Loading…
THYQUIDITY is a brand name for Levothyroxine (also known as Thyroxine). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Hypothyroidism THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression THYQUIDITY is indicated as an adjunct to surgery…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Administer once daily, preferably on an empty stomach, one-half to one hour before breakfast. 1) Administer at least 4 hours before or after drugs that are known to interfere with absorption. 1) Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect THYQUIDITY absorption.
1) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated.
Peak therapeutic effect may not be attained for 4-6 weeks. 2) See full prescribing information for dosing in specific patient populations. 3) Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status.
1 General Administration Information Administer THYQUIDITY as a single daily oral dose, on an empty stomach, one-half to one hour before breakfast. 1) ] . 3) ] . Administer THYQUIDITY directly to the mouth using a calibrated oral syringe provided by the pharmacy.
A household teaspoon or tablespoon is not an adequate measuring device. 3) , Warnings and Precautions (5) , and Drug Interactions (7) ] . 4) ] . The peak therapeutic effect of a given dose of THYQUIDITY may not be attained for 4 to 6 weeks.
3 Dosing in Specific Patient Populations Primary Hypothyroidism in Adults and in Adolescents in Whom Growth and Puberty are Complete Start THYQUIDITY at the full replacement dose in otherwise healthy, non-elderly individuals who have been hypothyroid for only a short time (such as a few months).
6 mcg per kg per day (for example: 100 to 125 mcg per day for a 70 kg adult). 5 to 25 mcg increments every 4 to 6 weeks until the patient is clinically euthyroid and the serum TSH returns to normal. Doses greater than 200 mcg per day are seldom required.
An inadequate response to daily doses of greater than 300 mcg per day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors. 5 to 25 mcg per day. Increase the dose every 6 to 8 weeks, as needed, until the patient is clinically euthyroid and the serum TSH returns to normal.
The full replacement dose of THYQUIDITY may be less than 1 mcg per kg per day in elderly patients. 5 to 25 mcg per day. 5 to 25 mcg increments every 2 to 4 weeks until the patient is clinically euthyroid and the serum TSH level is normalized.
6 ADVERSE REACTIONS Adverse reactions associated with THYQUIDITY therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) , Overdosage (10) ] .
They include the following:
General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal: tremors, muscle weakness, muscle spasm Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory: dyspnea Gastrointestinal: diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic: hair loss, flushing, rash Endocrine: decreased bone mineral density Reproductive: menstrual irregularities, impaired fertility Seizures have been reported rarely with the institution of levothyroxine therapy.
Adverse Reactions in Children Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height.
Hypersensitivity Reactions Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include urticaria, pruritus, skin rash, flushing, angioedema, various gastrointestinal symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness, and wheezing.
Hypersensitivity to levothyroxine itself is not known to occur. Adverse reactions associated with THYQUIDITY therapy are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash.
5 WARNINGS AND PRECAUTIONS Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate THYQUIDITY at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation.
5 ) Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. 2) Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of THYQUIDITY treatment.
3) Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism. 4) Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements.
Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy. 5) Decreased bone mineral density associated with thyroid hormone over- replacement: Over-replacement can increase bone resorption and decrease bone mineral density.
Give the lowest effective dose. 1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease Over-treatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients.
5) ] . Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive THYQUIDITY therapy. Monitor patients receiving concomitant THYQUIDITY and sympathomimetic agents for signs and symptoms of coronary insufficiency.
If cardiac symptoms develop or worsen, reduce the THYQUIDITY dose or withhold for one week and restart at a lower dose. 2 Myxedema Coma Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract.
3) ] . Uncorrected adrenal insufficiency. (4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Levothyroxine in United States of America.
Know a brand we are missing in United States of America? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Secondary or Tertiary Hypothyroidism Start THYQUIDITY at the full replacement dose in otherwise healthy, non-elderly individuals. Start with a lower dose in elderly patients, patients with underlying cardiovascular disease or patients with severe longstanding hypothyroidism as described above.
