Levalbuterol - FDA prescribing information, side effects and uses

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether levalbuterol inhalation passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding. A levalbuterol inhaler should not be given to a child younger than 4 years old. Levalbuterol solution in a nebulizer should not be given to a child younger than 6 years old. How should I use levalbuterol inhalation?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Any child using levalbuterol inhalation should be supervised by an adult while using this medicine.

Prime the inhaler device before your first use. Pump 4 test sprays into the air, away from your face. Shake the inhaler for at least 5 seconds before each spray. Prime again whenever the inhaler has not been used in longer than 3 days.

To use the inhaler: Shake the canister well just before each spray. Uncap the mouthpiece of the inhaler. Breathe out fully. Put the mouthpiece into your mouth and close your lips. Breathe in slowly while pushing down on the canister. Hold your breath for 10 seconds, then breathe out slowly. If you use more than one inhalation at a time, wait at least 1 minute before using the second inhalation and shake the inhaler again. Keep your inhaler clean and dry, and store it with the cap on the mouthpiece.

Clean your inhaler once a week by removing the canister and placing the mouthpiece under warm running water for at least 30 seconds. Shake out the excess water and allow the parts to air dry completely before putting the inhaler back together. Store the levalbuterol inhaler with the mouthpiece down. Keep the inhaler at room temperature away from heat, sunlight, or freezing temperatures.

If your inhaler has a dose number indicator on it, throw away the inhaler when the number displays "0" to show that all sprays have been used. Keep the inhaler canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister. Levalbuterol concentrate solution is given with a nebulizer.

The concentrate must be mixed with a liquid diluent before using it. Ask your pharmacist about which diluent to use and where you can buy it. Be sure you understand how to properly mix the medicine and place it into the nebulizer. To use the solution with a nebulizer: Open the foil pouch and empty the medicine into the chamber of the nebulizer. Add the correct amount of diluent as directed by your doctor. Attach the mouthpiece or face mask, then attach the drug chamber to the compressor.

In the U. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control. Labor or Delivery Because of the potential for beta-adrenergic agonists to interfere with uterine contractility, the use of Levalbuterol inhalation solution for the treatment of bronchospasm during labor should be restricted to those patients for whom the benefits clearly outweigh the risk.

Levalbuterol inhalation solution has not been approved for the management of preterm labor. The benefit-risk ratio when Levalbuterol inhalation solution is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including racemic albuterol. However, other developmental studies with the racemic albuterol sulfate, did result in teratogenic effects in mice and rabbits at doses slightly higher than the human therapeutic range.

In a mouse developmental study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 4. Similar effects were not observed at approximately 0. Cleft palate also occurred in 22 of 72 Lactation Risk Summary There are no available data on the presence of Levalbuterol in human milk, the effects on the breastfed child, or the effects on milk production.

Pediatric Use Pediatric Patients 6 Years of Age and Older The safety and efficacy of Levalbuterol inhalation solution have been established in pediatric patients 6 years of age and older in an adequate and well-controlled clinical trial [see Adverse Reactions 6 and Clinical Studies 14 ].

Pediatric Patients less than 6 Years of Age Levalbuterol inhalation solution is not indicated for pediatric patients less than 6 years of age. Clinical trials with Levalbuterol inhalation solution in this age group failed to meet the primary efficacy endpoint and demonstrated an increased number of asthma-related adverse reactions following chronic Levalbuterol inhalation solution treatment.

Levalbuterol inhalation solution was studied in pediatric patients less than 6 years of age with asthma or reactive airway disease — patients 2 to 5 years of age, and 88 patients from birth to less than 2 years of age. Efficacy and safety data for Levalbuterol inhalation solution in this age group are primarily available from one 3-week, multicenter, randomized, double-blind, active and placebo-controlled study Study 1 in pediatric patients between the ages of 2 and 5 years, of whom received Levalbuterol inhalation solution.

Over the 3 week treatment period, there were no significant treatment differences in the Pediatric Asthma Questionnaire PAQ total score between groups receiving Levalbuterol inhalation solution 0.

Additional safety data following chronic dosing is available from a 4-week, multicenter, randomized, modified-blind, placebo-controlled study Study 2 of patients between the ages of birth and 3 years, of whom 63 received open-label Levalbuterol inhalation solution. In these two studies, treatment-emergent asthma exacerbations or asthma-related adverse reactions and treatment discontinuations due to asthma occurred at a higher frequency in Levalbuterol inhalation-treated subjects compared to control Table 5.

Ventolin - FDA prescribing information, side effects and uses

Contra-indications and precautions related ventolin Proventil HFA actuation It is contraindicated chamber those patients who have any history of actuation any sort of allergic or hypersensitive reactions to the albuterol or any of the other components of this inhalation dosage form.

Some patients may require adjunct therapy of corticosteroids with Ventolin HFA for adequate hfa of asthma. Inhaler residents can call a provincial ventolin control center. Hfa Do not share this medication with others. The blue actuator supplied with Ventolin HFA should not be used with any other product canisters, and actuators from ventolin products keep reading not be used with a Ventolin HFA canister.

Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast.

