Flutispray Plus(137 mcg+50 mcg)/spray

Flutispray Plus is a fixed-dose combination intranasal spray that pairs an intranasal antihistamine (azelastine) with an intranasal corticosteroid (fluticasone) in a single metered-dose device. It is used for the symptomatic relief of allergic rhinitis.

• Seasonal allergic rhinitis (established/FDA-approved use): relief of nasal symptoms such as sneezing, rhinorrhea, nasal itching and nasal congestion in patients 6 years of age and older who require treatment with both an intranasal antihistamine and an intranasal corticosteroid for adequate control.
• Perennial allergic rhinitis (established/FDA-approved use): relief of nasal symptoms in patients 12 years of age and older who require combination intranasal antihistamine-corticosteroid therapy.

Flutispray Plus is intended for patients whose symptoms are not adequately controlled with either an intranasal antihistamine or an intranasal corticosteroid used alone; it is not recommended as a routine first-line monotherapy and should be used only when combination therapy is clinically indicated.

Each metered spray of Azelastine Hydrochloride + Fluticasone Propionate nasal spray delivers azelastine hydrochloride 137 micrograms and fluticasone propionate 50 micrograms per actuation, in an aqueous suspension base intended for intranasal use.

Flutispray Plus is a fixed-dose combination nasal spray combining a second-generation antihistamine with a synthetic corticosteroid, delivered directly onto the nasal mucosa. Combining both agents in a single device targets the multiple mediators (histamine and other inflammatory mediators) responsible for the symptoms of allergic rhinitis, and is intended for patients who need the additive effect of both drug classes.

The combination is supplied as a metered-dose pump spray for intranasal administration and is not intended for oral, ophthalmic, or injectable use.

Flutispray Plus belongs to the therapeutic class of intranasal antihistamine–corticosteroid combination preparations, used in the management of allergic rhinitis. It combines a topical H1-antihistamine with a topical corticosteroid.

Azelastine Hydrochloride + Fluticasone Propionate combines two complementary mechanisms of action targeting allergic inflammation of the nasal mucosa:

• Azelastine hydrochloride is a second-generation H1-receptor antagonist with additional mast-cell stabilizing and anti-inflammatory properties. It blocks the action of histamine at H1 receptors in the nasal mucosa, reducing itching, sneezing and rhinorrhea, and also inhibits the release of other inflammatory mediators.
• Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent local anti-inflammatory activity. It binds to glucocorticoid receptors, inhibiting the recruitment and activation of eosinophils, mast cells, lymphocytes and other inflammatory cells, and suppresses the release of cytokines and other inflammatory mediators, reducing nasal mucosal inflammation and congestion.

Onset of symptom relief with Azelastine Hydrochloride + Fluticasone Propionate is generally faster than with an intranasal corticosteroid alone because of the rapid antihistamine effect of azelastine, while the corticosteroid component provides sustained control of the underlying inflammation.

Flutispray Plus is for intranasal use only. Shake gently before use, prime the pump as directed if it has not been used recently, tilt the head slightly forward, and spray once into each nostril while sniffing gently, avoiding contact with the eyes. Do not swallow the spray or use it in the eyes or mouth.

Clinically significant interactions with Flutispray Plus are uncommon because intranasal administration results in low systemic absorption, but the following should be noted:

• CNS depressants and alcohol: the azelastine component may cause somnolence; concurrent use with alcohol, sedatives, hypnotics, or other CNS-depressant medications may cause additive drowsiness and impaired mental alertness.
• Strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole): may increase systemic exposure to the fluticasone component, raising the theoretical risk of systemic corticosteroid effects (including adrenal suppression); concurrent use should be avoided unless the benefit outweighs the risk.

Adverse effects of Flutispray Plus are generally local to the nose and mouth. The most commonly reported effects include:

Because of the sedating potential of the azelastine component, patients should use caution when driving or operating machinery until they know how Flutispray Plus affects them, and should avoid combining it with alcohol.

There are no adequate and well-controlled studies establishing the safety of Flutispray Plus in pregnant women. Flutispray Plus should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus, and only under medical supervision.

