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For Bronchospasm, Uses, Warning, Dosage, Side Effects & Interactions


PRECAUTIONS

General

Albuterol sulfate, as with all sympathomimetic amines,
should be used with caution in patients with cardiovascular disorders,
especially coronary insufficiency, cardiac arrhythmias, and hypertension; in
patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and
in patients who are unusually responsive to sympathomimetic amines. Clinically
significant changes in systolic and diastolic blood pressure have been seen in
individual patients and could be expected to occur in some patients after use
of any beta-adrenergic bronchodilator.

Large doses of intravenous albuterol have been reported
to aggravate preexisting diabetes mellitus and ketoacidosis. As with other
beta-agonists, albuterol may produce significant hypokalemia in some patients,
possibly through intracellular shunting, which has the potential to produce
adverse cardiovascular effects. The decrease is usually transient, not
requiring supplementation.

Information for Patients

See illustrated Patient’s Instructions for Use. SHAKE
WELL BEFORE USING. Patients should be given the following information: It is
recommended to prime the inhaler before using for the first time and in cases
where the inhaler has not been used for more than 2 weeks by releasing four
“test sprays” into the air, away from the face.

KEEPING THE PLASTIC MOUTHPIECE CLEAN IS VERY IMPORTANT TO
PREVENT MEDICATION BUILDUP AND BLOCKAGE. THE MOUTHPIECE SHOULD BE WASHED,
SHAKEN TO REMOVE EXCESS WATER, AND AIR DRIED THOROUGHLY AT LEAST ONCE A WEEK.
INHALER MAY CEASE TO DELIVER MEDICATION IF NOT PROPERLY CLEANED.

The mouthpiece should be cleaned (with the canister
removed) by running warm water through the top and bottom for 30 seconds at
least once a week. The mouthpiece must be shaken to remove excess water, then
air dried thoroughly (such as overnight). Blockage from medication buildup or
improper medication delivery may result from failure to thoroughly air dry the
mouthpiece.

If the mouthpiece should become blocked (little or no
medication coming out of the mouthpiece), the blockage may be removed by
washing as described above.

If it is necessary to use the inhaler before it is
completely dry, shake off excess water, replace canister, test spray twice away
from face, and take the prescribed dose. After such use, the mouthpiece should
be rewashed and allowed to air dry thoroughly.

The action of PROVENTIL® HFA Inhalation Aerosol should
last up to 4 to 6 hours. PROVENTIL HFA Inhalation Aerosol should not be used
more frequently than recommended. Do not increase the dose or frequency of
doses of PROVENTIL HFA Inhalation Aerosol without consulting your physician. If
you find that treatment with PROVENTIL HFA Inhalation Aerosol becomes less
effective for symptomatic relief, your symptoms become worse, and/or you need
to use the product more frequently than usual, medical attention should be
sought immediately. While you are taking PROVENTIL HFA Inhalation Aerosol,
other inhaled drugs and asthma medications should be taken only as directed by
your physician.

Common adverse effects of treatment with inhaled
albuterol include palpitations, chest pain, rapid heart rate, tremor, or
nervousness. If you are pregnant or nursing, contact your physician about use
of PROVENTIL HFA Inhalation Aerosol. Effective and safe use of PROVENTIL HFA
Inhalation Aerosol includes an understanding of the way that it should be
administered. Use PROVENTIL HFA Inhalation Aerosol only with the actuator supplied
with the product. Discard the canister after 200 sprays have been used.

In general, the technique for administering PROVENTIL
HFA Inhalation Aerosol to children is similar to that for adults. Children
should use PROVENTIL HFA Inhalation Aerosol under adult supervision, as
instructed by the patient’s physician. (See Patient’s Instructions for Use.)

