PROPYLTHIOURACIL tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Avera McKennan Hospital

INN（国际名称）:

PROPYLTHIOURACIL

组成:

PROPYLTHIOURACIL 50 mg

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

PROPYLTHIOURACIL- PROPYLTHIOURACIL TABLET
AVERA MCKENNAN HOSPITAL
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PROPYLTHIOURACIL TABLETS, USP
40-9158
Revised — March 2016
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, 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: lactose
monohydrate, corn starch, colloidal silicon dioxide, povidone,
pregelatinized corn starch, 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 AND USAGE
Propylthiouracil tablets, USP are indicated:
in patients with Gra