.
Delayed responses are sometimes noted when the thyroid is unusually large and when iodine in any form has previously been given. The course of therapy may last from 6 months to 3 years. Usually within 1 to 2 years, a prolonged remission in 50% of the cases can be expected.
When remission is observed, PROPYLTHIOURACIL TABLETS should be withdrawn over a period of 1- 2 months under close supervision. 2 Recommended Dose and Dosage Adjustment Adults (≥18 years of age): The recommended initial dose is 50-100 mg (1 to 2 tablets of PROPYLTHIOURACIL TABLETS) every 8 hours, with increases as necessary up to a maximum of 500 mg/day.
In some cases, initial doses as high as 900 mg/day may be required. When doses larger than 300 mg/day of PROPYLTHIOURACIL TABLETS are needed, the drug should be administered every 4 to 6 hours. The patient should be examined regularly by the physician and the dose of PROPYLTHIOURACIL TABLETS adjusted until the patient is euthyroid (usually after 6-8 weeks).
At this stage, the dose should be reduced by 1/3 every 4-6 weeks to a maintenance dosage of one tablet of PROPYLTHIOURACIL TABLETS 2 or 3 times daily, administered at regular intervals.
Geriatric (>65 years of age):
No data are available to determine whether subjects aged 65 or over respond differently from younger subjects. Dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
PROPYLTHIOURACIL TABLETS is contraindicated in patients who are hypersensitive to this drug, related thioamide derivatives 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 PACKAGING. PROPYLTHIOURACIL TABLETS is contraindicated in breast-feeding women.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Propylthiouracil in Canada.
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Renal impairment:
No clinical studies have been performed with PROPYLTHIOURACIL TABLETS in patients with renal impairment. M.
Bennett et al1:
Glomerular Filtration Rate (creatinine clearance) 10-50 mL/min <10 mL/min Reduce dose by 25% of the usual maintenance dose 50% of the usual maintenance dose 1. Bennett WM et al. Guidelines for drug therapy in renal failure. Ann Intern Med 1977; 86:754 -83.
4 Administration PROPYLTHIOURACIL TABLETS can be taken with or without food. Patients should be instructed to swallow tablets whole and not to chew, split, or crush tablets. Patients should not ingest if tablets are broken, cracked, or otherwise not intact.
PROPYLTHIOURACIL TABLETS should be taken at the same time each day. 5 Missed Dose Advise patients to not double a dose to make up for a missed dose.
Twice-daily dose:
If it is less than 6 hours before the patient’s next dose, skip the dose they missed and take their next dose when they are meant to. If the patient remembers with 6 or more hours before the next dose, they should take the missed dose as soon as they remember, then take the next dose at the scheduled time.
QID (4 times a day) dose:
If it is less than 3 hours before the patient’s next dose, skip the dose they missed and take their next dose when they are meant to. If the patient remembers to take PROPYLTHIOURACIL TABLETS with 3 or more hours before the next dose, they should take the missed dose as soon as they remember, then take the next dose at the scheduled time.
Close maternal, fetal and neonatal monitoring of thyroid function is recommended, with adjustment of PROPYLTHIOURACIL TABLETS as necessary. PROPYLTHIOURACIL TABLETS, used judiciously, is an effective drug for the treatment of hyperthyroidism in pregnant women.
However, the drug readily crosses the placental barrier where it can induce goiter and hypothyroidism in the developing fetus. Rare cases of congenital anomalies have been observed post-marketing. 5 Post-Market Adverse Reactions Epidemiological studies provide conflicting results regarding the risk of congenital malformations.
2 Breast-feeding Propylthiouracil is excreted in breast milk and is contraindicated in nursing mothers. 3 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics Geriatrics (>65 years of age): Clinical studies of propylthiouracil did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. 1 Adverse Reaction Overview The most serious adverse reactions associated with PROPYLTHIOURACIL TABLETS are agranulocytosis, hepatotoxicity and rarely, systemic vasculitis.
Recovery is often possible following immediate cessation of the drug. Inhibition of hemopoiesis (agranulocytosis, granulocytopenia, leucopenia, thrombocytopenia) is the most serious side effect. 5%. It usually develops in the first few months of therapy, is dose-related and is reversible on rapid withdrawal of the drug.
Leukopenia with granulocytopenia, hemolytic anemia, thrombocytopenia, hypoprothrombinemia with hemorrhagic manifestations, aplastic anemia, myeloblastic leukemia and hyperglobulinemia have been reported. Severe adverse reactions include liver injury presenting as hepatitis, liver failure necessitating liver transplantation or resulting in death.
See 7 WARNINGS AND PRECAUTIONS Hepatocellular necrosis and fulminant hepatic failure have been reported in patients treated with PROPYLTHIOURACIL TABLETS. Typically these reactions occur within the first two months of PROPYLTHIOURACIL TABLETS treatment.
