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Levalbuterol Inhalation Solution

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Last Updated: 20 October 2020

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General | Latest Info

Levalbuterol and albuterol are inhale medications that are prescribed to treat Asthma and chronic obstructive pulmonary disease. More specifically, both medications treat acute symptoms such as bronchospasms, wheezing, shortness of breath, and coughing. They are know as rescue inhalers that are used when necessary. Both Levalbuterol and albuterol are group in a class of medications called beta-2 agonists. They are essentially cousins due to their chemical similarities. Levalbuterol contains the active form of albuterol, know as R-albuterol, while albuterol contains a 50: 50 mixture of R-albuterol and S-albuterol. S-albuterol is know to be inactive form of albuterol that still contributes to side effects.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Side Effects

In deciding to use medicine, risks of taking medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, following should be consider: tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to effects of levalbuterol Solution and Solution concentrate in children younger than 6 years of age, and levalbuterol aerosol in children younger than 4 years of age. Safety and efficacy have not been established in these age groups. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levalbuterol in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and adjustment in dose for patients receiving levalbuterol. There are no adequate studies in women to determine infant risk when using this medication during breastfeeding. Weigh potential benefits against potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines. Albuterol Amineptine Amitriptyline Amitriptylinoxide Amoxapine Butriptyline Clomipramine Desipramine Dibenzepin Dothiepin Doxepin Epinephrine Fenoterol Hexoprenaline Imipramine Iprindole Lofepramine Melitracen Methacholine Nortriptyline Opipramol Propizepine Protriptyline Tianeptine Trimipramine Tulobuterol certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional about use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: diabetes or heart disease or heart rhythm problems or hypertension or Hyperthyroidism or Seizures, history ofUse with caution. May make these conditions worse. Kidney diseaseUse with caution. Effects may increase because of slower removal of medicine from the body.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Proper Use

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor order. Also, do not stop using this medicine or any other asthma medicine that you are taking without telling your doctor. Do so may increase the chance of breathing problems. Levalbuterol inhalation solution and inhalation solution concentrate should be used with a jet nebulizer that is connected to an air compressor with good air flow. Inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. To use inhalation solution or solution, concentrate on the nebulizer: open the pouch and remove one vial. Check the liquid in the vial. It should be clear or colorless. Do not use it if it is discolor. Open vial and place inhalation solution in medicine reservoir or nebulizer cup on machine. If you are using solution concentrate, mix it first with sterile normal saline before placing it in reservoir. Connect nebulizer to a face mask or mouthpiece. Use a face mask or mouthpiece to breathe in medicine. Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is go. Clean all parts of the nebulizer after each use. Do not use it if the solution becomes cloudy. Do not mix another inhalation medicine with levalbuterol in nebulizer, unless told to do so by your doctor. Levalbuterol aerosol canister provides about 200 inhalations, depending on the size of canister your doctor order. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot float in water to test its fullness. When you use an inhaler for the first time, or if you have not used it in a while, inhaler may not deliver the right amount of medicine with first puff. Test or prime inhaler before using it. Shake inhaler well immediately before each use. Take the cap off the actuator. Inspect the actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use. Prime inhaler by releasing 4 test sprays in air, away from your face. The Inhaler will now be ready to provide the right amount of medicine when you use it. Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding inhaler in a mouthpiece-down position and closing your lips around it. While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger. Immediately after the puff is deliver, release your finger from the canister and remove the inhaler from your mouth. Hold your breath for 10 seconds, if possible.


Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or directions on the label. The following information includes only average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of medicine. Also, number of doses you take each day, time allowed between doses, and length of time you take medicine depend on the medical problem for which you are using medicine. For preventing or treating bronchospasm: For inhalation aerosol dosage form: Adults and children 4 years of age and olderTwo puffs every 4 to 6 hours. In some patients, one puff every 4 hours may be enough. Children younger than 4 years of ageUse and dose must be determined by your doctor. For inhalation solution dosage form: Adults and children 12 years of age and olderAt first, 0. 63 milligrams in nebulizer 3 times a day, every 6 to 8 hours per day. Some patients may need to start at 1. 25 mg in nebulizer 3 times a day. Children 6 to 11 years of age0. 31 mg in nebulizer 3 times a day. Your doctor may increase your dose as needed However, dose is usually not more than 0. 63 mg 3 times a day. Children younger than 6 years of ageUse and dose must be determined by your doctor.


