Seroflo Rotacaps (Fluticasone Propionate and Salmeterol Powder for Inhalation) is a combination product containing a corticosteroid and a Long-acting beta2-adrenergic agonists (LABAs) used for treatment of asthma in patients aged 4 years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

1. Fluticasone Propionate and Salmeterol Rotacaps
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Seroflo Rotacaps (Fluticasone
Propionate and Salmeterol
Powder for Inhalation) is a
combination product containing
a corticosteroid and a Long-
acting beta2-adrenergic
agonists (LABAs) used for
treatment of asthma in patients
aged 4 years and older and
maintenance treatment of
airflow obstruction and reducing
exacerbations in patients with
chronic obstructive pulmonary
disease (COPD).

2. Seroflo Rotacaps
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Seroflo Rotacaps (Fluticasone
Propionate and Salmeterol Powder for
Inhalation) are manufactured by Cipla
Ltd. , India.
(Website: www.cipla.com)

3. Fluticasone Propionate & Salmeterol Rotacaps – Brand Names
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Fluticasone Propionate and
Salmeterol Powder for Inhalation is
available as Advair, Seroflo, Flutrol
CAP, Forair Novocart, Rheoran-SF
Rheocaps and Vent SF Easecaps.

4. Active Ingredients
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The active ingredients contained in Seroflo
Rotacaps are Fluticasone Propionate and
Salmeterol.
Each SEROFLO 250 Rotacap contains:
Salmeterol (As Salmeterol Xinafoate IP) 50
mcg and Fluticasone Propionate IP 250 mcg
and each SEROFLO 500 Rotacap contains:
Salmeterol (As Salmeterol Xinafoate IP) 50
mcg and Fluticasone Propionate IP 500 mcg

5. Chemical Structure
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The structure of Salmeterol is given below:

6. Chemical Structure
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The structure of Fluticasone Propionate is given below:

7. Uses of Seroflo Rotacaps
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Seroflo Rotacaps (Fluticasone Propionate
and Salmeterol Rotacaps) is a combination
product containing a corticosteroid and a
long-acting beta2-adrenergic agonist used
for the maintenance treatment of asthma in
patients 4 years of age and older.
Maintenance treatment of airflow obstruction
and reducing exacerbations in patients with
chronic obstructive pulmonary disease
(COPD).

8. Storage Instructions
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Seroflo 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.

9. Seroflo Rotacaps Dosage
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➢ Asthma Treatment In Adults and Adolescents
(12 years and older): SEROFLO-250 Rotacaps:
One rotacap twice daily or SEROFLO-500
Rotacaps One rotacap twice daily depending on
severity.
Seroflo Rotacaps must be inhaled with the Cipla
Rotahaler/Revolizer device. Seroflo Rotacaps
should not be swallowed.
The starting dosage is based on asthma severity.
The dosage of Seroflo Rotacaps (Fluticasone
Propionate and Salmeterol) is given below:

10. Seroflo Rotacaps Dosage
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➢COPD Treatment In Adults: SEROFLO-250
Rotacaps: One rotacap twice daily or
SEROFLO-500 Rotacaps: One rotacap twice
daily depending on severity.
The dosage of Seroflo Rotacaps (Fluticasone
Propionate and Salmeterol) is given below:

11. Warnings
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Long-acting beta2-adrenergic agonists, such as
Salmeterol, one of the active ingredients in
Seroflo Rotacaps, may increase the risk of
asthma-related death.
When treating patients with asthma, only
prescribe Seroflo Rotacaps for patients not
adequately controlled on other asthma-controller
medications or whose disease severity clearly
requires initiation of treatment with 2 maintenance
therapies.
Do not start treatment in acutely deteriorating
asthma or to treat acute symptoms.