It is not known whether the components of Flutispray Plus are excreted in human breast milk in clinically significant amounts. Caution should be exercised when Flutispray Plus is administered to a breastfeeding woman, and it should be used only if clearly needed, after consulting a physician.

The following precautions apply to the use of Flutispray Plus:

• Untreated infections: avoid use in patients with untreated localized nasal or sinus infections, as the corticosteroid component may mask or worsen an underlying infection.
• Nasal surgery or trauma: use with caution in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma; delay use until healing has occurred, as intranasal corticosteroids can impair wound healing.
• Glaucoma and cataracts: long-term use of intranasal corticosteroids has been associated with rare reports of glaucoma and cataracts; patients with a history of these conditions or with visual disturbance should be monitored.
• Growth effects in children: long-term intranasal corticosteroid therapy may be associated with a reduction in growth velocity in pediatric patients; growth should be monitored routinely in children on prolonged treatment.
• Immunosuppression: corticosteroids can reduce immune response; patients on Flutispray Plus should avoid exposure to chickenpox or measles unless already immune, and should seek medical advice if exposed.
• Somnolence: the azelastine component may cause drowsiness; caution is advised with driving, operating machinery, or consuming alcohol until individual response is known (see Side Effects).

See Contraindications and Pregnancy and Lactation for further safety information.

Deliberate or accidental overdose with intranasal Flutispray Plus is unlikely to cause significant toxicity given the low systemic absorption of intranasal administration; however, excessive or prolonged use, or accidental oral ingestion, may increase the risk of systemic effects such as marked drowsiness (from azelastine) or, rarely, features of hypercorticism (from fluticasone).

In case of suspected overdose or accidental ingestion, seek immediate medical attention or contact a poison control center/emergency services. Do not attempt specific home treatment; management is supportive and should be directed by a physician.

Store Flutispray Plus at room temperature (below 30°C), away from light and moisture. Do not freeze. Keep the bottle upright with the cap on when not in use, and keep out of reach of children.

Renal impairment: no specific dose adjustment of Flutispray Plus has been well established; use with routine caution.

Hepatic impairment: use with caution, as systemic corticosteroid exposure from the fluticasone component may be increased in significant hepatic impairment.

Elderly: no overall differences in safety or effectiveness have been established between elderly and younger adult patients; use with routine caution.

Pregnancy and lactation: see Pregnancy and Lactation section above.

Pediatric use: see Pediatric Use section below.

Flutispray Plus should be used for as long as allergic symptoms persist and as directed by the prescribing physician. If there is no improvement in symptoms after approximately 14 days of consistent use, the patient should be re-evaluated to confirm the diagnosis and consider alternative therapy. For long-term or seasonal use, periodic medical review is recommended, particularly to monitor for local nasal effects and, in children, growth.

Azelastine Hydrochloride + Fluticasone Propionate belongs to the following drug classes: Intranasal antihistamine (H1-receptor antagonist) combined with an intranasal corticosteroid

Azelastine Hydrochloride + Fluticasone Propionate acts through two complementary mechanisms: azelastine hydrochloride selectively blocks histamine H1 receptors on nasal mucosal cells, rapidly relieving itching, sneezing and rhinorrhea, and also has mast-cell stabilizing and anti-inflammatory effects; fluticasone propionate binds nasal glucocorticoid receptors, switching off multiple inflammatory genes and suppressing recruitment of eosinophils and other inflammatory cells, reducing nasal inflammation, congestion and mucus production. Together these actions provide broader and typically faster relief of allergic rhinitis symptoms than either agent alone.

Flutispray Plus is approved for seasonal allergic rhinitis in children 6 years of age and older, and for perennial allergic rhinitis in patients 12 years of age and older, at the same dose used in adults (1 spray per nostril twice daily).

Safety and efficacy of Flutispray Plus for perennial allergic rhinitis in children below 12 years of age, and for any indication in children below 6 years of age, have not been established. Growth velocity should be monitored in pediatric patients receiving long-term therapy (see Precautions and Warnings).