Storage

Do not keep outdated medicine or medicine you no longer need. Ask your healthcare professional how you should dispose of any medicine you do not use. Keep medicine on a foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze. Keep inhalation solution on foil pouch until you are ready to use it. The rest of the vials in the pouch should be used within 2 weeks after the foil pouch has been open. Use inhalation solution concentrate vial right away after opening the foil pouch. Throw away canister after either 200 sprays have been used. Ask your pharmacist if you are not sure. Do not place canister in water to see if the canister is full.


Uses for levalbuterol

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking levalbuterol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using levalbuterol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines. Albuterol Amineptine Amitriptyline Amitriptylinoxide Amoxapine Butriptyline Clomipramine Desipramine Dibenzepin Dothiepin Doxepin Epinephrine Fenoterol Hexoprenaline Imipramine Iprindole Lofepramine Melitracen Methacholine Nortriptyline Opipramol Propizepine Protriptyline Tianeptine Trimipramine Tulobuterol

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

BRAND NAME(S): Xopenex

Medication USE | HOW TO USE | SIDE EFFECTS | Precautions | Drug Interactions | Overdose | Notes | miss Dose | Storage HOW TO USE: Read Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. This product is USE with a special machine called nebulizer that changes the solution TO fine mist that you breathe in. Consult your doctor, pharmacist, or respiratory therapist on HOW TO inhale this medication properly with this equipment. If a child is using this equipment, parent or other responsible adult should supervise child. This product should be clear and colorless. Before using, check this product visually for particles or discoloration. If either is present, do not USE liquid. This product does not require any mixing before USE unless your doctor instructs you otherwise. This medication is inhaled into the lungs using a nebulizer as directed by your doctor, usually 3 times a day. Each treatment usually takes about 5 to 15 minutes. Use this medication only through nebulizer. Do not swallow or inject solution. Do not mix with other medications in nebulizer. To prevent infections, clean nebulizer and mouthpiece / face mask according to the manufacturer's directions. Dosage is based on your medical condition, age, and response TO treatment. Do not increase your dose or USE this more frequently than prescribed without your doctor's approval. Learn which of your inhalers / medications you should USE every day and which you should USE if your breathing suddenly worsen. Ask your doctor what TO do if you have worsening cough, shortness of breath, wheezing, increased sputum, or worsening peak flow meter readings. Learn when you can self-medicate and when you should get medical help right away. Side EFFECTS: Headache, nervousness, shaking, dizziness, trouble sleeping, dry mouth, nausea, stomach upset, diarrhea, or runny nose may occur. 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. Tell your doctor right away if any of these unlikely but serious SIDE EFFECTS occur: anxiety, leg / muscle cramps, swollen glands. Get medical help right away if you have any unlikely but very serious SIDE effect, including: fast / pounding / irregular heartbeat, chest pain, rapid breathing, confusion. Rarely, this medication cause severe, sudden worsening of breathing problems / asthma. If you experience sudden wheezing, get medical help right away. Very serious allergic reaction TO this drug is unlikely. However, get medical help right away if you notice any symptoms of serious allergic reaction, including: rash, itching / swelling, severe dizziness, trouble breathing. This is not a complete list of possible SIDE EFFECTS. If you notice other EFFECTS not listed above, contact your doctor or pharmacist. In the US-Call your doctor for medical advice about SIDE EFFECTS.


