PROPYLTHIOURACIL tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Macleods Pharmaceuticals Limited

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Propylthiouracil 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 samenvatting:

Propylthiouracil Tablets, USP 50 mg are white circular biconvex uncoated tablets, free from physical defects, with “I and II” debossed either side of breakline on one side and plain on other side. supplied as: NDC 33342-314-11      Bottle of 100 NDC 33342-314-44      Bottle of 1000 NDC 33342-314-12      Carton of 100’s (10 × 10) unit dose Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86° F). [See USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

PROPYLTHIOURACIL - PROPYLTHIOURACIL TABLET
Macleods Pharmaceuticals Limited
----------
SPL MEDGUIDE
MEDICATION GUIDE
PROPYLTHIOURACIL TABLETS, USP
(Proe-pil-thye-oh-ure’-a-sil)
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
· itchiness
· loss of appetite
· pain or tenderness in your right
upper stomach area (abdomen)
· nausea
· dark (tea colored) urine
· Vomiting
· pale or light colored bowel
movements (stools)
· tiredness
· 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 are propylthiouracil tablets?
Propylthiouracil is 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 t

Productkenmerken

PROPYLTHIOURACIL - PROPYLTHIOURACIL TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
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 CAN NOT
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,
CRYSTALLINE SUBSTANCE THAT HAS A BITTER TASTE AND IS VERY SLIGHTLY
SOLUBLE IN
WATER. PROPYLTHIOURACIL USP IS AN ANTITHYROID DRUG ADMINISTERED
ORALLY. THE
STRUCTURAL FORMULA IS:
Each tablet contains propylthiouracil USP 50 mg and the following
inactive ingredients:
microcrystalline cellulose, pregelatinized starch (maize), sodium
starch glycolate and
magnesium stearate.
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 & USAGE
Propylthiouracil are indicated:
• in patients with Graves’ disease with hyperthyroidism or toxic
mult