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proficient rx lp - liothyronine sodium (unii: gca9vv7d2n) (liothyronine - unii:06lu7c9h1v) - thyroid hormone drugs are indicated: liothyronine sodium tablets can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef. thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis and apparent hypersensitivity to any of their active or extraneous constituents. there is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

bryant ranch prepack - liothyronine sodium (unii: gca9vv7d2n) (liothyronine - unii:06lu7c9h1v) - liothyronine sodium tablets, usp are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. liothyronine sodium tablets, usp are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. liothyronine sodium tablets, usp are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. limitations of use - liothyronine sodium tablets, usp are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with liothyronine sodium tablets, usp may induce hyperthyroidism [see warnings and precautions (5.4)]. - liothyronine sodium tablets, usp are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. liothyronine sodiu

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

a-s medication solutions - liothyronine sodium (unii: gca9vv7d2n) (liothyronine - unii:06lu7c9h1v) - liothyronine sodium tablets, usp are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. liothyronine sodium tablets, usp are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. liothyronine sodium tablets, usp are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. limitations of use - liothyronine sodium tablets, usp are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with liothyronine sodium tablets, usp may induce hyperthyroidism [see warnings and precautions (5.4)]. - liothyronine sodium tablets, usp are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. liothyronine sodium tablets, usp are contraindicated in patients with uncorrected adrenal insufficiency [see  warnings and precautions (5.3)]. risk summary experience with liothyronine use in pregnant women, including data from post-marketing studies, have not reported increased rates of major birth defects or miscarriages (see data). there are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. since tsh levels may increase during pregnancy, tsh should be monitored and liothyronine sodium dosage adjusted during pregnancy (see clinical considerations). there are no animal studies conducted with liothyronine during pregnancy. liothyronine sodium tablets, usp should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. disease-associated maternal and/or embryo/fetal risk maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery. untreated maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. dose adjustments during pregnancy and the postpartum period pregnancy may increase liothyronine sodium requirements. serum tsh levels should be monitored and the liothyronine sodium dosage adjusted during pregnancy. since postpartum tsh levels are similar to preconception values, the liothyronine sodium dosage should return to the pre-pregnancy dose immediately after delivery [see dosage and administration (2.3)] . human data liothyronine is approved for use as a replacement therapy for hypothyroidism. data from post-marketing studies have not reported increased rates of fetal malformations, miscarriages, or other adverse maternal or fetal outcomes associated with liothyronine use in pregnant women. risk summary limited published studies report that liothyronine is present in human milk. however, there is insufficient information to determine the effects of liothyronine on the breastfed infant and no available information on the effects of liothyronine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for liothyronine sodium and any potential adverse effects on the breastfed infant from liothyronine sodium or from the underlying maternal condition. the initial dose of liothyronine sodium tablets, usp varies with age and body weight. dosing adjustments are based on an assessment of the individual patient's clinical and laboratory parameters [see dosage and administration (2.3, 2.4)]. in pediatric patients in whom a diagnosis of permanent hypothyroidism has not been established, discontinue thyroid hormone for a trial period, but only after the child is at least 3 years of age. obtain serum tsh, t4, and t3 levels at the end of the trial period, and use laboratory test results and clinical assessments to guide diagnosis and treatment, if warranted [see dosage and administration (2.6)]. congenital hypothyroidism  [see dosage and administration (2.2, 2.6)] rapid restoration of normal serum t4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on intellectual development as well as on overall physical growth and maturation. therefore, initiate thyroid hormone immediately upon diagnosis. thyroid hormone is generally continued for life in these patients. closely monitor infants during the first 2 weeks of thyroid hormone therapy for cardiac overload, arrhythmias, and aspiration from avid suckling. closely monitor patients to avoid undertreatment or overtreatment. undertreatment may have deleterious effects on intellectual development and linear growth. overtreatment is associated with craniosynostosis in infants, may adversely affect the tempo of brain maturation, and may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature [see dosage and administration (2.6) and adverse reactions (6)]. acquired hypothyroidism in pediatric patients closely monitor patients to avoid undertreatment and overtreatment. undertreatment may result in poor school performance due to impaired concentration and slowed mentation and in reduced adult height. overtreatment may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature. treated children may manifest a period of catch-up growth, which may be adequate in some cases to normalize adult height. in children with severe or prolonged hypothyroidism, catch-up growth may not be adequate to normalize adult height [see adverse reactions (6)]. because of the increased prevalence of cardiovascular disease among the elderly, initiate liothyronine sodium tablets, usp at less than the full replacement dose [see dosage and administration (2.3) and  warnings and precautions (5.1)] . atrial arrhythmias can occur in elderly patients. atrial fibrillation is the most common of the arrhythmias observed with thyroid hormone overtreatment in the elderly.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

piramal critical care, inc. - levothyroxine sodium anhydrous (unii: 054i36cpmn) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium for injection is indicated for the treatment of myxedema coma. important limitations of use: the relative bioavailability between levothyroxine sodium for injection and oral levothyroxine products has not been established. caution should be used when switching patients from oral levothyroxine products to levothyroxine sodium for injection as accurate dosing conversion has not been studied. none. 8.1 pregnancy pregnancy category a – there are no reported cases of levothyroxine sodium for injection used to treat myxedema coma in patients who were pregnant or lactating. studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities. therefore, pregnant patients who develop myxedema should be treated with levothyroxine sodium for injection as the risk of non-treatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. 8.2 labor and delivery patie

