PROPYLTHIOURACIL tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Chartwell RX, LLC

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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.

Přehled produktů:

Propylthiouracil Tablets, USP 50 mg, are white to off white, round scored tablets, debossed with “CE” above bisect “134” on one side and plain on other side. NDC 62135-606-90             Bottle of 90 tablets Store at controlled room temperature 15° to 30°C (59° to 86°F).

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

PROPYLTHIOURACIL- PROPYLTHIOURACIL TABLET
Chartwell RX, 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 • 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 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

Charakteristika produktu

PROPYLTHIOURACIL- PROPYLTHIOURACIL TABLET
CHARTWELL RX, 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 WARNINGSAND 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:
calcium stearate, corn starch, lactose monohydrate and pregelatinized
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 is indicated:
in patients with Graves’ disease with hyperthyroidism or toxic
multinodular goiter
who are intolerant of methi