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2018年11月7日,美国食品药品监督管理局批准(FDA)新配制Primatene Mist(epinephrineInhalation Aerosol),治疗轻度哮喘的非处方丙烯喷雾(肾上腺素).
Primatene喷雾(肾上腺素气溶胶吸入支气管扩张剂悬架),这是由计量剂量吸入器(MDI)non-chlorofluorocarbon(CFC)推进剂。Primatene Mist是FDA批准的美国唯一一种没有处方的哮喘吸入剂。在12岁及以上的人群中，新型喷雾可暂时缓解间歇性哮喘的轻微症状。
Amphastar的首席执行官Jack Zhang博士说:“我们很高兴获得FDA批准生产Primatene Mist，并自豪地将这一重要产品带回美国的场外市场。我们感谢FDA团队与我们密切合作，使批准成为可能，认识到非处方支气管扩张剂药物如普胺雾的重要作用。Amphastar的任务是开发并推向市场的创新药物产品和交付系统，将有意义地改善人们的生活，我们相信Primatene Mist公司将会做到这一点。
新批准的专利配方的Primatene雾是由相同的活性成分,肾上腺素,这是用于原始Primatene雾在2011年之前撤出市场环境原因根据《蒙特利尔议定书》,一个重要的国际环境条约,淘汰产品全球包含破坏臭氧层的氟利昂。该产品的新吸入输送系统不再包括CFC作为推进剂，还有其他重要的新功能，包括内置的喷雾指示器和金属筒，取代了最初的Primatene喷雾产品中使用的玻璃容器。
根据美国疾病控制与预防中心国家健康统计中心的数据，美国大约有2000万成年人患有哮喘。Amphastar很高兴能将Primatene喷雾作为暂时缓解间歇性哮喘症状的非处方药。
Primatene Mist(epinephrine)for Inhalation
DESCRIPTION
Drug Facts
Active ingredient (in each inhalation)
Epinephrine 0.22 mg with the purpose of being a Bronchodilator.
Inactive Ingredients
ascorbic acid, dehydrated alcohol (34%), dichlorodifluoromethane (CFC 12), dichlorotetrafluoroethane (CFC 114), hydrochloric acid, nitric acid, purified water
Indications & Dosage
INDICATIONS
Uses
for temporary relief of occasional symptoms of mild asthma
wheezing, tightness of chest, shortness of breath
DOSAGE AND ADMINISTRATION
DIRECTIONS
do not exceed dosage
supervise children using this product
adults and children 4 years and over: start with one inhalation, then wait at least 1 minute. If not relieved, use once more. Do not use again for at least 3 hours.
children under 4 years of age: ask a doctor
HOW SUPPLIED
For Inhalation Only
store at room temperature, between 20-25°C (68-77°F)
contains no sulfites
see insert for mouthpiece use and care instructions
SIDE EFFECTS
When using this product
- increased blood pressure or heart rate can occur, which could lead to more serious problems such as heart attack and stroke. Your risk may increase if you take more frequently or more than the recommended dose.
- nervousness, sleeplessness, rapid heart beat, tremor, and seizure may occur. If these symptoms persist or get worse, consult a doctor right away.
DRUG INTERACTIONS
Ask a doctor or pharmacist before use if you are
- taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
- taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)
WARNINGS
Asthma alert: Because asthma can be life threatening, see a doctor if you
are not better in 20 minutes
get worse
need 12 inhalations in any day
use more than 9 inhalations a day for more than 3 days a week
have more than 2 asthma attacks in a week
For Inhalation only
PRECAUTIONS
Do not use
unless a doctor said you have asthma
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
ever been hospitalized for asthma heart disease
high blood pressure diabetes thyroid disease seizures
narrow angle glaucoma a psychiatric or emotional condition
trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)
When using this product
increased blood pressure or heart rate can occur, which could lead to more serious problems such as heart attack and stroke. Your risk may increase if you take more frequently or more than the recommended dose.
nervousness, sleeplessness, rapid heart beat, tremor, and seizure may occur. If these symptoms persist or get worse, consult a doctor right away.
avoid caffeine-containing foods or beverages.
avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.
do not puncture or throw into incinerator. Contents under pressure.
do not use or store near open flame or heat above 120°F (49°C). May cause bursting.
Contains CFC 12, 114, substances which harm public health and environment by destroying ozone in the upper atmosphere.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
OVERDOSE
No Information Provided.
CONTRAINDICATIONS
Do not use
unless a doctor said you have asthma
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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