پیرازینامید
Propylthiouracil Tablet (Propylthiouracil)
پیرازینامید

نام ژنریک

Pyrazinamide

شکل دارویی

اشكال دارويي:


Tablet: 500mg

موارد مصرف

موارد و مقدار مصرف


درمان كمكي در سل (زماني كه داروهاي رده اول و دوم ضد سل را نتوان استفاده كرد يا مصرف آنها مؤثر نبوده است).


بزرگسالان: mg/kg 30-15 خوراكي روزانه در يك دوز يا دوزهاي منقسم مصرف مي‌شود. حداكثر روزانه 2 گرم و در صورت تجويز دو بار در هفته mg/kg 75-50 (بر حسب LBW) مي‌باشد. در بيماران با نارسايي كليوي دوزهاي كمتري از دارو استفاده شود.

موارد منع مصرف

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت مفرط شناخته شده نسبت به دارو و بيماري شديد كبدي، نقرس حاد.


موارد احتياط: سميت كبدي وابسته به دوز به صورت افزايش ترانس آمينازها تا يرقان، هپاتيت و آتروفي كبد با اين دارو رخ مي‌دهد. به همين دليل در سابقه بيماري‌هاي كبدي يا الكليسم با احتياط استفاده شود. دارو باعث مهار دفع اسيد اوريك مي‌شود لذا در بيماران با نقرس مزمن با احتياط به كار رود. در ديابت، پورفيري و نارسايي كليوي با احتياط استفاده شود.


در بيماري‌هايي كه ساير داروهاي هپاتوتوكسيك بخصوص ريفامپين را دريافت مي‌كنند نيز با احتياط به كار رود.

موارد قابل توجه

-

تداخل دارویی

اثر بر آزمايشهاي تشخيصي


پيرازيناميد ممكن است با آزمون‌هاي سنجش كتون ادرار تداخل كند. اثرات سيستميك دارو ممكن است به طور موقت غلظت 17-كتواستروئيد را كاهش دهد؛ اين دارو ممكن است غلظت يد پيونديافته به پروتئين، اسيداوريك و نتايج آزمون‌هاي آنزيمي كبد را افزايش دهد.

مکانیزم اثر

اثر بر آزمايشهاي تشخيصي


پيرازيناميد ممكن است با آزمون‌هاي سنجش كتون ادرار تداخل كند. اثرات سيستميك دارو ممكن است به طور موقت غلظت 17-كتواستروئيد را كاهش دهد؛ اين دارو ممكن است غلظت يد پيونديافته به پروتئين، اسيداوريك و نتايج آزمون‌هاي آنزيمي كبد را افزايش دهد.

فارماكوكینتیك

فارماكوكينتيك


جذب: از دستگاه گوارش به خوبي جذب مي‌شود. اوج غلظت سرمي دارو طي دو ساعت بعد از يك نوبت مصرف حاصل مي‌گردد.


پخش: به طور گسترده در بافت‌ها و مايعات بدن، از جمله ريه، كبد و مايع مغزي - نخاعي (CSF) انتشار مي‌يابد. حدود 50 درصد دارو به پروتئين پيوند مي‌يابد. عبور اين دارو از جفت مشخص نيست.


متابوليسم: در كبد هيدروليز مي‌شود؛ تا حدي از هيدروليز دارو در معده انجام مي‌گيرد.


دفع: تقريباً به طور كامل با فيلتراسيون گلومرولي از طريق ادرار دفع مي‌شود. ترشح اين دارو در شير مشخص نيست. نيمه عمر دفع دارو در بزرگسالان 10-9 ساعت است. نيمه عمر دارو در نارسايي كبد و كليه طولاني مي‌شود.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: پيرازين صناعي مشابه نيكوتيناميد.


طبقه‌بندي درماني: ضد سل.


