Application Information

This drug has been submitted to the FDA under the reference 016126/001.

Names and composition

"PRIMATENE MIST" is the commercial name of a drug composed of EPINEPHRINE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
016126/001 PRIMATENE MIST EPINEPHRINE AEROSOL, METERED/INHALATION 0.2MG per INH

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
007942/001 SUS-PHRINE SULFITE FREE EPINEPHRINE INJECTABLE/INJECTION 5MG per ML
007942/003 SUS-PHRINE SULFITE FREE EPINEPHRINE INJECTABLE/INJECTION 1.5MG per AMP
016126/001 PRIMATENE MIST EPINEPHRINE AEROSOL, METERED/INHALATION 0.2MG per INH
016803/001 BRONKAID MIST EPINEPHRINE AEROSOL, METERED/INHALATION 0.25MG per INH
019430/001 EPIPEN EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS 0.3MG per DELIVERY
019430/002 EPIPEN JR. EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS 0.15MG per DELIVERY
019430/003 EPIPEN E Z PEN EPINEPHRINE INJECTABLE/INTRAMUSCULAR 0.3MG per DELIVERY
019430/004 EPI E Z PEN JR EPINEPHRINE INJECTABLE/INTRAMUSCULAR 0.15MG per DELIVERY
020800/001 TWINJECT 0.3 EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS EQ 0.3MG per DELIVERY
020800/002 TWINJECT 0.15 EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS EQ 0.15MG per DELIVERY
020800/003 ADRENACLICK EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS EQ 0.15MG per DELIVERY
020800/004 ADRENACLICK EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS EQ 0.3MG per DELIVERY
087907/001 EPINEPHRINE EPINEPHRINE AEROSOL, METERED/INHALATION 0.2MG per INH
201739/001 AUVI-Q EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS EQ 0.3MG per DELIVERY
201739/002 AUVI-Q EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS EQ 0.15MG per DELIVERY
204200/001 ADRENALIN EPINEPHRINE INJECTABLE/INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS EQ 1MG BASE per ML (EQ 1MG BASE per ML)
204640/001 ADRENALIN EPINEPHRINE INJECTABLE/INTRAMUSCULAR, SUBCUTANEOUS EQ 30MG BASE per 30ML (EQ 1MG BASE per ML)
205029/001 EPINEPHRINE EPINEPHRINE SOLUTION/IV (INFUSION), INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS EQ 1MG BASE per ML (EQ 1MG BASE per ML)
207534/001 SYMJEPI EPINEPHRINE SOLUTION/INTRAMUSCULAR, SUBCUTANEOUS 0.3MG per ML (0.3MG per ML)

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Answered questions

Primatene Mist?
Compared to other inhalers that require a prescription, how would you compare Primatene Mist to those, such as Albuterol? Please include quality and safety in your answer. (asking on behalf of another) Asked by Darlene Laureles 1 year ago.

Not the best choice. Response is quick to the medication... but It's duration of action is extremely short. Also, you can build tolerance to the medication quickly, and has more cardiac side effects compared to anticholinergic drugs like Atrovent, and other Beta 2 drugs like Albuterol. Albuterol responds quickly (not quite as quick as Primatene Mist), but last hours instead of minutes. It is my suggestion you get a prescription from a primary care giver, and get good follow-up care. It's worth the money... Nikki (the model) Taylor's younger sister was found dead clutching a Primatene Mist Bottle when she died. It's a clear example of how "not" to manage asthma. Answered by Hobert Durrah 1 year ago.

I relatively have bronchial asthma. Primatene Mist is relatively undesirable for you. in case you should take an over the counter drug for it, ephedrine has labored for me interior the previous, yet there are relatively some comments out that say that's undesirable for you too. My suggestion could be to seek for suggestion from a physician. Or initiate out excercising ojnly relatively at a time, until your stamina has bigger. solid success, and that i'm hoping you come across some thing that works for you. Answered by Lavern Fuschetto 1 year ago.


Should I be using "Primatene Mist"?
I have had recurring bronchitis for the past four years, and last year the doctor said I "may" have asthma but for insurance purposes he wasn't going to say for sure. anywho--this time it's strange because it's usually in the fall that it occurs, and this time it's in the spring. also,... Asked by Yuko Armstead 1 year ago.