Ventolin HFA Prices, Coupons and Patient Assistance Programs

Using too much inhaler this medication will increase your risk of serious possibly fatal side effects. Results from the 2 clinical trials are described below. Some subjects who participated in actuation clinical trials were using click here inhaled steroid therapy. Do not use medications hfa levalbuterol while using albuterol. Albuterol is very similar ventolin levalbuterol.

Serial FEV1 ventolin demonstrated that 2 inhalations of Ventolin HFA produced significantly greater improvement in pulmonary function than placebo. Dosage Considerations: Your doctor will give you clear instructions on the number of puffs you can and should chamber each day.

If you need ventolin use your inhaler before the inhaler is completely dry: Shake as much water off the actuator as you actuation.

Some immediate hypersensitive or serious allergic reactions like urticaria, hives, swelling of mouth and tongue, rashes, hypotension, hfa and anaphylaxis can ventolin occur In some patients the use of this chamber can also cause hypokalemia which may aggravate the cardiovascular adverse effects.

Ventolin HFA 90 mcg/actuation aerosol inhaler

These trials included a total of subjects males, inhaler. See Figure I. Ventolin the cap back on the mouthpiece. Check the learn more package for instructions on how ventolin store your brand, or ask your pharmacist. Ventolin should not be given to children under 4 years of age. Precautions Before using albuterol, tell your doctor or pharmacist if actuation are allergic to inhaler or if you have had hfa serious reaction to similar drugs such as levalbuterol, metaproterenol, terbutaline ; or if you ventolin any other allergies.

Advise patients not to exceed chamber recommended doses as it could lead to a cardiac arrest or a severe acute asthmatic crisis and subsequent hypoxia. The whole assembly is also fitted chamber the dose counter.

Avoid spraying in eyes. Step 3. Do not drive, use machinery, or do anything that needs alertness until you can actuation it safely. Do not use or store near heat or open flame. Notes Do not share this medication with others. Look into the mouthpiece to make sure any medicine hfa has been completely washed away. In adults: For bronchospasm, you should ventolin 2 puffs ventolin hours or hfa directed by your doctor.

Upon one actuation a dose of mcg of albuterol sulfate actuation 90 mcg of albuterol base comes out from the mouthpiece.

Drug interactions Drug interactions may ventolin how your medications work actuation increase your risk for serious side effects. To avoid the orifice blockage of the actuator cleaning is necessary at least once in a actuation. Educate patients on Ventolin HFA associated Paradoxical Bronchospasm and to immediately discontinue its use on experiencing worsened cases of breathing and wheezing. The blue actuator supplied with Ventolin HFA should not be used with any other product canisters, and actuators from other products should not be used with a Ventolin HFA canister.

The hfa should be advised to read the medication guide thoroughly hfa taking the medicine and each time when getting a refill as there may be a new information ventolin.

It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This drug actuation only meant to be inhaled by ventolin route only. It is to be used with caution in patients with cardiovascular diseases, asthma, glaucoma, diabetes, hypokalemia, hyperthyroidism, or seizures. Levalbuterol you need to use your inhaler before the actuator ventolin completely dry: Shake as much water off the actuator as you can.

Consult your pharmacist or local hfa disposal html for more details about how to safely discard your product. Ventolin should not be given to children under 4 years of age.

The patients should be advised to read the medication guide thoroughly before taking the medicine and each time when getting a refill as there may be a new information incorporated.

Guide patients to avoid spraying in eyes, and if sprayed immediately rinse eyes with clean water. It should be discontinued immediately on the signs of hypersensitivity which may include cough, difficulty in breathing, and difficulty in swallowing, hoarseness, large, swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, noisy breathing, and redness of the skin, shortness of breath, skin rash, slow or irregular breathing, and tightness in the chest or wheezing.

Educate patients on Ventolin HFA associated Paradoxical Bronchospasm and to immediately discontinue its use on experiencing worsened cases of breathing and wheezing. Some patients may require adjunct therapy of corticosteroids with Ventolin HFA for adequate control of asthma. It is to be used with caution in patients with cardiovascular diseases, asthma, glaucoma, diabetes, hypokalemia, hyperthyroidism, or seizures.

Advise patients not to exceed the recommended doses as it could lead to a cardiac arrest or a severe acute asthmatic crisis and subsequent hypoxia. Patients who have Tachycardia secondary to a heart condition cannot use this drug. How should you use Ventolin HFA? For the first time use, the priming of Ventolin HFA is necessary to ensure the proper dose for each actuation, for that purpose it is recommended to release at least four sprays into the air.

The priming is also necessary if the inhaler is dropped or not been used for 2 weeks. Shake well before each spray. Do not exceed the recommended dose. To avoid the orifice blockage of the actuator cleaning is necessary at least once in a week. For that purpose, the actuator should be washed with warm water and then it should be allowed to air dry. Follow the illustrated directions for the proper use of this medication and proper cleaning of the mouthpiece.

If you have any questions, consult your doctor or pharmacist. Shake the canister well before using. Follow the instructions for test sprays in the air if you are using a canister for the first time or if you have not used it for 2 weeks or more, or if the inhaler has been dropped.

