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 Indications, Dosage, Storage, Stability - Cromolyn Sodium
Nasalcrom Indications, Dosage, Storage, Stability - Cromolyn Sodium
INDICATIONS
Gelatin Capsules
Gelatin capsules are indicated in the management of patients with
mastocytosis. Use of this product
has been associated with improvement in diarrhea,
flushing, headaches, vomiting,
urticaria, abdominal pain,
nausea, and itching in
some patients.
Capsules for Inhalation, Inhalation Aerosol, and Inhalation
Solution
Cromolyn sodium is a
prophylactic agent
indicated in the management of patients with bronchial
asthma.
In patients whose symptoms are sufficiently frequent to require
a continuous program of medication,
cromolyn sodium is given
by inhalation on
a regular daily basis
(see DOSAGE AND ADMINISTRATION
.) The effect
of cromolyn sodium is
usually evident after several weeks of treatment, although some
patients show an almost
immediate response.
Capsules for Inhalation and Inhalation Solution
In patients who develop
acute bronchoconstriction
in response to exposure
to exercise, toluene diisocyanate, environmental pollutants, etc.,
cromolyn sodium should
be given shortly before exposure
to the precipitating factor
(see DOSAGE AND ADMINISTRATION
.)
Inhalation Aerosol
If improvement occurs, it will
ordinarily occur within the first 4 weeks of administration
as manifested by a decrease in the severity of clinical
symptoms of asthma, or
in the need for concomitant
therapy, or both.
In patients who develop acute
bronchoconstriction
in response to exposure
to exercise, toluene
diisocyanate, environmental pollutants, known antigens, etc., cromolyn
sodium inhaler
should be used shortly before exposure
to the precipitating factor, i.e., within 10-15 minutes but not
more than 60 minutes (see DOSAGE AND ADMINISTRATION
.)
cromolyn sodium inhaler
may be effective in relieving bronchospasm
in some, but not all, patients with exercise
induced bronchospasm.
Nasal Solution
Cromolyn sodium nasal
solution is indicated
for the prevention
and treatment of the
symptoms of allergic
rhinitis.
DOSAGE AND ADMINISTRATION
Gelatin Capsules
NOT FOR INHALATION. SEE DIRECTIONS FOR USE.
The usual starting dose
is as follows:
Adults: Two capsules four times daily one-half hour before
meals and at bedtime.
Premature to Term Infants: Not recommended.
Term to 2 years: 20 mg/kg/day in four divided doses. Use
of this product in children less than 2 years is not recommended
and should be attempted only in those patients with severe incapacitating
diseases where the benefits clearly outweigh the risks.
Children 2-12 years: One capsule
four times daily one-half hour before meals and bedtime.
If satisfactory control
of symptoms is not achieved within two to three weeks the dosage
may be increased but should not exceed 40 mg/kg/day (30 mg/kg/day
for children six months to two years).
Patients should be advised that the effect
of oral cromolyn sodium
capsule therapy is dependent upon its administration
at regular intervals,
as directed.
Maintenance Dose: Once a therapeutic
response has been achieved
the dose may be reduced
to the minimum required
to maintain the patient with a lower degree
of symptomatology. To prevent relapses, the dosage should be maintained.
Administration: Oral cromolyn sodium capsules should be
administered as a solution
in water at least 1/2
hour before meals after preparation
according to the following directions:
Open capsule(s) and pour powder
contents of capsule(s) into 1/2 glass of hot
water.
Stir until completely dissolved (clear solution).
Add equal quantity
of cold water
while stirring.
DO NOT MIX WITH FRUIT JUICE, MILK OR
FOODS.
Drink all of the liquid.
Capsules for Inhalation
For management of bronchial
asthma in adults and
children (two years of age
and over) who are able to use the Spinhaler turbo-inhaler, the usual
starting dosage is the
contents of one cromolyn sodium
Capsule inhaled four times daily at regular
intervals.
Inhalation Aerosol
For management of bronchial
asthma in adults and
young children (5 years of age
and over) who are able to use the inhaler, the usual starting dosage
is two metered inhalations four times daily at regular
intervals. This dose should not be exceeded. Not all patients will
respond to the recommended dose and there is evidence
to suggest, at least in younger patients, that a lower dose
may provide efficacy.
Inhalation Solution
For management of bronchial
asthma in adults and
children (two years of age
and over), the usual starting dosage
is the contents of one ampule administered by nebulization
four times a day at regular
intervals.
