LEVALBUTEROL- levalbuterol hydrochloride solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

LEVALBUTEROL HYDROCHLORIDE (UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)

Disponibil de la:

Ritedose Pharmaceuticals, LLC

INN (nume internaţional):

LEVALBUTEROL HYDROCHLORIDE

Compoziție:

LEVALBUTEROL 0.31 mg in 3 mL

Calea de administrare:

RESPIRATORY (INHALATION)

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol Inhalation Solution, USP is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see Warnings and Precautions (5.6) ]. Risk Summary There are no adequate and well-controlled studies of Levalbuterol Inhalation Solution, USP in pregnant women. There are clinical considerations with the use of Levalbuterol Inhalation Solution, USP in pregnant women [see Clinical Considerations] . Following oral administration of levalbuterol HCl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (MRHDID) of levalbuterol HCl for adults on a mg/m 2 basis]; however, racemic albuterol sulfate was teratogenic in mice (cleft palate) and rabbits (cramioschisis) 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 Levalbuterol Inhalation Solution, USP for the treatment of bronchospasm during labor should be restricted to those patients for whom the benefits clearly outweigh the risk. Levalbuterol Inhalation Solution, USP has not been approved for the management of preterm labor. The benefit-risk ratio when Levalbuterol Inhalation Solution, USP 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 beta 2 -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 108 times the MRHDID of levalbuterol HCl for adults on a mg/m 2 basis). In a rat developmental study, racemic albuterol sulfate administered by inhalation did not produce any teratogenic effects at exposures approximately 63 times the MRHDID (on a mg/m 2 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 developmental study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 215 times the MRHDID for adults (on a mg/m 2 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 0.3 times the MRHDID for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg/day) and in 10 of 108 (9.3%) fetuses at approximately 3 times the MRHDID (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg/day). Similar effects were not observed at approximately 0.03 times the MRHDID for adults on a mg/m 2 basis at a maternal dose of 0.025 mg/kg/day (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). Non-Teratogenic Effects: A study in which pregnant rats were dosed with radiolabeled racemic albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. 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 Levalbuterol Inhalation Solution, USP and any potential adverse effects on the breastfed child from Levalbuterol Inhalation Solution, USP or from the underlying maternal condition. Pediatric Patients 6 Years of Age and Older The safety and efficacy of Levalbuterol Inhalation Solution, USP have been established in pediatric patients 6 years of age and older in an adequate and well-controlled clinical trial [see Adverse Reactions (6) and Clinical Studies (14) ]. Pediatric Patients less than 6 Years of Age Levalbuterol Inhalation Solution, USP is not indicated for pediatric patients less than 6 years of age. Clinical trials with Levalbuterol Inhalation Solution, USP in this age group failed to meet the primary efficacy endpoint and demonstrated an increased number of asthma related adverse reactions following chronic Levalbuterol Inhalation Solution, USP treatment. Levalbuterol Inhalation Solution, USP was studied in 379 pediatric patients less than 6 years of age with asthma or reactive airway disease - (291 patients 2 to 5 years of age, and 88 patients from birth to less than 2 years of age). Efficacy and safety data for Levalbuterol Inhalation Solution, USP in this age group are primarily available from one 3-week, multicenter, randomized, double-blind, active and placebo-controlled study (Study 1) in 211 pediatric patients between the ages of 2 and 5 years, of whom 119 received Levalbuterol Inhalation Solution, USP. Over the 3 week treatment period, there were no significant treatment differences in the Pediatric Asthma Questionnaire (PAQ) total score between groups receiving Levalbuterol Inhalation Solution, USP 0.31 mg, Levalbuterol Inhalation Solution, USP 0.63 mg, racemic albuterol, and placebo. Additional safety data following chronic dosing is available from a 4-week, multicenter, randomized, modified-blind, placebo-controlled study (Study 2) of 196 patients between the ages of birth and 3 years, of whom 63 received open-label Levalbuterol Inhalation Solution, USP. In these two studies, treatment-emergent asthma exacerbations or asthma-related adverse reactions and treatment discontinuations due to asthma occurred at a higher frequency in Levalbuterol Inhalation-treated subjects compared to control (Table 5). Other adverse reactions were consistent with those observed in the clinical trial population of patients 6 years of age and older [see Adverse Reactions (6.1) ]. * Asthma exacerbation defined as worsening of asthma symptoms or pulmonary function that required any of the following: emergency department visit, hospitalization, therapeutic intervention with oral or parenteral steroids, unscheduled clinic visit to treat acute asthma symptoms ** Includes the following Preferred Terms (whether considered by the investigator to be related or unrelated to drug): asthma, cough, hypoxia, status asthmaticus, tachypnea. Clinical studies of Levalbuterol Inhalation Solution, USP did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Only 5 patients 65 years of age and older were treated with Levalbuterol Inhalation Solution, USP in a 4-week clinical study [see Clinical Pharmacology (12) and Clinical Studies (14) ] (n = 2 for 0.63 mg and n = 3 for 1.25 mg). In these patients, bronchodilation was observed after the first dose on day 1 and after 4 weeks of treatment. In general, patients 65 years of age and older should be started at a dose of 0.63 mg of Levalbuterol Inhalation Solution, USP. If clinically warranted due to insufficient bronchodilator response, the dose of Levalbuterol Inhalation Solution, USP may be increased in elderly patients as tolerated, in conjunction with frequent clinical and laboratory monitoring, to the maximum recommended daily dose [see Dosage and Administration (2) ]. 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.

