PROPYLTHIOURACIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

QUAGEN PHARMACEUTICALS LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.

Product summary:

Propylthiouracil Tablets, USP, 50 mg, are White to off-white round, biconvex scored tablets debossed “T” above “34” and bisect on the other side, supplied as: NDC 70752-171-10 Bottle of 100 NDC 70752-171-11 Bottle of 1000 Store at controlled room temperature 15° to 30°C (59° to 86°F).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUAGEN PHARMACEUTICALS LLC
----------
MEDICATION GUIDE
Propylthiouracil (Pro-pil-thi-o-ur-a-sil) Tablets
Read this Medication Guide before you start taking Propylthiouracil
and each time you get a refill. There
may be new information. This Medication Guide does not take the place
of talking to your doctor about your
medical condition or treatment.
What is the most important information I should know about
Propylthiouracil?
Propylthiouracil can cause serious side effects, including:
•
Severe liver problems. In some cases, liver problems can happen in
people who take Propylthiouracil
including: liver failure, the need for liver transplant, or death.
Stop taking Propylthiouracil and call
your doctor right away if you have any of these symptoms:
•
fever
•
loss of appetite
•
nausea
•
vomiting
•
tiredness
•
itchiness
•
pain or tenderness in your right upper stomach area (abdomen)
•
dark (tea colored) urine
•
pale or light colored bowel movements (stools)
•
yellowing of your skin or whites of your eyes
•
Serious risks during pregnancy. Propylthiouracil may cause liver
problems, liver failure and death in
pregnant women and may harm your unborn baby. Propylthiouracil may
also cause liver problems or
death of infants born to women who take Propylthiouracil during
certain trimesters of pregnancy.
Propylthiouracil may be used when an antithyroid drug is needed during
or just before the first
trimester of pregnancy.
If you get pregnant while taking Propylthiouracil, call your doctor
right away about your therapy.
What is Propylthiouracil?
Propylthiouracil is a prescription medicine used to treat people who
have Graves’ disease with
hyperthyroidism or toxic multinodular goiter. Propylthiouracil is used
when:
•
certain other antithyroid medicines do not work well.
•
thyroid surgery or radioactive iodine therapy is not a treatment
option.
•
to decrease symptoms of hyperthyroidism in preparation for a
thyroidectomy (removal of the thyroid
gland) or radioactive iodine therapy.
Propylthiouracil is n

Summary of Product characteristics

PROPYLTHIOURACIL- PROPYLTHIOURACIL TABLET
QUAGEN PHARMACEUTICALS LLC
----------
PROPYLTHIOURACIL TABLETS, USP
WARNING
_SEVERE LIVER INJURY AND ACUTE LIVER FAILURE, IN SOME CASES FATAL,
HAVE_
_BEEN REPORTED IN PATIENTS TREATED WITH PROPYLTHIOURACIL. THESE
REPORTS_
_OF HEPATIC REACTIONS INCLUDE CASES REQUIRING LIVER TRANSPLANTATION
IN_
_ADULT AND PEDIATRIC PATIENTS._
_PROPYLTHIOURACIL SHOULD BE RESERVED FOR PATIENTS WHO CANNOT TOLERATE_
_METHIMAZOLE AND IN WHOM RADIOACTIVE IODINE THERAPY OR SURGERY ARE
NOT_
_APPROPRIATE TREATMENTS FOR THE MANAGEMENT OF HYPERTHYROIDISM._
_PROPYLTHIOURACIL MAY BE THE TREATMENT OF CHOICE WHEN AN ANTITHYROID_
_DRUG IS INDICATED DURING OR JUST PRIOR TO THE FIRST TRIMESTER OF
PREGNANCY_
_(SEE WARNINGS AND PRECAUTIONS)._
DESCRIPTION
Propylthiouracil is one of the thiocarbamide compounds. It is a white,
crystalline
substance that has a bitter taste and is very slightly soluble in
water. Propylthiouracil is
an antithyroid drug administered orally. The structural formula is:
Each tablet contains propylthiouracil 50 mg and the following inactive
ingredients:
anhydrous lactose, magnesium stearate, microcrystalline cellulose,
pregelatinized starch,
and sodium starch glycolate.
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 inhibits the conversion of thyroxine to
triiodothyronine in peripheral
tissues and may therefore be an effective treatment for thyroid storm.
Propylthiouracil is readily absorbed and is extensively metabolized.
Approximately 35%
of the drug is excreted in the urine, in intact and conjugated forms,
within 24 hours.
INDICATIONS AND USAGE
Propylthiouracil is indicated:
in patients with Graves’ disease with hyperthyroidism or toxic
multinodular go