Xopenex HFA

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Xopenex HFA uses


1 INDICATIONS AND USAGE

Xopenex HFA is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

1.1 Bronchospasm

Xopenex HFA is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.

2 DOSAGE AND ADMINISTRATION

For Oral Inhalation Only

2.1 Recommended Dosages

The recommended dosage of Xopenex HFA for adults and children 4 years of age and older is 2 inhalations (90 mcg of levalbuterol free base) repeated every 4 to 6 hours; in some patients, 1 inhalation (45 mg of levalbuterol free base) every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not routinely recommended.

If a previously effective dosage regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

2.2 Administration Information

For oral inhalation only

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3 DOSAGE FORMS AND STRENGTHS

Inhalation aerosol: Xopenex HFA is a pressurized, metered dose aerosol.

Each Xopenex HFA 15 gram canister contains 200 metered actuations (or inhalations).

Each canister is fitted with a dose indicator and is supplied with a blue plastic actuator mouthpiece and a red mouthpiece cap. After priming, each actuation of the inhaler delivers 59 mcg of Xopenex HFA (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece.

Inhalation Aerosol: Each actuation delivers 59 mcg of Xopenex HFA (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece.

4 CONTRAINDICATIONS

Xopenex HFA is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of Xopenex HFA. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

Hypersensitivity to levalbuterol, racemic albuterol or any other component of Xopenex HFA Inhalation Aerosol. (4)

5 WARNINGS AND PRECAUTIONS

5.1 Paradoxical Bronchospasm

Xopenex HFA can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, Xopenex HFA should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

5.2 Deterioration of Asthma

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Xopenex HFA than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

5.3 Use of Anti-Inflammatory Agents

The use of a beta-adrenergic agonist alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

5.4 Cardiovascular Effects

Xopenex HFA, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and symptoms. Although such effects are uncommon after administration of Xopenex HFA at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Xopenex HFA, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5.5 Do Not Exceed Recommended Dose

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

5.6 Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of racemic albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving Xopenex HFA.

5.7 Coexisting Conditions

Xopenex HFA, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after the use of any beta-adrenergic bronchodilator.

Large doses of intravenous racemic albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8 Hypokalemia

As with other beta-adrenergic agonist medications, Xopenex HFA may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

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6 ADVERSE REACTIONS

Use of Xopenex HFA may be associated with the following:


Most common adverse reactions (≥ 2% and > placebo) are accidental injury, bronchitis, dizziness, pain, pharyngitis, rhinitis, and vomiting. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 Years of Age and Older

Adverse reaction information concerning Xopenex HFA in adults and adolescents is derived from two 8-week, multicenter, randomized, double-blind, active- and placebo-controlled trials in 748 adult and adolescent patients with asthma that compared Xopenex HFA, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler. Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 2% or greater in the group treated with Xopenex HFA and more frequently than in the HFA-134a placebo inhaler group.

* This table includes all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 2% or greater in the group treated with Xopenex HFA and more frequently than in the HFA-134a placebo inhaler group.

Body System Preferred Term Xopenex HFA

90 mcg

(n=403)

Racemic Albuterol

HFA

180 mcg

(n=179)

Placebo

(n=166)

Respiratory System Asthma 9% 7% 6%
Pharyngitis 8% 2% 2%
Rhinitis 7% 2% 3%
Body as a Whole Pain 4% 3% 4%
Central Nervous System Dizziness 3% 1% 2%

Adverse reactions reported by less than 2% and at least 2 or more of the adolescent and adult patients receiving Xopenex HFA and by a greater proportion than receiving HFA-134a placebo inhaler include cyst, flu syndrome, viral infection, constipation, gastroenteritis, myalgia, hypertension, epistaxis, lung disorder, acne, herpes simplex, conjunctivitis, ear pain, dysmenorrhea, hematuria, and vaginal moniliasis. There were no significant laboratory abnormalities observed in these studies.

Pediatric Patients 4 to 11 Years of Age

Adverse reaction information concerning Xopenex HFA in children is derived from a 4-week, randomized, double-blind trial of Xopenex HFA, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler in 150 children aged 4 to 11 years with asthma. Table 2 lists the adverse reactions reported for Xopenex HFA in children at a rate of 2% or greater and more frequently than for placebo.

* This table includes all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from the trial that occurred at a rate of 2% or greater in the group treated with Xopenex HFA and more frequently than in the HFA-134a placebo inhaler group.

Body System Preferred Term Xopenex HFA

90 mcg

(n=76)

Racemic Albuterol HFA

180 mcg

(n=39)

Placebo

(n=35)

Digestive System Vomiting 11% 8% 6%
Body as a Whole Accidental injury 9% 10% 6%
Respiratory System Pharyngitis 7% 13% 6%
Bronchitis 3% 0% 0%

The incidence of systemic beta-adrenergic adverse reactions (e.g., tremor, nervousness) was low and comparable across all treatment groups, including placebo.

