Euthyrox 75 mcg 100 tablets

Euthyrox 75 mcg 100 tablets

Composition:
Each tablet contains:
75 microgram levothyroxine sodium.
Excipients:
Maize starch, citric acid, croscarmellose sodium, gelatin, magnesium stearate, mannitol.
Description
Euthyrox contains levothyroxine sodium, a synthetic thyroid hormone used for replacement therapy, suppression therapy, prevention of goiter recurrence, and diagnostic thyroid suppression testing.
Tablets are available in a wide dosage range (25-200 micrograms) for individualized daily dosing.
Indications for Use:
Euthyrox 25-200 micrograms:
- Treatment of benign euthyroid goiter
- Prevention of relapse after surgery for euthyroid goiter
- Replacement therapy in hypothyroidism
- Suppression therapy in thyroid cancer.
Euthyrox 25-100 micrograms:
Concomitant supplementation during antithyroid drug treatment of hyperthyroidism.
Euthyrox 100/150/200 micrograms:
Thyroid suppression testing (diagnostic use).
Dosage and Method of Administration:
- Tablets contain 25-200 micrograms of levothyroxine; most patients require only one daily tablet.
- Dose must be individualized based on laboratory results, especially serum TSH.
General rules:
- Start with a low dose; increase every 2-4 weeks.
- TSH is the most reliable parameter for dose adjustment.
Neonates and infants with congenital hypothyroidism:
10-15 micrograms/kg/day for the first 3 months; thereafter dose adjustments based on TSH and clinical status.
Elderly, cardiac disease, long-standing hypothyroidism: Initial dose: 12.5 micrograms/day. Increase slowly at long intervals (e.g., 12.5 micrograms every 2 weeks).
Recommended daily doses (micrograms/day):
- Benign euthyroid goiter: 75-200
- Relapse prophylaxis: 75-200
- Hypothyroidism in adults: initial 25-50, maintenance 100-200
- Hypothyroidism in children: initial 12.5-50, maintenance 100-150 micrograms/m²
- Concomitant use with antithyroid drugs: 50-100
- Thyroid cancer suppression: 150-300.
Administration:
- Once daily, in the morning on an empty stomach, 30 minutes before breakfast, with water.
- Infants: disperse the tablet in water and give before first feeding.
- Duration of therapy: lifelong in hypothyroidism and post-surgery cases.
Contraindications:
- Hypersensitivity to active substance or excipients
- Untreated adrenal insufficiency
- Untreated pituitary insufficiency
- Untreated thyrotoxicosis
- Acute myocardial infarction, myocarditis, pancarditis
- Combination of levothyroxine and antithyroid drugs during pregnancy.
Precautions:
- Exclude coronary disease, hypertension, atherosclerosis, pituitary insufficiency before therapy
- Treat adrenal insufficiency before starting levothyroxine
- Start with low dose in patients at risk of psychotic disorders
- Avoid drug-induced hyperthyroidism in cardiac patients
- Monitor hemodynamics in very low birth weight neonates
- In postmenopausal women avoid supraphysiological doses
- Levothyroxine must not be used for weight loss
- High doses combined with sympathomimetics may cause severe adverse effects
- Close monitoring required when switching brand
- Orlistat may reduce levothyroxine absorption
- Biotin interferes with thyroid tests → lab must be informed
- Contains <1 mmol sodium per tablet (“sodium-free”).
Side Effects:
Symptoms of hyperthyroidism may occur in overdose or excessive dosing:
- Cardiac arrhythmias, tachycardia, palpitations, angina
- Headache, muscle weakness, cramps
- Tremor, restlessness, insomnia, sweating
- Weight loss, diarrhoea, vomiting
- Menstrual disorders
- Pseudotumor cerebri
- Allergic reactions: rash, urticaria, respiratory involvement, angioedema.
Pregnancy and Breastfeeding:
Pregnancy:
Levothyroxine should be continued during pregnancy.
Dose may need to be increased.
TSH should be checked each trimester.
Postpartum dosage should return to pre-pregnancy levels.
Thyroid suppression tests contraindicated during pregnancy.
Breastfeeding:
Excreted into breast milk, but therapeutic doses are safe for infants.
Storage Conditions:
Store below 30°C.
Keep an outer carton to protect from light.
Keep out of reach of children.
Packaging
Carton box containing 4 blisters (aluminum/aluminum), each with 25 tablets, plus leaflet.
Total: 100 tablets.