Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1987
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Intal (Inhalant)
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For management of bronchial asthma in adults and pediatric
patients (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. Patients with chronic
asthma should be advised that the effect of Intal Inhaler therapy is dependent upon its administration at regular
intervals, as directed. Intal Inhaler
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. 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 before exposure
to the precipitating factor, i.e., within 10 to 15 minutes but not more than
60 minutes. Intal Inhaler
Therapy in Relation to Other Treatments for Asthma:Non-steroidal
agents:Intal Inhaler should
be added to the patient's existing
treatment regimen (e.g., bronchodilators). When a clinical response to Intal Inhaler 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. If
concomitant medications are eliminated or required on no more than a prn basis,
the frequency of administration of Intal 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 Intal Inhaler and the introduction
of, or increase in, symptomatic medications may be needed if the patient's
clinical condition deteriorates. Corticosteroids: In patients chronically receiving corticosteroids for the management
of bronchial asthma, the dosage should be maintained following the introduction
of Intal Inhaler. If the patient improves,
an attempt to decrease corticosteroids should be made. Even if the corticosteroid-dependent
patient fails to show symptomatic improvement following Intal Inhaler 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. For best results,
the canister should be at room temperature before use.
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| dailymed-instance:descripti... |
The active ingredient of Intal Inhaler is cromolyn sodium, USP. It is an inhaled anti-inflammatory
agent for the preventive management of asthma. Cromolyn sodium is disodium
5, 5'-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is CHNaO;
the molecular weight is 512.34. Cromolyn sodium is a water soluble, odorless,
white, hydrated crystalline powder. It is tasteless at first, but leaves a
slightly bitter aftertaste. The molecular structure of cromolyn sodium is: Intal Inhaler (cromolyn sodium inhalation aerosol)
is a metered dose aerosol unit for oral inhalation containing micronized cromolyn
sodium, sorbitan trioleate with dichlorotetrafluoroethane and dichlorodifluoromethane
as propellants. Each actuation delivers approximately 1 mg cromolyn sodium
from the valve and 800 mcg cromolyn sodium through the mouthpiece to the patient.
Each 8.1 g canister delivers at least 112 metered inhalations (56 doses);
each 14.2 g canister delivers at least 200 metered inhalations (100 doses).
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| dailymed-instance:clinicalP... |
In vitro and in vivo animal studies have shown that cromolyn
sodium inhibits sensitized mast cell degranulation which occurs after exposure
to specific antigens. Cromolyn sodium acts by inhibiting the release of mediators
from mast cells. Studies show that cromolyn sodium indirectly blocks calcium
ions from entering the mast cell, thereby preventing mediator release. Cromolyn
sodium inhibits both the immediate and non-immediate bronchoconstrictive reactions
to inhaled antigen. Cromolyn sodium also attenuates bronchospasm caused by
exercise, toluene diisocyanate, aspirin, cold air, sulfur dioxide, and environmental
pollutants, at least in some patients. Cromolyn sodium
has no intrinsic bronchodilator or antihistamine activity. After
administration of cromolyn sodium capsules by inhalation, approximately 8%
of the total dose administered is absorbed and rapidly excreted unchanged,
approximately equally divided between urine and bile. The remainder of the
dose is either exhaled or deposited in the oropharynx, swallowed, and excreted
via the alimentary tract.
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| dailymed-instance:contraind... |
Intal Inhaler is contraindicated
in those patients who have shown hypersensitivity to cromolyn sodium or other
ingredients in this preparation.
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| dailymed-instance:supply |
Intal Inhaler is supplied
as an aerosol canister which provides 112 metered dose actuations from the
8.1 gram inhaler and 200 metered dose actuations from the 14.2 gram inhaler.
The correct amount of medication in each inhalation cannot be assured after
112 actuations from the 8.1 gram canister or 200 actuations from the 14.2
gram canister even though the canister may not feel completely empty. The
canister should be discarded when the labeled number of actuations have been
used. Each actuation delivers 1 mg cromolyn sodium
through the valve and 800 mcg through the mouthpiece to the patient. The Intal Inhaler canister and accompanying mouthpiece
are designed to be used together. The Intal Inhaler canister should not be
used with other mouthpieces and the supplied mouthpiece should not be used
with other products' canisters. Intal Inhaler
is supplied with a white plastic mouthpiece with blue dust cap and patient
instructions. NDC 60793-011-14 .........................
14.2 g canister NDC 60793-011-08 ..........................
8.1 g canister Store between 15��to 30��C
(59��to 86��F). Contents under pressure. Do not puncture, incinerate,
or place near sources of heat. Exposure to temperatures above 120��F may
cause bursting. Avoid spraying in eyes. 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 (CFCs). WARNING:
Contains CFC-12 (dichlorodifluoromethane) and CFC-114 (dichlorotetrafluoroethane),
substances which harm public health and the environment by destroying ozone
in the upper atmosphere. A notice similar to the above
WARNING has been placed in the���Information For The Patient���portion of this package insert under the Environmental Protection Agency's
(EPA's) regulations. The patient's warning states that the patient
should consult his or her physician if there are questions about alternatives. Rx only Intal is
a registered trademark of King Pharmaceuticals, Inc. Distributed
by: King Pharmaceuticals, Inc., Bristol, TN 37620 Manufactured
by: Health Care Specialties Division, 3M Health Care Limited, Loughborough,
England LE11 1EP Made in United Kingdom. Prescribing
Information as of September 2005.