Injury is reversible upon discontinuation of PROPYLTHIOURACIL TABLETS although encephalopathy and/or substantial hepatic necrosis have been reported. 2% in patients treated with PROPYLTHIOURACIL TABLETS. Propylthiouracil-induced hepatotoxicity is not dose-related and is thought to be idiosyncratic with an autoimmune component.
There are reports of a vasculitis associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications and death. , Stevens Johnson syndrome and toxic epidermal necrolysis) in patients treated with PROPYLTHIOURACIL TABLETS.
See 7 WARNINGS AND PRECAUTIONS Itching, urticaria, pruritus and a mild papular rash which may be accompanied by purpura are the most common skin reactions; (incidence approximately 3%). Loss or depigmentation of the hair are less frequent.
Two cases of vesicular eruption in the newborn have been reported, secondary to maternal PROPYLTHIOURACIL TABLETS therapy. PROPYLTHIOURACIL TABLETS (propylthiouracil) Page 11 of 23 Other adverse reactions include nausea, vomiting, ageusia, abdominal discomfort, drowsiness, headache, dizziness, arthralgia and paresthesia occur occasionally.
Drug fever, lymphadenopathy, splenomegaly, hepatitis, cholestatic jaundice, neuritis, nephritis, unusual increase or decrease in urination, backache, sialadenopathy, recurrent keratitis, conjunctival disorders, connective tissue disorders resembling polyarteritis, arthritis, lupus […]
Pediatric (<18 years of age):
Health Canada has not authorized an indication for pediatric use.
Hepatic impairment:
No clinical studies have been performed with PROPYLTHIOURACIL TABLETS in patients with hepatic insufficiency. Since liver toxicity is associated with the use of PROPYLTHIOURACIL TABLETS, caution is warranted in patients with hepatic impairment.
Renal impairment:
No clinical studies have been performed with PROPYLTHIOURACIL TABLETS in patients with renal impairment. M.
Bennett et al1:
Glomerular Filtration Rate (creatinine clearance) 10-50 mL/min <10 mL/min Reduce dose by 25% of the usual maintenance dose 50% of the usual maintenance dose 1. Bennett WM et al. Guidelines for drug therapy in renal failure. Ann Intern Med 1977; 86:754 -83.
4 Administration PROPYLTHIOURACIL TABLETS can be taken with or without food. Patients should be instructed to swallow tablets whole and not to chew, split, or crush tablets. Patients should not ingest if tablets are broken, cracked, or otherwise not intact.
PROPYLTHIOURACIL TABLETS should be taken at the same time each day. 5 Missed Dose Advise patients to not double a dose to make up for a missed dose.
Twice-daily dose:
If it is less than 6 hours before the patient’s next dose, skip the dose they missed and take their next dose when they are meant to. If the patient remembers with 6 or more hours before the next dose, they should take the missed dose as soon as they remember, then take the next dose at the scheduled time.
QID (4 times a day) dose:
If it is less than 3 hours before the patient’s next dose, skip the dose they missed and take their next dose when they are meant to. If the patient remembers to take PROPYLTHIOURACIL TABLETS with 3 or more hours before the next dose, they should take the missed dose as soon as they remember, then take the next dose at the scheduled time.
5 OVERDOSAGE Agranulocytosis is the most serious adverse effect resulting from overdose and/or prolonged administration. There has been one reported case of overdose with PROPYLTHIOURACIL TABLETS in the literature where the patient developed Henoch-Schonlein purpura (HSP) for which causal relationship with the drug could not be confirmed.
Overdosage can result in enlargement of the thyroid gland, with signs and symptoms of hypothyroidism. This can be readily reversed by reducing or even temporarily withdrawing medication. Thyroxine replacement therapy, until the patient becomes euthyroid, may be indicated.
Overdosage in pregnant women may result in congenital goiter and hypothyroidism in the fetus. The newborn child should be examined carefully for signs of hypothyroidism and immediate thyroid therapy should be instituted if hypothyroidism is confirmed.
Haemorrhage may be controlled by the administration of vitamin K1 and the dosage of PROPYLTHIOURACIL TABLETS should be reduced. For management of a suspected drug overdose, contact your regional poison control centre. PROPYLTHIOURACIL TABLETS (propylthiouracil) Page 7 of 23 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1– Dosage Forms, Strengths, Composition and Packaging Description Propylthiouracil is a thioamide derivative which occurs as a white crystalline powder, odourless with a bitter taste, very slightly soluble in water, sparingly soluble in ethanol and soluble in solutions of alkali hydroxides or ammonia.
50 mg tablets: white, round, biconvex and uncoated; one side is debossed 'PRESTAB' and other side is plain. PROPYLTHIOURACIL TABLETS are supplied in bottles containing 100 tablets. 1 Warnings and Precautions Synopsis PROPYLTHIOURACIL TABLETS should be […]