Ptu Tablet (100 Tab)

PTU Tablet by Macleods Pharmaceuticals Ltd. is an anti-thyroid medication primarily used to manage conditions associated with an overactive thyroid gland.

Name

• Common Name: Propylthiouracil (PTU)
• Brand Name: PTU Tablet

Composition

Each tablet contains Propylthiouracil 50 mg as the active ingredient. Inactive ingredients typically include microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, and magnesium stearate.

Uses

PTU Tablet is prescribed for the treatment of hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. This includes:

• Graves' disease.
• Toxic multinodular goiter.
• Thyrotoxicosis (thyroid storm). It is also used to reduce high thyroid hormone levels prior to thyroid surgery or radioactive iodine treatment.

Dosage and Administration

PTU Tablet is taken orally, usually in equally divided doses, approximately every 8 hours.

• Adults: Initial doses for hyperthyroidism range from 300 to 450 mg daily, divided into three doses. Maintenance doses typically range from 100 to 150 mg daily.
• Pediatric: For children 6 years and older, an initial dose of 50 mg daily in three equally divided doses is suggested, with adjustments based on clinical response. However, its use in pediatric patients is generally not recommended due to the risk of severe liver toxicity unless other therapies are not an option.

Side Effects

Common Side Effects: Nausea, indigestion, headache, body pain, mild skin rash, drowsiness, hair loss, and changes in taste. Serious Side Effects: Agranulocytosis (low white blood cell count), aplastic anemia, liver injury (symptoms include yellowing skin/eyes, dark urine, severe stomach pain), severe allergic reactions, and vasculitis.

Precautions

• Liver Injury: Propylthiouracil carries a boxed warning for severe liver injury, including liver failure and death. Regular monitoring of liver function is essential.
• Blood Disorders: It can lower blood cell counts, increasing the risk of infection or bleeding. Patients should report fever, sore throat, or unusual bruising/bleeding.
• Pregnancy and Breastfeeding: Propylthiouracil can harm an unborn baby and is generally recommended for use in the first trimester of pregnancy only when other treatments are not suitable, often switching to methimazole for the remainder of pregnancy.
• Drug Interactions: May interact with anticoagulants (e.g., warfarin), digoxin, beta-blockers, and theophylline, potentially requiring dose adjustments.
• Immunizations: Avoid immunizations without a doctor's approval while on this medication.

Storage

Store PTU Tablet in a closed, light-resistant container at room temperature, between 20°C and 25°C (68°F and 77°F). Keep out of reach of children.

PTU Tablet, containing propylthiouracil, is a medication primarily used to manage hyperthyroidism, a condition where the thyroid gland produces excessive thyroid hormones. It is also utilized in specific situations like preparing for thyroid surgery or radioactive iodine therapy, and in the management of a thyroid storm.

What is PTU Tablet used for?

PTU Tablet is used to treat hyperthyroidism, which is an overactive thyroid gland that produces too much thyroid hormone. It helps to alleviate symptoms such as rapid heartbeat, weight loss, and anxiety by reducing the production of these hormones. It can also be used to control symptoms of an overactive thyroid before surgery or radioactive iodine treatment.

How does PTU Tablet work?

Propylthiouracil (PTU), the active ingredient in PTU Tablet, works by inhibiting the synthesis of new thyroid hormones within the thyroid gland. It achieves this by blocking the enzyme thyroid peroxidase, which is crucial for incorporating iodine into the hormones T4 and T3. Additionally, PTU interferes with the peripheral conversion of T4 to the more active T3, further reducing the overall thyroid hormone activity in the body.

What is the usual dosage?

For adults, the typical initial dose of Propylthiouracil for hyperthyroidism is 300 mg daily, usually divided into three equal doses taken every 8 hours. In cases of severe hyperthyroidism or very large goiters, the initial daily dose may range from 400 mg up to 600-900 mg. The usual maintenance dose is 100 to 150 mg daily, divided into three equal doses, adjusted based on thyroid function tests and clinical response. For children aged 6 years and older, an initial dose of 50 mg daily, divided into three equal doses, may be prescribed, with adjustments made by the doctor. Propylthiouracil is generally not recommended for pediatric use except in rare circumstances.

What are the possible side effects?

Common side effects of Propylthiouracil can include nausea, vomiting, stomach pain, loss or change in taste, headache, drowsiness, dizziness, hair loss, muscle or joint pain, numbness, and swelling of the ankles, hands, or feet. More serious, though less common, side effects that require immediate medical attention include signs of liver injury (e.g., right upper belly pain, dark urine, yellowing skin or eyes), blood disorders like agranulocytosis (sore throat, fever, chills, unusual weakness), aplastic anemia, or thrombocytopenia (unusual bleeding or bruising). Severe allergic reactions and skin conditions like Stevens-Johnson syndrome can also occur.

Is it safe during pregnancy or breastfeeding?

Pregnancy: Propylthiouracil was formerly classified as a Category D drug for pregnancy. It may be preferred for treating hyperthyroidism during the first trimester of pregnancy, as methimazole may pose a higher risk of birth defects during this period. However, PTU can cause serious liver damage in pregnant women and may harm the fetus, including causing congenital goiter and hypothyroidism. Your doctor will determine the best course of treatment.

Breastfeeding: Propylthiouracil is excreted into breast milk in small amounts. The American Thyroid Association suggests limiting PTU doses to 450 mg per day while breastfeeding, although some studies have reported no harmful effects on infants' thyroid function at doses up to 750 mg daily. No side effects have been reported in breastfed infants exposed to PTU. While it was once considered the preferred antithyroid drug during lactation, recent findings regarding liver injury associated with PTU have led some experts to consider methimazole as the preferred choice for nursing mothers.

Can it be taken with other medications?

Propylthiouracil can interact with several medications. It may increase the effects of oral anticoagulants like warfarin, requiring careful monitoring of PT/INR. It can also interact with certain blood pressure medications, drugs for heart disease, irregular heartbeats, digoxin, and theophylline. Concomitant use with potassium iodide may potentiate hypothyroid effects. It has serious interactions with drugs such as sodium iodide I-131, carbamazepine, clozapine, and pexidartinib. Always inform your doctor or pharmacist about all medications, supplements, and herbal products you are taking to prevent potential interactions.

What precautions should be taken?

Patients taking PTU should be under close medical surveillance due to the potential for serious adverse effects, including liver injury and blood disorders. Regular monitoring of thyroid function tests (TSH, T3, T4) and blood cell counts is necessary. If you experience any signs of infection (fever, sore throat, chills), unusual bleeding or bruising, or symptoms of liver problems (abdominal pain, dark urine, yellow skin/eyes), contact your doctor immediately. Avoid people with infections if your blood counts are low. If you are pregnant or planning to become pregnant, notify your doctor. Do not receive immunizations (vaccines) without your doctor's approval while on PTU, as it may lower your body's resistance to infection.

What happens if a dose is missed?

If you miss a dose of PTU Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double or extra dose to make up for a missed one.

How should it be stored?

PTU Tablets should be stored at room temperature, ideally between 68°F to 77°F (20°C to 25°C). It can tolerate brief exposures to temperatures between 59°F to 86°F (15°C to 30°C). Store the medicine in a closed, light-resistant container, away from heat, moisture, and direct light. Keep it out of reach of children and pets.