15．克敏能
出处：按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第57页（7594字）
【中文释文】：
片剂及糖浆，(氯雷他定)
长效、无镇静作用的抗组胺药
〔说明〕
每片克敏能含10mg微粉化氯雷他定和无作用的成分：玉米淀粉、乳糖及硬脂酸镁。
每5ml克敏能糖浆含5mg微粉化氯雷他定和无作用的成分：丙二醇、甘油、柠檬酸、苯甲酸钠、蔗糖及人造桃味香料及纯化水。
〔作用〕
氯雷他定为强力长效三环抗组胺药，具有选择性外周H1受体拮抗作用。
〔适应证及用途〕
克敏能片剂及糖浆适用于缓解过敏性鼻炎有关的症状，如喷嚏、鼻溢及鼻痒，以及眼部痒及烧灼感，口服药物后鼻和眼部症状及体征得以迅速缓解。
克敏能片剂及糖浆亦适用于缓解慢性荨麻疹及其它过敏性皮肤病的症状及体征。
〔用法及用量〕
成人和12岁及以上儿童：每天1次，1片或2茶匙糖浆(10mg)。2岁～12岁儿童：
体重＞30kg∶10mg(即2茶匙)克敏能糖浆，每天1次。
体重≤30kg∶5mg(即1茶匙)克敏能糖浆，每天1次。
〔药物相互作用〕
当与酒同时服用时，根据精神运动试验研究表明氯雷他定无药力相加作用。
〔配伍禁忌〕
克敏能禁用于对它的成分有过敏或特异体质的病人。
〔药物与实验室试验的相互影响〕
在作皮试前的大约48h应终止使用克敏能，因抗组胺药能防止或减轻皮肤对所用变应原的阳性反应。
〔不良反应〕
在世界范围的临床对照试验中，克敏能片剂的副作用发生率与安慰剂相同。在这些试验中，氯雷他定未显示临床上明显的镇静或抗胆碱能作用。乏力、镇静、头痛和口干的发生报告很罕见，其发生率与安慰剂相似。
同样地，克敏能糖浆的副作用发生率与安慰剂相似。在儿科临床对照试验中，与治病相关的头痛、镇静及神经过敏的报告很罕见，其发生率和安慰剂相似。
〔禁忌证〕
对克敏能片剂或糖浆中的成分具有超敏反应或特异体质的病人禁用。
〔注意事项〕
在两岁以下儿童克敏能片剂或糖浆的安全性及疗效目前尚未确定。
〔妊娠期及哺乳期母亲用药方法〕
妊娠期应用克敏能制剂的安全性还未被确定。因此，仅在权衡利弊之后，对胎儿有利的情况下方能应用。
因氯雷他定可以进乳汁排出，且抗组胺药对婴儿的危险性增大，特别是对新生儿和早产儿。固必须决定究竟是停止哺乳或停药。哺乳期妇女应用克敏能制剂必须非常谨慎。
〔包装〕
片剂：每板6片。
糖浆：每瓶100ml。
贮藏于2～30℃之间。
〔关于过量问题〕
到目前为止尚未发生过氯雷他定过量的情况。有1例单次口服160mg未产生不良作用。如果发生过量情况应立即采取对症性及支持性处理。
〔处理〕
必须引起病人呕吐，对已有自发性呕吐病人亦需如此。药物性诱发催吐可给于吐根糖浆，但当病人有意识障碍时不应催吐，如能给病人作身体运动及饮水240～360ml，能促进吐根的作用。如果15min内未发生呕吐，应再服1剂吐根。必须采取措施，特别是对儿童，应预防气管吸入，呕吐后服用水调成浆状的活性碳以吸附胃内残留的药物。如果催吐不成功或有禁忌，应施行洗胃。生理盐水是洗胃的首选溶液，特别对儿童。成人可用自来水。但是，在下一次洗胃前，要尽量排去已灌注胃内的液体。泻盐由于渗透作用能将水份导入肠内，因此，对于迅速稀释肠内内容物是有价值的。氯雷他定是否可透析尚不清楚。紧急处理后病人必须继续接受医疗监护直到正常。
〔生产厂家〕
比利时先灵保雅公司
【外文释文】：
Tablets and Syrup(RXFA，RXFB，ANNA)
Brand of loratadine long Acting，Non-Sedating Antihistamine
Description
Each Clarityne tablet(RXFA，RXFB)contains 10 mg micronized loratadine and the inactive ingredients coin starch，lactose and magnesium stearate．
Each 5 ml of Clarityne syrup(ANNA)contains 5 mg of micronized loratadine and the in active ingredients propylene glycol，glycerin，citric acid，monohydrate，sodium benzoate，sugar，peach flavor and purified water．
Actions
Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H-receptor antagonistic activity．
Indications and usage
Clarityne tablets and syrup are indicated for the relief of symptoms associated with allergic rhinitis，such as sneezing，nasal discharge(rhinorrhea)and itching，as well as ocular itching and burning．Nasal and ocular signs and symptoms are relieved rapidly after oral administration．
Clarityne Tablets and Syrup are also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders．
Dosage and administration
Adults and children 12-years of age and over：One Clarityne tablet or two teaspoonful of Clarityne syrup(10 mg)once daily．
Children 2-12 years of age：
Body weighy＞30 kg：10 mg(two teaspoonfuls)Clarityne syrup once daily．
Body weight≤30 kg：5 mg(one teaspoonful)Clarityne syrup once daily．
Drug interactions
When administered concomitantly with alcohol，loratadine has no potentiating effects as measured by psychomotor performance studies．
Drug／laboratory test interactions
Clarityne should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators．
Adverse reactions
