阿斯利康制药公司近日宣布其生产的Seroquel XR（quetiapine fumarate）已获得美国FDA批准上市。
SeroquelXR是用于双相Ⅰ型精神障碍抑郁发作、躁狂发作和混合发作的急性期治疗的缓释片，也可作为锂或双丙戊酸钠的辅助用药，用于双相精神障碍的维持治疗。

它是第一个获得FDA批准的、每日一次、用于双相精神障碍，治疗抑郁和躁狂期的急性期治疗药物。研究者指出，事实上该类病人抑郁症状出现的次数要比躁狂症状多3倍，SeroquelXR获批准上市，每天使用一次，已证实其控制双相精神障碍病人的抑郁和躁狂症状的效果显著。

SEROQUEL XR
Manufacturer
AstraZeneca Pharmaceuticals
Legal Classification
Rx
Pharmacological Class
Dibenzothiazepine.
Generic Name
Quetiapine (as fumarate) 50mg, 150mg, 200mg,300mg,400mg; ext-reltabs.
Also
SEROQUEL
Indications
Schizophrenia.
Children
Not recommended.
Adults
Swallow whole. Take on an empty stomach or with light meal. Initially 300mg once daily in the PM; may increase at 1-day intervals in increments of up to 300mg/day. Usual range:400–800mg/day; max 800mg/day. Elderly, debilitated, or risk of postural hypotension: titrate more slowly to lower target dose. Elderly or hepatic impairment: initially 50mg/day; may increase in increments of 50mg/day. Switching from Seroquel immediate-release: give XR at equivalent total daily dose taken once daily.

Precautions

Diabetes risk factors (obtain baseline fasting blood sugar). Monitorfor hyperglycemia. Cardio-orcerebrovascular disease. Hepaticdysfunction. Seizure risk. Exclude neuroleptic malignant syndrome if fever or other symptoms occur. Risk of aspiration pneumonia. Exposure to extreme heat. Dehydration. Hypovolemia. Do eye exam initially and every 6 months. History of breastcancer.PreexistinglowWBCsorhistoryofleukopenia/neutropenia;monitorCBCsduring1stfewmonthsoftreatment;discontinue if WBCs decline. Reevaluate periodically. Avoid abrupt cessation. Write Rx for smallest practical amount. Risk of suicide. Hypothyroidism. Elderly (not for dementia-related psychoses; may increaseriskofdeath).Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions

Potentiates CNS effects with alcohol (avoid), other CNS depressants. Antagonized by CYP3A inducers(eg,thioridazine, phenytoin,carbamazepine,phenobarbital, rifampin); adjust dose. Potentiates antihypertensives, lorazepam. Antagonizes effects of levodopa, dopamine agonists. Caution with drugsthatinterferewithtemperature regulation (eg, anticholinergics) andwithCYP3Ainhibitors (eg, azole antifungals, erythromycin).

Adverse Reactions

Drymouth,sedation,somnolence,dizziness,constipation,asthenia,abdominalpain,posturalhypotension, pharyngitis, weight gain, lethargy, hyperglycemia, nasal congestion, dyspepsia; increased ALT (transient), total cholesterol +/ortriglycerides;leukopenia,neutropenia,agranulocytosis; rarely:tardivedyskinesia,neurolepticmalignantsyndrome.
How Supplied

XR (50mg, 150mg)—60, 500 (available soon) XR (200mg, 300mg, 400mg)—60, 500 Tabs 25mg, 50mg—100, 1000 100mg, 200mg, 400mg—100 300mg—60 Additional Resources