药品信息:
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INDICATIONS AND USAGE SAMSCA is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Important Limitations: • Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological
symptoms should not be treated with SAMSCA. • It has not been established that SAMSCA provides a symptomatic benefit to patients.
------------------------------------------------------------------------ DOSAGE AND ADMINISTRATION • SAMSCA should be initiated and re-initiated in a hospital. • The recommended starting dose is 15 mg once daily. Dosage may be increased at intervals ≥24 hr to 30 mg once daily, and to a maximum of 60 mg once daily as needed to raise serum sodium. Monitor serum sodium and volume status.
------------------------------------------------------------------------ DOSAGE FORMS AND STRENGTHS • Tablets: 15 mg and 30 mg
------------------------------------------------------------------------ CONTRAINDICATIONS • Do not administer to patients requiring urgent intervention to raise serum sodium acutely. • Do not use in patients who are unable to sense or to respond appropriately to thirst. • Do not use in patients with hypovolemic hyponatremia. • Do not use with strong CYP 3A inhibitors. • Do not administer to patients who are anuric as no benefit is expected.
------------------------------------------------------------------------ WARNINGS/PRECAUTIONS • Monitor serum sodium and neurologic status as serious neurologic sequelae can result from over rapid correction of sodium. • Because of the potential increased risk of gastrointestinal bleeding in patients with cirrhosis, use in patients with cirrhosis only when the need to treat outweighs this risk. • Dehydration and hypovolemia may require intervention. • Avoid use with hypertonic saline. • Avoid use with CYP 3A inducers and moderate CYP 3A inhibitors. • Consider dose reduction if co-administered with P-gp inhibitors. • Monitor serum potassium in patients with potassium > 5 mEq/L or on drugs known to increase potassium.
------------------------------------------------------------------------- ADVERSE REACTIONS Most common adverse reactions (≥ 5% placebo) are thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, and hyperglycemia.
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FDA批准托伐普坦片(Samsca)治疗低钠血症
FDA 已经批准托伐普坦片(tolvaptan,Samsca)治疗低钠血症,本品是唯一获准治疗该症的口服型选择性加压素拮抗剂。
Samsca在美国地区的销售由Otsuka美国分公司负责。 FDA 新药审评中心心血管与肾病产品的主任Norman Stockbridge 医学博士对外发表声明时称:随着Samsca的获准,医生对治疗低钠血症又多了一种新的选择,本品被用来治疗由充血性心衰、肝硬化以及抗利尿激素分泌不足综合征导致的低钠血症。
当血浆中钠离子浓度降低时,为了保持细胞内外的钠离子浓度平衡,细胞外的液体就会进入细胞内,这样细胞就会肿胀。当脑细胞肿胀时,就会导致各种低钠血的症状出现。包括头昏、虚弱、头痛、恶心、意识错乱以及意识减缩和惊厥发生。严重的低钠血症会导致昏迷和死亡,目前Samsca在重度低血钠患者中还无相应的研究。 Samsca 可以升高血浆中钠离子浓度,帮助多余的水分从尿液排出。在临床研究中,本品与安慰剂相比,明显升高了患者血浆中的钠离子浓度。
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