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propylthiouracil (Rx)Brand and Other Names:PropylThyracil, PTU

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 50mg
more...

Hyperthyroidism

300-450 mg/day PO divided q8hr initially (may require up to 600-900 mg/day)

Maintenance: 100-150 mg/day divided q8hr

Thyrotoxic Crisis (Unlabeled)

Initial 200-300 mg PO q4-6hr initially on Day 1 (may require 800-1200 mg/day), then reduce gradually; some practitioners propose an initial dose of 600-1000 mg with gradual dose reduction after initial response

Maintenance: 100-150 mg/day PO divided q8-12hr

Graves Disease

50-150 mg PO q8hr initially

Maintenance: 50 mg PO q8-12hr for up to 12-18 months; then taper and discotinue if euthyroidism restored (TSH) is normal

Renal Impairment

Dose adjustment not necessary

Other Indications & Uses

Off-label: alcoholic liver disease

Dosage Forms & Strengths

tablet

  • 50mg
more...

Hyperthyroidism

Neonates (<28 days old): 5-10 mg/kg/day PO divided q8hr initially  

<6 years: 5-7 mg/kg/day PO divided q8hr initially OR

6-10 years: 50-150 mg/day PO divided q8hr

>10 years: 150-300 mg/day

Maintenance: Usually 1/3-2/3 of intial dose based on response divided q8-12hr

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Interactions

Interaction Checker

propylthiouracil and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Agranulocytosis

            Aplastic anemia

            Dermatologic reactions

            Hepatitis

            Polyarthritis

            Drowsiness

            Fever

            Headache

            Vertigo

            Alopecia

            Erythema nodosum

            Exfoliative dermatitis

            Skin rash

            Skin ulcers

            Goiter

            Weight gain

            Constipation

            Loss of taste

            Granulopenia

            Leukopenia

            Thrombocytopenia

            Postmarketing Reports

            Inhibition of myelopoiesis (agranulocytosis, granulopenia, aplastic anemia, and thrombocytopenia)

            Drug fever, a lupus-like syndrome (including splenomegaly and vasculitis)

            Periarteritis

            Hypoprothrombinemia

            Bleeding

            Nephritis

            Glomerulonephritis

            Interstitial pneumonitis

            Exfoliative dermatitis

            Erythema nodosum

            Vasculitis syndrome associated with the presence of antineutrophilic cytoplasmic antibodies (ANCA) Skin rash

            Uticaria

            Nausea

            Vomiting

            Epigastric distress

            Arthralgia

            Paresthesias

            Loss of taste

            Taste perversion

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            Warnings

            Black Box Warnings

            Severe liver injury and acute liver failure, some of which have been fatal, have been reported in adult and pediatric patients taking propylthiouracil

            Closely monitor for symptoms and signs of liver injury (eg, , anorexia, nausea, vomiting, fatigue, pruritus, dark colored urine, or jaundice), especially during first 6 months after initiating therapy

            Reserve propylthiouracil use for those unable to tolerate other treatments (eg, methimazole, radioactive iodine, surgery)

            Propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy (strong association of methimazole with congenital malformation during first trimester)

            Contraindications

            Hypersensitivity

            Cautions

            Liver disease, bleeding disorder, pregnancy, concurrency with other agranulocytosis-causing drugs

            Risk of severe liver injury and rare immunoallergenic hepatitis

            Discontinue immediately if abnormal LFTs (transmainase >3 times ULN)

            Risk of rare but serious agranulocytosis may occur

            Bone marrow suppression reported

            Severe dermatologic reactions reported

            Discontinue in the presence of unexplained fever

            Lupus-like syndrome reported (may need to discontinue)

            Glomerulonephritis and interstitial nephritis with acute renal failure reported

            Interstitial pneumonitis and different forms of vasculitis may occur

            High relapse rate (more likely in smokers)

            May cause hypoprothrombinemia

            Propylthiouracil can cause hypothyroidism necessitating routine monitoring of TSH and free T4 levels with adjustments in dosing to maintain a euthyroid state; because drug readily crosses placental membranes, propylthiouracil can cause fetal goiter and cretinism when administered to a pregnant woman

            Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, light colored stools, dark urine, right upper quadrant pain, etc.), particularly in the first six months of therapy; when symptoms occur, measurement should be made of liver function (bilirubin, alkaline phosphatase) and hepatocellular integrity (ALT/AST levels)

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: distributed in breast milk, contraindicated by some sources (AAP Committee states compatible w/ nursing ; AAFP states safe for nursing)

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits synthesis of thyroid hormone by blocking oxidation of iodine in thyroid gland; blocks synthesis of T4 and T3

            Pharmacokinetics

            Absorption: 75%

            Duration: 12-24 hr

            Half-life elimination: 1-2 hr, increase in ESRD

            Vd: 0.4 L/kg

            Protein Bound: 80-85%

            Concentration (200-400 mg single dose): 6-9 mcg/mL

            Peak plasma time: 1-2 hr

            Peak plasma concentration:  (200-400 mg single dose): 6-9 mcg/mL

            Metabolism: liver, to glucuronide conjugates, inorganic sulfates, sulfur metabolites

            Total body clearance: 7 L/hr

            Excretion: Urine (35%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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