I have had recurring bronchitis for the past four years, and last year the doctor said I "may" have asthma but for insurance purposes he wasn't going to say for sure. anywho--this time it's strange because it's usually in the fall that it occurs, and this time it's in the spring. also, i've been coughing and such for about a week now (it began with a coldiish/flu thing). i just bought primatene mist for bronchial asthma since it's about the only over the counter medication i could find, and i'm wondering if i shouldn't be taking it since i am not a "certain" case of asthma (athough i highly doubt it could possibly do any harm-- my dad is a smoker and has smoked up to 3 packs a day in my house my whole life.) should i see a doctor or see how this works? Answered by Ron Barrientes 1 year ago.

It's okay that you're using primatene mist because the only side effect of this medicine is increased energy with a jittery feeling. Epinephrine is the main ingredient in Primatene mist and this is a stimulant that relaxes the bronchial passage. Anyway you should check out the supplements, Mullein lung complex by planetary labs, and Lung Saver, both are ways to defeat asthma and bronchitis in strengthening the lungs naturally. You should definetly check with a doctor if your symptoms get worse. Answered by Daniel Coriaty 1 year ago.


Do you have Asthma / Did you use Primatene Mist?
I have had asthma for years and since the ban on the only Over the counter inhaler ( Primatene MIst ) I have not been able to find an inhaler that works well , or that doesn't come with many side effects .. If you have Asthma and have an inhaler that works well for you please help !!There are so many... Asked by Lorie Gilliss 1 year ago.

Primatene mist was an adrenalin derivative. it actually did very little for your lungs but a lot for your heart, not all of it good. As an asthmatic, you should be using a maintenance drug or drugs on a daily basis and saving the rescue inhaler for breakthrough symptoms. If you aren't you aren't managing your asthma well and that is why the inhalers don't work for you. Answered by Mindi Houghtelling 1 year ago.

I have asthma. Primatene Mist is very bad for you. If you have to take an over the counter drug for it, ephedrine has worked for me in the past, but there are a lot of reports out that say this is bad for you too. My advice would be to consult a doctor. Or start out excercising ojnly a little bit at a time, until your stamina has increased. Good luck, and I hope you find something that works for you. Answered by Rebeca Welle 1 year ago.

Try www.asthmanefrin.com! It is a great over-the-counter alternative to Primatene Mist. Answered by Lisha Coletta 1 year ago.


Have uncontrolled Asthma over 50 years, only help was Primatene Mist, Now What?
V: Indeed what can we do? While the effected range of those will be over 2 million in US, those effected in a dangerous level will be closer to 1 million. If only 250,000 Americans died, that would be more American deaths than in The US Wars of recent years.S; Albuterol was one of the first new medications that... Asked by Jerry Benno 1 year ago.

Have had warnings about primatene from doctors in last 25 years , some of the same doctors that very nearly killed me with their prescriptions. There have been warnings about dangerous side effects potential on packaging as well. I have used this mist for nearly 50 years and nearly died before I used it, used it perhaps a minimum of once a day to an average of 4 times a day up to 10 uses during a very severe attack, and that was a bit more than I should have used but when you need to breathe you do what you have to. If I used it for av 4 times a day times 365 days, well that's over 1200 inhalations a year, so in my life I have had over 50,000 inhalations , 50,000 times I was able to breathe again. Safely for me, but will have to admit someone else could have a far different reaction, that's what the warnings are about. I should add I use multiple antihistamines for other side effects from allergies, Primatene was mainly for breathing only, but do use Zyrtec and Benedryl daily. Answered by Patrick Singerman 1 year ago.

V: Indeed what can we do? While the effected range of those will be over 2 million in US, those effected in a dangerous level will be closer to 1 million. If only 250,000 Americans died, that would be more American deaths than in The US Wars of recent years. S; Albuterol was one of the first new medications that I had a severe reaction to as new asthma medications were developed, this was of course many decades ago. It was first used by me during a lung function test which actually used a fairly large amount of the medication. They continued with the test and discovered that my lung capacity had significantly declined, which had them somewhat concerned and then I became paralyzed and felt like my skin was burning. I was admitted to hospital and spent several days there. After-wards I was warned to never use that medication again, but have seen perhaps dozens of lung specialists since then, and inevitably they want to try a lung test using a bronco-dilator other than epinephrine, very Answered by Maira Scribner 1 year ago.

