Foracort Inhaler (Generic Formoterol Fumarate and Budesonide Inhaler)

Foracort Inhaler (Generic Formoterol Fumarate and Budesonide Inhaler) is an inhaler that is used to treat asthma in adults and adolescents aged 12 years to 17 years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It contains two different medicines: Budesonide belongs to a group of medicines called 'corticosteroids'. It works by reducing and preventing swelling and inflammation in the lungs. Formoterol Fumarate Dihydrate belongs to a group of medicines called 'long-acting beta2-adrenoceptor agonists' or 'bronchodilators'. It works by relaxing the muscles in the airways. This helps the patient to breathe more easily.

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Foracort Inhaler (Generic Formoterol Fumarate and
Budesonide Inhaler) is an inhaler that is used to treat asthma
in adults and adolescents aged 12 years to 17 years. It is also
used to treat the symptoms of Chronic Obstructive Pulmonary
Disease (COPD) in adults aged 18 years and older. It contains
two different medicines: Budesonide belongs to a group of
medicines called 'corticosteroids'. It works by reducing and
preventing swelling and inflammation in the lungs.
Formoterol Fumarate Dihydrate belongs to a group of
medicines called 'long-acting beta2-adrenoceptor agonists' or
'bronchodilators'. It works by relaxing the muscles in the
airways. This helps the patient to breathe more easily.

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Active Ingredients
The active ingredients present 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.
Each actuation of Foracort 200 inhaler contains Formoterol Fumarate
Dihydrate IP 6 mcg and Budesonide IP 200 mcg.
Each actuation of Foracort 400 inhaler contains Formoterol Fumarate
Dihydrate IP 6 mcg and Budesonide IP 400 mcg.

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Chemical Structure
The structure of Formoterol Fumarate Dihydrate is given
below:

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Chemical Structure
The structure of Budesonide is given below:

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Foracort Inhaler is manufactured by Cipla Limited, India is
available as Foracort 100 inhaler, Foracort 200 inhaler and
Foracort 400 inhaler.
(Website: https://www.cipla.com/ )
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Formoterol Fumarate and Budesonide Inhaler – Brand Names
Formoterol Fumarate and Budesonide
Inhaler is available under various drug
trade names that include Symbicort,
Foracort, Budamate, Combihale-FB and
Vent FB.

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Uses of Foracort Inhaler
Formoterol Fumarate Dihydrate and Budesonide (Foracort Inhaler)
is a combination of two medicines that are used to help control the
symptoms of asthma and improve lung function. It is used when a
patient's asthma has not been controlled sufficiently on other
asthma medicines, or when a patient's condition is so severe that
more than one medicine is needed every day. This medicine will not
relieve an asthma attack that has already started.
This medicine is also used to treat air flow blockage and reduce the
worsening of chronic obstructive pulmonary disease (COPD). This
includes chronic bronchitis and emphysema.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Uses of Foracort Inhaler
Inhaled Budesonide belongs to the family of medicines known
as corticosteroids (cortisone-like medicines). It works by
preventing inflammation (swelling) in the lungs that causes an
asthma attack.
Inhaled Formoterol belongs to the family of medicines known
as bronchodilators. It works by helping the muscles around the
airways in your lungs stay relaxed to prevent asthma
symptoms, such as wheezing and shortness of breath. This
increases the flow of air through the bronchial tubes.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Foracort Inhaler Dosage

The dosage of Foracort Inhaler (Generic Formoterol Fumarate and
Budesonide Inhaler) is given below:
The recommended dosage Foracort Inhaler (Formoterol and Budesonide
Inhaler) for various indications is given below: The dosage varies as per
individual being treated 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.
Adults (18 Years and Older): 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.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Foracort Inhaler Dosage

The dosage of Foracort Inhaler (Generic Formoterol Fumarate and
Budesonide Inhaler) is given below:
Adolescents (12-17 Years):Maintenance Therapy: FORACORT-100 Inhaler:
1 to 2 inhalations, twice daily. FORACORT-200 Inhaler: 1 to 2 inhalations,
twice daily. FORACORT- 400 Inhaler: 1 inhalation, twice daily
Children (6-11 Years):Maintenance Therapy: FORACORT-100 Inhaler: 2
inhalations, twice daily
Single Maintenance and Reliever Therapy (For FORACORT -100 and 200
Inhaler only): Patients take a daily maintenance dose of Foracort Inhaler
and in combination take Foracort Inhaler as needed in response to
symptoms. Patients should be advised to always have Foracort Inhaler
available for rescue use.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Foracort Inhaler Dosage