طبقه‌بندي مصرف در بارداري: رده C


ملاحظات اختصاصي


1- عملكرد كبد، بخصوص غلظت آنزيمي و بيلي‌روبين، عملكرد كليه، بخصوص غلظت سرمي اسيداوريك، قبل از درمان و سپس هر 4-2 هفته پيگيري شود. بيمار از نظر علائم آسيب كبدي يا كاهش عملكرد كليه بررسي گردد.


2- در بيماران مبتلا به ديابت، مصرف اين دارو ممكن است از تثبيت غلظت سرمي گلوكز جلوگيري كند.


3- پيرازيناميد به طور شايعي غلظت سرمي اسيد اوريک را افزايش مي‌دهد. اگرچه اين افزايش معمولاً بدون نشانه است ، ولي مصرف يك داروي دفع‌كننده اسيد اوريك، مانند آلوپورينول يا پروبنسيد، ممكن است ضروري باشد.


4- بيماران مبتلا به HIV نياز به دوره‌هاي درمان طولاني‌تر دارند. دارو را همراه ديگر داروهاي ضد سل استفاده كنيد.


5- دارو به ميزان زياد توسط دياليز برداشت مي‌شود، لذا بعد از دياليز تجويز شود.


نكات قابل توصيه به بيمار


1- دارو را طبق دستور مصرف كنيد. درمان طولاني مدت است.


2- در صورت بروز علائم و نشانه‌هاي حساسيت مفرط و عوارض جانبي ديگر و همچنين بروز علائم نقرس، به پزشك اطلاع دهيد.


3- دارو را به مقدار تجويز شده و سر وقت مصرف كنيد و به طور مرتب توسط پزشك خود معاينه شويد.


4- مصرف مايعات زياد (حدود دو ليتر در روز) از صدمه به كليه جلوگيري مي‌كند.


مصرف در سالمندان: در بيماران سالخورده به علت كاهش دفع پيرازيناميد ناشي از كاهش عملكرد كليه، اين دارو با احتياط تجويز شود.


مصرف در كودكان: مصرف اين دارو در كودكان توصيه نمي‌شود.


مصرف در شيردهي: بي‌ضرري مصرف دارو در دوران شيردهي ثابت نشده است. شيردهي در دوران مصرف اين دارو توصيه نمي‌شود.


عوارض جانبي


اعصاب مرکزي : تب، بي‌حالي.


پوست: بثورات ماكولوپاپولار، حساسيت به نور (تغيير رنگ پوست به قهوه‌اي متمايل به قرمز)، كهير، خارش.


دستگاه گوارش: بي‌اشتهايي، تهوع، استفراغ.


ادراري ـ تناسلي: سوزش ادرار، نفريت بينابيني.


خون: كم‌خوني سيدروبلاستيك، احتمال تمايل به خونريزي ناشي از ترومبوسيتوپني.


كبد: هپاتيت، يرقان.


متابوليك: تداخل در كنترل ديابت، افزايش اسيد اوريك خون.


ساير عوارض: كسالت، تب، ‌درد مفصلي، پورفيري.


توجه: در صورت بروز علائم واكنش‌هاي حساسيت مفرط يا آسيب كبدي، بايد مصرف دارو قطع شود.


مسموميت و درمان


تظاهرات باليني: هيچ گونه اطلاع خاصي در دسترس نيست.


درمان: شامل اقدامات حمايتي است. بعد از بلع اخير دارو (چهار ساعت يا كمتر)، محتويات معده بايد با القاي استفراغ يا شستشوي معده تخليه شود. به دنبال آن ذغال فعال، براي كاهش جذب، تجويز مي‌شود.

Propylthiouracil Tablet (Propylthiouracil)

PROPYLTHIOURACIL
(propylthiouracil) Tablet

DRUG DESCRIPTION

Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) (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 (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) is an antithyroid drug administered orally. The structural formula is:

PROPYLTHIOURACIL (propylthiouracil) Structural Formula Illustration

Molecular Weight : 170.23          C7H10N2OS

Each tablet contains propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) 50 mg and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.

