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
Nasalcrom Warnings, Precautions, Pregnancy, Nursing, Abuse - Cromolyn Sodium
Nasalcrom Warnings, Precautions, Pregnancy, Nursing, Abuse - Cromolyn Sodium
WARNINGS
Gelatin Capsules: The recommended dosage
should be decreased in patients with decreased renal
or hepatic function.
Severe anaphylactic reactions may occur rarely in association
with cromolyn sodium
administration.
Capsules for Inhalation and Inhalation Solution: Cromolyn
sodium has no role
in the treatment of
status asthmaticus.
Inhalation Aerosol: Cromolyn sodium
inhaler has no
role in the treatment
of an acute attack
of asthma, especially
status asthmaticus. Severe
anaphylactic reactions can occur after cromolyn sodium
administration. The recommended dosage
should be decreased in patients with decreased renal or hepatic
function. Cromolyn sodium
inhaler should be discontinued
if the patient develops
eosinophilic pneumonia
(or pulmonary infiltrates
with eosinophilia). Because of the propellants in this preparation,
it should be used with caution in patients with coronary
artery disease
or a history of cardiac
arrhythmias.
PRECAUTIONS
General
Gelatin Capsules: In
view of the biliary
and renal routes of excretion
of cromolyn sodium, consideration
should be given to decreasing the dosage
of the drug in patients
with impaired renal or
hepatic function.
Inhalation Aerosol and Nasal Solution: In
view of the biliary and renal
routes of excretion
for cromolyn sodium,
consideration should be given to decreasing the dosage
or discontinuing the administration
of the drug in patients
with impaired renal or
hepatic function.
Capsules for Inhalation, Inhalation Aerosol, and Inhalation
Solution: Occasionally, patients may experience
cough and/or bronchospasm
following cromolyn sodium
inhalation. At times, patients
who develop bronchospasm may not be able to continue cromolyn sodium
administration
despite prior bronchodilator administration. Rarely, very severe
bronchospasm has
been encountered.
Capsules for Inhalation and Inhalation Solution: Symptoms
of asthma may recur if cromolyn sodium
is reduced below the recommended dosage or discontinued.
Nasal Solution: Some patients may experience
transient nasal stinging
and/or sneezing immediately following instillation
of cromolyn sodium nasal
solution. Except in rare occurrences, these experiences have not
caused discontinuation of therapy.
Information for the Patient
Capsules for Inhalation and Inhalation Solution: Cromolyn
sodium is to be taken as directed by the physician. Because it is
preventive medication,
it may take up to four
weeks before the patient
experiences maximum
benefit.
Capsules for Inhalation: Patients may experience
irritation of the
throat or coughing after
inhalation of the
powder. In some cases, rinsing
the mouth or taking a
drink of water immediately
before and/or after using the Spinhaler will
eliminate the throat
irritation or cough.
If the patient experiences
difficulty in emptying the capsule,
which may require several deep
inhalations, check to
make certain the patient is following the directions carefully.
A light dusting of powder
remaining in the capsule
is normal, and is not
an indication that
the Spinhaler or capsule is faulty or that the proper dose
was not delivered. The Spinhaler should be washed in clean, warm
water at least once a
week, and dried thoroughly before use.
Inhalation Solution: Cromolyn sodium
inhalation solution
should be used in a power-driven nebulizer
with an adequate airflow rate
equipped with a suitable face
mask or mouthpiece.
For additional information, see the accompanying leaflet entitled
"Living a Full Life with Asthma."
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long term studies in mice
(12 months intraperitoneal
treatment followed
by 6 months observation), hamsters (12 months intraperitoneal
treatment followed by 12 months observation), and rats (18 months
subcutaneous treatment)
showed no neoplastic effect
of cromolyn sodium.
No evidence of chromosomal
damage or cytotoxicity was obtained in various mutagenesis studies.
No evidence of impaired
fertility was shown
in laboratory animal
reproduction studies.
Pregnancy
Pregnancy Category B
Reproduction studies with cromolyn sodium
administered parenterally to pregnant
mice, rats, and rabbits in doses up to 338 times the human clinical
dose produced no
evidence of fetal
malformations. Adverse fetal effects (increased resorptions and
decreased fetal weight)
were noted only at the very high parenteral
doses that produced maternal
toxicity. There are, however, no
adequate and well controlled studies in pregnant
women. Because animal
reproduction studies
are not always predictive of human response, this drug
should be used during pregnancy
only if clearly needed.
Nursing Mothers
Gelatin Capsules, Capsules for Inhalation, Inhalation Solution,
and Nasal Solution: It is not known whether this drug
is excreted in human milk. Because many drugs are excreted in human
milk, caution should be exercised when cromolyn sodium
is administered to a nursing
woman.
Inhalation Aerosol: It is not known whether this drug
is excreted in human milk,
therefore, caution should be exercised when cromolyn sodium inhaler
is administered to a nursing
woman and the attending
physician must make a benefit/risk assessment
in regard to its use in this situation.
Pediatric Use
Gelatin Capsules: Animal studies suggest increased risk
of toxicity in premature
animals when given doses much higher than clinically recommended.
In term infants up to six
months of age, available clinical
data suggest that the dose
should not exceed 20 mg/kg/day. The use of this product
in children less than two years should be reserved for patients
with severe disease in which the potential
benefits clearly outweigh the risks.
Capsules for Inhalation: Safety and effectiveness
in children below the age
of 2 years have not been established. For young children unable
to utilize the Spinhaler, cromolyn sodium
inhalation solution
is recommended.
Inhalation Aerosol: Safety and effectiveness
in children below the age
of 5 years have not been established. For young children unable
to utilize the inhaler, cromolyn sodium
inhalation solution
is recommended. Because of the possibility that adverse effects
of this drug could become
apparent only after many years, a benefit/risk consideration of
the long-term use of cromolyn sodium
inhaler is particularly
important in pediatric
patients.
Inhalation Solution: Safety and effectiveness
in children below the age
of 2 years have not been established.
Nasal Solution: Safety and effectiveness
in children below the age of 6 years have not been established.
top