The dosage of Foracort Inhaler (Generic Formoterol Fumarate and
Budesonide Inhaler) is given below:
Single Maintenance and Reliever Therapy (For FORACORT -100 and 200 Inhaler
only): Adults (18 years and older): 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 1
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 should be taken on any single occasion.
COPD (Chronic Obstructive Pulmonary Disease) FORACORT-200 Inhaler: The
recommended dosage is 2 inhalations, twice daily
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Contraindications
Foracort Inhaler is contraindicated in persons with a
hypersensitivity (allergy) to Formoterol Fumarate, Budesonide
or any of the other ingredients of this medicine.
This medicine is also contraindicated for the primary treatment
of status asthmaticus or acute episodes of asthma or COPD
requiring intensive measures.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Storage Instructions

Foracort Inhaler (Generic Formoterol Fumarate
and Budesonide Inhaler) have to be stored at
controlled room temperature i.e. from 20°C to
25°C (68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Warnings

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

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Warnings

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.
Hypercorticism and adrenal suppression: May occur with very high dosages or at
the regular dosage in susceptible individuals. If 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 Foracort Inhaler.
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.

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Warnings

Decreases in bone mineral density: Assess bone mineral density
initially and periodically thereafter.
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.

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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Side Effects
Most common Formoterol Fumarate and Budesonide
Inhaler(Foracort Inhaler) side effects with an incidence
rate of 3% or more are:
Asthma: nasopharyngitis, headache, upper respiratory
tract infection, pharygolaryngeal pain, sinusitis, influenza,
back pain, nasal congestion, stomach discomfort,
vomiting, and oral candidiasis.
COPD: nasopharyngitis, oral candidiasis, bronchitis,
sinusitis, upper respiratory tract infections
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Overdose
An overdose of Formoterol would likely lead to exaggeration of effects that are
typical for beta2-adrenergic agonists: seizures, angina, hypertension, hypotension,
tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache,
tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances,
metabolic acidosis, hyperglycemia, hypokalemia. As with all sympathomimetic
medications, cardiac arrest and even death may be associated with abuse of
Formoterol. No clinically significant adverse reactions were seen when Formoterol
was delivered to adult patients with acute bronchoconstriction at a dose of 90
mcg/day over 3 hours or to stable asthmatics 3 times a day at a total dose of 54
mcg/day for 3 days.
The potential for acute toxic effects following acute overdosage with Budesonide,
even in excessive doses, is not expected to be a clinical problem. If used at
excessive doses for prolonged periods, systemic corticosteroid effects such as
hypercorticism and adrenal suppression, could appear.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Overdose
Supportive and symptomatic treatment may be indicated in cases of
overdose. A dose of 90 mcg administered during three hours in patients
with acute bronchial obstruction raised no safety concerns.
Treatment of Formoterol overdosage consists of discontinuation of the
medication together with institution of appropriate symptomatic and/or
supportive therapy.
The judicious use of a cardioselective beta-receptor blocker may be
considered, bearing in mind that such medication can produce
bronchospasm. There is insufficient evidence to determine if dialysis is
beneficial for overdosage of Formoterol. Cardiac monitoring is
recommended in cases of overdosage.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
Foracort Inhaler During Pregnancy
Formoterol and Budesonide Inhaler (Foracort Inhaler) is 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. Formoterol Fumarate was
also embryocidal, increased pup loss at birth and during lactation,
and decreased pup weight in rats. Foracort Inhaler can be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus. The
lowest effective dose of Budesonide needed to maintain adequate asthma control
should be used.
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Foracort Inhaler (Generic Formoterol and Budesonide Inhaler)
For more details on
Foracort Inhaler click here
Foracort Inhaler (Generic Formoterol and Budesonide Inhaler) by
Cipla Limited, India.
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