What are the possible side effects of propylthiouracil ()?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking propylthiouracil and call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, headache, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding (nosebleeds, bleeding gums), unusual weakness;
  • dry cough, trouble breathing; or
  • severe blistering, peeling, and red skin rash.

Propylthiouracil may also cause severe liver symptoms....

Read All Potential Side Effects and See Pictures of Propylthiouracil »

What are the precautions when taking propylthiouracil tablet (Propylthiouracil)?

Before taking propylthiouracil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as agranulocytosis, thrombocytopenia), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication should be used only when clearly needed during the first 3 months of pregnancy. It is not recommended for use during the last 6 months of pregnancy. Discuss...

Read All Potential Precautions of Propylthiouracil »

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) is indicated in the medical treatment of hyperthyroidism. Long-term therapy may lead to remission of the disease. Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) may also be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy of radioactive iodine therapy. Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) is also used when thyroidectomy is contraindicated or not advisable.

DOSAGE AND ADMINISTRATION

Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) is administered orally. The total daily dosage is usually given in 3 equal doses at approximately 8-hour intervals.

Adults

The initial dose is 300 mg daily. In patients with severe hyper-thyroidism, very large goiters, or both, the beginning dosage usually should be 400 mg daily, an occasional patient will require 600 to 900 mg/day initially. The usual maintenance dosage is 100 to 150 mg daily.

Pediatric Patients

For children 6 to 10 years of age, the initial dosage is 50 to 150 mg daily. For pediatric patients 10 years and over, the initial dosage is 150 to 300 mg daily. The maintenance dosage is determined by the response of the patient.

HOW SUPPLIED

Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) Tablets, USP, 50 mg: White, scored tablet, imprinted “West-ward 480”.

Bottles of 100 tablets.

Bottles of 1000 tablets.

Unit Dose Boxes of 100 tablets.

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.

Manufactured By: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. Revised November 2002

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Major adverse reactions (much less common than the minor adverse reactions) include inhibition of myelopoiesis (agranulocytosis, granulopenia, and thrombo-cytopenia), aplastic anemia, drug fever, a lupus-like syndrome including solenomegaly, hepatitis, periartentis, and hypoprothrombinemia and bleeding. Nephritis, glomerulonephritis, interstitial pneumonitis, exfoliative dermatitis, and erythema nodosum have been reported. Reports of a vasculitic syndrome associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA) have also been received. Manifestations of ANCA-positive vasculitis may include rapidly progressive glomerulonephritis (crescentic and pauci-immune necrotizing glomerulonephritis) sometimes leading to acute renal failure; fever; pulmonary infiltrates or alveolar hemorrhage; skin ulcers; and leucocytoclastic vasculitis.

Minor adverse reactions include skin rash, urticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesias, loss of taste, abnormal Ioss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, lymphadenopathy, vasculitis, glomerulonephritis, and taste perversion.

It should be noted that about 10% of patients with untreated hyperthyroidism have leukopenia (white blood cell count of less than 4,000/mm³), often with relative granulopenia.

Read the Propylthiouracil (propylthiouracil tablet) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Anticoagulants (oral)

The activity of anticoagulants may be potentiated by anti-vitamin-K activity attributed to propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) .

β-Adrenergic blocking agents

Hyperthyroidism may cause an increased clearance of beta blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid.

Digitalis Glycosides

Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dosage of digitalis glycosides may be required.

Theophylline

Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Agranulocytosis is potentially the most serious side effect of propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) therapy. Patients should be instructed to report any symptoms of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. The drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, interstitial pneumonitis, fever, or exfoliative dermatitis. The patient's bone marrow function should be monitored. Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) can cause fetal harm when administered to a pregnant woman. Because the drug readily crosses placental membranes and can induce goiter and even cretinism in the developing fetus, it is important that a sufficient, but not excessive, dose be given. In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently a reduction of dosage may be possible. In some instances, propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) can be withdrawn 2 or 3 weeks before delivery.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus. Postpartum patients receiving propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) should not nurse their babies.

