Levalbuterol Concentrate

Drug overview for LEVALBUTEROL CONCENTRATE (levalbuterol hcl):

Generic name: LEVALBUTEROL HCL (LEV-al-BUE-ter-ol)
Drug class: Beta-Adrenergic Agents Short-Acting (Inhaled)
Therapeutic class:

Albuterol (a racemic mixture) and levalbuterol (the R-enantiomer) are synthetic sympathomimetic amines that stimulate beta-adrenergic receptors. The drugs are relatively selective, short-acting beta2-adrenergic agonists.

No enhanced Uses information available for this drug.

DRUG IMAGES

LEVALBUTEROL CONC 1.25 MG/0.5

The following indications for LEVALBUTEROL CONCENTRATE (levalbuterol hcl) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for LEVALBUTEROL CONCENTRATE (levalbuterol hcl):

Dosing
Administration
Dosing Information
Generic

Dosage of albuterol sulfate is expressed in terms of albuterol. Dosage of levalbuterol hydrochloride or tartrate is expressed in terms of levalbuterol. Dosage of albuterol sulfate and levalbuterol must be carefully adjusted according to individual requirements and response.

The albuterol oral aerosol inhalers deliver 90 mcg of albuterol from the mouthpiece per metered spray. The levalbuterol tartrate oral aerosol inhaler delivers 45 mcg of levalbuterol from the mouthpiece per metered spray. The oral aerosol inhaler containing albuterol sulfate and ipratropium bromide delivers 18 mcg of ipratropium bromide and 103 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol) from the mouthpiece per metered spray.

Using in vitro testing at an average flow rate of 3.6 L/minute for an average of 15 minutes, the Pari-LC Plus(R) nebulizer delivered at the mouthpiece approximately 46 or 42% of the original dosage of albuterol or ipratropium bromide, respectively. Using in vitro testing at an average flow rate of 3.6

L/minute for an average of 15 minutes or less, the Pari-LC Plus(R) nebulizer delivered at the mouthpiece approximately 43 or 39% of the original dosage of albuterol at the 1.25- or 0. 63-mg strength, respectively.

Commercially available albuterol sulfate aerosol with a hydrofluoroalkane (HFA) propellant delivers at least 200 metered sprays per 18-g (Ventolin(R) HFA), 6.7-g (Proventil(R) HFA), or 8.5-g (ProAir(R) HFA) canister, respectively.

The commercially available aerosol inhaler containing albuterol sulfate in fixed combination with ipratropium bromide delivers 200 metered sprays per 14.7-g canister. The commercially available levalbuterol aerosol inhaler delivers 200 metered sprays per 15-g canister. The canister should be discarded after the labeled number of actuations have been used.

Albuterol sulfate is administered orally or by oral inhalation via a metered-dose inhaler or nebulization. Albuterol sulfate is administered in fixed combination with ipratropium bromide via a metered-dose aerosol inhaler or via nebulization. Levalbuterol hydrochloride is administered by oral inhalation via nebulization.

Levalbuterol tartrate with hydrofluoroalkane (HFA) propellant is administered by oral inhalation via a metered-dose inhaler. To avoid microbial contamination, proper aseptic technique should be used when albuterol or levalbuterol is administered via nebulization. Albuterol sulfate extended-release tablets should not be chewed or crushed.

No dosing information available.

No generic dosing information available.

