Xopenex HFA

Dosage Forms & Strengths

nebulizer solution

• 0.31mg/3mL
• 0.63mg/3mL
• 1.25mg/3mL
• 1.25mg/0.5mL

aerosol

• 45mcg/actuation

Bronchospasm

Nebulizer solution: 0.63-1.25 mg 3 times daily q6-8hr

Aerosol: 90 mcg (2 actuations of metered-dose inhaler) q4-6hr

Asthma Exacerbation

Nebulizer solution: 1.25-2.5 mg q20min for 3 doses, then 1.25-5 mg q1-4hr PRN

Aerosol: 180-360 mcg (4-8 actuations of metered-dose inhaler) q20min for ≤4 hr, then q1-4hr PRN

Dosage Forms & Strengths

nebulizer solution

• 0.31mg/3mL
• 0.63mg/3mL
• 1.25mg/3mL
• 1.25mg/0.5mL

aerosol

• 45mcg/actuation

Bronchospasm

Nebulizer solution

• <5 years: 0.31-1.25 mg q4-6hr PRN
• 5-12 years: 0.31 mg q8hr; not to exceed 0.63 mg q8hr PRN
• >12 years: 0.63-1.25 mg q8hr PRN

Aerosol

• <4 years: Safety and efficacy not established
• ≥4 years: 90 mcg (2 actuations of metered-dose inhaler) q4-6hr PRN

Asthma Exacerbation

Nebulizer solution

• <12 years: 0.075 mg/kg (≥1.25 mg) q20min for 3 doses, then 0.075-0.15 mg/kg (≤5 mg) q1-4hr PRN  
• ≥12 years: 1.25-2.5 mg q20min for 3 doses, then 1.25-5 mg q1-4hr PRN

Aerosol

• <4 years: Safety and efficacy not established
• ≥4 years: 180-360 mcg (4-8 actuations of metered-dose inhaler) q20min for 3 doses, then q1-4hr PRN

Nebulizer solution: 0.63 mg initially in patients >65 years

Contraindications

Hypersensitivity to levalbuterol or racemic albuterol

Cautions

Cardiovascular disorder (eg, arrhythmias, hypertension, coronary insufficiency)

Risk of paradoxical bronchospasm

Has higher affinity for beta1- and beta2-adrenergic receptors than racemic albuterol has

Risk of hypersensitivity reactions

Use with caution in diabetes mellitus (beta2 agonists may increase glucose)

Risk of hypokalemia (usually transient)

Xopenex HFA can cause serious side effects. See "Xopenex HFA Precautions" section.

The most common side effects of Xopenex HFA include:

• accidental injury
• inflammation of the tubes which carry air to and from the lungs (bronchitis)
• dizziness
• pain
• sore throat
• runny nose
• vomiting
• palpitations
• chest pain
• fast heart rate
• tremors
• nervousness

Tell your doctor if you have any side effects that bother you or that does not go away.

These are not all the possible side effects of Xopenex HFA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects have been reported with Xopenex HFA including the following:

• sudden shortness of breath (bronchospasm). Sudden shortness of breath can happen right away after using Xopenex HFA.
• worsening asthma
• heart problems
• death. If you use too much Xopenex HFA you can have heart or lung problems that can lead to death.
• serious allergic reactions. Call your doctor and stop using Xopenex HFA right away if you have any symptoms of an allergic reaction such as:
  • swelling of the face, throat or tongue
  • hives
  • rash
  • breathing problems
• low potassium levels in your blood

Call your doctor or go to the nearest hospital emergency room right away if you have any of the serious side effects listed above or if you have worsening lung symptoms.

Do not use Xopenex if you are allergice to Xoponex HFA, levalbuterol, racemic albuterol, or any of the ingredients in Xopenex HFA. 

Before you use Xopenex HFA, tell your doctor if you have:

• had an allergic reaction to levalbuterol or racemic albuterol or Xopenex HFA
• heart problems
• high blood pressure
• seizures
• diabetes
• thyroid problems
• any other medical conditions
• are pregnant or planning to become pregnant 
• are breastfeeding or plan to breastfeed

Xopenex HFA may affect the way other medicines work, and other medicines may affect how  Xopenex HFA works.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Xopenex HFA crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Xopenex HFA.

In the U.S.