In worldwide controlled clinical studies，the incidence of adverse effects associated with Clarityne Tablets has been comparable to that of placebo．In these trials，loratadine has shown no clinically significant sedative or anticholinergic properties．Fatigue，sedation and headache were rarely reported events which were also reported with similar incidence in placebo-treated patients．
Similarly，the incidence of adverse effects associated with Clarityne Syrup has been comparable to that of placebo．In controlled pediatric clinical trials，the incidence of treatmentrelated headache，sedation and nervousness，which were rarely reported events，was similar to that of placebo．
Contraindications
Clarityne tablets and syrup are contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components．
Precautions
Safety and efficacy of Clarityne tablets and syrup in children younger than two years of age have not been established．
Usage during pregnancy and in nursing mothers
Safe use of Clarityne products during pregnancy has not been established；therefore，use only if potential benefit justifies potential risk to fetus．
Since loratadine is excreted in breast milk and because of the increased risk of antihistamines for infants，particularly newborns and premature infants，a decision should be made whether to discontinue nursing or discontinue the drug．
How supplied
Clarityne tablets are supplied in blister pack of 6s in carton．
Clarityne syrup，in bottle of 100 ml．
Store between 2-30℃
Further information can be obtained from the doctor or pharmacist．
Overdosage information
To date，overdosage has not occurred with loratadine．A single acute ingestion 160 mg produced no adverse effects．
In the event of overdosage，treatment，which should be started immediately，is symptomatic and supportive．
Treatment
The patient should be induced to vomit，even if emesis has occurred spontaneously．Pharmacologically-induced vomiting by the administration of ipecac syrup is a preferred method．However，vomiting should not be induced in patients with impaired consciousness．The action of ipecac is facilitated by physical activity and by the administration of 240 to 360 milliliters of water．If emesis does not occur within 15 minutes，the dose of ipecac should be repeated．Precautions against aspiration must be taken，especially in children．Following emesis，adsorption of any drugs remaining in the stomach may be attempted by the administration of activated charcoal as a slurry with water．If vomiting is unsuccessful，or contraindicated，gastric lavage should be performed．Physiologic saline solution is the lavage solution of choice，particularly in children．In adults，tap water can be used；however，as much as possible of the amount administered should be removed before the next instillation．Saline cathartics draw water into the bowel by osmosis and，therefore，may be valuable for their action in rapid dilution of bowel content．Loratadine is not cleared by hemodialysis to any appreciable extent．After emergency treatment，the patient should continue to be medically monitored．
Manufacturer
Schering-Plough Labo N．V．，Industriepark 30，Heist-op-den-Berg，Belgium