Propylthiouracil

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• PROPYLTHIOURACIL DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• PROPYLTHIOURACIL CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• PROPYLTHIOURACIL ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• REFERENCES
• STORAGE AND HANDLING
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

PROPYLTHIOURACIL DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

• ●     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 CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

PROPYLTHIOURACIL ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

REFERENCES

STORAGE AND HANDLING

SPL MEDGUIDE

• ●     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

• ●     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.

• ●     plan to have surgery.

• ●     have any other medical conditions

• ●     are pregnant or plan to become pregnant. Talk to your doctor right away if you are pregnant or plan to become pregnant.

• ●     Propylthiouracil may cause liver problems, liver failure and death in pregnant women.

• ●     Propylthiouracil may harm your unborn baby.

• ●     are breast-feeding or plan to breast-feed. Propylthiouracil can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take propylthiouracil.

• ●     a blood thinner medicine warfarin sodium (CoumadinJantoven

• ●     medicine for heart problems

• ●     medicine for high blood pressure

• ●     Digoxin (LanoxicapsLanoxin

• ●     Theophylline (ElixophyllinTheolairTheochronTheo-24Uniphyl

• ●     Take propylthiouracil exactly as your doctor tells you to take it.

• ●     Your doctor may change your dose if needed.

• ●     Propylthiouracil is usually taken 3 times a day (every 8 hours).

• ●     If you take too much propylthiouracil, call your Regional Poison Control Center or go to the nearest hospital emergency room right away.

• ●     If you take too much propylthiouracil you may have the following symptoms:

• ●If you miss a dose of propylthiouracil, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not double your dose.

• ●     liver problems. SeeWhat is the most important information I should know about propylthiouracil?

• ●     low white blood cell counts. This usually happens within the first 3 months of treatment and can be life-threatening. You may have a higher chance of getting an infection when your white blood cell count is low.

• ●     a fever

• ●     chills

• ●     sore throat

• ●     hypothyroidism. Your doctor should do blood tests regularly during treatment to check your thyroid.

• ●     increased bleeding especially with surgical procedures and particularly if you are taking blood thinners.

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