Rare reports exist of severe hepatic reactions including encephalopathy, fulminant hepatic necrosis, and death in patients receiving propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) . Symptoms suggestive of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc.) should prompt evaluation of liver function. Treatment with propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) should be discontinued promptly in the event of clinically significant evidence of liver abnormality, including hepatic transaminases in excess of 3 times the upper limit of normal.

PRECAUTIONS

General

Patients who receive propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) should be under close surveillance and should be impressed with the necessity of reporting immediately any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise. In such cases, white blood cell and differential counts should be made to determine whether agranulocytosis has developed. Particular care should be exercised with patients who are receiving additional drugs known to cause agranulocytosis.

Laboratory Tests

Because propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) may cause hypoprothrombinemia and bleeding, prothrombin time should be monitored during therapy with the drug, especially before surgical procedures. Thyroid function tests should be monitored periodically during therapy. Once clinical evidence of hyperthyroidism has resolved, the finding of an elevated serum TSH indicates that a lower maintenance dose of propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) should be employed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Laboratory animals treated with propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) for > 1 year have demonstrated thyroid hyperplasia and carcinoma formation1. Such animal findings are seen with continuous suppression of thyroid function by sufficient doses of a variety of antithyroid agents, as well as in dietary iodine deficiency, subtotal thyroidectomy, and implantation of autonomous thyrotropic hormone - secreting pituitary tumors. Pituitary adenomas have also been described.

Pregnancy

Pregnancy Category D. SEE WARNINGS.

Nursing Mothers

The drug appears in human milk and is contraindicated in nursing mothers. See CONTRAINDICATIONS and WARNINGS.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 have not been established. For pediatric patients 6 years and older, see DOSAGE & ADMINISTRATION.

REFERENCE

1. International Agency for Research on Cancer, IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. 1974; 7:67-76.

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Signs and Symptoms

Nausea, vomiting, epigastric distress, headache, fever, arthralgia, pruritus, edema, and pancytopenia. Agranulocytosis is the most serious effect. Rarely, exfoliative dermatitis, hepatitis, neuropathies, or CNS stimulation or depression may occur.

No information is available on the following

LD50: concentration of propyl-thiouracil in biologic fluids associated with toxicity and/ or death; the amount of drug in a single dose usually associated with symptoms of overdosage; or the amount of propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) in a single dose likely to be life-threatening.

Treatment

To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physician's Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient. Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. The patient's bone marrow function should be monitored. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric empyting or charcoal. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of propylthiouracil.

CONTRAINDICATIONS

Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) is contraindicated in the presence of hypersensitivity to the drug or any of the other product components and in nursing mothers because the drug is excreted in milk.

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) 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 (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) is readily absorbed from the gastrointestinal tract. It is metabolized rapidly and requires frequent administration. Approximately 35% of the drug is excreted in the urine, in intact and in conjugated forms, within 24 hours.

In laboratory animals, various interventions, including propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) administration, that continuously suppress thyroid function and thereby increase TSH secretion result in thyroid tissue hypertrophy.

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be advised that if they become pregnant during therapy or intend to become pregnant, they should contact their physician immediately about the desirability of discontinuing the drug. They also should not use propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) while nursing. Patients should report immediately any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise.

They should report symptoms suggestive of hepatic dysfunction (anorexia, pruritis, right upper quadrant pain, etc).

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be advised that if they become pregnant during therapy or intend to become pregnant, they should contact their physician immediately about the desirability of discontinuing the drug. They also should not use propylthiouracil (propylthiouracil (propylthiouracil (propylthiouracil tablet) tablet) tablet) while nursing. Patients should report immediately any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise.

They should report symptoms suggestive of hepatic dysfunction (anorexia, pruritis, right upper quadrant pain, etc).