Proper Use

Use levalbuterol only as directed by your doctor. Do not use more of it and do not use it more often than your doctor order. Also, do not stop using levalbuterol or any other asthma medicine that you are taking without telling your doctor. Do so may increase the chance of breathing problems. Levalbuterol inhalation solution and inhalation solution concentrate should be used with a jet nebulizer that is connected to an air compressor with good air flow. Inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. To use inhalation solution or solution, concentrate on the nebulizer: open the pouch and remove one vial. Check the liquid in the vial. It should be clear or colorless. Do not use it if it is discolor. Open vial and place inhalation solution in medicine reservoir or nebulizer cup on machine. If you are using solution concentrate, mix it first with sterile normal saline before placing it in reservoir. Connect nebulizer to a face mask or mouthpiece. Use a face mask or mouthpiece to breathe in medicine. Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is go. Clean all parts of the nebulizer after each use. Do not use it if the solution becomes cloudy. Do not mix another inhalation medicine with levalbuterol in nebulizer, unless told to do so by your doctor. Levalbuterol aerosol canister provides about 200 inhalations, depending on the size of canister your doctor order. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot float in water to test its fullness. When you use an inhaler for the first time, or if you have not used it in a while, inhaler may not deliver the right amount of medicine with first puff. Test or prime inhaler before using it. Shake inhaler well immediately before each use. Take the cap off the actuator. Inspect the actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use. Prime inhaler by releasing 4 test sprays in air, away from your face. The Inhaler will now be ready to provide the right amount of medicine when you use it. Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding inhaler in a mouthpiece-down position and closing your lips around it. While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger. Immediately after the puff is deliver, release your finger from the canister and remove the inhaler from your mouth. Hold your breath for 10 seconds, if possible.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Neutropenia

Levalbuterol Inhalation Solution is for oral inhalation only. Administer by nebulization Using a standard Jet nebulizer connected to an air compressor. Do not exceed the recommended dose. Children 6 To 11 Years Old: recommended dosage of Levalbuterol Inhalation Solution For patients 6 to 11 years old is 0. 31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0. 63 mg three times a day. Adults and Adolescents 12 Years Old: recommend starting dosage of Levalbuterol Inhalation Solution For patients 12 years of age and older is 0. 63 mg administered three times a day, every 6 to 8 hours, by nebulization. Patients 12 years of age and older with more severe Asthma or patients who do not respond adequately to dose of 0. 63 mg of Levalbuterol Inhalation Solution may benefit from dosage of 1. 25 mg three times a day. Patients receiving the highest dose of Levalbuterol Inhalation Solution should be monitored closely for adverse systemic effects, and risks of such effects should be balanced against potential for improved efficacy. Use of Levalbuterol Inhalation Solution can be continued as medically indicated to help control recurring bouts of Bronchospasm. During this time, most patients gain optimal benefit from regular use of Inhalation Solution. If a previously effective dosage regimen fails to provide the usual response, this may be a marker of destabilization of Asthma and require reevaluation of patient and treatment regimen, giving special consideration to possible need for anti-inflammatory treatment, eg, corticosteroids. Drug compatibility, efficacy, and safety of Levalbuterol Inhalation Solution when mixed with other drugs in nebulizers have not been establish. Safety and efficacy of Levalbuterol Inhalation Solution have been established in Clinical Trials when administered using PARI LC Jet TM and PARI LC Plus TM nebulizers, and PARI Master Dura-Neb 2000 and Dura-Neb 3000 compressors. The safety and efficacy of Levalbuterol Inhalation Solution when administered using other nebulizer systems has not been establish. Levalbuterol Inhalation Solution, USP is supplied in 3 mL unit-dose, low-density polyethylene vials as clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of Levalbuterol. Each strength of Levalbuterol Inhalation Solution, USP is available in shelf carton containing two foil pouches, each containing 12 unit-dose LDPE vials, five foil pouches, each containing 5 unit-dose LDPE vials and six foil pouches, each containing 5 unit-dose LDPE vials. Expect symptoms with overdosage are those of excessive beta-adrenergic receptor stimulation and / or occurrence or exaggeration of any of the symptoms listed under Adverse Reactions, eg, seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats / min., Arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia also may occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Levalbuterol Inhalation Solution. Treatment consists of discontinuation of Levalbuterol Inhalation Solution together with appropriate symptomatic therapy. Judicious use of cardioselective beta-receptor blocker may be consider, bearing in mind that such medication can produce Bronchospasm.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Levalbuterol