I have been using Primatene Mist for about 2 years for COPD (mild). It was inexpensive and it always worked. Now that it is off the market I had to see a doctor who prescribed Advair (269.00 at Walmart, ProAir --a rescue inhaler for sudden flair ups...79.00.) Plus I had to have a chest -xray, a bone density test, a mammogram and blood work before the doctor would prescribe anything. I have no health insurance either. The Advair is supposed to be inhaled 2 times a day as it is supposed to keep your airways open for 12 hours. Well after one hour I was gasping for breath. Luckily I have some Primatene Mist left or I would have had to go to the hospital. The Pharmacys had plenty of time to develope another way to administer P.Mist. I don't know what I am going to do as I can afford all these expensive meds that don't work. Edit. Plus the doctors and pharmacists don't seem to care! What can we do??? Answered by Chere Heholt 1 year ago.

Primatine Mist Answered by Sanjuana Cossano 1 year ago.

Albuterol, the active ingredient in Ventolin, ProAir, and Proventil is NOT a steroid and you can get a prescription for it from your doctor. There have been non steroidal options for controlling asthma for years now. For one of the other answers - the prices you name for Advair and ProAir are about double what they should be even without insurance. What on earth do you expect pharmacists to do about a world wide mandate that all products with CFCs be removed?? Answered by Kimber Helmen 1 year ago.

I don't mean to scare you but I would not trust Primatene Mist sprays. That is how Niki Taylor's younger sister died from using that over the counter spray. They had a huge lawsuit against them in the 90's. Ever since then I squirm when I see people buying Primatene. Just wanted to educate you on that. Answered by Talia Havelka 1 year ago.


Primatene mist inhaler for bronchitis?
i have had bronchitis numerous of times and i saw that some people use this inhaler called primatine mist inhaler, and i was wondering if that was safe to use for bronchitis because my cest is hurting and so is my throat and i just wanted to know if this was safe and what are the side effects? Asked by Reyes Lokken 1 year ago.

Primatine Mist contains epinephrine which dilates the bronchial tubes. Unfortunately, it can also speed up the heart rate and jack up the blood pressure. When overused, it can cause the heart to beat irregularly. Deaths have been reported. Prescription inhalers like albuterol are safer, although they, too, can be overused and cause death. Your doctor may be able to recommend better alternatives than inhalers to clear up your breathing. Answered by Diedre Sonnenberg 1 year ago.

Primatene Mist Answered by Geraldo Ibara 1 year ago.

I once suffered from Chronic Bronchitis. I would suffer sometimes 3 to 4 times per year! Usually when there was a major change in the pressure outside (I live in the north, and the temperature spikes and dips do wonders to chronic sufferers of bronchitis!). Each time I would get horrible hacking coughs, hoarking up green phlegm..it was so frustrating! The key to getting rid of your bronchitis is to find a way to completely eliminate the germs that are causing all the phlegm and irritation leading to your hoarking cough and heavy breathing. Keep reading to learn how to do kill these germs!! This page it will change your life and make you feel 100% better within just 24 hours! Answered by Vickey Aldrow 1 year ago.

I really don't think that stuff works. The only time I use it is in an emergency situation when my regular inhaler runs out. I would seek the opinion of a doctor. Answered by Alyce Ronda 1 year ago.

please do not use primatine mist. it tastes bad, it will make you hyper, and it will make you dizzy. go to the doctor. or if you need some over-the-counter relief...you should get a humidifier. Answered by Rodrigo Hartnett 1 year ago.


Is Primatene Mist safe? How long does it take to leave your system?
Would it show up on a tox screen? Asked by Cami Rubison 1 year ago.

The epinephrine that is in Primatene Mist is used during a code to help restart the heart. It acts on the receptors in the heart that cause it to contract quicker and stronger - thus your pounding heart. Epinephrine's duration is 1-3 hours but I'm not sure how long it is in the body. It is excreted in urine so it can be detected by a drug screen. Answered by Judie Guillotte 1 year ago.