Serum TSH is not a reliable measure of THYQUIDITY dose adequacy in patients with secondary or tertiary hypothyroidism and should not be used to monitor therapy. Use the serum free-T4 level to monitor adequacy of therapy in this patient population.
Titrate THYQUIDITY dosing per above instructions until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range. Pediatric Dosage - Congenital or Acquired Hypothyroidism The recommended daily dose of THYQUIDITY in pediatric patients with hypothyroidism is based on body weight and changes with age as described in Table 1.
Start THYQUIDITY at the full daily dose in most pediatric patients. Start at a lower starting dose in newborns (0-3 months) at risk for cardiac failure and in children at risk for hyperactivity (see below). 4) ]. Table 1. 4) ] .
Newborns (0-3 months) at risk for cardiac failure :
Consider a lower starting dose in newborns at risk for cardiac failure. Increase the dose every 4 to 6 weeks as needed based on clinical and laboratory response.
Children at risk for hyperactivity :
To minimize the risk of hyperactivity in children, start at one-fourth the recommended full replacement dose, and increase on a weekly basis by one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.
Pregnancy Pre-existing Hypothyroidism:
THYQUIDITY dose requirements may increase during pregnancy. Measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at a minimum, during each trimester of pregnancy. In patients with primary hypothyroidism, maintain serum TSH in the trimester-specific reference range.
5 to 25 mcg/day and measure TSH every 4 weeks until a stable THYQUIDITY dose is reached and serum TSH is within the normal trimester-specific range. Reduce THYQUIDITY dosage to pre-pregnancy levels immediately after delivery and measure serum TSH levels 4 to 8 weeks postpartum to ensure THYQUIDITY dose is appropriate.
New Onset Hypothyroidism :
Normalize thyroid function as rapidly as possible. 1) ] . 1 mIU per liter, and this usually requires a THYQUIDITY dose of greater than 2 mcg per kg per day. However, in patients with high-risk tumors, the target level for TSH suppression may be lower.
4 Monitoring TSH and/or Thyroxine (T4) Levels Assess the adequacy of therapy by periodic assessment of laboratory tests and clinical evaluation. Persistent clinical and laboratory evidence of hypothyroidism, despite an apparent adequate replacement dose of THYQUIDITY, may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors.
Adults In adult patients with primary hypothyroidism, monitor serum TSH levels after an interval of 6 to 8 weeks after any change in dose. In patients on a stable and appropriate replacement dose, evaluate clinical and biochemical response every 6 to 12 months and whenever there is a change in the patient's clinical status.
Pediatrics In patients with congenital hypothyroidism, assess the adequacy of replacement therapy by measuring both serum TSH and total or free-T4. Monitor TSH and total or free-T4 in children as follows: 2 and 4 weeks after the initiation of treatment, 2 weeks after any change in dosage, and then every 3 to 12 months thereafter following dose stabilization until growth is completed.
Poor compliance or abnormal values may necessitate more frequent monitoring. Perform routine clinical examination, including assessment of development, mental and physical growth, and bone maturation, at regular intervals. Although the general aim of therapy is to normalize the serum TSH level, TSH may not normalize in some patients due to in utero hypothyroidism causing a resetting of pituitary-thyroid feedback.
Failure of the serum T4 to increase into the upper half of the normal range within 2 weeks of initiation of THYQUIDITY therapy and/or of the serum TSH to decrease below 20 mIU per liter within 4 weeks may indicate the child is not receiving adequate therapy.
4) ] . Secondary and Tertiary Hypothyroidism Monitor serum free-T4 levels and maintain in the upper half of the normal range in these patients.
gov/medwatch.
Use of oral thyroid hormone drug products is not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma. 3 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency Thyroid hormone increases metabolic clearance of glucocorticoids.
Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with THYQUIDITY [see Contraindications (4) ].
4 Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism THYQUIDITY has a narrow therapeutic index. 4) ] . 4) ] . 3) ] . 5 Worsening of Diabetic Control Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements.
2) ] . 6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in post-menopausal women.
The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase, and suppressed serum parathyroid hormone levels. Administer the minimum dose of THYQUIDITY that achieves the desired clinical and biochemical response to mitigate this risk.