PROPYLTHIOURACIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPYLTHIOURACIL (UNII: 721M9407IY) (PROPYLTHIOURACIL - UNII:721M9407IY)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

PROPYLTHIOURACIL

Composition:

PROPYLTHIOURACIL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propylthiouracil is indicated in the medical treatment of hyperthyroidism. Long-term therapy may lead to remission of the disease. Propylthiouracil may also be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy. Propylthiouracil is also used when thyroidectomy is contraindicated or not advisable. Propylthiouracil is contraindicated in the presence of hypersensitivity to the drug or any of the other product components and in nursing mothers because the drug is excreted in milk.

Product summary:

50 mg — Each white, round, tablet imprinted with on one side and 348 and partial bisect on the other side contains 50 mg of Propylthiouracil, USP. Tablets are supplied in blisterpacks of 30 (NDC 0615-7583-39).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPYLTHIOURACIL- PROPYLTHIOURACIL TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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PROPYLTHIOURACIL TABLETS, USP
40-8756
REVISED – JANUARY 2008
RX ONLY
DESCRIPTION
Propylthiouracil (6-propyl-2-thiouracil) is one of the thiocarbamide
compounds. It is a white,
crystalline substance that has a bitter taste and is very slightly
soluble in water.
Each tablet contains propylthiouracil, 50 mg (293.7, µmol), lactose
monohydrate, corn starch, colloidal
silicon dioxide, povidone, pregelatinized starch, and magnesium
stearate.
Propylthiouracil is an antithyroid drug administered orally. The
molecular weight is 170.23. The
molecular formula is C H N OS, and the structural formula is as
follows:
CLINICAL PHARMACOLOGY
Propylthiouracil inhibits the synthesis of thyroid hormones and thus
is effective in the treatment of
hyperthyroidism. The drug does not inactivate existing thyroxine and
triiodothyronine that are stored in
the thyroid or circulating in the blood nor does it interfere with the
effectiveness of thyroid hormones
given by mouth or by injection.
Propylthiouracil is readily absorbed from the gastrointestinal tract.
It is metabolized rapidly and
requires frequent administration. Approximately 35% of the drug is
excreted in the urine, in intact and in
conjugated forms, within 24 hours.
In laboratory animals, various interventions, including
propylthiouracil administration, that continuously
suppress thyroid function and thereby increase TSH secretion result in
thyroid tissue hypertrophy.
INDICATIONS AND USAGE
Propylthiouracil is indicated in the medical treatment of
hyperthyroidism. Long-term therapy may lead to
remission of the disease. Propylthiouracil may also be used to
ameliorate hyperthyroidism in
preparation for subtotal thyroidectomy or radioactive iodine therapy.
Propylthiouracil is also used
when thyroidectomy is contraindicated or not advisable.
CONTRAINDICATIONS
Propylthiouracil is contraindicated in the presence of
hypersensitivity to the drug or any of the other
product components and in nu