6.2 Post-marketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in post-approval use of levalbuterol inhalation solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediated mechanism: angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dysphonia, dyspnea, gastrooesophageal reflux disease (GERD), metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria.

In addition, Xopenex HFA, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of the oropharynx.

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7 DRUG INTERACTIONS

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with Xopenex HFA. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

  • Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect.
  • Beta-blockers: May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. (7.1)
  • Diuretics: May worsen electrocardiographic changes or hypokalemia associated with diuretics may worsen. Consider monitoring potassium levels. (7.2)
  • Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. (7.3)
  • Monoamine oxidase inhibitors (MAOs) or tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants. (7.4)

7.1 Beta-blockers

Beta-blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-adrenergic agonists, such as Xopenex HFA, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.

7.2 Diuretics

The ECG changes or hypokalemia that may result from the administration of non-potassium-sparing diuretics can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium-sparing diuretics. Consider monitoring potassium levels.

7.3 Digoxin

Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of racemic albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving Xopenex HFA and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and Xopenex HFA.

7.4 Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

Xopenex HFA should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no adequate and well-controlled studies of Xopenex HFA in pregnant women. There are clinical considerations with the use of Xopenex HFA in pregnant women .

Following oral administration of levalbuterol HCl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 750 times the maximum recommended human daily inhalation dose of Xopenex HFA for adults on a mg/m2 basis]; however, racemic albuterol sulfate was teratogenic in mice (cleft palate) and rabbits (cranioschisis) at doses slightly higher than the human therapeutic range (see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. 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 Xopenex HFA for the treatment of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Xopenex HFA has not been approved for the management of preterm labor. The benefit:risk ratio when Xopenex HFA 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.

Data

Animal Data

The oral administration of levalbuterol HCl to pregnant New Zealand White rabbits during the period of organogenesis found no evidence of teratogenicity at doses up to 25 mg/kg/day (approximately 750 times the MRHDID of Xopenex HFA for adults on a mg/m2 basis). In a rat developmental study, a racemic albuterol sulfate (comprising approximately 50% levalbuterol)/HFA-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 160 times the MRHDID (on a mg/m2 basis at a maternal dose of 10.5 mg/kg).

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 rabbit development study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 1500 times the MRHDID (on a mg/m2 basis at a maternal dose of 50 mg/kg). In a mouse developmental study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure approximately 2 times MRHDID for adults (on a mg/m2 basis at a maternal dose of 0.25 mg/kg/day) and in 10 of 108 (9.3%) fetuses at approximately 20 times MRHDID (on a mg/m2 basis at a maternal dose of 2.5 mg/kg/day). Similar effects were not observed at approximately 0.2 times MRHDID of Xopenex HFA for adults on a mg/m2 basis (i.e., less than the therapeutic dose). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control).

8.2 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.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Xopenex HFA and any potential adverse effects on the breastfed child from Xopenex HFA or from the underlying maternal condition.

8.4 Pediatric Use

Pediatric Patients 4 Years of Age and Older

The safety and efficacy of Xopenex HFA have been established in pediatric patients 4 years of age and older in an adequate and well-controlled clinical trial [see Adverse Reactions and Clinical Studies (14)].

Pediatric Patients less than 4 Years of Age

Xopenex HFA is not indicated for pediatric patients less than 4 years of age. A clinical trial in pediatric patients below the age of 4 years showed no statistical significant difference between treatment groups in the primary efficacy endpoint. There was an increased incidence of asthma-related adverse reactions reported in pediatric patients below the age of 4 years treated with Xopenex HFA compared to placebo.

Xopenex HFA was evaluated in one 4-week, multicenter, randomized, modified-blind, placebo-controlled, parallel group trial of 196 pediatric patients ages birth to <4 years of age with asthma or reactive airway disease (68 patients birth to <2 years of age and 128 patients 2 to <4 years of age). Xopenex HFA 45 mcg (N=23), Xopenex HFA 90 mcg (N=42), levalbuterol inhalation solution 0.31 mg (N=63), and placebo HFA (N=68) were administered three times daily. Xopenex HFA or placebo HFA was delivered with the Monaghan AeroChamber MAX Valved Holding Chamber with mask. The primary efficacy endpoint was the mean change in Pediatric Asthma Caregiver Assessment (PACA) total score from baseline over the 4 week treatment period. There was no statistical difference in the change in PACA total score between Xopenex HFA and placebo. Regarding safety, an increased number of treatment-emergent asthma-related adverse reactions were reported in XOPENEX HFA-treated patients. Eight subjects reported asthma-related adverse reactions for Xopenex HFA compared to 3 subjects for placebo. There was one subject that discontinued treatment due to asthma in the Xopenex HFA group compared to zero subjects in the placebo group (Table 3). Other adverse reactions were consistent with those observed in the clinical trial population of patients 4 years of age and older .