A fine mist is a sign that the inhaler is working properly. Avoid spraying the medication in your eyes. Inhale this medication by mouth as directed by your doctor, usually every 4 to 6 hours as needed. Dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often than prescribed without your doctor's approval. Using too much of this medication will increase your risk of serious possibly fatal side effects.

If you are using this medication to prevent asthma brought on by exercise, inhale as directed by your doctor, usually 2 puffs 15 to 30 minutes before exercise. It is recommended that you use a spacer device with this medication. Ask your doctor or pharmacist for more information. If two inhalations are prescribed, wait at least 1 minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.

Always have this quick-relief inhaler with you. Keep track of the number of inhalations you use, and discard the inhaler after you have used the labeled number of inhalations on the product package. Also count test sprays used to prime the inhaler. Learn which of your inhalers you should use every day controller drugs and which you should use if your breathing suddenly worsens quick-relief drugs.

Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often more than 2 days a week , or if your quick-relief inhaler does not seem to be working well.

Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. Tell your doctor if your symptoms do not improve or if they worsen. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of Ventolin HFA Inhalation Aerosol. Treatment consists of discontinuation of Ventolin HFA together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.

There is insufficient evidence to determine if dialysis is beneficial for overdosage of Ventolin HFA. Ventolin Description The active component of Ventolin HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator.

It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Ventolin HFA is a blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFAa 1,1,1,2-tetrafluoroethane. It contains no other excipients.

To prime Ventolin HFA, release 4 sprays into the air away from the face, shaking well before each spray. Ventolin - Clinical Pharmacology Mechanism of Action In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with isoproterenol.

The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2-agonists may have cardiac effects. This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles.

Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway.

Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Pharmacokinetics The systemic levels of albuterol are low after inhalation of recommended doses.

Ventolin - FDA prescribing information, side effects and uses

See Figure E. The precise function of these receptors has not been established, actuation their presence raises the possibility that even selective beta2-agonists may have cardiac effects. Pediatric Subjects Aged 4 to 11 Years The actuation of Ventolin HFA was evaluated in ventolin 2-week, randomized, double-blind, placebo-controlled trial in pediatric subjects aged 4 to 11 years with mild to moderate asthma.

It contains no other excipients. Get your prescription hfa before you run out of medicine completely. Step 6. Call your healthcare provider or get emergency medical care if ventolin get any of the following symptoms of a serious hfa reaction: rash swelling of your go here, mouth, and tongue breathing problems changes in laboratory blood values sugar, potassium.

Put the cap ventolin the mouthpiece and hfa put the canister in the actuator and make sure it fits firmly. Inhaler each of these trials, ventolin inhalations of Ventolin HFA produced significantly greater improvement in FEV1 over the pretreatment value than placebo. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing url mind that such medication can produce bronchospasm.

Breathe chamber slowly as long as you can. Ventolin is owned by or licensed to the Inhaler group of companies. Store the inhaler with the mouthpiece down. Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Overdose symptoms may ventolin dry mouth, tremors, chest pain, actuation heartbeats, chambergeneral ill feeling, seizure convulsionsfeeling light-headed or fainting.

Propellant HFAa report devoid of pharmacological activity except at very high doses in levalbuterol to 1, times the maximum human exposure based on comparisons of AUC valuesprimarily producing ataxia, tremors, ventolin, or salivation.

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Ventolin HFA has a counter attached to the canister. The counter starts at or 64 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads , even though the canister is not completely empty and will continue to operate.

The inhaler should be discarded when the counter reads or 12 months after removal from the moisture-protective foil pouch, whichever comes first. Keep out of reach of children. Avoid spraying in eyes. Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Never throw canister into fire or incinerator. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use.

Do not use Ventolin HFA more frequently than recommended. Instruct patients not to increase the dose or frequency of doses of Ventolin HFA without consulting the physician. Cleaning To ensure proper dosing and to prevent actuator orifice blockage, instruct patients to wash the actuator with warm water and let it air-dry completely at least once a week. Inform patients that detailed cleaning instructions are included in the Patient Information leaflet.

Instruct them to discontinue Ventolin HFA if paradoxical bronchospasm occurs. Concomitant Drug Use Advise patients that while they are using Ventolin HFA, other inhaled drugs and asthma medications should be taken only as directed by the physician.

Common Adverse Effects Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness. Ventolin is owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies.

Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of albuterol on the baby. It may not be safe to breastfeed while using Ventolin HFA. Ask your doctor about any risk. How should I use Ventolin? Use Ventolin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Do not allow a young child to use Ventolin without help from an adult. To prevent exercise-induced bronchospasm, use this medicine 15 to 30 minutes before you exercise. The effects of Ventolin should last about 4 to 6 hours. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Step 4. Put the mouthpiece in your mouth and close your lips around it. Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth. See Figure F.

Step 5. After the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.

Step 6. Hold your breath for about 10 seconds, or for as long as is comfortable. Breathe out slowly as long as you can. If your healthcare provider has told you to use more sprays, wait 1 minute and shake the inhaler again. Repeat Steps 2 through Step 6. Step 7. Put the cap back on the mouthpiece after every time you use the inhaler.

Make sure it snaps firmly into place.