Foratec Rotacaps (Generic Formoterol Fumarate Powder for Inhalation)

Foratec Rotacaps (Formoterol Fumarate Inhalation Powder)
© The Swiss Pharmacy

Foratec Rotacaps (Generic Formoterol Fumarate Powder for
Inhalation) are indicated in adults and children (5 years and older)
for the treatment of asthma as an add-on to a long-term asthma
control medication such as an inhaled corticosteroid.
Foratec Rotacaps are also indicated for the prevention of exercise-
induced bronchospasm (EIB) in patients in patients 5 years and
older and for the maintenance treatment of airflow obstruction in
patients with COPD including chronic bronchitis and emphysema.
Foratec rotacaps have to be used with an appropriate inhaler i.e.
Cipla Rotahaler.
This medicine is not indicated for the relief of acute bronchospasm.

Foratec Rotacaps are manufactured
by Cipla Limited, India in the
strengths of 12 mcg.

Formoterol Fumarate Dihydrate - Chemical Structure

The active ingredient contained in
Foratec rotacaps is Formoterol Fumarate
Dihydrate.
Each Foratec rotacap contains 12 mcg of
Formoterol Fumarate Dihydrate.

Uses of Foratec Rotacaps (Generic Formoterol Fumarate
Powder for Inhalation):
Foratec Rotacaps (Formoterol Fumarate Inhalation Powder) is a long-acting
bronchodilator. Foratec is used to prevent asthma attacks or exercise-induced
bronchospasm in adults and children who are at least 5 years old.
Foratec Rotacaps is also used to prevent bronchospasm in adults with chronic
obstructive pulmonary disease(COPD), including emphysema and chronic
bronchitis.
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.
We also have Budesonide and Formoterol Fumarate Dihydrate powder for
inhalation (Foracort Rotacaps) which is also used to treat the same indications.

Recommended Dosage
The dosage of
Foratec Rotacaps (Generic Formoterol Fumarate Powder for Inhalation)
for various indications is given below:
Treatment Of Asthma in Patients 5 years and Above: The recommended
dosage is inhalation of one capsule every 12 hours in addition to
concomitant treatment with a long-term control medication such as an
inhaled corticosteroid.
Exercise Induced Bronchospasm (EIB): Inhalation of one capsule at least
15 minutes before exercise. Additional doses should not be used for 12
hours.
Maintenance Treatment Of Bronchoconstriction In Patients With COPD:
Inhalation of one capsule every 12 hours.

Recommended 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.
This medicine is for oral inhalation only. DO NOT swallow capsule.
Foratec capsule should be always used with with an appropriate inhaler
i.e. Cipla Rotahaler inhaler.

Contraindications
➔Foratec Rotacaps are contraindicated in patients with a known
hypersensitivity to Formoterol Fumarate, or any component of
the medication.
➔
Asthma: Without concomitant use of a long-term asthma
control medication such as an inhaled corticosteroid.
➔
Foratec Rotacaps (Formoterol Fumarate) is contraindicated
in patients with cardiac tachyarrhythmias.

Storage Instructions
Foratec Rotacaps (Generic Formoterol Fumarate
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.

Warnings
Long-acting beta2-adrenergic agonists (LABA), such as Formoterol Fumarate the
active ingredient in Foratec Rotacaps, increase the risk of asthma-related death. A
large placebo-controlled study with another LABA (Salmeterol) showed an
increase in asthma-related deaths in patients receiving Salmeterol. This finding
with Salmeterol is considered a class effect of LABA, including Formoterol.
Asthma-Related Deaths And Asthma-Related Hospitalizations: Long-acting
beta2-adrenergic agonists (LABA) increase the risk. Prescribe for asthma only as
concomitant therapy with a long-term control medication such as an inhaled
corticosteroid.
Deterioration of Asthma and Acute Episodes: Do not initiate during acutely
deteriorating asthma. Do not use to treat acute symptoms.

Warnings
Corticosteroids: Not a substitute for corticosteroids. Corticosteroids should
not be stopped or reduced when Foratec Rotacaps (Generic Formoterol
Fumarate Powder for Inhalation) is started.
Use With Additional Long-Acting Beta2-Agonist: Do not use in
combination because of risk of overdose.
Paradoxical Bronchospasm: Discontinue Foratec Rotacaps and institute
alternative therapy if paradoxical bronchospasm occurs.
Patients With Cardiovascular or Central Nervous System Disorders: Use
with caution because of beta-adrenergic stimulation.

Warnings
Coexisting Conditions: Use with caution in patients with convulsive
disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
Metabolic Effects: Be alert to hypokalemia and hyperglycemia.

Possible Side Effects
Most common Formoterol Fumarate Powder for Inhalation
(Foratec Rotacaps) side effects with an incidence rate of 1% and
more common than placebo are:
Treatment of Asthma: viral infection, bronchitis, chest infection,
dyspnea, chest pain, tremor, dizziness, insomnia, tonsillitis, rash,
dysphonia, and serious asthma exacerbation.
Treatment of COPD: Upper respiratory tract infection, back pain,
pharyngitis, chest pain, sinusitis, fever, leg cramps, muscle cramps,
anxiety, pruritus, increased sputum, and dry mouth.

Foratec Rotacaps Overdosage
The expected signs and symptoms with overdosage of Foratec Rotacaps are those
of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any
of the side effects, e.g., angina, hypertension or hypotension, tachycardia, with
rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, seizures,
muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise,
hypokalemia, hyperglycemia, and insomnia. Metabolic acidosis may also occur.
Cardiac arrest and even death may be associated with an overdose of Foratec
Rotacaps.
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.

Treatment of Foratec Rotacaps Overdosage
Treatment of overdosage consists of discontinuation of Foratec
Rotacaps 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 Foratec Rotacaps. Cardiac monitoring is
recommended in cases of overdosage.

Foratec Rotacaps During Pregnancy
Formoterol Fumarate Powder for Inhalation (Foratec Rotacaps) has
been classified by the US FDA as Pregnancy Category C.
There are no adequate and well-controlled studies of Formoterol
Fumarate Powder for Inhalation (Foratec Rotacaps) in pregnant
women. Animal reproduction studies of Formoterol Fumarate in rats
and rabbits revealed evidence of teratogenicity as well as other
developmental toxic effects. Because there are no adequate and well-
controlled studies in pregnant women, Foratec Rotacaps should be
used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.

Foratec Rotacaps During Pregnancy
Formoterol Fumarate administered throughout organogenesis did not
cause malformations in rats or rabbits following oral administration.
When given to rats throughout organogenesis, oral doses equal to or
greater than 80 times the maximum recommended human dose
(MRHD) for adults (on a mcg/m2 basis for maternal doses of 0.2 mg/kg
and above) delayed ossification of the fetus and doses equal to or
greater than 2,400 times the MRHD for adults (on a mcg/m2 basis for
maternal doses of 6 mg/kg and above) decreased fetal weight.

Foratec Rotacaps are manufactured by
Cipla Limited, India.
For More details Click Here

Foratec Rotacaps (Generic Formoterol Fumarate Powder for Inhalation)

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