Table

LevalbuterolAlbuterol
Asthma (acute symptoms) Chronic Obstructive Pulmonary Disease (COPD)Asthma (acute symptoms) Chronic Obstructive Pulmonary Disease (COPD)
Beta-2 Adrenergic AgonistBeta-2 Adrenergic Agonist
GenericGeneric
Bronchitis Dizziness Sore throat Vomiting Runny nose Accidental injury Palpitations Chest pain Tremors Nervousness Fast Heart RateDizziness Bronchitis Sore throat Fast Heart Rate Chest pain Palpitations Tremors Nervousness Vomiting Runny nose Accidental injury
Yes Levalbuterol is the genericYes Albuterol is the generic
Varies according to your providerVaries according to your provider
Inhalation solution Inhalation powderInhalation solution Inhalation powder Oral tablet Oral tablet, extended release Oral syrup
$167.25 per 25 vials (3ml) ((1.25mg/ml)$15 (per 2.5 mg inhalation solution)
Levalbuterol PriceAlbuterol Price
Digoxin Beta-blockers (atenolol, carvedilol, etc.) Diuretics (hydrochlorothiazide, furosemide, etc.) MAO inhibitors (selegiline, isocarboxazid, etc.) Tricyclic antidepressants (amitriptyline, doxepin, etc.)Digoxin Beta-blockers (atenolol, carvedilol, etc.) Diuretics (hydrochlorothiazide, furosemide, etc.) MAO inhibitors (selegiline, isocarboxazid, etc.) Tricyclic antidepressants (amitriptyline, doxepin, etc.)
Levalbuterol is in Pregnancy Category C. Consult a physician regarding taking levalbuterol while pregnant or breastfeeding.Albuterol is in Pregnancy Category C. Consult a physician regarding taking albuterol while pregnant or breastfeeding.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor order. Also, do not stop using this medicine or any other asthma medicine that you are taking without telling your doctor. Do so may increase the chance of breathing problems. Levalbuterol inhalation solution and inhalation solution concentrate should be used with a jet nebulizer that is connected to an air compressor with good air flow. Inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. To use inhalation solution or solution, concentrate on the nebulizer: open the pouch and remove one vial. Check the liquid in the vial. It should be clear or colorless. Do not use it if it is discolor. Open vial and place inhalation solution in medicine reservoir or nebulizer cup on machine. If you are using solution concentrate, mix it first with sterile normal saline before placing it in reservoir. Connect nebulizer to a face mask or mouthpiece. Use a face mask or mouthpiece to breathe in medicine. Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is go. Clean all parts of the nebulizer after each use. Do not use it if the solution becomes cloudy. Do not mix another inhalation medicine with levalbuterol in nebulizer, unless told to do so by your doctor. Levalbuterol aerosol canister provides about 200 inhalations, depending on the size of canister your doctor order. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot float in water to test its fullness. When you use an inhaler for the first time, or if you have not used it in a while, inhaler may not deliver the right amount of medicine with first puff. Test or prime inhaler before using it. Shake inhaler well immediately before each use. Take the cap off the actuator. Inspect the actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use. Prime inhaler by releasing 4 test sprays in air, away from your face. The Inhaler will now be ready to provide the right amount of medicine when you use it. Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding inhaler in a mouthpiece-down position and closing your lips around it. While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger. Immediately after the puff is deliver, release your finger from the canister and remove the inhaler from your mouth. Hold your breath for 10 seconds, if possible.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Summary