*This table includes the following Preferred Terms (whether considered by the investigator to be related or unrelated to drug): asthma, cough, hypoxia, status asthmaticus, tachypnea

Xopenex HFA

45-90 mcg

(n=65)

Levalbuterol

inhalation solution

0.31 mg

(n=63)

Placebo

(n=68)

Asthma-related adverse reactions*, n (%) 8 (12%) 6 (10%) 3 (4%)
Treatment discontinuations due to asthma, n (%) 1 (2%) 2 (3%) 0

8.5 Geriatric Use

Clinical studies of Xopenex HFA did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 diseases or other drug therapy.

8.6 Renal Impairment

Albuterol is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

10 OVERDOSAGE

The expected 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 (6), e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/minute, 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 the abuse of Xopenex HFA. Treatment consists of discontinuation of Xopenex 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 Xopenex HFA.

11 DESCRIPTION

The active component of Xopenex HFA inhalation aerosol is Xopenex HFA, the (R)-enantiomer of albuterol. Xopenex HFA is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. Xopenex HFA has the chemical name (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), and it has the following chemical structure:

  • Xopenex HFA comes as a canister that fits into an actuator with a dose indicator.
    • Do not use the Xopenex HFA actuator with a canister of medicine from any other inhaler.
    • Do not use the Xopenex HFA canister with an actuator from any other inhaler.
  • The dose indicator display window will show you how many sprays of medicine you have left in your inhaler. A spray of medicine is released each time you press down on the center of the dose indicator.
  • It is important that you pay attention to the number of sprays left in your Xopenex HFA inhaler by reading the dose indicator. You should also keep track of the number of sprays used from your inhaler.

Each canister of Xopenex HFA contains enough medicine for you to spray your medicine 200 times .

  • The pointer will be pointing between 180 and 200 after you take 10 sprays. This means that there are 190 sprays of medicine left in the canister (See Figure 2b ).
  • The pointer will be pointing to 180 after you take 10 more sprays. This means that there are 180 sprays of medicine left in the canister (See Figure 2c ).
  • The dose indicator display window will change to red, as shown in the shaded area, when there are only 20 sprays of medicine left in your inhaler (See Figure 2d ). You should refill your prescription or ask your doctor if you need another prescription for Xopenex HFA.
  • When the number in the dose indicator display window reaches zero “0”, this means that 200 sprays of medicine have been used. Throw away your Xopenex HFA inhaler.

Note: Do not place the canister under water to find out the amount of medicine left in the canister.

Preparing your Xopenex HFA inhaler for use:

  • Your Xopenex HFA inhaler should be at room temperature before you use it.
  • Shake the inhaler well before each use.

Priming your Xopenex HFA inhaler:

Before you use Xopenex HFA for the first time or if you have not taken your medicine for 3 days in a row, you must prime the inhaler.

  • Look at the dose indicator on top of the inhaler. Make sure that the pointer on the dose indicator is pointing to the “200” inhalation mark before you use your Xopenex HFA inhaler for the first time.
  • Take the cap off the mouthpiece of the actuator (See Figure 3 ). Check inside the mouthpiece for objects before use.
  • Hold the inhaler in the upright position away from the face and shake the inhaler well (See Figure 4 ).
  • Press down fully on the center of the dose indicator to release a spray of medicine from the mouthpiece (See Figure 5 ). You may hear a soft click from the dose indicator as it counts down during use.
  • Avoid spraying in your eyes.
  • Repeat the priming steps 3 more times (See Figure 4 and Figure 5 ) to finish priming the inhaler.
  • After priming 4 times the first time you use your Xopenex HFA inhaler, the dose indicator should be pointing to “200” and your inhaler is now ready to use.

If you do not use your Xopenex HFA inhaler for more than 3 days, you will need to prime the inhaler again before use.

Using your Xopenex HFA inhaler:

Step 1: Take the cap off the mouthpiece of the actuator (See Figure 3 ). Check inside the mouthpiece for objects. Make sure the canister fits firmly in the actuator.

Step 2: Shake the inhaler well for 5 seconds before use.

Step 3: Hold the inhaler upright with the mouthpiece pointing towards you. Before you put the mouthpiece in your mouth, breathe out through your mouth and push out as much air from your lungs as you can (See Figure 6 ).

Step 4: Put the mouthpiece in your mouth and close your lips around it.