Primatene Mist contains epinephrine, which is why you get high blood pressure and a rapid heart rate when you use it. Most doctors also feel that Primatene is NOT a good drug to control asthma. Albuterol is a better drug with fewer side effects. If you have or think you have asthma, you should see your doctor. Answered by Daniel Subijano 1 year ago.


Primatene Mist makes my tongue feel strange.?
When ever I use my Primatene Mist, it burned my tongue and throat for a while. Has this ever happened to anybody? Is it normal? I don't really like Primatene Mist, but it's my last resort and it's better than nothing and gasping for air. Asked by Allyson Schaarschmidt 1 year ago.

You'd better check right away; in my area (Chicago, Illinois) they've taken Primatene off the market because of the fluorocarbons used as a propellant. They've taken most of the effective medications off the market for asthma. Even with the huge increase of numbers of people with asthma, they're reducing the number of medications available---especially over the counter ones. Answered by Arline Debro 1 year ago.

yeah it's the steroids and stuff in there. it's a bit shortsighted to get rid of everything with the CFC's in it. one day I went to pick up my inhaler, and I couldn't get the same one I'd been using forever. Freaked me out a bit. Answered by Jamee Kasahara 1 year ago.

Mine always did the same to me...usually lasted 3 minutes or so...made things taste funny too. Answered by Norris Schoeninger 1 year ago.

You drink scorching hot water mixed with ice cream Answered by Darline Rogness 1 year ago.


Medical Doctors how dangerous or what are possible side effects for anyone using primatene mist?
Just curious about anytime we hear stories about anyone who has breathing problems an even they have been told by their Doctors not to use primatene mist and anyone in their family who visits them in the hospital by bringing them primatene mist just like sneaking the behind the Doctors back? Asked by Trinity Smietana 1 year ago.

Primatene mist is something you do not need a prescription for. It is very addictive, and depending on the person it can cause high or low blood pressure, a high or low heart rate, and really doesn't work nearly as well as other breathing medications. So why not just get a prescription from your doctor for a better less dangerous medication? Answered by Melodee Mcfadden 1 year ago.

Sure! WARNING following this religion may cause other simple minded people to judge you based on the views and actions of a minority of the followers simply because they are the loudest and make for good news stories. Ironically many of these people will also call you prejudice. Despite this you will feel they need to love them anyway. I'm sorry for all those that are hurt in the name of religion. But I do believe that it is not the religion that is doing the hurting. I have came to see that these people that are hurting others only try to justify their hatered with religion. Even without their religion the would still spread their pain around only now some man with a tie has told them it is love. It is not the Gospel that I know and love. Never once did we see Jesus tell someone that they would burn in Hell. He gave them what they needed and showed them they were loved and then went on His way. When people start filling in the blanks with what they think should be there it is going to be trouble. I am well aware of your equal symbol. I suggest you try living up to it. Remember it is not equality for me or you but for all. Answered by Brooke Hajdas 1 year ago.


Anyone know of any o.t.c. asthma inhalers,now that primetene mist has been taken off the shelves? ?
Asked by Gemma Chittom 1 year ago.

Primatene Mist Inhalers will no longer be available after December 31, 2011. Contact your healthcare professional to decide what type of medication and treatment is best for you to control your asthma. These inhalers use chlorofluorocarbons (CFCs) to move the dose of medication out of the inhaler for the patient to breathe into his or her lungs. CFCs are being phased out of use in the United States and many other countries because they damage the Earth's ozone layer and harm the environment. Here’s what you need to do: If you use a Primatene Mist inhaler, see a healthcare professional to get another medicine for your asthma. Make your change to another medicine or treatment soon since Primatene Mist may be harder to find near the end of the year. Learn how to use and clean your new inhaler or other medicine. If you haven’t used up your Primatene Mist by December 31, check the expiration date on the product and its packaging. If the product has not expired, it’s safe to continue to use it. That is from CDC. So talk with YOUR doctor and get a medicine and an action plan that works. Answered by Val Baggette 1 year ago.


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