Capsules for Inhalation, Inhalation Aerosol, and Inhalation
Solution
Patients with chronic
asthma should be advised
that the effect of cromolyn
sodium therapy is dependent
upon its administration
at regular intervals,
as directed. Cromolyn sodium
should be introduced into the patient's therapeutic regimen when
the acute episode
has been controlled, the airway
has been cleared, and the patient
is able to inhale adequately.
Capsules for Inhalation
For the prevention
of acute bronchospasm
which follows exercise
or exposure to cold dry
air, environmental agents (e.g., animal
danders, toluene diisocyanate, pollutants), etc., the usual dose
is the contents of one cromolyn sodium
Capsule inhaled shortly before exposure
to the precipitating factor.
It should be emphasized to the patient
that the drug is poorly
absorbed when swallowed and is not effective by this route of administration.
Inhalation Aerosol
For the prevention
of acute bronchospasm
which follows exercise, exposure to cold
dry air or environmental
agents, the usual dose
is two metered inhalations shortly, i.e., 10-15 minutes but not
more than 60 minutes, before exposure
to the precipitating factor.
Inhalation Solution
For the prevention
of acute bronchospasm
which follows exercise
or exposure to cold dry
air, environmental agents (e.g., animal
danders, toluene diisocyanate, pollutants), etc., the usual dose
is the contents of one ampule administered by nebulization
shortly before exposure
to the precipitating factor.
It should be emphasized to the patient
that the drug is poorly
absorbed when swallowed and is not effective by this route of administration.
Capsules for Inhalation, Inhalation Aerosol, and Inhalation
Solution
Cromolyn Sodium Therapy in Relation to Other Treatments for
Asthma: Non-steroidal agents: Cromolyn sodium
should be added to the patient's existing treatment
regimen (e.g.,
bronchodilators). When a clinical
response to cromolyn
sodium is evident, usually
within two to four weeks, and if the asthma
is under good control,
an attempt may be made to decrease concomitant
medication usage
gradually.
Capsules for Inhalation
If concomitant
medications are eliminated or required on no
more than a p.r.n. basis,
the frequency of administration
of cromolyn sodium may
be titrated downward to the lowest level consistent with the desired
effect. The usual decrease is from four capsules to three to two
capsules per day. It is
important that the dosage
be reduced gradually to avoid exacerbation of asthma. It is emphasized
that in patients whose dosage
has been titrated to fewer than four capsules per
day, an increase in the dosage
of cromolyn sodium and the introduction of, or increase in, symptomatic
medications may be needed if the patient's clinical
condition deteriorates.
Inhalation Aerosol
If concomitant
medications are eliminated or required on no
more than a prn basis, the frequency
of administration
of cromolyn sodium inhaler
may be titrated downward to the lowest level consistent with the
desired effect. The usual decrease is from two metered inhalations
four times daily to three times daily to twice daily. It is important
that the dosage be reduced
gradually to avoid exacerbation
of asthma. It is emphasized that in patients whose dosage
has been titrated to fewer than four inhalations per day, an increase
in the dosage of cromolyn
sodium inhaler
and the introduction of, or increase in, symptomatic
medications may be needed if the patient's clinical condition
deteriorates.
Inhalation Solution
If concomitant
medications are eliminated or required on no
more than a prn basis, the frequency
of administration
of cromolyn sodium may
be titrated downward to the lowest level consistent with the desired
effect. The usual decrease is from four to three ampules per
day. It is important that the dosage
be reduced gradually to avoid exacerbation
of asthma. It is emphasized that in patients whose dosage
has been titrated to fewer than four ampules per
day, an increase in the dose
of cromolyn sodium and
the introduction of, or increase in, symptomatic
medications may be needed if the patient's clinical
condition deteriorates.
Capsules for Inhalation, Inhalation Aerosol, and Inhalation
Solution
Corticosteroids: In
patients chronically receiving corticosteroids for the management
of bronchial asthma,
the dosage should be
maintained following the introduction of cromolyn sodium. If the
patient improves, an
attempt to decrease corticosteroids should be made. Even if the
corticosteroid-dependent patient fails to show
symptomatic improvement
following cromolyn sodium administration, the potential
to reduce corticosteroids
may nonetheless be present. Thus, gradual tapering of corticosteroid
dosage may be attempted.
It is important that the dose
be reduced slowly, maintaining close supervision of the patient
to avoid an exacerbation
of asthma.
