Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)

Duolin Rotacaps (Generic Ipratropium Bromide And Levosalbutamol Sulphate (Levalbuterol Sulphate) Rotacaps) are used for the treatment or prevention of bronchospasm in adults, adolescents, and children (4 years of age and older) with reversible obstructive airway diseases like asthma and COPD, including chronic bronchitis and emphysema.
Duolin Rotacaps are a combination of an anticholinergic and beta-adrenergic used for patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

1. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy

2. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Duolin Rotacaps (Generic Ipratropium Bromide And
Levosalbutamol Sulphate (Levalbuterol Sulphate)
Rotacaps) are used for the treatment or prevention of
bronchospasm in adults, adolescents, and children (4 years
of age and older) with reversible obstructive airway diseases
like asthma and COPD, including chronic bronchitis and
emphysema.
Duolin Rotacaps are a combination of an anticholinergic
and beta-adrenergic used for patients with chronic
obstructive pulmonary disease (COPD) on a regular aerosol
bronchodilator who continue to have evidence of
bronchospasm and who require a second bronchodilator.

3. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Duolin Rotacaps are manufactured
by Cipla Limited, India in the strength
of 140mcg (40 mcg of Ipratropium
Bromide and 100mcg of
Levosalbutamol).

4. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Ipratropium Bromide Chemical Structure

5. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Levalbuterol Sulphate Chemical Structure

6. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
The active ingredients contained in Duolin
Rotacaps are Ipratropium Bromide and
Levalbuterol Sulphate (Levosalbutamol Sulphate).
Each puff contains 100 mcg of Levalbuterol
(Levosalbutamol) and 40 mcg of Ipratropium
Bromide.

7. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Uses of Duolin Rotacaps :
Duolin Rotacaps (Ipratropium Bromide and Levalbuterol Sulphate)
combination is used to help control the symptoms (wheezing and shortness
of breath) of lung diseases, such as asthma, and chronic obstructive
pulmonary disease-COPD which includes chronic bronchitis and
emphysema. It is also used to treat air flow blockage and prevent the
worsening of chronic obstructive pulmonary disease (COPD) in patients who
need another medicine.
Ipratropium Bromide and Levalbuterol Sulphate belong to the family of
medicines known as bronchodilators. Bronchodilators are medicines that are
breathed in through the mouth to open up the bronchial tubes (air passages)
in the lungs.
Both drugs work by relaxing the muscles around the airways so that they
open up and you can breathe more easily. Controlling symptoms of
breathing problems can decrease time lost from work or school.
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8. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Recommended Adult Dosage
The dosage of Duolin Rotacaps (Generic Ipratropium and
Levalbuterol Rotacaps) is is 1 rotacap, four times a day.
Patients may take additional inhalations as required; however,
the total number of rotacaps should not exceed 6 in 24 hours.
Duolin Rotacaps should be used only with the Cipla
Rotahaler/ Revolizer.
Duolin Rotacaps must not be swallowed.
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9. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Recommended Adult Dosage
Duolin Rotacaps (Generic Ipratropium and Levalbuterol
Rotacaps) are used in a plastic device called a Rotahaler.
When used in your Cipla Rotahaler (Generic HandiHaler
device), your Duolin Rotacaps provide a measured
amount of medicine for you to breathe into your lungs.
Your Duolin Rotacaps help you to breathe more easily.
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10. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
How To Use The Rotahaler:
1.Hold the Rotahaler vertically and position the two halves of the Rotahaler
such that the fin is not directly below the rotacap hole.
2.Remove the rotacap from its bottle and insert it into the rotacap hole with
its transparent end facing downwards
3.Hold the mouth piece firmly with one hand and rotate the base
4.Breathe out fully and place the mouthpiece of the Rotahaler between your
teeth.
5.Close your lips tightly around it & tilt your head slightly backward &
breathe in through the mouth rapidly & deeply.
6.Hold your breath for 10 seconds or for as long as you are comfortable and
then breathe out normally. In case some powder remains repeat step 4.
7.Open the Rotahaler and dispose the empty capsule.
8.You can continue to use your Rotahaler daily for up to 6 months. Then
discard it and replace with a new one.

11. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Contraindications
➔Duolin Rotacaps are contraindicated in patients with a known
hypersensitivity to Ipratropium Bromide, Levosalbutamol
Sulphate Racemic Albuterol or any component of the tablet.
Reactions have included urticaria, angioedema, rash,
bronchospasm, anaphylaxis, and oropharyngeal edema
➔Administration of Ipratropium bromide is contraindicated in
patients who are hypersensitive to atropine or its derivatives.
➔Duolin Rotacaps are contraindicated in patients with a history of
hypersensitivity to soya lecithin or related food products such as
soybean and peanut.
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12. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Storage Instructions
Duolin Rotacaps (Generic Ipratropium Bromide And
Levalbuterol Sulphate Rotacaps) 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. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Warnings
Paradoxical Bronchospasm: Discontinue Duolin Rotacaps immediately and
treat with alternative therapy if paradoxical bronchospasm occurs.
Deterioration of Asthma: Asthma may deteriorate acutely over a period of
hours or chronically over several days or longer. If the patient needs more
doses of Levosalbutamol (Levalbuterol) than usual, this may be a marker of
destabilization of asthma and requires re-evaluation of the patient and
treatment regimen.
Use of Anti-Inflammatory Agents: The use of a beta-adrenergic agonist alone
may not be adequate to control asthma in many patients. Early consideration
should be given to adding anti-
­inflammatory agents, e.g., corticosteroids, to
the therapeutic regimen.
Patients with cardiovascular system disorders: Like other beta-adrenergic agonists, the
Levosalbutamol sulphate contained in Duolin Rotacaps can produce clinically
significant cardiovascular effects in some patients, as measured by pulse rate, blood
pressure and/or symptoms. Use with caution because of beta-adrenergic stimulation.

14. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Warnings
Ocular effects: Advise patients to avoid spraying into eyes and to contact a
physician if blurred vision, halos, or other visual disturbances occur. Monitor
patients with narrow-angle glaucoma.
Do Not Exceed Recommended Dose: Fatalities have been reported in
association with excessive use of inhaled sympathomimetic drugs in patients
with asthma. The exact cause of death is unknown, but cardiac arrest
following an unexpected development of a severe acute asthmatic crisis and
subsequent hypoxia is suspected.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions
may occur after administration of Ipratropium Bromide or racemic Salbutamol
(Albuterol), as demonstrated by rare cases of urticaria, angioedema, rash,
bronchospasm, anaphylaxis, and oropharyngeal edema. In case such a
reaction occurs, Duolin Rotacaps must be stopped at once and alternative
treatment should be considered.

15. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Warnings
Urinary retention: Use with caution in patients with prostatic
hyperplasia or bladder-neck obstruction
Coexisting conditions: Levalbuterol (Levosalbutamol), like all
sympathomimetic amines, should be used with caution in patients with
cardiovascular disorders, especially coronary insufficiency,
hypertension, and cardiac arrhythmias; in patients with convulsive
disorders, hyperthyroidism, or diabetes mellitus; and in patients who
are unusually responsive to sympathomimetic amines.
Ipratropium Bromide: Ipratropium bromide is a bronchodilator for the
maintenance treatment of bronchospasm associated with COPD and is
not indicated for the initial treatment of acute episodes of
bronchospasm, where rescue therapy is required for rapid response.
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16. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Possible Side Effects
Use of Levalbuterol (Levosalbutamol) may be associated with the
following serious side effects: Paradoxical bronchospasm,
Cardiovascular effects, Immediate hypersensitivity reactions and
Hypokalemia.
Following side effects were observed in 2% or more of the patients
receiving Levalbuterol inhalation or racemic Albuterol and more
frequently than in patients receiving placebo during placebo-
controlled trial in patients with asthma 12 years of age and older:
Allergic reaction, Flu syndrome, Accidental injury, Pain, Back pain,
Tachycardia, Migraine, Dyspepsia, Leg cramps, Dizziness, Hypertonia,
Nervousness, Tremor, Anxiety, Cough increased, Infection viral,
Rhinitis, Sinusitis and Turbinate edema.
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17. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Possible Side Effects
Ipratropium Bromide inhalation side effects reported by three
percent or more patients in the 12-week controlled clinical
trials from 12-week active-controlled clinical trials are
Headache, Pain, Influenza-like symptoms, Back Pain, Chest
Pain, Hypertension/Hypertension Aggravated, Dizziness,
Insomnia, Tremor, Nervousness, Mouth Dryness, Nausea,
Constipation, Arthritis, Coughing, Dyspnea, Bronchitis,
Bronchospasm, Sputum Increased, Respiratory Disorder,
Upper Respiratory Tract Infection, Pharyngitis, Rhinitis and
Sinusitus.
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18. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Overdosage
Levalbuterol Sulphate: The expected symptoms with overdosage are those of
excessive beta-adrenergic receptor stimulation and/or occurrence or
exaggeration of any of the symptoms listed under adverse reactions, e.g.,
seizures, angina, hypertension or hypotension, tachycardia with rates up to
200 beats/minute, arrhythmias, nervousness, headache, tremor, dry mouth,
palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness.
Hypokalemia may also occur. As with all sympathomimetic medications,
cardiac arrest and, even, death may be associated with the abuse of
Levalbuterol (Levosalbutamol).
Ipratropium Bromide: Dose of Ipratropium Bromide up to 1.2 mg (60 puffs)
have been administered by inhalation without the appearance of serious
systemic anticholinergic effects. Minor systemic manifestations of
anticholinergic action, including dry mouth, visual accommodation disorder
and increase of heart rate may occur.

19. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Treatment of Duolin Rotacaps Overdosage
Levalbuterol Sulphate: Treatment consists of discontinuation of Levalbuterol
Sulphate (Levosalbutamol) together with appropriate symptomatic 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 in treating overdosage of Levalbuterol.
Ipratropium Bromide: Should signs of serious anticholinergic toxicity appear,
cholinesterase inhibitors may be considered.
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20. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Duolin Rotacaps During Pregnancy
Ipratropium Bromide and Levalbuterol Sulphate Rotacaps (Duolin
Rotacaps) has been classified by the US FDA as Pregnancy Category
C.
There are no adequate and well-controlled studies of Ipratropium
Bromide and Levalbuterol Sulphate combination Rotacaps (Duolin
Rotacaps) in pregnant women.
Because animal reproduction studies are not always predictive of
human response, Duolin Rotacaps should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
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21. Duolin Rotacaps (Generic Ipratropium Bromide And Levalbuterol Sulphate Rotacaps)
© The Swiss Pharmacy
Duolin Rotacaps (Generic Ipratropium And
Levalbuterol Rotacaps) are manufactured by Cipla
Limited, India.
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