Rezumat produs:

Levalbuterol Inhalation Solution, USP is supplied in 3 mL unit-dose, low-density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of levalbuterol (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each pouch containing one or more unit-dose LDPE vials. Levalbuterol Inhalation Solution, USP, 0.31 mg/3 mL ( foil pouch label color green ) contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below. NDC 76204-700-01 30 vials per carton / 1 vial per foil pouch NDC 76204-700-55 25 vials per carton / 5 vials per foil pouch NDC 76204-700-25 25 vials per carton / 25 vials per foil pouch Levalbuterol Inhalation Solution, USP, 0.63 mg/3 mL ( foil pouch label color yellow ) contains 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below. NDC 76204-800-01 30 vials per carton / 1 vial per foil pouch NDC 76204-800-55 25 vials per carton / 5 vials per foil pouch NDC 76204-800-25 25 vials per carton / 25 vials per foil pouch Levalbuterol Inhalation Solution, USP, 1.25 mg/3 mL ( foil pouch label color red ) contains 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below. NDC 76204-900-01 30 vials per carton / 1 vial per foil pouch NDC 76204-900-55 25 vials per carton / 5 vials per foil pouch NDC 76204-900-25 25 vials per carton / 25 vials per foil pouch Store Levalbuterol Inhalation Solution, USP in the protective foil pouch at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Rx only

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LEVALBUTEROL- LEVALBUTEROL HYDROCHLORIDE SOLUTION
RITEDOSE PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
LEVALBUTEROL INHALATION SOLUTION, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL
INHALATION SOLUTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LEVALBUTEROL INHALATION SOLUTION, USP.
LEVALBUTEROL INHALATION SOLUTION, USP, FOR INHALATION USE
INITIAL U.S. APPROVAL: 1999
RX ONLY
INDICATIONS AND USAGE
Levalbuterol Inhalation Solution, USP is a beta
-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in adults, adolescents, and
children 6 years of age and older
with reversible obstructive airway disease. ( 1)
DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY ( 2)
_Children 6-11 years old: _0.31 mg administered three times a day, by
nebulization. Routine dosing
should not exceed 0.63 mg three times a day. ( 2)
_Adults and Adolescents _≥ _12 years old: _0.63 mg administered
three times a day, every 6 to 8 hours, by
nebulization. The maximum recommended dose is 1.25 mg three times a
day. ( 2)
For use with a standard jet nebulizer (with a face mask or mouthpiece)
connected to an air compressor.
( 2)
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit-dose vial for nebulization): 0.31 mg/3 mL,
0.63 mg/3 mL and 1.25 mg/3 mL. ( 3)
CONTRAINDICATIONS
Hypersensitivity to levalbuterol or racemic albuterol. ( 4)
WARNINGS AND PRECAUTIONS
Life-threatening paradoxical bronchospasm may occur. Discontinue
Levalbuterol Inhalation Solution,
USP immediately and treat with alternative therapy. ( 5.1)
Need for more doses of Levalbuterol Inhalation Solution, USP than
usual may be a sign of deterioration
of asthma and requires reevaluation of treatment. ( 5.2)
Levalbuterol Inhalation Solution, USP is not a substitute for
corticosteroids. ( 5.3)
Cardiovascular effects may occur. Consider discontinuation of
Levalbuterol Inhalation Solution, USP if
these effects occur. Use with caution in patients with underlying
cardiovascular disor