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Euthyrox

Euthyrox

levothyroxine sodium

Manufacturer:

PT. Merck Tbk
Concise Prescribing Info
Contents
Levothyroxine Na
Indications/Uses
Euthyroid goitre. Relapse prophylaxis after strumectomy. Hypothyroidism. Concomitant therapy when taking medication for hyperthyroidism after normal function has been achieved. After total thyroidectomy due to thyroid carcinoma.
Dosage/Direction for Use
Euthyroid goitre Adult 75-200 mcg daily. Adolescent 50-150 mcg daily. Relapse prophylaxis after strumectomy 75-200 mcg daily. Hypothyroidism Adult Initially 25-50 mcg daily, may be increased by 25-50 mcg at 2-4 wkly intervals. Maintenance: 125-250 mcg daily. Childn Initially 12.5-50 mcg daily. Maintenance: 100-150 mcg/m2 daily. Concomitant therapy w/ medication against hyperthyroidism 50-100 mcg daily. After total thyroidectomy 150-300 mcg daily. Thyroid suppression test 200 mcg daily.
Administration
Should be taken on an empty stomach: Take at least 30 min before breakfast.
Contraindications
Hypersensitivity. Untreated adrenal insufficiency, pituitary insufficiency & thyrotoxicosis. Not to be initiated in acute MI, myocarditis & pancarditis. Combination therapy w/ antithyroid agent for hyperthyroidism is not indicated during pregnancy.
Special Precautions
Not to be given in hyperthyreotic states other than as concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism; for wt reduction. Avoid slight drug-induced hyperthyroidism & frequently check thyroid hormone parameters in patients w/ coronary failure, cardiac insufficiency or tachycardiac arrhythmias; supra-physiological serum levels in postmenopausal women w/ hypothyroidism & increased risk of osteoporosis. Coronary failure, angina pectoris, arteriosclerosis, HTN, pituitary insufficiency. Diabetic. Patients w/ severe or long-standing hypothyroidism. Treat adrenocortical dysfunction before starting therapy to prevent acute adrenal insufficiency. Monitor patients at risk of psychotic disorders. Consider adjusting dose if signs of psychotic disorders occur. Close monitoring including clinical & biological monitoring during transition to another levothyroxine-containing product due to potential risk of thyroid imbalance. Not to be combined w/ certain substances for wt reduction ie, sympathomimetics. Concomitant use w/ orlistat; anticoagulants. Interference on thyroid immunoassays w/ biotin. Measure TSH during each trimester for pregnant woman on therapy. Monitor haemodynamic parameters if therapy is initiated in very low birth wt preterm neonates. Excessive doses may produce craniosynostosis in infants. Elderly.
Adverse Reactions
Cardiac arrhythmias (eg, atrial fibrillation & extrasystoles), tachycardia, palpitations, anginal conditions, cephalalgia, muscular weakness & cramps, flushing, fever, vomiting, menstrual disorders, pseudotumor cerebri, tremor, restlessness, insomnia, hyperhidrosis, wt loss, diarrhoea. Rash, urticaria, angioedema.
Drug Interactions
Reduced effect of antidiabetic agents. Intensified effect of anti-coagulant therapy. May influence effect w/ PIs (eg, ritonavir, indinavir, lopinavir); phenytoin. Inhibited absorption w/ Al-containing medicinal products (antacids, sucralfate). Elevated fT4 fraction w/ salicylates, dicumarol, furosemide in high doses (250 mg), clofibrate. Decreased absorption w/ PPIs; orlistat; sevelamer. Decreased efficacy w/ tyrosine kinase inhibitors (eg, imatinib, sunitinib). Inhibited peripheral conversion of T4 to T3 w/ propylthiouracil, glucocorticoids, β-sympatholytics, amiodarone & iodine containing contrast media. Can trigger hyperthyroidism as well as hypothyroidism w/ amiodarone. Decreased efficacy & increased serum TSH level w/ sertraline, chloroquine/proguanil. Reduced serum conc w/ enzyme inducing medicinal products eg, barbiturates, carbamazepine, or products containing St. John's Wort (Hypericum perforatum L.). Increased need w/ oestrogen-containing contraceptives & HRT. Decreased intestinal absorption w/ soy-containing compd. Falsely decreased or increased test results of thyroid immunoassays w/ biotin.
MIMS Class
Thyroid Hormones
ATC Classification
H03AA01 - levothyroxine sodium ; Belongs to the class of thyroid hormones.
Presentation/Packing
Form
Euthyrox tab 100 mcg
Packing/Price
4 × 25's (Rp411,020/boks)
Form
Euthyrox tab 150 mcg
Packing/Price
4 × 25's
Form
Euthyrox tab 50 mcg
Packing/Price
4 × 25's (Rp231,340/boks)
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