美国食品药品监督管理局（FDA）批准先灵葆雅公司的Saphris（阿莫沙平）舌下片上市。阿莫沙平是一种非典型抗精神病药物，用于治疗成人精神分裂症、慢性重度脑功能障碍和I型双相性精神障碍。
FDA基于3项短期、安慰剂对照和阳性药物对照的临床试验证明Saphris治疗精神分裂症的有效性；基于2项短期、安慰剂和阳性药物对照的临床试验证明Saphris治疗双相性精神障碍的有效性。
作为精神疾病治疗药物，该药的说明书中有[黑框警示]信息，警示医生，
老年痴呆症患者用药存在治疗风险。Saphris的治疗精神分裂症的临床试验常见不良反应为燥动、口腔鼓味觉减退和嗜睡。治疗双相性精神障碍的临床试验常见不良反应为燥动、体重增加、嗜睡、眩晕和运动失调。

SAPHRIS

Generic Name for SAPHRIS

Asenapine 5mg, 10mg; sublingual (SL) tabs.

Legal Classification:

Rx

Pharmacological Class for SAPHRIS

Atypical antipsychotic (dibenzo-oxepino pyrrole).

Manufacturer of SAPHRIS

Merck & Co., Inc.

Indications for SAPHRIS

Schizophrenia.

Adult dose for SAPHRIS

Do not crush, chew, or swallow; do not eat or drink for 10 min after administration. Allow tablet to dissolve on tongue completely. Acute treatment: 5mg twice daily. Maintenance: 5mg twice daily for 1 week, then increase to 10mg twice daily. Max dose: 10mg twice daily. Reevaluate periodically.

Children's dosing for SAPHRIS

Not recommended.

Warnings/Precautions for SAPHRIS

Avoid in congenital long QT syndrome, cardiac arrhythmias. Severe hepatic impairment: not recommended. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1^st few months of treatment; discontinue if WBCs decline. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia. History of seizures. Exposure to extreme heat. Dysphagia. Write ℞ for smallest practical amount. Elderly (not for dementia-related psychosis). Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3^rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions for SAPHRIS

Avoid drugs that can prolong QT interval (eg, Class 1A or Class III antiarrhythmics, ziprasidone, chlorpromazine, thioridazine, moxifloxacin, alcohol). Potentiates antihypertensives. Potentiated by fluvoxamine. Caution with other CNS drugs, drugs that are CYP2D6 substrates /inhibitors, drugs that cause orthostatic hypotension, and drugs with anticholinergic activity.

Adverse Reactions for SAPHRIS

Akathisia, oral hypoesthesia, somnolence, dizziness, extrapyramidal effects, GI upset; orthostatic hypotension, syncope, QT prolongation, hyperglycemia, weight gain, hypersensitivity reactions, hyperprolactinemia.

How is SAPHRIS supplied?

SL tabs—60
SL tabs (black cherry flavor)—60