ABD - İngilizce - 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) ].

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

boucher & muir (nz) ltd t/a mercury pharma (nz) - levothyroxine sodium 0.05mg (anhydrous) - tablet - 0.05 mg - active: levothyroxine sodium 0.05mg (anhydrous) excipient: acacia lactose monohydrate magnesium stearate maize starch sodium citrate - levothyroxine is indicated for the treatment of hypothyroidism. this product should only be prescribed to patients already taking this product who are known to be intolerant to all other levothyroxine containing products. this product may also be prescribed to patients already taking this product who are not known to be intolerant to all other levothyroxine containing products, but for whom changing to another levothyroxine containing product is not clinically appropriate.

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

boucher & muir (nz) ltd t/a mercury pharma (nz) - levothyroxine sodium 0.1mg (anhydrous) - tablet - 0.1 mg - active: levothyroxine sodium 0.1mg (anhydrous) excipient: acacia lactose monohydrate magnesium stearate maize starch sodium citrate - levothyroxine is indicated for the treatment of hypothyroidism. this product should only be prescribed to patients already taking this product who are known to be intolerant to all other levothyroxine containing products. this product may also be prescribed to patients already taking this product who are not known to be intolerant to all other levothyroxine containing products, but for whom changing to another levothyroxine containing product is not clinically appropriate.

ABD - İngilizce - NLM (National Library of Medicine)

cardinal health 107, llc - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium anhydrous 25 ug - hypothyroidism: levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. pituitary thyrotropin (thyroid-stimulating hormone, tsh) suppression:  levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. limitations of use: levothyroxine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see warnings and precautions (5.3)] . experience with levothyroxine 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, ts

ABD - İngilizce - NLM (National Library of Medicine)

mylan institutional inc. - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium anhydrous 88 ug - hypothyroidism: levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. pituitary thyrotropin (thyroid-stimulating hormone, tsh) suppression:  levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. limitations of use: - levothyroxine sodium tablets 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 levothyroxine sodium tablets may induce hyperthyroidism [see warnings and precautions (5.4)]. - levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. levothyroxine sodium tablets are contraindicated in patients with uncorrected adrenal insufficie

ABD - İngilizce - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium anhydrous 25 ug - hypothyroidism: levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. pituitary thyrotropin (thyroid-stimulating hormone, tsh) suppression: levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer . limitations of use: levothyroxine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see warnings and precautions (5.4) ] . the clinical experience, including data from postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated wit

ABD - İngilizce - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium anhydrous 150 ug - hypothyroidism levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. pituitary thyrotropin (thyroid-stimulating hormone, tsh) suppression levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. limitations of use: • levothyroxine sodium tablets 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 levothyroxine sodium tablets may induce hyperthyroidism [see warnings and precautions (5.4)]. • levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. levothyroxine sodium tablets is contraindicated in patients with uncorrected adrenal insufficiency [see warnings and precauti

ABD - İngilizce - NLM (National Library of Medicine)

mylan institutional inc. - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium anhydrous 25 ug - hypothyroidism: levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. pituitary thyrotropin (thyroid-stimulating hormone, tsh) suppression:  levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. limitations of use: - levothyroxine sodium tablets 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 levothyroxine sodium tablets may induce hyperthyroidism [see warnings and precautions (5.4)]. - levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. levothyroxine sodium tablets are contraindicated in patients with uncorrected adrenal insufficie

ABD - İngilizce - NLM (National Library of Medicine)

sagent pharmaceuticals - 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. 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. 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 non-treatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. 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. 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. 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)].

ABD - İngilizce - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium is used for the following indications: hypothyroidism - as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. pituitary tsh suppression - in the treatment or prevention of various types of euthyroid goiters (see warnings and precautions ), including thyroid nodules (see warnings and precautions ), subacute or chronic iymphocytic thyroiditis (hashimoto's thyroiditis), multinodular goiter (see warnings and precautions ), and, as an adjunct to surgery and radioiodine therapy in the managem