The following precautions are available for LEVALBUTEROL CONCENTRATE (levalbuterol hcl):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Experts from the National Asthma Education and Prevention Program (NAEPP) state that maintaining adequate control of asthma during pregnancy is important for the health and well-being of the mother and the fetus. Because of the risks associated with asthma symptoms and exacerbations (e.g., increased perinatal mortality, preeclampsia, preterm birth, low birth weight during pregnancy, such experts consider use of antiasthmatic agents to be safer than the complications of inadequately controlled asthma. Albuterol is the preferred short-acting inhaled beta2-agonist because more data are available on use of albuterol in pregnant women than on use of other short-acting inhaled beta2-agonists, and such data indicate an excellent safety profile. The manufacturers of albuterol or levalbuterol state that the drugs should be used during pregnancy only if the possible benefits outweigh the potential risks. During marketing experience with the drug, various congenital anomalies, including cleft palate and limb defects, have been reported in the children of patients being treated with albuterol; however, some women were receiving multiple medications during their pregnancies. Because no consistent pattern of congenital abnormality development can be discerned, a relationship between albuterol use and the development of congenital anomalies cannot be established. Large IV doses of albuterol have reportedly inhibited uterine contractions, and the drug has reportedly delayed preterm labor following oral administration. Serious adverse effects, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol. There are currently no well-controlled studies to show that albuterol will stop preterm labor or prevent labor at term, and the risks versus benefits of tocolytic therapy with levalbuterol or albuterol have not been established. Albuterol or orally inhaled levalbuterol should be used with caution in pregnant women when needed for relief of bronchospasm during labor and only when the potential benefits are expected to clearly outweigh the possible risks, since the drugs may interfere with uterine contractility. Albuterol has been shown to be teratogenic in mice and rabbits. Reproduction studies in mice given subcutaneous albuterol doses of 0.025, 0.25, or 2.5 mg/kg (approximately 0.003, 0.03, or 0.3 times, respectively, the maximum recommended daily oral dosage for adults; 0.125, 1.25, and 12.5 times the maximum recommended human albuterol single-use inhalation solution via nebulization; less than the maximum recommended adult daily inhalation solution dosage on a mg/m2 basis; and up to 8 times the maximum recommended daily inhalation aerosol dosage on a mg/m2 basis) showed cleft palate formation in 4.5% of fetuses at 0.25

mg/kg and in 9.3% of fetuses at 2.5 mg/kg (approximately equal to the maximum daily nebulized levalbuterol, albuterol sulfate, or albuterol sulfate/ipratropium bromide dosage in adults on a mg/m2 basis); cleft palate did not occur in mice receiving 0.025

mg/kg of albuterol (representing less than the maximum daily adult inhalation dosage of albuterol sulfate alone via metered-dose inhalation or nebulization or in fixed combination with ipratropium bromide via nebulization on a mg/m2 basis). Cleft palate also occurred in 30.5% of fetuses treated with 2.5

mg/kg of isoproterenol (positive control). A reproduction study with oral albuterol in rabbits revealed cranioschisis in 37% of fetuses at 50 mg/kg (approximately 25, 55, 60 or 80 times the maximum recommended daily adult oral albuterol sulfate dosage, albuterol sulfate/ipratropium bromide nebulized adult dosage, nebulized pediatric albuterol dosage or nebulized albuterol sulfate adult dosage, respectively, on a mg/m2 basis; 630-680 times the maximum daily adult inhalation aerosol dosage; or 250 times the maximum albuterol inhalation solution dosage via nebulization for a 50-kg human). In a reproduction study in rats given albuterol sulfate aerosol containing a hydrofluoroalkane propellant by oral inhalation, the drug did not exhibit any teratogenic effects at 10.5

mg/kg daily (approximately 60-65 times the maximum recommended human daily inhalation dosage on a mg/m2 basis). Safe use of the drug in pregnant women has not been established. A reproduction study in rabbits given oral levalbuterol dosages of up to 25 mg/kg (approximately 110 times the maximum recommended daily adult oral inhalation dosage on a mg/m2 basis) revealed no evidence of teratogenicity.

It is not known whether albuterol, albuterol sulfate, or levalbuterol is distributed into milk. Because of the potential for tumorigenicity shown for albuterol in animal studies, a decision should be made whether to discontinue nursing or albuterol or levalbuterol, taking into account the importance of the drug to the woman.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Levalbuterol	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Plasma levels very low in humans; mfr recommends caution

No enhanced Geriatric Use information available for this drug.

Precaution Exists
Geriatric management or monitoring precaution exists.

Drug Name	Narrative	REN	HEP	CARDIO	NEURO	PULM	ENDO
Levalbuterol	Cardiovascular-Use caution in severe cardiovascular diseases, particularly coronary insufficiency, since beta-agonists increase heart rate and blood pressure. Endocrine-Use caution in poorly controlled hyperthyroidism or diabetes.	N	N	Y	N	N	Y