Flutispray-Plus
Generic Name
Fluticasone Furoate + Azelastine Hydrochloride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
flutispray plus 137 mcg nasal spray | ৳ 320.00 | N/A |
Description
Overview of the medicine
Flutispray-Plus is a combination nasal spray containing fluticasone furoate, a corticosteroid, and azelastine hydrochloride, an antihistamine. It is used to relieve symptoms of seasonal and perennial allergic rhinitis.
Uses & Indications
Dosage
Adults
Adults and adolescents 12 years and older: 1 spray in each nostril twice daily.
Elderly
No dosage adjustment is required for elderly patients.
Renal_impairment
No dosage adjustment is required for patients with renal impairment due to low systemic absorption.
Hepatic_impairment
No dosage adjustment is required for patients with hepatic impairment due to low systemic absorption.
How to Take
For intranasal use only. Shake the bottle gently before each use. Prime the pump before first use or if not used for more than 7 days. Insert the nozzle into the nostril, pointing slightly away from the septum, and spray while breathing in gently. Avoid blowing your nose immediately after use.
Mechanism of Action
Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. Azelastine hydrochloride is a phthalazinone derivative with antihistaminic and mast cell stabilizing properties.
Pharmacokinetics
Onset
Azelastine: within 15-30 minutes; Fluticasone furoate: several hours to days for full therapeutic effect.
Excretion
Primarily fecal for fluticasone furoate and metabolites; primarily fecal for azelastine with some renal excretion.
Half life
Fluticasone furoate: approximately 15.1 hours; Azelastine: approximately 25 hours.
Absorption
Low systemic absorption for both components after intranasal administration. Fluticasone furoate bioavailability is <1%. Azelastine bioavailability is ~40%.
Metabolism
Primarily hepatic (CYP3A4 for fluticasone furoate; multiple CYP isoforms for azelastine).
Side Effects
Contraindications
- Hypersensitivity to fluticasone furoate, azelastine hydrochloride, or any excipients.
- Untreated localized infection involving the nasal mucosa.
Drug Interactions
CNS Depressants
Concomitant use with alcohol or other CNS depressants may enhance CNS depression effects of azelastine, such as somnolence.
CYP3A4 Inhibitors
Coadministration with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) may increase systemic exposure to fluticasone furoate, potentially leading to Cushing's syndrome or adrenal suppression.
Storage
Store upright below 30°C (86°F). Do not freeze. Protect from light. Keep out of reach of children.
Overdose
Acute overdose is unlikely with intranasal administration. Symptoms may include mild systemic corticosteroid effects with fluticasone furoate or drowsiness with azelastine. Management is supportive and symptomatic.
Pregnancy & Lactation
Use during pregnancy and lactation only if the potential benefit justifies the potential risk to the fetus or infant. Consult a physician. (Pregnancy Category C for Fluticasone Furoate, Category C for Azelastine Hydrochloride).
Side Effects
Contraindications
- Hypersensitivity to fluticasone furoate, azelastine hydrochloride, or any excipients.
- Untreated localized infection involving the nasal mucosa.
Drug Interactions
CNS Depressants
Concomitant use with alcohol or other CNS depressants may enhance CNS depression effects of azelastine, such as somnolence.
CYP3A4 Inhibitors
Coadministration with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) may increase systemic exposure to fluticasone furoate, potentially leading to Cushing's syndrome or adrenal suppression.
Storage
Store upright below 30°C (86°F). Do not freeze. Protect from light. Keep out of reach of children.
Overdose
Acute overdose is unlikely with intranasal administration. Symptoms may include mild systemic corticosteroid effects with fluticasone furoate or drowsiness with azelastine. Management is supportive and symptomatic.
Pregnancy & Lactation
Use during pregnancy and lactation only if the potential benefit justifies the potential risk to the fetus or infant. Consult a physician. (Pregnancy Category C for Fluticasone Furoate, Category C for Azelastine Hydrochloride).
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years unopened. Discard 6 months after first opening.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of fluticasone furoate/azelastine hydrochloride nasal spray in treating allergic rhinitis symptoms.
Lab Monitoring
- Not routinely required. However, for long-term use, monitor for signs of systemic corticosteroid effects, especially in children.
Doctor Notes
- Emphasize proper administration technique to ensure optimal drug delivery and minimize local side effects.
- Counsel patients on the potential for drowsiness, especially when initiating therapy.
- Advise patients that full therapeutic benefit may not be observed for several days and consistent use is important.
Patient Guidelines
- Read the patient information leaflet carefully before use.
- Shake the bottle well before each use.
- Use regularly as prescribed, even when symptoms improve.
- Avoid spraying into the eyes or directly onto the nasal septum.
- Clean the spray nozzle regularly.
Missed Dose Advice
If a dose is missed, take the next dose at the usual time. Do not double the dose to compensate for a missed dose.
Driving Precautions
Azelastine may cause drowsiness or fatigue in some individuals. Patients should be cautioned about engaging in activities requiring mental alertness, such as driving or operating machinery, until they know how the medication affects them.
Lifestyle Advice
- Identify and avoid known allergens.
- Maintain good nasal hygiene.
- Avoid irritants like smoke and strong fumes.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.