Levalbuterol tartrate HFA inhalation

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Overview

What is Levalbuterol tartrate HFA inhalation?

The active component of Levalbuterol tartrate 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. Levalbuterol tartrate HFA inhalation aerosol is a pressurized metered-dose aerosol inhaler (MDI), 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 Levalbuterol tartrate HFA inhalation look like?

What are the available doses of Levalbuterol tartrate HFA inhalation?

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 Levalbuterol tartrate HFA inhalation?

How should I use Levalbuterol tartrate HFA inhalation?

Levalbuterol tartrate HFA inhalation aerosol 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 Levalbuterol tartrate HFA inhalation aerosol 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 Levalbuterol tartrate HFA inhalation?

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What are the warnings of Levalbuterol tartrate HFA inhalation?

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What are the precautions of Levalbuterol tartrate HFA inhalation?

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What are the side effects of Levalbuterol tartrate HFA inhalation?

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What should I look out for while using Levalbuterol tartrate HFA inhalation?

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

What might happen if I take too much Levalbuterol tartrate HFA inhalation?

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 Levalbuterol tartrate HFA inhalation aerosol. Treatment consists of discontinuation of Levalbuterol tartrate HFA inhalation aerosol 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 Levalbuterol tartrate HFA inhalation aerosol.

How should I store and handle Levalbuterol tartrate HFA inhalation?

Levalbuterol tartrate HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister 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. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.The blue actuator supplied with Levalbuterol tartrate HFA inhalation aerosol should not be used with any other product canisters. Actuators from other products should not be used with a Levalbuterol tartrate HFA inhalation aerosol canister. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used from the 15 g canister. Levalbuterol tartrate HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister 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. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.The blue actuator supplied with Levalbuterol tartrate HFA inhalation aerosol should not be used with any other product canisters. Actuators from other products should not be used with a Levalbuterol tartrate HFA inhalation aerosol canister. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used from the 15 g canister. Levalbuterol tartrate HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister 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. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.The blue actuator supplied with Levalbuterol tartrate HFA inhalation aerosol should not be used with any other product canisters. Actuators from other products should not be used with a Levalbuterol tartrate HFA inhalation aerosol canister. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used from the 15 g canister. Levalbuterol tartrate HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister 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. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.The blue actuator supplied with Levalbuterol tartrate HFA inhalation aerosol should not be used with any other product canisters. Actuators from other products should not be used with a Levalbuterol tartrate HFA inhalation aerosol canister. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used from the 15 g canister. Levalbuterol tartrate HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister 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. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.The blue actuator supplied with Levalbuterol tartrate HFA inhalation aerosol should not be used with any other product canisters. Actuators from other products should not be used with a Levalbuterol tartrate HFA inhalation aerosol canister. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used from the 15 g canister. Levalbuterol tartrate HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box: Each canister 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. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.The blue actuator supplied with Levalbuterol tartrate HFA inhalation aerosol should not be used with any other product canisters. Actuators from other products should not be used with a Levalbuterol tartrate HFA inhalation aerosol canister. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used from the 15 g canister.

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Clinical Information

Chemical Structure

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Clinical 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

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

ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Aspirin

When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.

Diuretics

Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.

Lithium

Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Warfarin-type anticoagulants

Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

H-2 Antagonists

In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

Levalbuterol tartrate HFA inhalation aerosol can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, Levalbuterol tartrate HFA inhalation aerosol 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 Levalbuterol tartrate HFA inhalation aerosol may be associated with the following:

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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