Step 5: While breathing in deeply and slowly, press down on the center of the targeting rings (See Figure 7 ) until a spray of medicine has been released. Then stop pressing the dose indicator.

Step 6: When you have finished breathing in, remove the mouthpiece from your mouth. Close your mouth and hold your breath for 10 seconds if possible. Then breathe out gently.

Step 7: Wait about 1 minute, then shake the inhaler well. Repeat steps 3 through 6 to take your second spray of Xopenex HFA.

Step 8: Put the cap back on the mouthpiece right away after use.

Make sure the cap snaps firmly into place.

Cleaning your Xopenex HFA inhaler:

Clean the inhaler 1 time each week. It is very important to keep the actuator clean so that medicine will not build up and block the spray from the mouthpiece (See Figure 8 ).

To clean the actuator:

Step 1: Take the canister out of the actuator (See Figure 9 ). Do not clean the canister or let it get wet.

Step 2: Take the cap off the mouthpiece.

Step 3: Hold the actuator under the faucet and run warm water through it for at least 30 seconds. Turn the actuator upside down and rinse the actuator again through the mouthpiece for at least 30 seconds (See Figure 10 ).

Step 4: Shake off as much water from the actuator as you can.

Step 5: Look inside the actuator and mouthpiece to make sure any medicine build-up has been completely washed away. Medicine build-up is more likely to happen if the actuator is not allowed to air-dry completely.

Step 6: Let the actuator air-dry overnight. Do not put the canister back into the actuator if it is still wet.

Step 7: When the actuator is dry, put the canister back in the actuator and put the cap back on the mouthpiece. Make sure to firmly press the canister down in the actuator.

Note: If your actuator becomes blocked, it means that little or no medicine is coming out of the mouthpiece (See Figure 11 ). Repeat Steps 1 through 7 above in the section “ To clean the actuator ”.

If you need to use your inhaler before the plastic actuator is completely dry:

  • Shake off as much water from the actuator as you can.
  • Put the canister back into the actuator and shake the inhaler well.
  • To remove most of the water from your inhaler, press down on the center of the targeting rings 2 times to release a total of 2 sprays into the air away from your face.
  • Take your prescribed dose of medicine.
  • Repeat Steps 1 through 7 above in the section “ To clean the actuator”.

How should I store Xopenex HFA?

  • Store Xopenex HFA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not use or store Xopenex HFA inhaler near heat or open flame. Temperatures above 120°F may cause the canister to burst.
  • Do not freeze Xopenex HFA.
  • Keep Xopenex HFA out of direct sunlight.
  • Do not put a hole in the Xopenex HFA canister.
  • Store Xopenex HFA with the mouthpiece down.
  • Throw away Xopenex HFA when the dose indicator display window reaches zero “0”, showing that all 200 sprays (actuations) have been used.
  • Do not throw Xopenex HFA into a fire or incinerator.

Keep Xopenex HFA and all medicines out of the reach of children.

For more information, go to www. XOPENEX.com.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

SUNOVION

Manufactured for

Sunovion Pharmaceuticals Inc.

Marlborough, MA 01752 USA

© 2017 Sunovion Pharmaceuticals Inc. All rights reserved.

For customer service, call 1-888-394-7377.

To report adverse events, call 1-877-737-7226.

For medical information, call 1-800-739-0565.

Revised February 2017

901715R03

Figure 1 Figure 2a Figure 2b Figure 2c Figure 2d Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11

PRINCIPAL DISPLAY PANEL – TRADE CANISTER LABEL – 45 MCG 200 ACTUATIONS

NDC 63402-510-01 Net Contents: 15 g

Xopenex HFA®

(levalbuterol tartrate)

Inhalation Aerosol

45 mcg/actuation

200 Metered Inhalations

FOR ORAL INHALATION WITH Xopenex HFA® ACTUATOR ONLY

Shake well before using.

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE CARTON - 45 MCG 200 ACTUATIONS

NDC 63402-510-01 Net Contents: 15g

Xopenex HFA®

(levalbuterol tartrate)

Inhalation Aerosol

45 mcg/actuation

200 Metered Inhalations

FOR ORAL INHALATION WITH Xopenex HFA® ACTUATOR ONLY

Shake well before using.

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE CARTON - 45 MCG 200 ACTUATIONS

Xopenex HFA pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Xopenex HFA available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Xopenex HFA destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Xopenex HFA Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Xopenex HFA pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [SUNOVION PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Levalbuterol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "Levalbuterol". http://www.drugbank.ca/drugs/DB1313... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Xopenex HFA?

Depending on the reaction of the Xopenex HFA after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Xopenex HFA not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Xopenex HFA addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Xopenex HFA, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Xopenex HFA consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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