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

In a 2-year study in SPRAGUE-DAWLEY® rats, albuterol
sulfate caused a dose-related increase in the incidence of benign leiomyomas of
the mesovarium at the above dietary doses of 2 mg/kg (approximately 15 times
the maximum recommended daily inhalation dose for adults on a mg/m² basis and
approximately 6 times the maximum recommended daily inhalation dose for
children on a mg/m² basis). In another study this effect was blocked by the
coadministration of propranolol, a nonselective betaadrenergic antagonist. In
an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of
tumorigenicity at dietary doses of up to 500 mg/kg (approximately 1700 times
the maximum recommended daily inhalation dose for adults on a mg/m² basis and
approximately 800 times the maximum recommended daily inhalation dose for children
on a mg/m² basis). In a 22-month study in Golden Hamsters, albuterol sulfate showed
no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately
225 times the maximum recommended daily inhalation dose for adults on a mg/m² basis
and approximately 110 times the maximum recommended daily inhalation dose for children
on a mg/m² basis).

Albuterol sulfate was not mutagenic in the Ames test or a
mutation test in yeast. Albuterol sulfate was not clastogenic in a human
peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay.

Reproduction studies in rats demonstrated no evidence of
impaired fertility at oral doses up to 50 mg/kg (approximately 340 times the
maximum recommended daily inhalation dose for adults on a mg/m² basis).

Pregnancy

Teratogenic Effects

Pregnancy Category C

Albuterol sulfate has been shown to be teratogenic in
mice. A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft
palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the
maximum recommended daily inhalation dose for adults on a mg/m² basis) and in
10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately 8 times the maximum
recommended daily inhalation dose for adults on a mg/m² basis). The drug did
not induce cleft palate formation at a dose of 0.025 mg/kg (less than the maximum
recommended daily inhalation dose for adults on a mg/m² basis). Cleft palate also
occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with
2.5 mg/kg of isoproterenol (positive control).

A reproduction study in Stride Dutch rabbits revealed
cranioschisis in 7 of 19 (37%) fetuses when albuterol sulfate was administered
orally at 50 mg/kg dose (approximately 680 times the maximum recommended daily
inhalation dose for adults on a mg/m² basis).

In an inhalation reproduction study in SPRAGUE-DAWLEY
rats, the albuterol sulfate/HFA-134a formulation did not exhibit any
teratogenic effects at 10.5 mg/kg (approximately 70 times the maximum
recommended daily inhalation dose for adults on a mg/m² basis).

A study in which pregnant rats were dosed with radiolabeled
albuterol sulfate demonstrated that drug-related material is transferred from
the maternal circulation to the fetus.

There are no adequate and well-controlled studies of
PROVENTIL HFA Inhalation Aerosol or albuterol sulfate in pregnant women.
PROVENTIL HFA Inhalation Aerosol should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.

During worldwide marketing experience, various congenital
anomalies, including cleft palate and limb defects, have been reported in the
offspring of patients being treated with albuterol. Some of the mothers were
taking multiple medications during their pregnancies. Because no consistent
pattern of defects can be discerned, a relationship between albuterol use and
congenital anomalies has not been established.

Use In Labor And Delivery

Because of the potential for beta-agonist interference
with uterine contractility, use of PROVENTIL HFA Inhalation Aerosol for relief
of bronchospasm during labor should be restricted to those patients in whom the
benefits clearly outweigh the risk.

Tocolysis

Albuterol has not been approved for the management of
preterm labor. The benefit: risk ratio when albuterol is administered for
tocolysis has not been established. Serious adverse reactions, including
pulmonary edema, have been reported during or following treatment of premature
labor with beta2-agonists, including albuterol.

Nursing Mothers

Plasma levels of albuterol sulfate and HFA-134a after
inhaled therapeutic doses are very low in humans, but it is not known whether
the components of PROVENTIL HFA Inhalation Aerosol are excreted in human milk.

Because of the potential for tumorigenicity shown for
albuterol in animal studies and lack of experience with the use of PROVENTIL
HFA Inhalation Aerosol by nursing mothers, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother. Caution should be exercised when
albuterol sulfate is administered to a nursing woman.

Pediatrics

The safety and effectiveness of PROVENTIL HFA Inhalation
Aerosol in pediatric patients below the age of 4 years have not been
established.

Geriatrics

PROVENTIL HFA Inhalation Aerosol has not been studied in
a geriatric population. As with other beta2-agonists, special caution should be
observed when using PROVENTIL HFA Inhalation Aerosol in elderly patients who
have concomitant cardiovascular disease that could be adversely affected by
this class of drug.

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