Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)

Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for inhalation) are used in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting beta2 adrenoceptor agonist) is appropriate.
Foracort Rotacaps are also indicated as maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema.

1. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy

2. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Foracort Rotacaps (Generic Budesonide and Formoterol
Fumarate Dihydrate powder for inhalation) are used in
adults and adolescents (12 years and older) for the regular
treatment of asthma, where use of a combination (inhaled
corticosteroid and long-acting beta2 adrenoceptor agonist)
is appropriate.
Foracort Rotacaps are also indicated as maintenance
treatment of airflow obstruction in patients with COPD
including chronic bronchitis and emphysema.

3. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Foracort Rotacaps are
manufactured by Cipla Limited,
India in the strengths of Foracort-
100 Rotacaps (Formoterol 6 mcg
and Budesonide 100 mcg),
Foracort-200 Rotacaps
(Formoterol 6 mcg and
Budesonide 200 mcg) and
Foracort-400 Rotacaps
(Formoterol 6 mcg and
Budesonide 400 mcg).

4. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Chemical Structure - Formoterol Fumarate Dihydrate

5. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Chemical Structure - Budesonide

6. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
The active ingredients
contained in Foracort
Rotacaps are Formoterol
Fumarate Dihydrate and
Budesonide.
Each Foracort rotacap
(capsule) contains 6 mcg of
Formoterol Fumarate
Dihydrate whereas the amount
of Budesonide is 100 mcg, 200
mcg or 400 mcg.

7. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Uses of Foracort Rotacaps (Generic Formoterol Fumarate
Dihydrate and Budesonide Capsules):
Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate
Dihydrate powder for inhalation) is used to treat asthma in adults and
adolescents aged 12 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 and Formoterol
Fumarate Dihydrate.
Budesonide belongs to a group of medicines called ‘corticosteroids’. It
works by reducing and preventing swelling and inflammation in your 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 your airways. This helps you to breathe more easily.
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8. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Recommended Adult Dosage
The dosage of Foracort Rotacaps (Budesonide and
Formoterol powder for inhalation) for various indications is given
below:
Asthma (Maintenance Therapy): The recommended dosage for adults (18
Years and Older) is
Foracort-100 Rotacaps 1 to 2 rotacaps, twice daily. Maximum dose is 4
rotacaps, twice daily
Foracort-200 Rotacaps 1 to 2 rotacaps, twice daily. Maximum dose is 4
rotacaps, twice daily
Foracort-400 Rotacaps 1 rotacap, twice daily. Maximum dose is 2
rotacaps, twice daily
Patients should be advised to have their separate rapid acting
bronchodilator available for rescue use at all times.

9. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Recommended Adult Dosage
Asthma: Adults (18 years and older - Single Maintenance and
Reliever Therapy for Foracort 100 and Foracort 200 Rotacaps
only):
Patients take a daily maintenance dose of Foracort Rotacaps
and in combination take Foracort Rotacaps as needed in
response to symptoms. Patients should be advised to always
have Foracort Rotacaps available for rescue use.
Close monitoring for dose-related adverse effects is needed in
patients who frequently take high numbers of Foracort
Rotacaps as-needed inhalations.
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10. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Recommended Adult Dosage
The recommended maintenance dosage is 2 rotacaps per day as
maintenance therapy (either one rotacap twice daily, or two
rotacaps in either the morning or the evening).
Patients should take 1 additional rotacap as needed in response
to symptoms. If symptoms persist after a few minutes, an
additional rotacap should be taken. Not more than 6 rotacaps
should be taken on any single occasion.
A total daily dose of more than 8 rotacaps is not normally
needed.
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11. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Recommended Adult 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 Rotacaps used once daily. Foracort Rotacaps
should only be used for inhalation through Cipla Rotahaler/
Revolizer.
COPD (Chronic Obstructive Pulmonary Disease) in Adults:
Foracort-200 Rotacaps 2 rotacaps, twice daily
Foracort Rotacaps should only be used for inhalation through
Cipla Rotahaler/ Revolizer.
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12. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Contraindications
➔
Foracort Rotacaps are contraindicated in patients with a known
hypersensitivity to Formoterol Fumarate Dihydrate, Budesonide
or any component of the medication.
➔Primary treatment of status asthmaticus or other acute episodes
of asthma or COPD where intensive measures are required.
➔
Relief from acute bronchospasm
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13. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Storage Instructions
Foracort Rotacaps (Generic Budesonide and
Formoterol Fumarate Dihydrate powder for
Inhalation) 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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14. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Warnings
Serious Asthma-Related Events – Hospitalizations, Intubations and Death:
Use of long-acting beta -adrenergic agonist (LABA) as monotherapy
(without inhaled corticosteroids) for asthma is associated with an
increased risk of asthma related death.
Deterioration of Disease and Acute Episodes: Formoterol/Budesonide
combination should not be initiated in patients during rapidly deteriorating
or potentially life threatening episodes of asthma or COPD.
Excessive Use of Formoterol/Budesonide Combination and Use with
Other Long-Acting Beta-Agonists:
As with other inhaled drugs containing beta -adrenergic agents,
formoterol/budesonide combination should not be used more often than
recommended, at higher doses than recommended, or in conjunction
with other medications containing LABA, as an overdose may result.

15. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Warnings
Local Effects: During clinical studies, the development of localized
infections of the mouth and pharynx with Candida albicans has occurred
in patients treated with Formoterol/Budesonide combination. When such
an infection develops, it should be treated with appropriate local or
systemic (i.e., oral antifungal) therapy while treatment with
Formoterol/Budesonide combination continues, but at times therapy with
Formoterol/Budesonide combination may need to be interrupted.
Pneumonia and Other Lower Respiratory Tract Infections: Physicians
should remain vigilant for the possible development of pneumonia in
patients with COPD as the clinical features of pneumonia and
exacerbations frequently overlap. Lower respiratory tract infections,
including pneumonia, have been reported following the inhaled
administration of corticosteroids.

16. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Warnings
Immunosuppression: Patients who are on drugs that suppress the immune
system are more susceptible to infection than healthy individuals. Chicken pox
and measles, for example, can have a more serious or even fatal course in
susceptible children or adults using corticosteroids.
Transferring Patients from Systemic Corticosteroid Therapy: Particular care is
needed for patients who have been transferred from systemically active
corticosteroids to inhaled corticosteroids because deaths due to adrenal
insufficiency have occurred in patients with asthma during and after transfer from
systemic corticosteroids to less systemically available inhaled corticosteroids.
After withdrawal from systemic corticosteroids, a number of months are required
for recovery of hypothalamic pituitary adrenocortical (HPA) function.
Paradoxical Bronchospasm and Upper Airway Symptoms: As with other inhaled
medications, Formoterol/ Budesonide combination can produce paradoxical
bronchospasm, which may be life threatening.
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17. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Warnings
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may
occur after administration of Formoterol/Budesonide combination, as
demonstrated by cases of urticaria, angioedema, rash, and bronchospasm.
Cardiovascular and Central Nervous System Effects: Excessive beta-adrenergic
stimulation has been associated with seizures, angina, hypertension or
hypotension, tachycardia with rates up to 200 beats/min, arrhythmias,
nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise,
and insomnia. Therefore, Formoterol/Budesonide combination, like all products
containing sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders.
Effects on Bone Density: Potential effects on bone should be considered,
particularly in patients on high doses for prolonged periods that have co-existing
risk factors for osteoporosis.
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18. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Warnings
Effect on Growth: Orally inhaled corticosteroids may cause a reduction in growth
velocity when administered to pediatric patients.
Visual Disturbance: Visual disturbance may be reported with systemic and
topical corticosteroid use. If a patient presents with symptoms such as blurred
vision or other visual disturbances, the patient should be considered for referral
to an ophthalmologist for evaluation of possible causes.
Glaucoma and Cataracts: Glaucoma, increased intraocular pressure, and
cataracts have been reported in patients with asthma and COPD following the
long-term administration of inhaled corticosteroids, including Budesonide, a
component of Formoterol / Budesonide combination.
Coexisting Conditions: Formoterol/Budesonide combination, like all medications
containing sympathomimetic amines, should be used with caution in patients
with convulsive disorders or thyrotoxicosis, pheochromocytoma, diabetes
mellitus, and in those who are unusually responsive to sympathomimetic amines.
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19. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Warnings
Hypokalemia and Hyperglycemia: Beta-adrenergic agonist
medications may produce significant hypokalemia in some
patients, possibly through intracellular shunting, which has the
potential to produce adverse cardiovascular effects. The
decrease in serum potassium is usually transient, not requiring
supplementation.
Clinically significant changes in blood glucose and/or serum
potassium were seen infrequently during clinical studies with
Formoterol/Budesonide combination at recommended
doses.
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20. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Possible Side Effects
The common side effects seen in 3% or more of the patients in
clinical trials with asthmatic patients 12 years and older are:
nasopharyngitis, headache, upper respiratory tract infection,
pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal
congestion, stomach discomfort, vomiting and oral candidiasis.
The common side effects with an incidence of 3% or more in
clinical trials with duration of 12 weeks in adult COPD patients
are: nasopharyngitis, oral candidiasis, bronchitis, sinusitis, viral
upper respiratory tract infections.
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21. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Foracort Rotacaps Overdosage
Foracort contains both Budesonide and Formoterol; therefore, the risks
associated with overdosage for the individual components described
below apply to Foracort Rotacaps.
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.
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.

22. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Treatment of Foracort Rotacaps 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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23. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Foracort Rotacaps During Pregnancy
Budesonide and Formoterol Fumarate Dihydrate powder for
inhalation (Foracort Rotacaps) has been classified by the US FDA
as Pregnancy Category C.
For Formoterol/Budesonide combination or the concomitant
treatment with Formoterol and Budesonide, no clinical data on
exposed pregnancies are available. Data from an embryo-fetal
development study in the rat, showed no evidence of any
additional effect from the combination.
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.
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24. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Foracort Rotacaps During Pregnancy
During pregnancy, Foracort Rotacaps should only be used
when the benefits outweigh the potential risks. The lowest
effective dose of Budesonide needed to maintain adequate
asthma control should be used.
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25. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation)
© The Swiss Pharmacy
Foracort Rotacaps (Generic Budesonide and
Formoterol Fumarate Dihydrate powder for Inhalation)
are manufactured by Cipla Limited, India.
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