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

piramal critical care, inc. - levothyroxine sodium anhydrous (unii: 054i36cpmn) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium for injection is indicated for the treatment of myxedema coma. important limitations of use: the relative bioavailability between levothyroxine sodium for injection and oral levothyroxine products has not been established. caution should be used when switching patients from oral levothyroxine products to levothyroxine sodium for injection as accurate dosing conversion has not been studied. none. 8.1 pregnancy pregnancy category a – there are no reported cases of levothyroxine sodium for injection used to treat myxedema coma in patients who were pregnant or lactating. studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities. therefore, pregnant patients who develop myxedema should be treated with levothyroxine sodium for injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. 8.2 labor and delivery patients in labor who develop myxedema have not been reported in the literature. however, patients should be treated with levothyroxine sodium for injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. 8.3 nursing mothers adequate replacement doses of thyroid hormones are required to maintain normal lactation. there are no reported cases of levothyroxine sodium for injection used to treat myxedema coma in patients who are lactating. however, such patients should be treated with levothyroxine sodium for injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the nursing patient. 8.4 pediatric use myxedema coma is a disease of the elderly. an approved, oral dosage form of levothyroxine should be used in the pediatric patient population for maintaining a euthyroid state in non-complicated hypothyroidism. 8.5 geriatric use and patients with underlying cardiovascular disease see section 2, dosage and administration, for full prescribing information in the geriatric patient population. because of the increased prevalence of cardiovascular disease in the elderly, cautious use of levothyroxine sodium for injection in the elderly and in patients with known cardiac risk factors is advised. atrial fibrillation is a common side effect associated with levothyroxine treatment in the elderly [ see dosage and administration ( 2) and warnings and precautions ( 5) ].

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

acella pharmaceuticals, llc - levothyroxine (unii: q51bo43mg4) (levothyroxine - unii:q51bo43mg4), liothyronine (unii: 06lu7c9h1v) (liothyronine - unii:06lu7c9h1v) - levothyroxine 9.5 ug - indications and usage:  np thyroid® tablets (thyroid tablets, usp) are indicated: 1. as replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. this category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (see warnings). 2. as pituitary tsh suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (hashimoto’s), multinodular goiter, and in the management of thyroid cancer. contraindications:  thyroid hormone preparations are generally

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

acella pharmaceuticals, llc - levothyroxine (unii: q51bo43mg4) (levothyroxine - unii:q51bo43mg4), liothyronine (unii: 06lu7c9h1v) (liothyronine - unii:06lu7c9h1v) - levothyroxine 76 ug - indications and usage: np thyroid® tablets (thyroid tablets, usp) are indicated: 1. as replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. this category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (see warnings). 2. as pituitary tsh suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (hashimoto’s), multinodular goiter, and in the management of thyroid cancer. contraindications: thyroid hormone preparations are generally

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

bryant ranch prepack - levothyroxine (unii: q51bo43mg4) (levothyroxine - unii:q51bo43mg4), liothyronine (unii: 06lu7c9h1v) (liothyronine - unii:06lu7c9h1v) - levothyroxine 19 ug - indications and usage: np thyroid® tablets (thyroid tablets, usp) are indicated: 1. as replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. this category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (see warnings). 2. as pituitary tsh suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (hashimoto’s), multinodular goiter, and in the management of thyroid cancer. contraindications: thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. there is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone. pediatric use — pregnant mothers provide little or no thyroid hormone to the fetus. the incidence of congenital hypothyroidism is relatively high (1:4,000) and the hypothyroid fetus would not derive any benefit from the small amounts of hormone crossing the placental barrier. routine determinations of serum t4 and/or tsh is strongly advised in neonates in view of the deleterious effects of thyroid deficiency on growth and development. treatment should be initiated immediately upon diagnosis, and maintained for life, unless transient hypothyroidism is suspected; in which case, therapy may be interrupted for 2 to 8 weeks after the age of 3 years to reassess the condition. cessation of therapy is justified in patients who have maintained a normal tsh during those 2 to 8 weeks.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

acella pharmaceuticals, llc - levothyroxine (unii: q51bo43mg4) (levothyroxine - unii:q51bo43mg4), liothyronine (unii: 06lu7c9h1v) (liothyronine - unii:06lu7c9h1v) - levothyroxine 19 ug - indications and usage: np thyroid® tablets (thyroid tablets, usp) are indicated: 1. as replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. this category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (see warnings). 2. as pituitary tsh suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (hashimoto’s), multinodular goiter, and in the management of thyroid cancer. contraindications: thyroid hormone preparations are generally

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

acella pharmaceuticals, llc - levothyroxine (unii: q51bo43mg4) (levothyroxine - unii:q51bo43mg4), liothyronine (unii: 06lu7c9h1v) (liothyronine - unii:06lu7c9h1v) - levothyroxine 57 ug - indications and usage: np thyroid® tablets (thyroid tablets, usp) are indicated: 1. as replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. this category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (see warnings). 2. as pituitary tsh suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (hashimoto’s), multinodular goiter, and in the management of thyroid cancer. contraindications: thyroid hormone preparations are generally