• Xopenex
• Xopenex HFA
• Xopenex Pediatric

Available Dosage Forms:

• Solution
• Aerosol Powder

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Fast heartbeat

• Chest pain or tightness
• dizziness
• feeling “faint”
• lightheadedness
• troubled breathing

• Cough
• difficult or labored breathing
• difficulty swallowing
• extra heartbeats
• fainting
• fast, pounding, slow, or irregular heartbeat or pulse
• hives, welts, itching, or rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• redness of the skin
• tightness in the chest
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Chest pain
• dizziness
• dry mouth
• general feeling of discomfort or illness
• headache
• impaired consciousness
• irregular or fast heartbeat
• lightheadedness
• nausea
• nervousness
• seizures
• sleeplessness
• sweating
• tremor

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Accidental injury (in children 4 to 11 years of age)
• anxiety
• body aches or pain
• chills
• congestion
• cough or hoarseness
• dryness or soreness of the throat
• fever
• general aches and pains
• headache
• hoarseness
• increased cough
• leg cramps
• loss of appetite
• migraines or other headaches
• muscle tightness
• nervousness
• runny or stuffy nose

• Abdominal or stomach pain
• abnormal growth filled with fluid or semisolid material
• blemishes on the skin
• blood in the urine
• bloody nose
• burning, dry, or itching eyes
• burning or stinging of the skin
• cough producing mucus
• cramps
• diarrhea
• difficulty having a bowel movement (stool)
• discharge from the eye
• dry mouth or throat
• ear pain
• excessive tearing
• eye itch
• heavy menstrual bleeding
• muscle pain
• night sweats
• numbness or decreased sensitivity of the hand
• pain
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pimples
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• tingling sensation in the arms or legs
• vaginal yeast infection
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Xopenex HFA (levalbuterol inhalation aerosol), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xopenex HFA. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Xopenex HFA.

Review Date: October 4, 2017

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.

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.

Diuretics

The ECG changes or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop and thiazide 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.

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.

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.

Applies to levalbuterol: inhalation aerosol, inhalation solution

General

This drug has been associated with paradoxical bronchospasm, cardiovascular effects, immediate hypersensitivity reactions, and hypokalemia.[Ref]

Cardiovascular

ECG abnormal, ECG change, hypotension, and syncope occurred in less than 2%.[Ref]

Common (1% to 10%): Hypertension, tachycardia
Frequency not reported: ECG abnormal, ECG change, hypotension, syncope
Postmarketing reports: Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)[Ref]

Musculoskeletal

Myalgia occurred in less than 2%.[Ref]

Common (1% to 10%): Leg cramps
Frequency not reported: Myalgia[Ref]

Metabolic

Metabolic acidosis occurred in less than 2%.[Ref]

Frequency not reported: Changes in plasma glucose and serum potassium; metabolic acidosis[Ref]

Nervous system

Central nervous system stimulation and hyperesthesia of the hand occurred in less than 2%.[Ref]

Common (1% to 10%): Dizziness, migraine, tremor, nervousness
Frequency not reported: Central nervous system stimulation, hyperesthesia of the hand[Ref]

Other

Common (1% to 10%): Pain, flu syndrome, accidental injury, asthenia, fever
Frequency not reported: Ear pain, herpes simplex, chills, cyst[Ref]

Ear pain, herpes simplex, chills, and cyst occurred in less than 2%.[Ref]

Gastrointestinal

Diarrhea, dry mouth, dry throat, nausea, gastroenteritis, vomiting, and constipation occurred in less than 2%.

Common (1% to 10%): Dyspepsia
Frequency not reported: Diarrhea, dry mouth, dry throat, nausea, gastroenteritis, vomiting, constipation
Postmarketing reports: Gastroesophageal reflux disease (GERD), nausea

Respiratory

Common (1% to 10%): Asthma, pharyngitis, rhinitis, bronchitis, sinusitis, turbinate edema, cough increased, viral infection
Frequency not reported: Epistaxis, lung disorder, asthma exacerbation, wheezing
Postmarketing reports: Chest pain, dysphonia, dyspnea

Viral infection, epistaxis, lung disorder, asthma exacerbation, and wheezing occurred in less than 2%.

Dermatologic

Frequency not reported: Acne, sweating
Postmarketing reports: Rash, urticaria

Acne and sweating occurred less than 2%.

Hypersensitivity

Common (1% to 10%): Allergic reactions
Postmarketing reports: Angioedema, anaphylaxis

Genitourinary

Frequency not reported: Hematuria, dysmenorrhea, vaginal moniliasis

Hematuria, dysmenorrhea, vaginal moniliasis occurred in less than 2%.

Immunologic

Frequency not reported: Lymphadenopathy

Lymphadenopathy occurred in less than 2%.

Ocular

Eye itch occurred in less than 2%.

Frequency not reported: Eye itch

Psychiatric

Insomnia occurred in less than 2%.

Common (1% to 10%): Anxiety
Frequency not reported: Insomnia

Some side effects of Xopenex HFA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.