It should be borne in mind
that prolonged corticosteroid
therapy frequently causes
an impairment in
the activity of the
hypothalamic- pituitary-adrenal axis and a reduction
in the size of the adrenal
cortex. A potentially critical degree of impairment
or insufficiency
may persist asymptomatically for some time
even after gradual discontinuation of adrenocortical
steroids. Therefore, if a patient
is subjected to significant
stress, such as a severe
asthmatic attack, surgery,
trauma or severe illness
while being treated or within one year (occasionally up to two years)
after corticosteroid treatment has been terminated, consideration
should be given to reinstituting corticosteroid therapy. When respiratory
function is impaired,
as may occur in severe exacerbation
of asthma, a temporary
increase in the amount of corticosteroids may be required to regain
control of the patient's
asthma.
It is particularly important that great care be exercised if, for
any reason, cromolyn sodium
is withdrawn in cases where its use has permitted a reduction
in the maintenance dose
of corticosteroids. In such
cases, continued close supervision of the patient
is essential since
there may be sudden reappearance of severe manifestations of asthma
which will require immediate
therapy and possible
reintroduction of corticosteroids.
Nasal Solution
The dose for adults and
children 6 years and older is one spray
in each nostril 3-4 times daily at regular
intervals. If needed, this dose may be increased to one spray
to each nostril 6 times
daily. The patient should be instructed to clear the nasal
passages before administering the spray and should inhale
through the nose during
administration.
In the management of seasonal (pollenotic) rhinitis,
and for prevention of rhinitis
caused by exposure
to other types of specific
inhalant allergens,
treatment with cromolyn sodium
nasal solution
will be more effective
if started prior to expected contact
with the offending allergen. Treatment should be continued throughout
the period of exposure
i.e., until the pollen season is over or until exposure
to the offending allergen
is terminated.
In the management of perennial allergic
rhinitis, the effects
of treatment with cromolyn sodium
nasal solution
may become apparent
only after two to four weeks of treatment. The concomitant
use of antihistamines and/or nasal decongestants may be necessary
during the initial phase
of treatment, but the need
for this type of medication
should diminish and may be eliminated when the full benefit
of cromolyn sodium nasal
solution is achieved.
HOW SUPPLIED
Gelatin Capsules
Each capsules contains 100 mg
of cromolyn sodium and
is supplied in aluminum cans containing 100 capsules.
Each capsule contains
a precisely measured dose. The capsules are intentionally oversized
to prevent the powder
from spilling when the capsule
is opened.
Keep tightly closed and out of the reach of children.
Store between 15°-30°C (59°-86°F).
Capsules for Inhalation
Capsules for inhalation, each containing 20 mg
of cromolyn sodium, are
available in foil strip
packs of 120 capsules. Each yellow
and clear capsule is imprinted with the product
identification
code: Fisons 670
Store capsules between 15°-30°C (59°- 86°F). Keep
out of the reach of children. Spinhaler turbo- inhalers are supplied
separately in individual containers. The Spinhaler should be replaced
after 6 months of use.
Inhalation Aerosol
Intal Inhaler, 8.1 g or 14.2 g canister, box of one. Supplied with
mouthpiece and patient
instructions.
Store between 15°-30°C (59°-86°F). Contents under
pressure. Do not puncture, incinerate, or place near sources of
heat. Keep out of the reach of children.
Note: The indented statement below is required by the Federal government's
Clean Air Act for all products containing or manufactured with chlorofluorocarbons
(CFC's).
Warning: Contains CFC-12 and CFC-114, substances which harm
public health and environment
by destroying ozone in
the upper atmosphere.
A notice similar to the above WARNING has been placed in the "Patient
Instructions for Use" portion of this package circular
pursuant to EPA regulations.
Inhalation Solution
Intal inhalation
solution is a colorless
solution supplied in
a low density polyethylene
plastic unit
dose ampule
with 12 ampules per foil
pouch. Each 2 ml ampule
contains 20 mg cromolyn sodium,
USP, in purified water.
Intal inhalation
solution should be
stored between 15°- 30°C (59°-86°F) and protected
from light. Do not use if it contains a precipitate
or becomes discolored. Keep out of the reach of children.
Store ampules in foil
pouch until ready for
use.
Nasal Solution
Nasalcrom is available in bottles of 13 ml
and 26 ml. Each fully assembled unit consists of a pump
unit and actuator
with cover in position
on the bottle of nasal
solution. The amount of cromolyn sodium
in each bottle is: 13 ml
- 520 mg (40 mg/ml); 26 ml
- 1040 mg (40 mg/ml).
Nasalcrom should be stored between 15°-30°C (59°-86°F).
Protect from light.
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