Formoterol and Budesonide Inhaler (Foracort Inhaler)

Formoterol and Budesonide Inhaler
© Clearsky Pharmacy
Formoterol and Budesonide Inhaler (Foracort Inhaler) is
a combination medication containing a corticosteroid
and a long-acting beta2-adrenergic agonist used for
treatment of asthma in patients 12 years of age and
older and maintenance treatment of airflow obstruction
in patients with chronic obstructive pulmonary disease
(COPD) including chronic bronchitis and emphysema.

Foracort Inhaler
Foracort Inhaler is manufactured by
Cipla Limited, India.
(Website: www.cipla.com)

Formoterol and Budesonide Inhaler – Brand Names
Formoterol and Budesonide Inhaler is
available as Symbicort, Foracort,
Budamate, Combihale-FB and Vent
FB.

Active Ingredients
The active ingredients contained in Foracort
inhaler are Formoterol Fumarate Dihydrate
and Budesonide.
Each actuation of Foracort 100 inhaler
contains Formoterol Fumarate Dihydrate IP 6
mcg and Budesonide IP 100 mcg.

Chemical Structure
The structure of Formoterol Fumarate
Dihydrate is given below:

Chemical Structure
The structure of Budesonide is given below:

Uses of Foracort Inhaler
Foracort Inhaler is used to control and prevent
symptoms (wheezing and shortness of breath)
caused by asthma or ongoing lung disease
(chronic obstructive pulmonary disease-COPD,
which includes chronic bronchitis and
emphysema). It contains 2 medicines:
Budesonide and Formoterol. Budesonide belongs
to a class of drugs known as corticosteroids.
It works by reducing the irritation and swelling of
the airways. Formoterol belongs to the class of
drugs known as long-acting beta agonists. It
works by opening airways in the lungs to make
breathing easier.

Formoterol and Budesonide Inhaler Dosage
➢The dosage is individual and should be adjusted
according to disease severity. When control has been
achieved, the dose should be titrated to the lowest effective
dose, which could include Foracort Inhaler used once daily.
➢Maintenance Therapy: Patients should be advised to
have their separate rapid acting bronchodilator available for
rescue use at all times. FORACORT-100 Inhaler: 1 to 2
inhalations, twice daily. Maximum dose is 4 inhalations,
twice daily. FORACORT-200 Inhaler: 1 to 2 inhalations,
twice daily. Maximum dose is 4 inhalations, twice daily.
FORACORT- 400 Inhaler: 1 inhalation, twice daily.
Maximum dose is 2 inhalations, twice daily
The adult dosage of Foracort Inhaler (Formoterol
and Budesonide Inhaler) is given below:

Foracort Inhaler Dosage
➢The recommended maintenance dosage is 2 inhalations
per day as maintenance therapy (either one inhalation twice
daily, or two inhalations in either the morning or the
evening). Patients should take one additional inhalation as
needed in response to symptoms. In case symptoms
persist after a few minutes, an additional inhalation should
be taken. Not more than 6 inhalations can be taken on any
single occasion.
The adult (18 years and older) dosage of
Foracort Inhaler (Formoterol and Budesonide
Inhaler) Single Maintenance and Reliever Therapy
(For FORACORT -100 and 200 Inhaler only) is
given below:

Storage Instructions
Foracort Inhaler (Formoterol and
Budesonide Inhaler) has to be stored at
controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) .
Store the inhaler with the mouthpiece
down. Keep this as well as all other
medicines away from children and pets.

Foracort Inhaler
Contraindications
Foracort Inhaler is contraindicated in patients with
a hypersensitivity to Formoterol Fumarate,
Budesonide or any other component of this
medication.
This medicine is also contraindicated for the
primary treatment of status asthmaticus or acute
episodes of asthma or COPD requiring intensive
measures.

Warnings
Asthma-related death: Long-acting beta2-adrenergic
agonists increase the risk. Prescribe only for
recommended patient populations
Deterioration of disease and acute episodes: Do not
initiate in acutely deteriorating asthma or to treat acute
symptoms.
Use with additional long-acting beta2-agonist: Do not
use in combination because of risk of overdose.
Localized infections: Candida albicans infection of the
mouth and throat may occur. Monitor patients
periodically for signs of adverse effects on the oral
cavity. Advise patients to rinse the mouth following
inhalation.