63 mg inhaled via nebulization 3 times per day, given every 6 to 8 hours, as needed for Bronchospasm. Patients with more severe Asthma or patients who do not respond adequately may benefit from a dosage of 1. 25 mg by nebulization 3 times per day. For acute asthma exacerbations, National Asthma Education and Prevention Program Expert Panel recommends 1. 25 To 2. 5 mg every 20 minutes For 3 doses, then 1. 25 To 5 mg every 1 To 4 hours as needed Initiate dosage at lower end of range for geriatric patients; if clinically indicate, dosage may be increased as tolerate, up to maximum adult dosage. Patients receiving higher doses should be monitored closely for adverse systemic effects, and risks of such effects should be balanced against the potential for improved efficacy. 2 puffs every 4 to 6 hours is needed for Bronchospasm; in some patients, 1 puff every 4 hours may be sufficient. More frequent administration or larger number of inhalations is not routinely recommend. For acute asthma exacerbations, National Asthma Education and Prevention Program Expert Panel recommends 4 to 8 puffs every 20 minutes for up to 4 hours, then decrease to every 1 to 4 hours as needed. 2 inhalations administered 15 minutes before exercise. The American Thoracic Society strongly recommends administration of inhaled short-acting beta-2 agonist 15 minutes before exercise for prevention. Efficacy of Levalbuterol For Prevention of EIB was assessed in a randomized, double-blind, placebo-control, cross over study in 15 asthmatic adults with stable Asthma and EIB. Patients were required to have 2050% decrease in FEV1 following exercise challenge and dose of placebo meter dose inhaler. Low or moderate dose leukotriene inhibitors and inhaled corticosteroids were allowed if the patient was stable on drug 30 days prior to entry; montelukast, inhaled steroids, and antihistamines were used in 6. 7%, 33. 3%, and 13. 3% of patients, respectively. The primary endpoint was maximum percent decrease in FEV1 from baseline. The study consisted of 3 visits; baseline values and EIB diagnosis were confirmed during visit 1, randomization occurred at visit 2 followed by exercise, and patients were crossed over to opposite treatment at visit 3, followed by exercise. The maximum percent FEV1 decrease was significantly less when patients receive Levalbuterol compared to placebo. Following exercise challenge with Levalbuterol prophylaxis, no patients required rescue medication, while 3 patients required rescue medication following placebo prophylaxis.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Levalbuterol Inhalation Solution (XopenexSepracor)

Table

Body as a Whole:chills, pain, chest pain
Cardiovascular System:ECG abnormal, ECG change, hypertension,
hypotension, syncope
Digestive System:diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, nausea
Hemic and Lymphatic System:lymphadenopathy
Musculoskeletal System:leg cramps, myalgia
Nervous System:anxiety, hypesthesia of the hand, insomnia, paresthesia, tremor
Special Senses:eye itch

Safety and efficacy of Xopenex Inhalation Solution were evaluated in a 4-week, multicenter, randomize, double-blind, placebo-control, parallel-group study in 362 adult and adolescent patients 12 years of age and older, with mild-to-moderate Asthma. Approximately half of patients were also receiving inhaled corticosteroids. Patients were randomized to receive Xopenex 0. 63 mg, Xopenex 1. 25 mg, racemic albuterol sulfate 1. 25 mg, racemic albuterol sulfate 2. 5 mg, or placebo three times a day administered via PARI LC Plus nebulizer and Dura-Neb portable compressor. Racemic albuterol delivered by chlorofluorocarbon meter Dose inhaler was used on an as-needed basis as rescue medication. Efficacy, as measured by Mean Percent Change from Baseline FEV 1, was demonstrated for all active treatment regimens compared with placebo on Day 1 and Day 29. On both Day 1 and Day 29 1. 25 mg of Xopenex demonstrates the largest Mean Percent Change from Baseline FEV 1 compared with other active treatments. Dose of 0. 63 mg of Xopenex and 2. 5 mg of racemic albuterol sulfate produced a clinically comparable Mean Percent Change from Baseline FEV 1 on both Day 1 and Day 29. Figure 1: Mean Percent Change from Baseline FEV 1 on Day 1, Adults and Adolescents 12 Years old Figure 2: Mean Percent Change from Baseline FEV 1 on Day 29, Adults and Adolescents 12 Years old Mean time to onset of 15% increase in FEV 1 over Baseline For levalbuterol at doses of 0. 63 mg and 1. 25 mg was approximately 17 minutes and 10 minutes, respectively, and the mean time to peak effect for both doses was approximately 1. 5 hours after 4 weeks of treatment. The mean duration of effect, as measured by > 15% increase from Baseline FEV 1, was approximately 5 hours after ADMINISTRATION of 0. 63 mg of levalbuterol and approximately 6 hours after ADMINISTRATION of 1. 25 mg of levalbuterol after 4 weeks of treatment. In some patients, duration of effect was as long as 8 hours.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Indications and Usage for Levalbuterol Inhalation Solution Concentrate

