Seroflo Rotacaps (Fluticasone Propionate and Salmeterol)

Fluticasone Propionate and Salmeterol Rotacaps

Clearsky Pharmacy

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).

Seroflo Rotacaps

Clearsky Pharmacy

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

Fluticasone Propionate & Salmeterol Rotacaps Brand Names

Clearsky Pharmacy

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

Active Ingredients

Clearsky Pharmacy

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

Chemical Structure

Clearsky Pharmacy

The structure of Salmeterol is given below:

Chemical Structure

Clearsky Pharmacy

The structure of Fluticasone Propionate is given below:

Uses of Seroflo Rotacaps

Clearsky Pharmacy

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).

Storage Instructions

Clearsky Pharmacy

Seroflo Rotacaps have to be stored at controlled room temperature i.e. from 20C to 25C (68F to 77F) with excursions permitted between 15 to 30C (59 to 86F). Keep this as well as all other medicines away from children and pets.

Seroflo Rotacaps Dosage

Clearsky Pharmacy

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:

Seroflo Rotacaps Dosage

Clearsky Pharmacy

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:

Warnings

Clearsky Pharmacy

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.

Warnings

Clearsky Pharmacy

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.

Warnings

Clearsky Pharmacy

Coexisting conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosisMetabolic 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.

Seroflo Rotacaps

Clearsky Pharmacy

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.

Seroflo Rotacaps Side Effects

Clearsky Pharmacy

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

Seroflo Rotacaps Overdose

Clearsky Pharmacy

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.

Seroflo Rotacaps Overdose

Clearsky Pharmacy

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.

Seroflo Rotacaps During Pregnancy

Clearsky Pharmacy

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.

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Clearsky Pharmacy

Seroflo Rotacaps (Fluticasone Propionate and Salmeterol Powder for Inhalation) by Cipla Limited.