A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Xopenex Indications, Dosage, Storage, Stability - Levalbuterol
Xopenex Indications, Dosage, Storage, Stability - Levalbuterol
INDICATIONS
Xopenex (levalbuterol HCl) Inhalation Solution is indicated for
the treatment or prevention
of bronchospasm
in adults and adolescents 12 years of age
and older with reversible
obstructive airway disease.
DOSAGE AND ADMINISTRATION
The usual starting dosage
of Xopenex (levalbuterol HCl) Inhalation Solution for patients 12
years of age and older is
0.63 mg administered three
times a day, every 6 to 8 hours, by nebulization.
Patients 12 years of age
and older with more severe asthma
or patients who do not respond adequately to a dose
of 0.63 mg of Xopenex Inhalation
Solution may benefit
from a dosage of 1.25
mg three times a day. Patients
receiving the higher dose
of Xopenex Inhalation Solution should be monitored closely for adverse
systemic effects, and
the risks of such effects
should be balanced against the potential
for improved efficacy.
The use of Xopenex Inhalation Solution can be continued as medically
indicated to control
recurring bouts of bronchospasm. During this time, most patients
gain optimal benefit
from regular use of
the inhalation solution.
If a previously effective dosage
regimen fails to provide
the expected relief, medical
advice should be sought immediately, since this is often a sign
of seriously worsening asthma
that would require reassessment of therapy.
The drug compatibility
(physical and chemical), efficacy,
and safety of Xopenex Inhalation Solution when mixed
with other drugs in a nebulizer have not been established.
The safety and efficacy
of Xopenex Inhalation Solution have been established in clinical
trials when administered using the PARI LC Jet™ and the PARI LC
Plus™ nebulizers, and the PARI Master® and Dura-Neb®
2000 compressors. The safety and efficacy
of Xopenex Inhalation Solution when administered using other nebulizer
systems have not been established.
HOW SUPPLIED
Xopenex (levalbuterol HCl) Inhalation Solution is supplied in 3
mL unit-dose, low-density polyethylene
(LDPE) vials as a clear, colorless, sterile,
preservative-free, aqueous solution
in two different strengths of levalbuterol (0.63 mg, 1.25 mg). Each
strength of Xopenex
Inhalation Solution is available in a shelf-carton containing multiple
foil pouches (2 or 8),
each containing 12 unit-dose LDPE vials.
Xopenex (levalbuterol HCl) Inhalation Solution, 0.63 mg
(foil pouch label color
yellow) contains 0.63 mg
of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available
in cartons of 24 unit-dose LDPE vials (NDC 63402-512-24).
Xopenex (levalbuterol HCl) Inhalation Solution, 1.25 mg
(foil pouch label color
red) contains 1.25 mg of
levalbuterol (as 1.44 mg
of levalbuterol HCl) and is available in cartons of 96 unit-dose
LDPE vials (NDC 63402-513-96).
CAUTION: Federal law
(U.S.) prohibits dispensing without prescription.
Store the Xopenex (levalbuterol HCl) Inhalation Solution in the
protective foil pouch
between 15°C and 25°C (59°F and 77°F). 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 two weeks. Discard the
vial if the solution
is not colorless.
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