Table

Body as a Whole:chills, pain, chest pain
Cardiovascular System:ECG abnormal, ECG change, hypertension,
hypotension, syncope
Digestive System:diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, nausea
Hemic and Lymphatic System:lymphadenopathy
Musculoskeletal System:leg cramps, myalgia
Nervous System:anxiety, hypesthesia of the hand, insomnia, paresthesia, tremor
Special Senses:eye itch

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Levalbuterol Inhalation Solution Concentrate Dosage and Administration

Table

Body as a Whole:chills, pain, chest pain
Cardiovascular System:ECG abnormal, ECG change, hypertension,
hypotension, syncope
Digestive System:diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, nausea
Hemic and Lymphatic System:lymphadenopathy
Musculoskeletal System:leg cramps, myalgia
Nervous System:anxiety, hypesthesia of the hand, insomnia, paresthesia, tremor
Special Senses:eye itch

Levalbuterol Inhalation Solution is for oral inhalation only. Dilute with sterile normal saline before administration. Administer by nebulization using a standard Jet nebulizer connected to an air compressor. Do not exceed the recommended dose. For dosages less than 1. 25 mg, non-concentrate formulation must be used. Children 6 to 11 years Old: recommended dosage of levalbuterol Inhalation Solution for patients 6 to 11 years old is 0. 31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0. 63 mg three times a day. Adults and Adolescents 12 Years Old: recommend starting dosage of levalbuterol Inhalation Solution for patients 12 years of age and older is 0. 63 mg administered three times a day, every 6 to 8 hours, by nebulization. Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to dose of 0. 63 mg of levalbuterol Inhalation Solution may benefit from dosage of 1. 25 mg three times a day. Patients receiving the highest dose of levalbuterol Inhalation Solution should be monitored closely for adverse systemic effects, and risks of such effects should be balanced against potential for improved efficacy. Use of levalbuterol Inhalation Solution can be continued as medically indicated to help control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of Inhalation Solution. If a previously effective dosage regimen fails to provide the usual response, this may be a marker of destabilization of asthma and require reevaluation of patient and treatment regimen, giving special consideration to possible need for anti-inflammatory treatment, eg, corticosteroids. Drug compatibility, efficacy, and safety of levalbuterol Inhalation Solution when mixed with other drugs in nebulizers have not been establish. The safety and efficacy of levalbuterol Inhalation Solution has been established in clinical trials when administered using PARI LC Jet and PARI LC Plus nebulizers, and PARI Master Dura-Neb 2000 and Dura-Neb 3000 compressors. Safety and efficacy of levalbuterol Inhalation Solution when administered using other nebulizer systems have not been establish.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Contraindications

Table

Body as a Whole:chills, pain, chest pain
Cardiovascular System:ECG abnormal, ECG change, hypertension,
hypotension, syncope
Digestive System:diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, nausea
Hemic and Lymphatic System:lymphadenopathy
Musculoskeletal System:leg cramps, myalgia
Nervous System:anxiety, hypesthesia of the hand, insomnia, paresthesia, tremor
Special Senses:eye itch