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| dailymed-instance:precautio... |
General: 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. Occasionally, patients may experience
cough and/or bronchospasm following cromolyn sodium inhalation. At times,
patients who develop bronchospasm may not be able to continue administration
despite prior bronchodilator administration. Rarely, very severe bronchospasm
has been encountered.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies of cromolyn sodium in mice (12 months intraperitoneal
administration at doses up to 150 mg/kg/day three days per week), hamsters
(intraperitoneal administration at doses up to 53 mg/kg/day three days per
week for 15 weeks followed by 17.5 mg/kg/day three days per week for 37 weeks),
and rats (18 months subcutaneous treatment at doses up to 75 mg/kg/day six
days per week) showed no neoplastic effects. These doses in mice, hamsters,
and rats correspond to approximately 40,10, and 80 times, respectively, the
maximum recommended daily inhalation dose in adults on a mg/mbasis,
or, approximately 20, 5, and 40 times, respectively, the maximum recommended
daily inhalation dose in children on a mg/mbasis. Cromolyn
sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays,
mitotic gene conversion in Saccharomyces cerevisiae, and in an in vitro cytogenetic
study in human peripheral lymphocytes. No evidence of
impaired fertility was shown in laboratory reproduction studies conducted
subcutaneously in rats at the highest doses tested, 175 mg/kg/day in males
and 100 mg/kg/day in females. These doses are approximately 220 and 130 times,
respectively, the maximum recommended daily inhalation dose in adults on a
mg/mbasis.<br/>Pregnancy: Pregnancy Category B: Reproduction
studies with cromolyn sodium administered subcutaneously to pregnant mice
and rats at maximum daily doses of 540 mg/kg/day and 160 mg/kg/day, respectively,
and intravenously to rabbits at a maximum daily dose of 485 mg/kg/day produced
no evidence of fetal malformations. These doses represent approximately 340,
210, and 1,200 times, respectively, the maximum recommended daily inhalation
dose in adults on a mg/mbasis. Adverse fetal effects (increased
resorption 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, Intal Inhaler should be used during pregnancy only
if clearly needed.<br/>Drug Interactions During Pregnancy: Cromolyn sodium and isoproterenol were studied following
subcutaneous injections in pregnant mice. Cromolyn sodium alone in doses up
to 540 mg/kg/day (approximately 340 times the maximum recommended daily inhalation
dose in adults on a mg/mbasis) did not cause significant increases
in resorptions or major malformations. Isoproterenol alone at a dose of 2.7
mg/kg/day (approximately 7 times the maximum recommended daily inhalation
dose in adults on a mg/mbasis) increased both resorptions and
malformations. The addition of 540 mg/kg/day of cromolyn sodium (approximately
340 times the maximum recommended daily inhalation dose in adults on a mg/mbasis)
to 2.7 mg/kg/day of isoproterenol (approximately 7 times the maximum recommended
daily inhalation dose in adults on a mg/mbasis) appears to have
increased the incidence of both resorptions and malformations.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk,
therefore, caution should be exercised when Intal 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.<br/>Pediatric Use: Safety and effectiveness in pediatric patients below the
age of 5 years have not been established. For young pediatric patients unable
to utilize the Inhaler, Intal Nebulizer
Solution (cromolyn sodium inhalation solution, USP) 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 Intal Inhaler is particularly important in pediatric
patients.<br/>Geriatric Use: Clinical studies of Intal Inhaler
did not include sufficient numbers of subjects aged 65 and over to determine
whether they respond differently from younger subjects. Other reported clinical
experience has not identified differences in responses between the elderly
and younger patients.
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| dailymed-instance:overdosag... |
There is no clinical syndrome associated with an overdosage
of cromolyn sodium. In several animal species acute toxicity with cromolyn
sodium occurs only with very high exposure levels. No deaths occurred at the
highest oral doses tested in mice, 8000 mg/kg (approximately 5100 and 2700
times the maximum recommended daily inhalation doses in adults and children,
respectively, on a mg/mbasis) or in rats, 8000 mg/kg (approximately
10,000 and 5400 times the maximum recommended daily inhalation doses in adults
and children, respectively, on a mg/mbasis).
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cromolyn sodium
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Intal (Inhalant)
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| dailymed-instance:adverseRe... |
In controlled clinical studies of Intal Inhaler, the most frequently reported adverse reactions attributed
to cromolyn sodium treatment were: The most frequently reported adverse reactions attributed
to other forms of cromolyn sodium (on the basis of reoccurrence following
readministration) involve the respiratory tract and are: bronchospasm [sometimes
severe, associated with a precipitous fall in pulmonary function (FEV)],
cough, laryngeal edema (rare), nasal congestion (sometimes severe), pharyngeal
irritation, and wheezing. Adverse reactions which occur
infrequently and are associated with administration of the drug are: anaphylaxis,
angioedema, dizziness, dysuria and urinary frequency, joint swelling and pain,
lacrimation, nausea and headache, rash, swollen parotid gland, urticaria,
pulmonary infiltrates with eosinophilia, substernal burning, and myopathy. The
following adverse reactions have been reported as rare events and it is unclear
whether they are attributable to the drug: anemia, exfoliative dermatitis,
hemoptysis, hoarseness, myalgia, nephrosis, periarteritic vasculitis, pericarditis,
peripheral neuritis, photodermatitis, sneezing, drowsiness, nasal itching,
nasal bleeding, nasal burning, serum sickness, stomachache, polymyositis,
vertigo, and liver disease.
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| dailymed-instance:warning |
Intal 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. Intal 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.
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| dailymed-instance:indicatio... |
Intal Inhaler 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, Intal Inhaler is
given by inhalation on a regular daily basis. The effect of Intal Inhaler
is usually evident after several weeks of treatment, although some patients
show an almost immediate response. 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., IntalInhaler should be used shortly before exposure to the precipitating
factor, i.e., within 10 to 15 minutes but not more than 60 minutes. Intal Inhaler may be effective
in relieving bronchospasm in some, but not all, patients with exercise induced
bronchospasm.
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Intal
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