EUTHYROX 50MCG TABLET (TABLET)

Administration Should be taken on an empty stomach: Take 30 min before breakfast. Contraindications Levothyroxine (Euthyrox) must not be used in patients with: untreated adrenal insufficiency (dysfunction of the adrenal gland); untreated pituitary insufficiency (dysfunction of the pituitary gland); untreated thyrotoxicosis (excessive overproduction of thyroid hormones); acute myocardial infarction (heart disease); acute myocarditis or acute pancarditis (heart inflammation); hypersensitivity to any of the excipients of the product. Combination therapy of levothyroxine (Euthyrox) and an anti-thyroid agent for hyperthyroidism is not indicated during pregnancy. Special Precautions : Even mild hyperthyroidism due to Euthyrox must be avoided by all means, especially in patients with coronary heart disease, heart failure or heart rhythm disturbances of the rapid type. In patients with hypothyroidism due to a disease of the pituitary gland, it must be clarified whether underactivity of the adrenal cortex (adrenocortical insufficiency) is also present. If so, the latter should be treated before initiating thyroid hormone therapy. Effects on the Ability to Drive or Operate Machinery: There are no indications that Euthyrox interferes with driving a vehicle, operating machinery or working without a firm hold. Use in Elderly: In elderly people, Euthyrox should be dosed very carefully. A small dose should be chosen to start with, which can then be increased gradually and at long intervals with frequent thyroid hormone checks. Adverse Reactions Where the individual tolerance limit for levothyroxine is exceeded or in the case of overdosage, it is possible for the following clinical symptoms typical of hyperthyroidism to occur, especially if the dose is increased too quickly at the start of treatment: irregular or rapid heart rate (tachycardia, palpitations, arrhythmias such as atrial fibrillation and extrasystoles), chest pain (angina pectoris), headache, muscle weakness or cramps, warmth and redness of the face (flushing), fever, vomiting, disorders of menstruation, pseudotumor cerebri (increased pressure in the head with eye swelling), trembling, restlessness, sleep disturbances, sweating (hyperhidrosis), weight loss, diarrhea. In such cases the daily dose should be reduced or the medication withdrawn for several days. Therapy may carefully be resumed once the adverse effects have disappeared. In case of hypersensitivity to any of the ingredients of levothyroxine (Euthyrox), allergic reactions, particularly of the skin, may occur. Cases of angioedema (swelling of the face or throat) have been reported. At the first sign of any adverse drug reaction, patient must seek medical attention immediately. Interactions May reduce effect of antidiabetics. May intensify anticoagulant effect of coumarin derivatives. May influence effect w/ PIs (eg, ritonavir, indinavir, lopinavir). Elevated fT4 & fT3 fraction & increased hepatic metabolization w/ phenytoin. Elevated fT4 fraction w/ salicylates, dicoumarol, furosemide (in high doses) & clofibrate. Hypothyroidism &/or reduced hypothyroidism control w/ orlistat. May decrease absorption w/ sevelamer. May decrease efficacy w/ tyrosine-kinase inhibitors (eg, imatinib, sunitinib). Inhibit absorption w/ ion exchange resins (eg, cholestyramine, colestipol). Potentially decreased effect w/ Al (eg, antacids, sucralfates) & Fe containing drugs. Propylthiouracil, glucocorticoids, β-sympatholytics, iodine-containing media & amiodarone inhibit peripheral conversion of T4 to T3. Decreased efficacy & increased TSH level w/ sertraline, chloroquine/proguanil. Increased hepatic clearance w/ hepatic enzyme inducers (eg, barbiturates, carbamazepine). Women on estrogen-containing contraceptives or postmenopausal under hormone-replacement therapy may have increased need for levothyroxine. May lower the uptake w/ soy products.