Warnings
Pneumonia: Increased risk in patients with COPD.
Monitor patients for signs and symptoms of pneumonia
and other potential lung infections.
Immunosuppression: Potential worsening of infections
(e.g., existing tuberculosis, fungal, bacterial, viral, or
parasitic infection; or ocular herpes simplex). Use with
caution in patients with these infections. More serious
or even fatal course of chickenpox or measles can
occur in susceptible patients.
Transferring patients from systemic corticosteroids:
Risk of impaired adrenal function when transferring
from oral steroids. Taper patients slowly from systemic
corticosteroids if transferring to Foracort Inhaler.

Warnings
Hypercorticism and adrenal suppression: May occur with
very high dosages or at the regular dosage in susceptible
individuals. In case such changes occur, discontinue
Foracort Inhaler slowly.
Strong cytochrome P450 3A4 inhibitors (e.g., Ritonavir):
Risk of increased systemic corticosteroid effects. Exercise
caution when used with this medicine.
Paradoxical bronchospasm: Discontinue using this
medicine and institute alternative therapy if paradoxical
bronchospasm occurs.
Patients with cardiovascular or central nervous system
disorders: Use with caution because of beta-adrenergic
stimulation.
Decreases in bone mineral density: Assess bone mineral
density initially and periodically thereafter.

Warnings
Effects on growth: Monitor growth of pediatric
patients.
Glaucoma and cataracts: Close monitoring is
warranted.
Metabolic effects: Be alert to eosinophilic
conditions, hypokalemia, and hyperglycemia.
Coexisting conditions: Use with caution in
patients with convulsive disorders,
thyrotoxicosis, diabetes mellitus, and
ketoacidosis.

Formoterol and Budesonide Inhaler Side Effects
➢Most common Formoterol and Budesonide
Inhaler (Foracort Inhaler) side effects with an
incidence rate of 3% or more observed during
treatment of Asthma: nasopharyngitis,
headache, upper respiratory tract infection,
pharygolaryngeal pain, sinusitis, influenza, back
pain, nasal congestion, stomach discomfort,
vomiting, and oral candidiasis.
➢Most common side effects with an incidence
rate of 3% or more observed during treatment
of COPD: nasopharyngitis, oral candidiasis,
bronchitis, sinusitis, upper respiratory tract
infections.

Foracort Inhaler Overdose
An overdose of Formoterol would likely lead to
effects that are typical for beta2-adrenergic
agonists: tremor, headache, palpitations.
Symptoms reported from isolated cases are
tachycardia, hyperglycaemia, hypokalaemia,
prolonged QTc-interval, arrhythmia, nausea
and vomiting.
Acute overdosage with Budesonide, even in
excessive doses, is not expected to be a
clinical problem. When used chronically in
excessive doses, systemic glucocorticosteroid
effects, such as hypercorticism and adrenal
suppression, could appear.

Foracort Inhaler Overdose
Supportive and symptomatic treatment may
be indicated.
A dose of 90 mcg administered during
three hours in patients with acute bronchial
obstruction raised no safety concerns.

Formoterol and Budesonide Inhaler During Pregnancy
Formoterol and Budesonide Inhaler (Foracort Inhaler)
has been classified by the US FDA as Pregnancy
Category C.
There are no adequate and well-controlled
studies of Formoterol and Budesonide Inhaler in
pregnant women.
Budesonide alone was teratogenic and embryocidal
in rats and rabbits, but not in humans at
therapeutic doses. Formoterol Fumarate alone was
teratogenic in rats and rabbits.
Foracort Inhaler can be used during pregnancy only
if the potential benefit justifies the potential risk to the
fetus.

Foracort Inhaler
For more details on
Foracort Inhaler click here
Foracort Inhaler (Formoterol and Budesonide
Inhaler) by Cipla Limited, India.

Formoterol and Budesonide Inhaler (Foracort Inhaler)

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