Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)

Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler) is used treat asthma in patients 12 years of age and older where the use of a combination (long-acting, beta2-agonist and inhaled corticosteroid) has been found to be appropriate. It is also used for maintenance treatment of airflow obstruction in patients with moderate to severe obstructive pulmonary disease (COPD)with frequent symptoms and a history of exacerbations.

1. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy

2. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Foracort Inhaler (Generic Formoterol Fumarate and
Budesonide Inhaler) is used treat asthma in patients 12
years of age and older where the use of a combination
(long-acting, beta2-agonist and inhaled corticosteroid) has
been found to be appropriate. It is also used for
maintenance treatment of airflow obstruction in patients
with moderate to severe obstructive pulmonary disease
(COPD) with frequent symptoms and a history of
exacerbations.

3. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Foracort Inhaler is
manufactured by Cipla
Limited, India in the following
strengths: Foracort 100 (6 mcg of
Formoterol Fumarate Dihydrate
and 100 mcg of Budesonide),
Foracort 200 (6 mcg of
Formoterol Fumarate Dihydrate
and 200 mcg of Budesonide) and
Foracort 400 (6 mcg of
Formoterol Fumarate Dihydrate
and 400 mcg of Budesonide).

4. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Chemical Structure - Budesonide

5. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Chemical Structure - Formoterol Fumarate

6. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
The active ingredients
contained in Foracort Inhaler
are Budesonide And
Formoterol Fumarate
Dihydrate.
Each actuation of Foracort
inhaler contains 6 mcg of
Formoterol Fumarate Dihydrate
whereas the quantity of
Budesonide BP is 100 mcg,
200 mcg or 400 mcg
respectively.

7. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Uses of Foracort 100, 200 and 400 Inhaler:
Foracort Inhaler is a combination of two medicines Formoterol
Fumarate and Budesonide that are used to help control the
symptoms of asthma and improve lung function in patients 12 years
of age and older. 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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8. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Uses of Foracort 100, 200 and 400 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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9. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Recommended Adult Dosage
For most patients, the starting dose of
Foracort (Generic Formoterol and Budesonide Inhaler) for treatment
of asthma in patients 18 years and older is one to two inhalations of
Foracort-100 or Foracort-200 Inhaler twice daily. Starting dosage is
based on asthma severity. The maximum dose is 4 inhalations, twice
daily.
For the treatment of asthma in patients 18 years and older the dosage
of Foracort- 400 Inhaler is 1 inhalation, twice daily. The maximum dose
is 2 inhalations, twice daily.
For the treatment of COPD (Chronic Obstructive Pulmonary Disease) in
adults the dosage is 2 inhalations of Foracort-200 Inhaler, twice daily.
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10. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Recommended Dosage - Children
For most patients, the starting dose of
Foracort (Generic Formoterol and Budesonide Inhaler) for treatment
of asthma in patients 12 to 17 years and older is one to two inhalations
of Foracort-100 or Foracort-200 Inhaler twice daily. Starting dosage is
based on asthma severity.
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11. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Contraindications
➔Foracort Inhaler is contraindicated in patients with a known
hypersensitivity to Formoterol Fumarate Dihydrate, Budesonide
or any component of the inhaler.
➔
Administration of Foracort Inhaler is also contraindicated in
patients that require primary treatment of status asthmaticus
acute episodes of asthma or COPD requiring intensive measures.
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12. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
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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13. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Warnings
Serious asthma-related events: Long-acting beta2-adrenergic agonists as
monotherapy increase the risk.
Deterioration of disease and acute episodes: Do not initiate in acutely
deteriorating asthma or COPD 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 the patient to rinse his/her mouth with water without
swallowing after inhalation to help reduce the risk.
Pneumonia: Increased risk in patients with COPD. Monitor patients for signs
and symptoms of pneumonia and other potential lung infections.
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14. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Warnings
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.
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.

15. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Warnings
Paradoxical bronchospasm: Discontinue Foracort Inhaler 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.
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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16. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Possible Side Effects
Most common Formoterol Fumarate and Budesonide Inhaler
(Foracort Inhaler) side effects with an incidence rate of 3% or
greater are:
Asthma: nasopharyngitis, headache, upper respiratory tract
infection, pharyngolaryngeal 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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17. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Overdosage
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, hyperglycemia, hypokalemia, prolonged QTc-
interval, arrhythmia, nausea and vomiting.
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.
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18. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Overdosage
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, may appear.
If Foracort (Generic Formoterol and Budesonide Inhaler)
therapy has to be withdrawn due to overdose of the
Formoterol component of the drug, provision of appropriate
inhaled corticosteroid therapy must be considered.
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19. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Treatment of Overdosage
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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20. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Foracort Inhaler During Pregnancy
Budesonide and Formoterol Fumarate Dihydrate Inhaler (Foracort
Inhaler) is classified by the US FDA as Pregnancy Category C. No
clinical data on exposed pregnancies are available with regard to
treatment with Formoterol and Budesonide combination medication.
There are no adequate data from use of Formoterol in pregnant
women.
In animal studies Formoterol has caused adverse effects in
reproduction studies at very high systemic exposure levels. Data on
approximately 2000 exposed pregnancies indicate no increased
teratogenic risk associated with the use of inhaled Budesonide. In
animal studies glucocorticosteroids have been shown to induce
malformations.
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21. Foracort Inhaler (Generic Budesonide and Formoterol Fumarate Inhaler)
© The Swiss Pharmacy
Foracort Inhaler (Generic Budesonide and
Formoterol Fumarate Inhaler) is manufactured by
Cipla Limited, India.
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