12. Warnings
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Do not use in combination with additional long-acting
beta2-agonist because of risk of overdose.
Candida albicans infection of the mouth and throat may
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.
Immunosuppression: Potential worsening of infections
(e.g., existing tuberculosis, fungal, bacterial, viral, or
parasitic infection; or ocular herpes simplex).
Hypercorticism and adrenal suppression: May occur with
very high dosages or at the regular dosage in
susceptible individuals.

13. Warnings
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Coexisting conditions: Use with caution in patients with
convulsive disorders, thyrotoxicosis, diabetes mellitus, and
ketoacidosis
Metabolic effects: Be alert to eosinophilic conditions,
hypokalemia, and hyperglycemia.
Effects on growth: Monitor the growth of pediatric patients.
Glaucoma and cataracts: Close monitoring is required.
Paradoxical bronchospasm: Discontinue Seroflo Rotacaps
and institute alternative therapy in case paradoxical
bronchospasm occurs.
Patients with cardiovascular or central nervous system
disorders: Use with caution in such patients because of beta-
adrenergic stimulation.
Decreases in bone mineral density: Assess bone mineral
density initially and periodically thereafter.

14. Seroflo Rotacaps
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Contraindications
Seroflo Rotacaps are contraindicated in patients
with a hypersensitivity to Fluticasone Propionate,
Salmeterol or any other component of this
medication.
The use of Seroflo Rotacaps is contraindicated in
primary treatment of status asthmaticus or other
acute episodes of asthma or COPD where
intensive measures are necessary.
This medicine is also contradicted in patients with
severe hypersensitivity to milk proteins.

15. Seroflo Rotacaps Side Effects
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➢Most common side effects of Seroflo
Rotacaps with an incidence rate of 3% or more
observed during treatment of:
➢Asthma: upper respiratory tract infection or
inflammation, pharyngitis, dysphonia, oral
candidiasis, bronchitis, cough, headaches,
nausea and vomiting.
➢COPD: pneumonia, oral candidiasis, throat
irritation, dysphonia, viral respiratory infections,
headaches, musculoskeletal pain

16. Seroflo Rotacaps Overdose
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Fluticasone Propionate: Chronic overdosage with
Fluticasone Propionate can result in signs/symptoms of
hypercorticism.
Salmeterol: The expected signs and symptoms with
overdosage of Salmeterol are those of excessive beta-
adrenergic stimulation and/or occurrence or exaggeration
of any of the following: seizures, angina, hypertension or
hypotension, tachycardia with rates up to 200 beats/min,
arrhythmias, nervousness, headache, tremor, muscle
cramps, dry mouth, palpitation, nausea, dizziness, fatigue,
malaise, and insomnia.
Overdosage with Salmeterol may lead to clinically
significant prolongation of the QTc interval, which can
produce ventricular arrhythmias. Other symptoms of
overdosage may include hypokalemia and hyperglycemia.

17. Seroflo Rotacaps Overdose
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Treatment for overdose consists of immediate
discontinuation of Salmeterol along 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 for overdosage of
salmeterol.
Cardiac monitoring is recommended in cases
of overdosage.

18. Seroflo Rotacaps During Pregnancy
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Seroflo Rotacaps (Fluticasone Propionate and
Salmeterol) has been classified by the US FDA as
Pregnancy Category C. There are no adequate and
well-controlled trials with Fluticasone Propionate and
Salmeterol Rotacaps in pregnant women.
Corticosteroids and beta2-agonists have been observed
to be teratogenic in laboratory animals when
administered systemically at relatively low dosage
levels.
Administration of Seroflo Rotacaps to pregnant women
must only be considered if the expected benefit to the
mother is greater than any possible risk to the foetus.
The lowest effective dose of Fluticasone Propionate
required to maintain adequate asthma control should be
used in the treatment of pregnant women.

19. For more details on
Seroflo Rotacaps click here
© Clearsky Pharmacy
Seroflo Rotacaps (Fluticasone Propionate and
Salmeterol Powder for Inhalation) by Cipla Limited.