This nasal spray is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.

This is a metered-dose manual nasal spray containing an aqueous suspension of a fixed-dose combination of olopatadine hydrochloride and mometasone furoate monohydrate.

Olopatadine is a selective histamine-1 (H1) receptor antagonist with antihistaminic activity demonstrated in isolated tissues, animal studies, and humans.

Mometasone furoate is a potent corticosteroid with anti-inflammatory properties. The exact mechanism in allergic rhinitis is not fully understood, but corticosteroids are known to inhibit multiple inflammatory cells such as mast cells, eosinophils, neutrophils, macrophages, and lymphocytes, as well as inflammatory mediators including histamine, leukotrienes, eicosanoids, and cytokines.

Adults and Adolescents (12 years of age and older): The recommended dosage of Olonase is 2 sprays in each nostril twice daily.

Children (6 to 11 years of age): The recommended dosage of Olonase is 1 spray in each nostril twice daily.

For nasal use only. Shake the bottle well before each use. Avoid spraying into the eyes or mouth. See illustrated patient instructions for proper use of nasal spray. Read the complete instructions carefully and use only as directed.

HOW TO USE THE NASAL SPRAY

1. Shake the bottle gently. Remove the cover and child resistant lock.
2. Hold the spray with forefinger and middle finger on either side of the nozzle and thumb underneath the bottle. Before first use or after a long gap, press the actuator until a fine mist appears.
3. Gently blow your nose to clear nostrils.
4. Close one nostril. Tilt head slightly forward. Insert nasal actuator into the other nostril while keeping bottle upright. Breathe in through the nose and press the actuator firmly and quickly to release the spray. Avoid spraying into eyes.
5. Breathe out through the mouth.
6. Repeat in the same or other nostril for next dose.
7. Wipe the actuator with clean tissue and replace the cover.
8. Do not exceed the labeled number of sprays even if the bottle is not empty.

CLEANING: Clean the nasal spray at least once weekly.
Remove cover, pull off actuator, wash in warm water, dry naturally, then reattach.

WARNING: Do not use pins or sharp objects to clean the nozzle.

Concurrent use of this combination with alcohol or other central nervous system (CNS) depressants should be avoided, as somnolence and impairment of CNS performance may occur.
Concomitant use with CYP3A4 inhibitors may reduce the metabolism of mometasone furoate, leading to increased plasma concentration and a potential rise in adverse effects. Caution is advised when co-administering with strong CYP3A4 inhibitors.

This nasal spray is contraindicated in patients with known hypersensitivity to olopatadine hydrochloride, mometasone furoate, or any component of the formulation.

Common side effects include

• dysgeusia,
• epistaxis,
• and nasal discomfort.

Clinically significant adverse reactions include

• local nasal reactions,
• somnolence and impaired mental alertness,
• glaucoma and cataracts,
• hypersensitivity reactions,
• immunosuppression with risk of infections,
• and hypercorticism with adrenal suppression.

There are no adequate data on the use of mometasone furoate or olopatadine in pregnant women. It is not known whether these drugs are excreted in human milk. Other corticosteroids are known to be excreted in breast milk; however, systemic exposure after nasal use is low, so breast milk levels are expected to be minimal. Use during pregnancy and lactation only if clearly needed.

Patients should be monitored for nasal adverse effects such as epistaxis, ulceration, septal perforation, and fungal infection.

Use caution in patients with glaucoma, cataracts, or changes in vision.

Somnolence may occur; avoid driving or operating machinery.

Avoid alcohol and CNS depressants due to additive sedative effects.

Use with caution in patients with infections including tuberculosis, fungal, bacterial, viral, or parasitic diseases.

Monitor for signs of immunosuppression, adrenal suppression, and growth retardation in children.

Discontinue if hypersensitivity reactions occur.

Olopatadine Hydrochloride:Olopatadine overdose may cause drowsiness, agitation, and restlessness, followed by sedation, especially in children.  Treatment is symptomatic and supportive.
Mometasone Furoate: Mometasone overuse may lead to signs of hypercorticism.

Do not store above 25°C. Do not refrigerate. Protect from light and moisture. Keep out of reach of children.