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Xopenex HFA
Overview
What is Xopenex HFA?
The active component of XOPENEX HFA inhalation aerosol is levalbuterol tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a relatively selective beta-adrenergic receptor agonist [see ]. Levalbuterol tartrate has the chemical name (R)-α-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), and it has the following chemical structure:
The molecular weight of levalbuterol tartrate is 628.71, and its empirical formula is (CHNO) · CHO. It is a white to light-yellow solid, freely soluble in water and very slightly soluble in ethanol.
Levalbuterol tartrate is the generic name for (R)-albuterol tartrate in the United States. XOPENEX HFA inhalation aerosol is a pressurized metered-dose aerosol inhaler (MDI) fitted with a dose indicator, which produces an aerosol for oral inhalation. It contains a suspension of micronized levalbuterol tartrate, propellant HFA-134a (1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid NF.
After priming with 4 actuations, each actuation of the inhaler delivers 67.8 mcg of levalbuterol tartrate (equivalent to 51.6 mcg of levalbuterol free base) from the valve and 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece. Each 15 g canister provides 200 actuations (or inhalations).
What does Xopenex HFA look like?
What are the available doses of Xopenex HFA?
Inhalation Aerosol: Each actuation delivers 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece.
What should I talk to my health care provider before I take Xopenex HFA?
How should I use Xopenex HFA?
XOPENEX HFA is a beta-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ()
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.
What interacts with Xopenex HFA?
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What are the warnings of Xopenex HFA?
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What are the precautions of Xopenex HFA?
Sorry No Records found
What are the side effects of Xopenex HFA?
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What should I look out for while using Xopenex HFA?
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.
What might happen if I take too much Xopenex HFA?
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 , 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.
How should I store and handle Xopenex HFA?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].XOPENEX HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister is fitted with a dose indicator and is supplied with a blue plastic actuator mouthpiece, a red mouthpiece cap, and patient's instructions. Shake well before usingContents under pressureDo not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. The blue actuator supplied with XOPENEX HFA should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA canister. The correct amount of medication in each actuation cannot be assured after 200 actuations, even though the canister is not completely empty. When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required. The canister should be discarded when the dose indicator display window shows zero, indicating that 200 actuations have been used. XOPENEX HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister is fitted with a dose indicator and is supplied with a blue plastic actuator mouthpiece, a red mouthpiece cap, and patient's instructions. Shake well before usingContents under pressureDo not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. The blue actuator supplied with XOPENEX HFA should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA canister. The correct amount of medication in each actuation cannot be assured after 200 actuations, even though the canister is not completely empty. When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required. The canister should be discarded when the dose indicator display window shows zero, indicating that 200 actuations have been used. XOPENEX HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister is fitted with a dose indicator and is supplied with a blue plastic actuator mouthpiece, a red mouthpiece cap, and patient's instructions. Shake well before usingContents under pressureDo not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. The blue actuator supplied with XOPENEX HFA should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA canister. The correct amount of medication in each actuation cannot be assured after 200 actuations, even though the canister is not completely empty. When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required. The canister should be discarded when the dose indicator display window shows zero, indicating that 200 actuations have been used. XOPENEX HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister is fitted with a dose indicator and is supplied with a blue plastic actuator mouthpiece, a red mouthpiece cap, and patient's instructions. Shake well before usingContents under pressureDo not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. The blue actuator supplied with XOPENEX HFA should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA canister. The correct amount of medication in each actuation cannot be assured after 200 actuations, even though the canister is not completely empty. When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required. The canister should be discarded when the dose indicator display window shows zero, indicating that 200 actuations have been used. XOPENEX HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister is fitted with a dose indicator and is supplied with a blue plastic actuator mouthpiece, a red mouthpiece cap, and patient's instructions. Shake well before usingContents under pressureDo not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. The blue actuator supplied with XOPENEX HFA should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA canister. The correct amount of medication in each actuation cannot be assured after 200 actuations, even though the canister is not completely empty. When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required. The canister should be discarded when the dose indicator display window shows zero, indicating that 200 actuations have been used. XOPENEX HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister is fitted with a dose indicator and is supplied with a blue plastic actuator mouthpiece, a red mouthpiece cap, and patient's instructions. Shake well before usingContents under pressureDo not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. The blue actuator supplied with XOPENEX HFA should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA canister. The correct amount of medication in each actuation cannot be assured after 200 actuations, even though the canister is not completely empty. When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required. The canister should be discarded when the dose indicator display window shows zero, indicating that 200 actuations have been used.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Activation of beta-adrenergic receptors on airway smooth muscle leads to the activation of adenylate cyclase and to an increase in the intracellular concentration of cyclic-3', 5'-adenosine monophosphate (cyclic AMP). The increase in cyclic AMP is associated with the activation of protein kinase A, which in turn, inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Levalbuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. Increased cyclic AMP concentrations are also associated with the inhibition of the release of mediators from mast cells in the airways. Levalbuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. While it is recognized that beta-adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there are beta-receptors in the human heart, 10% to 50% of which are beta-adrenergic receptors. The precise function of these receptors has not been established [see ]. However, all beta-adrenergic agonist drugs can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.
Non-Clinical Toxicology
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.Caution should be used when lithium and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. Patients receiving such combined therapy should have serum lithium levels monitored closely and the lithium dosage adjusted if necessary.
Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg b.i.d. with celecoxib 200 mg b.i.d. as compared to subjects receiving lithium alone.
Concurrent use of metronidazole with lithium may provoke lithium toxicity due to reduced renal clearance. Patients receiving such combined therapy should be monitored closely.
There is evidence that angiotensin-converting enzyme inhibitors, such as enalapril and captopril, and angiotensin II receptor antagonists, such as losartan may substantially increase steady-state plasma lithium levels, sometimes resulting in lithium toxicity. When such combinations are used, lithium dosage may need to be decreased, and plasma lithium levels should be measured more often.
Concurrent use of calcium channel blocking agents with lithium may increase the risk of neurotoxicity in the form of ataxia, tremors, nausea, vomiting, diarrhea and/or tinnitus. Caution is recommended.
The concomitant administration of lithium with selective serotonin reuptake inhibitors should be undertaken with caution as this combination has been reported to result in symptoms such as diarrhea, confusion, tremor, dizziness and agitation.
The following drugs can lower serum lithium concentrations by increasing urinary lithium excretion: acetazolamide, urea, xanthine preparations and alkalinizing agents such as sodium bicarbonate.
The following have also been shown to interact with lithium: methyldopa, phenytoin and carbamazepine.
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.
Use of XOPENEX HFA may be associated with the following:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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