英文药名: Tessalon(benzonatate Capsules)

中文药名: 苯佐那酯胶囊

生产厂家：辉瑞公司
药品介绍
苯佐那酯是一种非麻醉性止咳药。工作原理是麻木的喉咙和肺部，使咳嗽反射不活跃。苯佐那酯用于缓解咳嗽
适应症和用法
TESSALON的适应症为咳嗽的症状缓解
用法用量
成人和儿童在10岁以上：常用剂量为100毫克胶囊根据需要为咳嗽，一天三次。如果必要的话，以在三个分开的剂量每日控制咳嗽，高达600毫克，可给予。
TESSALON应整粒吞服。 TESSALON PERLES不被打破，咀嚼，溶解，切割或粉碎。
包装规格：
100mg *100Perles
DESCRIPTION
TESSALON, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7.
Each TESSALON Perle contains:

Benzonatate, USP 100 mg
TESSALON Perles (capsules) also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben.
CLINICAL PHARMACOLOGY
TESSALON acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. TESSALON has no inhibitory effect on the respiratory center in recommended dosage.
INDICATIONS AND USAGE
TESSALON is indicated for the symptomatic relief of cough.
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.
WARNINGS
HypersensitivitySevere hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.
Psychiatric Effects
Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking TESSALON in combination with other prescribed drugs.
Accidental Ingestion and Death in ChildrenKeep TESSALON out of reach of children. Accidental ingestion of TESSALON resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).
PRECAUTIONS
Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.
Information for PatientsSwallow TESSALON Perles whole. Do not break, chew, dissolve, cut, or crush TESSALON Perles. Release of TESSALON from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.
Keep TESSALON out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.
Overdosage resulting in death may occur in adults.
Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of TESSALON, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of TESSALON at one time.
Usage in Pregnancy
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with TESSALON. It is also not known whether TESSALON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TESSALON should be given to a pregnant woman only if clearly needed.
Nursing MothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when TESSALON is administered to a nursing woman.
Carcinogenesis, Mutagenesis, Impairment of FertilityCarcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON.
Pediatric UseSafety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.
ADVERSE REACTIONS
Potential Adverse Reactions to TESSALON may include:
Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
CNS
sedation; headache; dizziness; mental confusion; visual hallucinations.
GI
constipation; nausea; GI upset.
Dermatologicpruritus; skin eruptions.
Other
nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest; hypersensitivity.
Deliberate or accidental overdose has resulted in death, particularly in children.
OVERDOSAGE
Intentional and unintentional overdose may result in death, particularly in children.
The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.
Signs and SymptomsThe signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise.
CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.
TreatmentIn case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.
Do not use CNS stimulants.
DOSAGE AND ADMINISTRATION
Adults and Children over 10 years of age: Usual dose is one 100 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. TESSALON should be swallowed whole. TESSALON Perles are not to be broken, chewed, dissolved, cut or crushed.
美国食药监局警告： Tessalon （苯佐那酯）对幼儿构成风险
2010年12月14日，美国食药监局（FDA）警告说，10岁以下幼儿误服Tessalon可能导致严重副作用或死亡。
Tessalon经FDA批准，用于缓解10岁以上儿童咳嗽症状。该药因外观可人，吸引了幼儿的注意。苯佐那酯在10岁以下儿童中的安全性尚未确立。
“苯佐那酯应存放在儿童不易打开的容器中，”FDA防止药物误用分部主任Carol Holquist 说。“ FDA鼓励医药专业人士就误服或过量服用的风险与患者和患者护理人员沟通。”
据对FDA不良反应报告数据库至2010年5月19日的调查，共发生了31例苯佐那酯过量服用的病例（患者年龄1到66岁，平均年龄18岁）。常见不良事件有心搏停止、昏迷和惊厥。苯佐那酯胶囊摄入的量从1或2粒30粒。6个病例（年龄1到39岁，平均10岁）过量后发生不良事件的时间范围都在服药后的 1 小时内。
在31个上报FDA的过量服药病例中， 7个病例与误服有关，均为10岁以下儿童。其中5个病例导致2岁及以下患儿死亡。两个患儿（分别为 12 个月和四岁）因误服苯佐那酯危及生命而住院。
FDA 建议医药专业人士：
苯佐那酯处方量控制在刚好缓解咳嗽的量以内。
知晓苯佐那酯过量的体征和症状据报发生在15-20分钟内，死亡发生在数小时内。