Propylthiouracil 50 mg/1
Propylthiouracil · TABLET · Teva Pharmaceuticals, Inc.
Propylthiouracil is a tablet containing propylthiouracil at 50 mg/1, taken oral. Manufactured by Teva Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Propylthiouracil
- Generic Name
- Propylthiouracil
- NDC Code (Product)
0480-9242- Manufacturer
- Teva Pharmaceuticals, Inc.
- Strength
- 50 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA080172
- Drug Class
- Thyroid Hormone Synthesis Inhibitor [EPC]
- Marketing Start
- 07/10/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Propylthiouracil is indicated: in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole.
Dosage & Administration
DOSAGE AND ADMINISTRATION Propylthiouracil is administered orally. The total daily dosage is usually given in 3 equal doses at approximately 8-hour intervals. Adults The initial dose is 300 mg daily. In patients with severe hyperthyroidism, very large goiters, or both, the initial dose may be increased to 400 mg daily; an occasional patient will require 600 to 900 mg daily initially. The usual maintenance dose is 100 to 150 mg daily. Pediatric Patients Propylthiouracil is generally not recommended for use in the pediatric patient population except in rare instances in which other alternative therapies are not appropriate options. Studies evaluating appropriate dosing regimen have not been conducted in the pediatric population although general practice would suggest initiation of therapy in patients 6 years or older at a dosage of 50 mg daily with careful upward titration based on clinical response and evaluation of TSH and free T4 levels. Although cases of severe liver injury have been reported with doses as low as 50 mg/day, most cases were associated with doses of 300 mg/day and higher. Geriatric Patients Clinical studies of propylthiouracil did not include sufficient numbers of …
Warnings
WARNINGS Liver Toxicity Liver injury resulting in liver failure, liver transplantation, or death, has been reported with propylthiouracil therapy in adult and pediatric patients. No cases of liver failure have been reported with the use of methimazole in pediatric patients. For this reason, propylthiouracil is not recommended for pediatric patients except when methimazole is not well-tolerated and surgery or radioactive iodine therapy are not appropriate therapies. Biochemical monitoring of liver function (bilirubin, alkaline phosphatase) and hepatocellular integrity (ALT, AST) is not expected to attenuate the risk of severe liver injury due to its rapid and unpredictable onset. Patients should be informed of the risk of liver failure. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc.), particularly in the first six months of therapy. When these symptoms occur, propylthiouracil should be discontinued immediately and liver function tests and ALT and AST levels obtained. Use in Pregnancy There are cases of liver injury, including liver failure and death, in women treated with propylthiouracil during pregna…
Contraindications
CONTRAINDICATIONS Propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been reported with the use of propylthiouracil. Because these events generally come from voluntary reporting from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Severe adverse reactions include liver injury presenting as hepatitis, liver failure necessitating liver transplantation or resulting in death (see WARNINGS ). Inhibition of myelopoiesis (agranulocytosis, granulopenia, aplastic anemia, and thrombocytopenia), drug fever, a lupus-like syndrome (including splenomegaly and vasculitis), periarteritis, hypoprothrombinemia, and bleeding have been reported. Nephritis, glomerulonephritis, interstitial pneumonitis, exfoliative dermatitis, and erythema nodosum have also been reported. There are reports of a vasculitis associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications and death (see WARNINGS ). There have been rare reports of serious hypersensitivity reactions (e.g., Stevens Johnson syndrome and toxic epidermal necrolysis) in patients treated with propylthiouracil. Other adve…
Frequently Asked Questions
What is Propylthiouracil used for?
Propylthiouracil contains Propylthiouracil. It is a tablet taken oral. Consult your doctor for specific uses.
Is Propylthiouracil a controlled substance?
Propylthiouracil is not classified as a controlled substance by the DEA.
What is the generic name for Propylthiouracil?
The generic name for Propylthiouracil is Propylthiouracil. There are 3 other brand versions of Propylthiouracil.
What is the NDC code for Propylthiouracil 50 mg/1?
The NDC (National Drug Code) for Propylthiouracil 50 mg/1 is 0480-9242, listed by Teva Pharmaceuticals, Inc..