Mometasone Furoate + Olopatadine Hydrochloride

This preparation 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 unit containing an aqueous suspension of a fixed-dose combination of a olopatadine hydrochloride and mometasone furoate monohydrate.

Olopatadine is a histamine-1 (H1) receptor inhibitor. The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans.

Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

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’s 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. Then remove the cover and child resistant lock.

2. Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Before using the nasal spray for the first time or if you have not used it for a longer period, press the nasal actuator several times until a fine mist comes out from the container.

3. Gently blow your nose to clear your nostrils.

4. Close one nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal actuator into the other nostril. Start to breathe in through your nose, and WHILE BREATHING IN press firmly and quickly down once on the actuator to release the spray. To get a full actuation, use your forefinger and middle finger to spray while supporting the base of the bottle with your thumb. Avoid spraying in eyes. Breathe gently inwards through the nostril.

5. Breathe out through your mouth.

6. Repeat the above steps in the same/other nostril for consecutive doses.

7. Wipe the nasal actuator with a clean tissue and replace the cover.

8. Do not use this bottle for more than the labeled number of sprays even though the bottle is not completely
empty.

CLEANING: The nasal spray should be cleaned at least once a week. The procedures are as follows:

• Remove the cover.
• Gently pull off the nasal actuator.
• Wash the actuator and cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the actuator back on the top of the bottle and re-fix the cover.

WARNING: Please do not use a pin or other pointed things to clean the orifice of the nasal actuator.

Concurrent use of this combination with alcohol or other central nervous system depressants should be avoided because somnolence and impairment of central nervous system performance may occur. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the mometasone furoate plasma
concentration and potentially increase the risk for adverse reactions. Caution should be exercised when considering the coadministration of this combination with strong CYP3A4 inhibitors.

Hypersensitivity to any component of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray.

Common side effects are-

• Dysgeusia
• Epistaxis
• Nasal discomfort

The following clinically significant adverse reactions are described-

• Local Nasal Adverse Reactions
• Somnolence and Impaired Mental Alertness
• Glaucoma and Cataracts
• Hypersensitivity Reactions
• Immunosuppression and Risk of Infections
• Hypercorticism and Adrenal Suppression

There are no available data of mometasone furoate use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcome. There are no available data on the presence of olopatadine or mometasone furoate or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids similar to mometasone furoate, are excreted in human milk. However, mometasone furoate concentrations in plasma after nasal therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low.

Epistaxis, nasal ulcerations, nasal septal perforations, impaired wound healing, and Candida albicans infection: Monitor patients periodically for signs of adverse reactions on the nasal mucosa.

Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery when taking this nasal spray.

Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with this nasal spray because additional reductions in alertness and additional impairment of CNS performance may occur.

Glaucoma and cataracts: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Hypersensitivity Reactions: Hypersensitivity reactions can occur with this nasal spray. Hypersensitivity reactions including wheezing, have occurred after the nasal administration of mometasone furoate. Discontinue this nasal spray if such reactions occur.

Immunosuppression and Risk of Infections: Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients: Use caution in patients with the above because of the potential for worsening of these infections.

Hypercorticism and adrenal suppression with misuse or use of higher- than-recommended dosages or at the regular dosage in susceptible patients at risk for such effects.

Potential reduction in growth velocity in children: Routinely monitor the growth in pediatric patients receiving this nasal spray.

Olopatadine Hydrochloride: Symptoms of antihistamine overdose may include drowsiness in adults and children. Agitation and restlessness, followed by drowsiness in children. If overdose occur, symptomatic or supportive treatment is recommended.

Mometasone Furoate: Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism.

Do not store above 25°C temperature. Do not refrigerate. Keep away from light and wet place. Keep out of reach of children.