propylthiouracil (Oral route)

proe-pil-thye-oh-URE-a-sil

Available Dosage Forms:

• Tablet

Therapeutic Class: Antithyroid Agent

Chemical Class: Thionamide

Uses For propylthiouracil

Propylthiouracil is used to treat hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. It is also used before thyroid surgery or radioactive iodine treatment.

Propylthiouracil is an antithyroid medicine. It works by making it harder for the body to use iodine to make thyroid hormone. It does not block the effects of thyroid hormone that was made by the body before its use was begun.

propylthiouracil is available only with your doctor’s prescription.

Before Using propylthiouracil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For propylthiouracil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to propylthiouracil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of propylthiouracil in children. However, safety and efficacy have not been established in children below 6 years of age.

Geriatric

No information is available on the relationship of age to the effects of propylthiouracil in geriatric patients.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using propylthiouracil with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Dicumarol
• Phenindione
• Phenprocoumon
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of propylthiouracil. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia, thrombocytopenia) or
• Liver disease—Use with caution. May make these conditions worse.

Proper Use of propylthiouracil

Take propylthiouracil only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

propylthiouracil works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, if you are taking more than one dose a day, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 3 doses a day, the doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your doctor.

Dosing

The dose of propylthiouracil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of propylthiouracil. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of hyperthyroidism (overactive thyroid):
    • Adults—At first, 300 to 900 milligrams (mg) daily, divided into 3 equal doses and given every 8 hours. The maintenance dose is usually 100 to 150 mg daily.
    • Children 10 years of age and older—At first, 150 to 300 mg daily, divided into 3 equal doses and given every 8 hours. Your doctor may adjust your dose as needed.
    • Children 6 to 10 years of age—At first, 50 to 150 mg daily, divided into 3 equal doses and given every 8 hours. Your doctor may adjust your dose as needed.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of propylthiouracil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using propylthiouracil

It is very important that your doctor check your progress at regular visits to make sure that propylthiouracil is working properly. Blood tests may be needed to check for unwanted effects.

Using propylthiouracil while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking propylthiouracil. If you think you have become pregnant while using the medicine, tell your doctor right away.

Propylthiouracil can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

While you are being treated with propylthiouracil, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor’s approval. Propylthiouracil may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Liver problems may occur while you are using propylthiouracil. Stop using propylthiouracil and check with your doctor right away if you are having more than one of these symptoms: stomach pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Before having any kind of surgery, tell the medical doctor in charge that you are using propylthiouracil. Taking propylthiouracil together with medicines used during surgery may increase the risk of side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

propylthiouracil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• chest pain
• chills
• cough
• fever
• painful or difficult urination
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

• Abdominal or stomach pain
• agitation
• bleeding gums
• bleeding under the skin
• blood in the urine or stools
• bloody or cloudy urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• coma
• confusion
• cough or hoarseness
• cracks in the skin
• dark urine
• decreased urine output
• depression
• difficulty with breathing
• difficulty with moving
• dizziness
• fever with or without chills
• general feeling of discomfort, illness, or weakness
• general feeling of tiredness or weakness
• headache
• high blood pressure
• hostility
• irritability
• joint pain
• lethargy
• light-colored stools
• loss of appetite and weight
• loss of heat from the body
• lower back or side pain
• muscle aching or cramping
• muscle pain or stiffness
• muscle twitching
• nausea or vomiting
• numbness or tingling of the hands, feet, or face
• pain in the ankles or knees
• painful, red lumps under the skin, mostly on the legs
• pinpoint red spots on the skin
• rapid weight gain
• red, swollen skin
• redness, soreness, or itching skin
• scaly skin
• seizures
• soreness of the muscles
• sores on the skin
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welting, or blisters
• stupor
• swelling of the face, ankles, hands, feet, or lower legs
• swollen joints
• swollen salivary glands
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• unusual weight gain
• upper right abdominal or stomach pain
• wheezing
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abnormal loss of hair
• change in taste or bad unusual or unpleasant (after) taste
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• heartburn
• hives or welts
• itching
• loss of taste
• pain or discomfort in the chest, upper stomach, or throat
• sensation of spinning
• skin rash
• sleepiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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