Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler)

Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler)
© The Swiss Pharmacy

Seroflo Inhaler (Fluticasone Propionate and Salmeterol
Xinafoate Inhaler) is used in the regular treatment of
asthma, where use of a combination (long-acting beta2-
agonist and inhaled corticosteroid) has been found to
be appropriate. This medicine is also used in the
maintenance treatment of airflow obstruction and
reducing exacerbations in patients with chronic
obstructive pulmonary disease (COPD).

Seroflo Inhalers (Fluticasone Propionate and Salmeterol
Xinafoate Inhalers) are manufactured by Cipla Limited, India.
They are available as Seroflo 50 Inhaler, Seroflo 125 Inhaler and
Seroflo 250 Inhaler.

Chemical Structure -Fluticasone Propionate

Chemical Structure - Salmeterol Xinafoate

The active ingredients
contained in Seroflo
inhaler are Fluticasone
Propionate and Salmeterol
Xinafoate.
Each actuation delivers 25
mcg Salmeterol (as
Salmeterol Xinafoate IP).
The quantity of Fluticasone
Propionate IP is 50 mcg, 125
mcg or 250 mcg.

Uses of Seroflo Inhaler 50, 125 and 250:
Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate
Inhaler) is a combination of two medicines that are used to help
control the symptoms of asthma and improve breathing. 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.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html

Uses of Seroflo Inhaler 50, 125 and 250:
Inhaled fluticasone belongs to the family of medicines known
as corticosteroids or steroids (cortisone-like medicines). It works
by preventing certain cells in the lungs and breathing passages
from releasing substances that cause asthma symptoms.
Inhaled salmeterol is a long-acting bronchodilator.
Bronchodilators are medicines that are breathed in through the
mouth to open up the bronchial tubes (air passages) in the
lungs. It relieves cough, wheezing, shortness of breath, and
troubled breathing by increasing the flow of air through the
bronchial tubes. Seroflo Inhaler is NOT indicated for the relief of
acute bronchospasm.

Recommended Adult Dosage
The dose of Seroflo Inhaler (Fluticasone and Salmeterol Inhaler)
for various indications is given below:
Treatment of Asthma in Adults and Adolescents (12 years and
older):
Seroflo 50 Inhaler: Two inhalations twice daily
Improvement in asthma control following inhaled administration
of Seroflo Inhaler can occur within 30 minutes of beginning
treatment, although maximum benefit may not be achieved for 1
week or longer after starting treatment.

Recommended Adult Dosage
Treatment of Chronic Obstructive Pulmonary Disease (COPD) in
Adults and Adolescents (12 years and older):
Seroflo Inhaler may be used with a Zerostat/ Zerostat VT
Spacer device in patients who find it difficult to synchronize
aerosol actuation with inspiration of breath.

Contraindications
➔
Seroflo Inhaler is contraindicated in patients with a known
hypersensitivity to Fluticasone Propionate, Salmeterol Xinafoate
or any component of the tablet.
➔
Administration of Seroflo Inhaler is contraindicated in the
primary treatment of status asthmaticus or other acute episodes
of asthma where intensive measures are required.

Storage Instructions
Seroflo Inhaler (Fluticasone Propionate and
Salmeterol Xinafoate 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.

Warnings
Serious Asthma-Related Events – Hospitalizations, Intubations, Death:
Use of long-acting beta2-adrenergic agonist (LABA) as monotherapy
(without inhaled corticosteroid (ICS)) for asthma is associated with an
increased risk of asthma-related death. Available data from controlled
clinical trials also suggest that use of LABA as monotherapy increases
the risk of asthma-related hospitalization in pediatric and adolescent
patients.
Deterioration of Disease and Acute Episodes: Seroflo Inhaler should
not be initiated in patients during rapidly deteriorating or potentially
life-threatening episodes of asthma. Fluticasone Propionate and
Salmeterol Xinafoate Inhaler (Seroflo Inhaler) has not been studied in
subjects with acutely deteriorating asthma.

Warnings
Excessive Use of Fluticasone and Salmeterol Inhaler and Use with Other
Long-acting Beta2-agonists: Seroflo Inhaler should not be used more often
than recommended, at higher doses than recommended, or in conjunction
with other medicines containing LABA, as an overdose may result. Clinically
significant cardiovascular effects and fatalities have been reported in
association with excessive use of inhaled sympathomimetic drugs.
Local Effects of Inhaled Corticosteroids: In clinical trials, the development of
localized infections of the mouth and pharynx with Candida albicans has
occurred in subjects treated with Seroflo Inhaler. When such an infection
develops, it should be treated with appropriate local or systemic (i.e., oral)
antifungal therapy while treatment with Seroflo Inhaler continues, but at times
therapy with Seroflo Inhaler may need to be interrupted. Advise the patient to
rinse his/her mouth with water without swallowing following inhalation to
help reduce the risk of oropharyngeal candidiasis.

