PROPYLTHIOURACIL tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Rebel Distributors Corp.

INN (Jina la Kimataifa):

PROPYLTHIOURACIL

Tungo:

PROPYLTHIOURACIL 50 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

Propylthiouracil Tablets, USP, 50 mg: White, Round, Scored Tablet, Debossed “West-ward 480”. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Reference: Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised August 2011 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

Rebel Distributors Corp.
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MEDICATION GUIDE
PROPYLTHIOURACIL TABLETS, USP (Pro-pil-thi-o-ur-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?
Propythiouracil can cause serious side effects, including:
Severe liver problems. In some cases, these liver problems can lead to
liver failure, the need for liver
transplant, or death.
Stop taking Propylthiouracil and call your doctor right away if you
have:
•
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
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 not recommended for use in children.
Propylthiouracil may be used when an antithyroid drug is needed during
or just before the first trimester
of pregnancy.
Who should not take Propylthiouracil?
Do not take Propylthiouracil if you are allergic to Propylthiouracil
or any of its ingredients. See the end of
this Medication Guide for a complete list of ingredients in
Propylthiouracil.
What should I tell my doctor before taking Propylthiouracil?
Before you take Propylthiouracil, tell your doctor if you:
•
plan to have surgery.
•
have any other medical conditions.
•
are pregnant

Tabia za bidhaa

PROPYLTHIOURACIL- PROPYLTHIOURACIL TABLET
REBEL DISTRIBUTORS CORP.
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PROPYLTHIOURACIL
TABLETS, USP
Rev. 08/11
RX ONLY
BOXED WARNING
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.
Because of the risk of fetal abnormalities associated with
methimazole, proplythiouracil 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 (6-propyl-2-thiouracil) 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
triodothyronine 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
conversation of thyroxine to
triiodothyronine to 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 in conjugated forms, within 24
hours.
INDICATIONS AND US