PROPYLTHIOURACIL Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Propylthiouracil 50mg Tablets.
Qualitative and quantitative composition
Propylthiouracil 50mg. For excipients, see 6.1.
Pharmaceutical form
Tablet. White, circular biconvex tablets with breakline embossed on one face or breakline embossed on one face and CP on the reverse.
Therapeutic indications
Hyperthyroidism.
Posology and method of administration
Adults and elderly Initially 300 to 600mg daily, once daily or in divided doses until the patient becomes euthyroid. When the condition is controlled (usually after 1-2 months), the dose is reduced to ...
Contraindications
Previous severe hypersensitivity reaction e.g. agranulocytosis, hepatitis, vasculitis, nephritis. Owing to the presence of Lactose, patients with rare hereditary problems of galactose intolerance, the ...
Special warnings and precautions for use
Because of the risk of agranulocytosis it is advised that patients should be warned to report to their doctor in the event of a sore throat, fever, mouth ulcers, bruising, malaise, non-specific illness ...
Interaction with other medicinal products and other forms of interaction
Drug induced changes in thyroid status may affect the dosage requirements for theophylline, digoxin or beta-blockers. The doses of theophylline, digoxin or beta-blockers may need to be reduced as thyroid ...
Pregnancy and lactation
Women of childbearing potential Women of childbearing potential should be informed about the potential risks of propylthiouracil use during pregnancy. Pregnancy Hyperthyroidism in pregnant women should ...
Effects on ability to drive and use machines
None known.
Undesirable effects
<u>Blood and lymphatic system:</u> Reversible leucopenia. Rarely, agranulocytosis, thrombocytopenia, leucopenia, aplastic anaemia, pancytopenia. A rare complication of therapy is a tendency to haemorrhage ...
Overdose
Symptoms Goitre and hypothyroidism may be induced by repeated over dosage. Single overdose is not dangerous. Overdose may manifest as vomiting, epigastric distress, headache, fever, arthralgia, pruritus, ...
Pharmacodynamic properties
Propylthiouracil is an antithyroid drug that depresses the formation of thyroid hormone. This is effected by interference both with the incorporation of iodine into tyrosyl residues and the coupling of ...
Pharmacokinetic properties
Propylthiouracil is rapidly absorbed from the gut with average peak blood levels about one hour after administration of an oral dose. Between half and three quarters of the oral dose is bioavailable, due ...
Preclinical safety data
There have been no systematic long term animal toxicology studies performed. Some short term studies carried out when this class of drugs was introduced (approx 45 years ago) show that rats and rodents ...
List of excipients
Lactose Starch maize Pregelatinised starch maize Magnesium stearate Sodium starch glycollate
Incompatibilities
None known.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Polypropylene or polyethylene container with tamper evident closure of 28, 30, 56, 60, 84, 90 and 100 tablets.
Special precautions for disposal and other handling
The tablets are administered orally.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K.
Marketing authorization number(s)
PL 29831/0179
Date of first authorization / renewal of the authorization
5 March 2008
Date of revision of the text
30/09/2019
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