Warnings
Pneumonia: Lower respiratory tract infections, including pneumonia,
have been reported in patients with chronic obstructive pulmonary
disease (COPD) following the inhaled administration of corticosteroids,
including Fluticasone Propionate and Fluticasone and Salmeterol
Inhaler.
Immunosuppression: Persons who are using medicines that suppress
the immune system are more susceptible to infections than healthy
individuals. Chickenpox and measles, for example, can have a more
serious or even fatal course in susceptible children or adults using
corticosteroids. In such children or adults who have not had these
diseases or been properly immunized, particular care should be taken
to avoid exposure.

Warnings
Transferring Patients from Systemic Corticosteroid Therapy: Particular
care is needed for patients who have been transferred from
systemically active corticosteroids to ICS because deaths due to
adrenal insufficiency have occurred in patients with asthma during and
after transfer from systemic corticosteroids to less systemically
available ICS. After withdrawal from systemic corticosteroids, a number
of months are required for recovery of hypothalamic-pituitary-adrenal
(HPA) function.

Possible Side Effects
Most common Fluticasone Propionate and Salmeterol Xinafoate
Inhaler (Seroflo Inhaler) side effects that occurred during Clinical
trials with an incidence rate of greater than or equal to 3% in the
groups receiving the medicine and at a greater incidence than with
placebo were:
Ear, nose, and throat: Upper respiratory tract infection, pharyngitis,
upper respiratory inflammation, sinusitis, hoarseness/dysphonia,
candidiasis of mouth/throat, throat irritation
Lower respiratory: Viral respiratory infections, bronchitis, cough
Neurology: Headache, dizziness

Possible Side Effects
Gastrointestinal: Nausea and vomiting, gastrointestinal
discomfort and pain, diarrhea, viral gastrointestinal infections
Non-site specific: Candidiasis unspecified site, fever, malaise,
and fatigue
Musculoskeletal: Musculoskeletal pain, muscle cramps and
spasms, traumatic fractures, arthralgia, myalgia

Overdosage
There are no data available from clinical trials on overdose with
Fluticasone Propionate and Salmeterol Xinafoate Inhaler (Seroflo
Inhaler). However data on overdose with both the individual medicines
are given below:
The signs and symptoms of salmeterol overdose are tremor, headache
and tachycardia. The preferred antidotes are cardioselective beta-
blocking agents, which should be used with caution in patients with a
history of bronchospasm. In case Seroflo Inhaler therapy has to be
withdrawn due to overdose of the beta agonist component of the drug,
provision of appropriate replacement steroid therapy should be
considered.
Additionally, hypokalaemia can occur and potassium replacement
should be considered.

Overdosage
Acute: Acute inhalation of Fluticasone Propionate doses in excess of
those recommended may lead to temporary suppression of adrenal
function. This does not need emergency action as adrenal function is
recovered in a few days, as verified by plasma cortisol measurements.
Chronic Overdose of Inhaled Fluticasone Propionate: Adrenal reserve
should be monitored and treatment with a systemic corticosteroid may
be necessary. When stabilised, treatment should be continued with an
inhaled corticosteroid at the recommended dose. In cases of both
acute and chronic Fluticasone Propionate overdose SFC therapy may
still be continued at a suitable dosage for symptom control.

Seroflo Inhaler During Pregnancy
Fluticasone Propionate and Salmeterol Xinafoate Inhaler (Seroflo Inhaler)
has been classified by the US FDA as Pregnancy Category C.
There are no adequate and well-controlled studies with Fluticasone
Propionate and Salmeterol Xinafoate Inhaler (Seroflo Inhaler) in pregnant
women. Fluticasone and Salmeterol Inhaler was teratogenic in mice and
not in rats, although it lowered fetal weight in rats. Fluticasone propionate
alone was teratogenic in mice, rats, and rabbits, and Salmeterol alone
was teratogenic in rabbits and not in rats. From the reproduction toxicity
studies in mice and rats, no evidence of enhanced toxicity was seen
using combinations of Fluticasone Propionate and Salmeterol Xinafoate
when compared with toxicity data from the components administered
separately.
Seroflo Inhaler should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.

Seroflo Inhaler (Fluticasone Propionate and
Salmeterol Xinafoate Inhaler) is manufactured by
Cipla Limited, India.

Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler)

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