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Warnings and Precautions

Xopenex Inhalation Solution is not indicated for pediatric patients less than 6 years of age. Clinical Trials with XOPENEX Inhalation Solution in this age group fail to meet the primary efficacy endpoint and demonstrate an increased number of Asthma-related Adverse Reactions following chronic XOPENEX treatment. Xopenex Inhalation Solution was studied in 379 pediatric patients less than 6 Years of Age with Asthma or reactive airway disease-. Efficacy and safety data for XOPENEX Inhalation Solution in this age group are primarily available from one 3-Week, multicenter, randomize, double-blind, active and placebo-control study in 211 pediatric patients between the ages of 2 and 5 years, of whom 119 received XOPENEX Inhalation Solution. Over the 3 week treatment period, there were no significant treatment differences in Pediatric Asthma Questionnaire total score between groups receiving XOPENEX Inhalation Solution 0. 31 mg, XOPENEX Inhalation Solution 0. 63 mg, racemic albuterol, and placebo. Additional safety data following chronic dosing is available from 4-Week, multicenter, randomize, modify-blind, placebo-control study of 196 patients between the ages of birth and 3 years, of whom 63 received open-label XOPENEX Inhalation Solution. In these two studies, treatment-emergent Asthma exacerbations or Asthma-related Adverse Reactions and treatment discontinuations due to Asthma occur at higher frequency in XOPENEX Inhalation-treated subjects compared to control. Other Adverse Reactions were consistent with those observed in a Clinical trial population of patients 6 years of age and older. Table 5: Asthma-related Adverse Reactions in 3-and 4-Week Clinical Trials in Children Birth to < 6 Years of Age

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Patient Counseling Information

Xopenex INHALATION SOLUTION 0. 31 mg, 0. 63 mg, 1. 25 mg XOPENEX INHALATION SOLUTION is only for US E with nebulizer. Read this Patient Information before you start to use XOPENEX INHALATION SOLUTION and each time you get refill. There may be new information. This information does not take place of talking with your doctor about your medical condition or your treatment. Xopenex INHALATION SOLUTION is inhale prescription medicine used for treatment or prevention of Bronchospasm in people 6 years of age and older. Xopenex INHALATION SOLUTION has not been shown to be safe and effective in children younger than 6 years of age. Xopenex INHALATION SOLUTION is supplied in 3 mL unit-dose vials in three different strengths of levalbulterol. Vials do not require dilution before use. Do not Use XOPENEX INHALATION SOLUTION If you are allergic to LEVALBUTEROL, racemic albuterol, or any of the ingredients in XOPENEX. See end of this leaflet for complete list of ingredients in XOPENEX INHALATION SOLUTION. What should I tell my doctor before using XOPENEX INHALATION SOLUTION? Before you use XOPENEX INHALATION SOLUTION, tell your doctor if you have: had allergic reaction to LEVALBUTEROL or racemic albuterol heart problems, high blood pressure, seizures, diabetes, thyroid problems, any other medical conditions are pregnant or planning to become pregnant. It is not know if XOPENEX INHALATION SOLUTION will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Are you breastfeeding or planning to breastfeed. It is not know if XOPENEX INHALATION SOLUTION passes into your breast milk. You and your doctor should decide if you will use XOPENEX INHALATION SOLUTION or breastfeed. You should not do both. Tell your doctor about all medicines you take, including prescription and over-counter medicines, vitamins, and herbal supplements. Xopenex INHALATION SOLUTION may affect the way other medicines work, and other medicines may affect how XOPENEX INHALATION SOLUTION works. Other Asthma medicines heart medicines medicines that increase urination, antidepressant medicine to treat chronic obstructive pulmonary disease. Ask your doctor if you are not sure if any of your medicines are the kinds listed above. Know medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get new medicine. Read step-by-step Instructions for Using XOPENEX INHALATION SOLUTION at the end of this leaflet. Use XOPENEX INHALATION SOLUTION exactly as your doctor tells you to. Do not change your dose without talking to your doctor first. Your doctor will tell you how many times and when to use your XOPENEX INHALATION SOLUTION. Adults should help children use XOPENEX INHALATION SOLUTION. Do not Use your XOPENEX INHALATION SOLUTION more often than your doctor tells you to.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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