ELTROXIN 100MG TAB (TABLET)

Administration: Eltroxin tablets should preferably be taken on an empty stomach. Missed Dosage: If a scheduled daily dose is missed, the dose should be taken as soon as the patient remembers, unless it is almost time for the patient's next dose. Two doses should not be taken together. Due to a lack of data, it is not appropriate to crush Eltroxin tablets and thyroxine tablets without a score-line must not be halved. Contraindications : Hypersensitivity. Thyrotoxicosis. Special Precautions Eltroxin has a narrow therapeutic index. Appropriate Eltroxin dosage is based upon clinical assessment and laboratory monitoring of thyroid function tests. During the initial titration period, careful dosage titration and monitoring is necessary to avoid consequences of under- or overtreatment. The symptoms of excessive Eltroxin dosage are the same as many features of endogenous thyrotoxicosis. Treatment with Eltroxin in patients with panhypopituitarism or other causes predisposing to adrenal insufficiency may cause reactions including dizziness, weakness, malaise, weight loss, hypotension and adrenal crisis. It is advisable to initiate corticosteroid therapy before giving Eltroxin in these cases. Special care is needed in the elderly and in patients with symptoms of myocardial insufficiency or ECG evidence of myocardial infarction or ischemia and also those with diabetes mellitus or insipidus. Eltroxin raises blood sugar levels and this may upset the stability of patients receiving antidiabetic agents. Special Patient Populations: Renal and hepatic disease do not appear to have any significant effect on the disposition of thyroxine. Effects on the Ability to Drive or Operate Machinery: From the pharmacokinetic and pharmacodynamic properties of thyroxine, treatment with Eltroxin would not be expected to interfere with ability to drive or operate machinery. Use in pregnancy: Thyroxine sodium has been taken by a large number of pregnant women and women of childbearing age without any form of definite disturbances in the reproductive process having been observed so far. Thyroid, hypo- or hyperactivity in the mother may however, unfavorably influence the fetal outcome or well-being. Use in lactation: Thyroxine is excreted in breast milk in low concentrations and this may be sufficient to interfere with neonatal screening for hypothyroidism. Use In Pregnancy & Lactation Use in pregnancy: Thyroxine sodium has been taken by a large number of pregnant women and women of childbearing age without any form of definite disturbances in the reproductive process having been observed so far. Thyroid, hypo- or hyperactivity in the mother may however, unfavorably influence the fetal outcome or well-being. Use in lactation: Thyroxine is excreted in breast milk in low concentrations and this may be sufficient to interfere with neonatal screening for hypothyroidism. Dosage Adults: Initially, 50-100 mcg daily and adjusted at 4- to 6-week intervals by 50 mcg until attainment of clinical and biochemical euthyroidism. Normal metabolism is steadily maintained. This may require doses of 100-200 mcg daily. In patients >50 years, it is not advisable to exceed 50 mcg/day initially. When patient has a cardiac disease, 50 mcg on alternate days is more suitable. In this condition, the daily dosage may be increased by 50 mcg on alternate days at intervals of approximately 4 weeks. Children: Congenital Hypothyroidism and Juvenile Myxedema: The largest dose consistent with freedom from toxic effects should be given. The dosage is guided by clinical response, growth assessment and appropriate thyroid function tests; clinically, normal pulse rate and absence of diarrhea or constipation are the most useful indicators. Thyrotrophin levels may remain elevated during the 1st year of life in children with neonatal hypothyroidism due to resetting of the hypothalamic-pituitary axis. For infants with congenital hypothyroidism, a suitable starting dose is 50 mcg on alternate days with increments of 50 mcg on alternate days at intervals of every 2-4 weeks until optimal response is achieved. The same dosing regimen applies to juvenile myxoedema, except that the starting dose for children >1 year may be 2.5-5 mcg/kg/day. The calculated daily dose equivalent should be rounded to the nearest 25 mcg to determine the actual prescribed dose. If the dose of Eltroxin is increased too rapidly, symptoms eg, diarrhea, nervousness, rapid pulse, insomnia, tremors and sometimes anginal pain where there is latent myocardial ischemia may occur and the dosage must be reduced or withheld for a day or two, then restarted at a lower level. A pre-therapy electrocardiogram (ECG) is valuable, as changes induced by hypothyroidism may be confused with ECG evidence of ischemia. Interactions Phenytoin levels may be increased. May increase the effects of anticoagulants & sympathomimetics. Carbamazepine, cardiac glycosides. Accelerates response to TCAs. Cholestyramine reduces GI absorption of thyroxine, Al hydroxide, colestipol, kayexalat, sevelamer, sucralfate, Ca carbonate, Fe sulfate. OC, tamoxifen, clofibrate, methadone & 5-fluorouracil. HMG-CoA reductase inhibitors, androgens & anabolic steroids. Imatinib, sunitinib, amiodarone. Carbamazepine. Adverse Reactions The following effects are indicative of excessive dosage and usually disappear on reduction of dosage or withdrawal of treatment for a few days: The frequency classification for these adverse reactions is not known due to a lack of robust clinical trial data to accurately determine frequency estimates. Immune System Disorders: Hypersensitivity reactions eg, skin rash and pruritus. Metabolism and Nutrition Disorders: Increased appetite, abdominal cramps, nausea, vomiting and diarrhea. Nervous System Disorders: Excitability, insomnia, restlessness, headache, tremors, seizure. Rare cases of pseudotumor cerebri (benign intracranial hypertension) have been reported especially in children. Cardiac Disorders: Anginal pain, cardiac arrhythmias, palpitations, tachycardia, increased blood pressure, heart failure, myocardial infarction. Respiratory, Thoracic and Mediastinal Disorders: Dyspnea. Skin and Subcutaneous Tissue Disorders: Sweating, flushing, hair loss. Musculoskeletal, Connective Tissue and Bone Disorders: Cramps in the skeletal muscle, muscular weakness, decreased bone mineral density. Excessive dose may result in craniosynostosis in infants and premature closure of epiphyses in children with compromised adult height. Reproductive System and Breast Disorders: Menstrual irregularity, impaired fertility. General Disorders and Administration Site Conditions: Fatigue, heat intolerance, fever, excessive weight loss.