复方福尔可定口服溶液说明书
 
【药品名称】通用名称：复方福尔可定口服溶液
商品名称：澳特斯
英文名称：Compound Pholcodine Oral Solution 汉语拼音：Fufang Fuerkeding Koufurongye
【成分】本品为复方制剂，其组成成分为：每5 ml含福尔可定5.0 mg,盐酸曲谱利啶 0.6 mg,盐酸伪麻黄碱15.0 mg和愈创木酚甘油醚50.0 mg,
【性状】深红色澄清口服溶液
【适应症】伤风、流感、咽喉及支气管利激所引起的咳嗽、痰多咳嗽、干咳、敏感性咳、流 涕、鼻塞和咽喉痛。
【规格】每5 ml含福尔可定5.0 mg,盆酸曲谱利啶0.6 mg,盐酸伪麻黄碱15.0 mg和愈创木酚甘油醚50.0 mg。
【用法用量】口服。
2岁以下儿童：一次2.5 ml,一日3-4次。
2-6岁儿童：一次5 ml,—日3-4次。
6岁以上儿童及成人：一次10 ml,—日3-4次；或遵医嘱。
【不良反应】偶有肠胃不适、胃痉挛、便秘、恶心、呕吐，口干、嗜睡、头晕。
【禁忌】对本品有耐受性的患者禁用；有严重商血压、冠心病或正服用单胺氧化酶抑制剂的患者禁用本品。
【注意事项】1.本品为处方药。
操作机械成驾驶时需谨慎。有严重肝肾功能摘害者，需调整剂量。
运动员慎用。
【孕妇及哺乳期妇女用药】盐酸伪麻黄喊和盐酸曲谱利啶可经乳汁排泄，但并无相关 危害性报道；怀孕期间服用本品的安全性尚未确证，需谨慎用药。
【儿纛用药】见用法用量。
【老年用药】老年人使用本品参照成人剂量用药。
【药物相互作用】1.与单胺氧化酶抑制刑合用会导致血压升高。
避免与其他拟交感神经药合用，如：抗充血剂，食欲抑制剂，苯丙
按，抗高血压药及其他抗组胺药。
【药物过量】药物过量会导致神经紧张、头晕或失眠；可洗胃、取用安定或依症治疗。
【药理毒理】盐酸曲谱利啶是一种具有中枢镇定及抗毒作用的强效H受体抗剂，通过
竞争性、可逆性阻断组织上的组胺受体而消除组胺导致的过敏性反应。盐酸伪麻黄碱是一种拟交感神经药，有效对抗鼻充血及咽鼓管充血。愈创木酚甘油醚是一种祛痰剂，通过扩张支气管及降低支气管分泌物黏度 发挥化痰作用。
【药代动力学】福尔可定口服吸收良好，口服生物利用度约为40%,仅10%与血浆蛋白结合，代谢及消除缓慢，消除半衰期约为37小时。盐酸曲谱利啶的半衰期约为3-5小时；代谢物为酸酯类衍生物，约50%经尿液排泄。盐醎伪麻黄碱半衰期约为数小时；大部分以原形经尿液排泄，少量经乳汁排泄。口服愈创木酚甘油醚后，血浆达峰时间约为15分钟，半衰 期约为1小时，代谢物经尿液排泄。
【贮藏】常温，遮光密封贮存；置于儿童不易触及之处。
【包装】塑料瓶装，每瓶60、100或150 ml;铝塑袋装，每袋10 ml，每盒30袋。
【有效期】136个月
【生产企业】香港澳美制药厂
Compound Pholcodine Oral Solution
[Name] Generic Name: Compound Pholcodine Oral Solution
Brand Name: Photifed-M Children Cough Syrup
Chinese Spelling: Fufang Fuerkeding Koufurongye
[Ingredient ] It is a compounded prescription. Each 5ml syrup contains 5.0mg Pholcodine, 0.6mg Triprolidine HCI, 15.0mg Pseudoephedrine HCI and 50. Omg Guaifenesin.
[Description ] Deep red clear oral solution
[Indications] For the treatment of symptoms associated with common cold, influenza, throat and bronchial irritation: productive cough, dry cough, irritable cough, runny nose, nasal congestion and sore throat.
[Strength ] Each 5ml syrup contains 5.0mg Pholcodine, 0.6mg Triprolidine HCI, 15.0mg Pseudoephedrine HCI and 50.0mg Guaifenesin.
[Dosage & Administration] Children under 2: 2.5ml to be taken orally 3 -4 times daily; Children 2-6:5ml to be taken orally 3-4 times daily; Children over 6&adults; 10ml to be taken orally 3-4 times daily; Or as directed by the physician.
[Side Effects ] Adverse reactions include gastrointestinal disturbance t stomach cramp, constipation, nausea and vomiting, drymouth, drowsiness and dizziness.
[Contraindications] Not recommend to those who have exhibited intolerance to one of the ingredients； Not recommend to those who has severe hypertension, coronary artery disease or those are taking monoamine oxidase inhibitors (MAOI).
[Precautions] 1. This product is a prescription medicine.
Caution should be taken in operating machinery or in driving: Dosage adjustment is recommended in case of severe hepatic or renal dysfuncion.
Use with caution in athletes.
[For Pregnancy & Lactation] Pseudoephedrine and triprolidine are excreted in breast milk although no harmful effects have been reported. Safety in the treatment of infection during pregnancy has not established. Caution should be exercised.
[For Pediatric Use] Refer to the dosage & administration.
[For Geriatric Use] Refer to the dosage for adults.
[Drug Interaction] I. Concomitant use of MAOI could cause a rise in blood pressure.
2. Concomitant use of other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine, antihypertensive agents or other antihistamines should be avoided.
[Overdose ] Overdose may result in nervousness t dizziness or sleeplessness ； Overdose patient could be managed by gastric lavage, diazepam treatment to control convulsions or other symptomatic treatments.
[Pharmacology ] Pseudoephedrine HCI is a direct-and indirect-acting sympathomimetic agent. It is used primarily for decongestion of nasal mucosa and eustachian tubes. Guaifenesin，a mucolytic agent, is an expectorant and acts by increasing the volume and reducing the viscosity of bronchial secretions.
[Pharmacokinetics ] Pholcodine is well absorbed after oral administration. Oral bioavailability is over 40%，about 10% of the dose is bound with serum protein. It is metabolized and eliminated slowly with time about 37 hours. Half life of Triprolidine is about 3-5 hours. It is metabolized as carboxylated derivatives and about 50% excreted in the urine. Pseudoephedrine has a half life of several hours； It is largely excreted unchanged in the urine and small amounts are excreted in breast milk. Peak concentration of Guaifenesin is achieved within 15mins following oral administration. Half life is about I hour. It is metabolized and excreted in the urine.
[Storage ] Store in a tightly closed container at room temperature and protect from light. Keep out of the reach of children.
[Package] 60ml/100ml/150ml per PET bottle; 10ml per Sachet, 30 Sachets per box. [Shelf Life] 36 MONTHS.
[Manufacturer] Bright Future Pharmaceuticals Factory