过敏,烦躁,失眠,震颤,肌肉无力,食欲增加,体重减轻,腹泻,热不耐受,月经不规则,皮疹。
要报告疑似不良反应,请致电1-855-346-8326报告Jerome Stevens Pharmaceuticals Inc.,或致电1-800-FDA-1088或www.fda.gov/medwatch报告FDA。
药物相互作用
查看影响甲状腺激素药代动力学和代谢(例如吸收,合成,分泌,分解代谢,蛋白质结合和靶组织反应)的药物的完整处方信息,并可改变对UNITHROID的治疗反应。
用于特定人群
怀孕可能需要使用更高剂量的左旋甲状腺素。
包装提供/存储和处理
UNITHROID(左旋甲状腺素钠)片剂为圆形和颜色编码,可按如下方式提供:
储藏条件
储存温度在20°C-25°C(68°F-77°F)之间,允许偏差在15°C-30°C(59°F-86°F)之间。
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07562e72-7eaa-4ce6-94f0-e08814787e50
UNITHROID® (levothyroxine sodium) tablets, for oral use
Initial U.S. Approval: 2001
INDICATION
UNITHROID is indicated 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.
MPORTANT SAFETY INFORMATION (continued)
Levothyroxine is contraindicated in patients with untreated subclinical or overt thyrotoxicosis, acute myocardial infarction, uncorrected adrenal insufficiency, or with hypersensitivity to any of the inactive tablet ingredients.
In patients with nontoxic diffuse goiter or nodular thyroid disease, particularly the elderly or those with underlying cardiovascular disease, levothyroxine sodium therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis. If the serum TSH level is not suppressed, levothyroxine should be used with caution in conjunction with careful monitoring of thyroid function for evidence of hyperthyroidism and clinical monitoring for adverse cardiovascular signs and symptoms of hyperthyroidism.
Levothyroxine should not be used in the treatment of male or female infertility unless this condition is associated with hypothyroidism.
Levothyroxine has a narrow therapeutic index. Regardless of the indication for use, careful dosage titration is necessary to avoid the consequences of over- or under-treatment.
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.
Patients receiving levothyroxine sodium should be given the minimum dose necessary to achieve the desired response.
Patients with coronary artery disease who are receiving levothyroxine therapy should be monitored closely during surgical procedures, since the possibility of precipitating cardiac arrhythmias may be greater in those treated with levothyroxine.
In patients with secondary or tertiary hypothyroidism, additional hypothalamic/pituitary hormone deficiencies should be considered, and, if diagnosed, treated.
Patients with concomitant adrenal insufficiency should be treated with replacement glucocorticoids prior to initiation of treatment with levothyroxine sodium. Failure to do so may precipitate an acute adr |