PROPYLTHIOURACIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

PROPYLTHIOURACIL

Composition:

PROPYLTHIOURACIL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propylthiouracil tablets are 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 are available as follows: 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 bottles of 100 (NDC 0228-2348-10). Dispense in a well-closed container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Actavis Pharma, Inc.
----------
Medication Guide
Dispense with Medication Guide available at: www.tevausa.com/medguides
Propylthiouracil (proe" pil thye" oh ure' a sil)
Tablets
Rx only
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 (re

Summary of Product characteristics

PROPYLTHIOURACIL- PROPYLTHIOURACIL TABLET
ACTAVIS PHARMA, INC.
----------
PROPYLTHIOURACIL TABLETS, USP
RX ONLY
_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, USP is one of the thiocarbamide compounds. It is a
white, powdery,
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, USP 50 mg and the following
inactive ingredients:
colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium
stearate,
povidone, and pregelatinized corn starch,.
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 tablets are indicated:
in patients with Graves’ disease with hyp