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Eltroxin Tablets
Eltroxin contains Levothyroxine Sodium that is identical to the thyroid hormone produced in the human thyroid gland. It is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. Levothyroxine is also used to help decrease the size of enlarged thyroid glands (also called a goiter). Eltroxin helps to reduce the symptoms of low thyroid hormone such as weight gain, sensitivity to cold, lack of energy, and dry skin.
Active Ingredient
The active ingredient present in Eltroxin Tablets is Levothyroxine Sodium.Eltroxin 50 mcg contains 50 micrograms (0.05 mg) of Levothyroxine Sodium whereas Eltroxin 100 mcg contains 100 micrograms (0.1 mg) of Levothyroxine Sodium.The inactive ingredients present are as per the old formula of GlaxoSmithKline.
Chemical Structure
Inactive ingredients present in Eltroxin 25 mcg tablets:
Sodium Citrate
Lactose
Starch Maize
Acacia Powder
Magnesium Stearate
Purified Water
Inactive ingredients present in Eltroxin 50 mcg tablets:
Sodium Citrate
Lactose
Starch Maize
Acacia Powder
Magnesium Stearate
Purified Water
Inactive ingredients present in Eltroxin 100 mcg tablets:
Sodium Citrate
Lactose
Starch Maize
Gelatin
Methyl Hydroxybenzoate
Propyl Hydroxybenzoate
Magnesium Stearate
Purified Water
Recommended Adult Dosage
Eltroxin is administered as a single daily dose, on an empty stomach preferably one-half to one hour before breakfast. Eltroxin tablets should be taken at least 4 hours apart from medicines that are known to interfere with its absorption.The Initial recommended dose is 50 to 100 micrograms daily and adjusted at four or six week intervals by 50 micrograms until attainment of adequate clinical response.
Administration
Should preferably be taken on an empty stomach
Should be swallowed whole
Should be taken with a full glass of water
Eltroxin tablets should not be split
Contraindications
Hypersensitivity to Levothyroxine Sodium or any inactive ingredient of the preparation.
Patients with untreated subclinical or overt thyrotoxicosis
Patients with acute myocardial infarction
Patients with uncorrected adrenal insufficiency
Possible Side Effects
Immune system disorders: Hypersensitivity reactions such as skin rash and pruritis
Metabolism and nutrition disorders: Increased appetite, abdominal cramps, nausea, vomiting and diarrhea
Nervous system disorders: Excitability, insomnia, restlessness, headache, tremors, seizure
Possible Side Effects
Cardiac disorders: Anginal pain, cardiac arrhythmias, palpitations, tachycardia, increased blood pressure, heart failure, myocardial infarction
Respiratory, thoracic and mediastinal disorders: Dysponea
Skin and subcutaneous tissue disorders: Sweating, flushing, hair loss
Possible Side Effects
Musculoskeletal, connective tissue and bone disorders : Cramps in the skeletal muscle, muscular weakness, decreased bone mineral density.
Reproductive system and breast disorders: Menstrual irregularity, impaired fertility
General disorders and administration site conditions: Fatigue, heat intolerance, fever, excessive loss of weight.
Appropriate thyroxine 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 the consequences of under- or over-treatment.
Treatment with thyroxine 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 levothyroxine sodium in these cases.
Warnings And Precautions
Special care is needed in the elderly and in patients with symptoms of myocardial insufficiency or ECG evidence of myocardial infarction or ischaemia and also those with diabetes mellitus or insipidus.
Levothyroxine raises blood sugar levels and this may upset the stability of patients receiving antidiabetic agents.
Levothyroxine is excreted in breast milk in low concentrations and this may be sufficient to interfere with neonatal screening for hypothroidism.
Warnings And Precautions
In women, long-term levothyroxine sodium therapy has been associated with increased bone resorption, thereby decreasing bone mineral density, especially in post-menopausal women on greater than replacement doses or in women who are receiving suppressive doses of levothyroxine sodium.
Warnings And Precautions
Overdose Symptoms
In addition to exaggeration of side effects the following symptoms may be seen: agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have also been reported. Seizures have occurred in a child ingesting 18 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium.
Overdose Treatment
Levothyroxine Sodium should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur.In case of an acute overdose, symptomatic and supportive therapy should be instituted immediately. If not contraindicated (e.g., by seizures, coma, or loss of the gag reflex), the stomach should be emptied by emesis or gastric lavage to decrease gastrointestinal absorption. Activated charcoal or cholestyramine may also be used to decrease absorption.
Overdose Treatment
Central and peripheral increased sympathetic activity may be treated by administering Beta-receptor antagonists, e.g., propranolol, provided there are no medical contraindications to their use.Provide respiratory support as needed; control congestive heart failure and arrhythmia; control fever, hypoglycemia, and fluid loss as necessary. Large doses of antithyroid drugs (e.g., methimazole or propylthiouracil) followed in one to two hours by large doses of iodine may be given to inhibit synthesis and release of thyroid hormones. Glucocorticoids may be given to inhibit the conversion of T4 to T3.
Eltroxin Tablets 25 mcg, 50 mcg & 100 mcg from GlaxoSmithKline.
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Eltroxin Tablets
The Swiss Pharmacy, Geneva Switzerland