Last reviewed on RxList: 1/25/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Propylthiouracil Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PROPYLTHIOURACIL - ORAL

(PROE-pil-THYE-oh-URE-a-sil)

WARNING: Propylthiouracil has rarely caused very serious (possibly fatal) liver disease, especially during the first 6 months of treatment. Stop taking propylthiouracil and tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

USES: Propylthiouracil is used to treat overactive thyroid (hyperthyroidism). It works by stopping the thyroid gland from making too much thyroid hormone.

This medication is not recommended for use in children.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking propylthiouracil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually 3 times a day (every 8 hours).

Dosage is based on your medical condition and response to treatment.

Take this medication exactly as directed. Do not increase your dose or take it more often than prescribed. Your condition will not improve faster, and your risk of side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor.

Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Propylthiouracil Consumer (continued)

SIDE EFFECTS: Stomach upset, nausea, vomiting, mild rash/itching, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: muscle/joint pain, change in the amount of urine.

This medication may rarely cause very serious blood disorders (such as a low number of red cells, white cells, and platelets), especially during the first few months of treatment. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Propylthiouracil (propylthiouracil tablet) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking propylthiouracil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as agranulocytosis, thrombocytopenia), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication should be used only when clearly needed during the first 3 months of pregnancy. It is not recommended for use during the last 6 months of pregnancy. Discuss the risks and benefits with your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Propylthiouracil Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), digoxin, theophylline.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood counts, liver/thyroid function tests, prothrombin time) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised February 2011. Copyright(c) 2011 First Databank, Inc.

Propylthiouracil Patient Information Including Side Effects

Brand Names:

Generic Name: propylthiouracil (Pronunciation: PRO pil THYE oh URE a sil)

What is propylthiouracil ?

Propylthiouracil prevents the thyroid gland from producing too much thyroid hormone.

Propylthiouracil is used to treat hyperthyroidism (overactive thyroid) or Graves' disease.

Propylthiouracil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of propylthiouracil ?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking propylthiouracil and call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, headache, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding (nosebleeds, bleeding gums), unusual weakness;
  • dry cough, trouble breathing; or
  • severe blistering, peeling, and red skin rash.

Propylthiouracil may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

  • low fever, itching;
  • nausea, stomach pain, loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • upset stomach, vomiting;
  • dizziness, spinning sensation;
  • mild skin rash or itching;
  • mild joint or muscle pain;
  • decreased sense of taste; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Propylthiouracil (propylthiouracil tablet) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about propylthiouracil ?

Propylthiouracil can pass into breast milk and may harm a nursing baby. Do not use propylthiouracil while you are breast-feeding a baby.

Propylthiouracil can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Contact your doctor at once if you develop signs of infection.

Propylthiouracil may cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms: low fever, itching, nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Side Effects Centers

Propylthiouracil Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking propylthiouracil ?

You should not use this medication if you are allergic to propylthiouracil, or if you are breast-feeding a baby.

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • liver problems; or
  • a blood disorder.

FDA pregnancy category D. Do not use propylthiouracil if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Propylthiouracil can pass into breast milk and may harm a nursing baby. Do not use propylthiouracil while you are breast-feeding a baby.

How should I take propylthiouracil ?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Propylthiouracil can be taken with or without food.

Use propylthiouracil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Propylthiouracil can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

Store at room temperature away from moisture and heat.

Side Effects Centers

Propylthiouracil Patient Information including If I Miss a Dose

What happens if I miss a dose ?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose ?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, stomach pain, headache, joint pain, fever, sore throat, itching, rash, swelling, loss of appetite, numbness or tingling, and feeling restless or drowsy.

What should I avoid while taking propylthiouracil ?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What other drugs will affect propylthiouracil ?

Tell your doctor about all other medications you use, especially:

  • digoxin (Lanoxin, digitalis);
  • theophylline (Elixophyllin, Theo-24, Uniphyl);
  • a blood thinner such as warfarin (Coumadin); or
  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and other drugs may interact with propylthiouracil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about propylthiouracil.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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