Momelo Nasal Spray

Indications

Momelo nasal spray is designed to alleviate symptoms of seasonal allergic rhinitis in adults and children aged 12 years and older.

• Always use this medication as directed by a registered healthcare professional.

Pharmacology

Momelo is a metered-dose nasal spray that delivers a precise combination of olopatadine hydrochloride and mometasone furoate monohydrate in an aqueous suspension.

Olopatadine acts as a histamine-1 (H1) receptor antagonist, demonstrating effective antihistamine properties in various studies involving isolated tissues, animal models, and human subjects.

Mometasone furoate, a potent corticosteroid, exhibits significant anti-inflammatory effects. While the exact mechanism by which corticosteroids mitigate allergic rhinitis is not fully understood, they are known to inhibit multiple cell types (such as mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and inflammatory mediators (including histamine, eicosanoids, leukotrienes, and cytokines).

Dosage & Administration

For optimal results, the recommended dosage is 2 sprays in each nostril twice daily. It is essential to shake the bottle well before each application. To prime the spray before initial use, release 6 sprays or until a fine mist is visible. If the spray has not been used for 14 days or more, re-prime by releasing 2 sprays or until a fine mist appears. Take care to avoid contact with the eyes or mouth.

Pediatric Use: The safety and efficacy of this nasal spray in children under 12 years have not yet been established.

• Always use this medication as directed by a registered healthcare professional.

Interaction

No formal studies have been conducted to examine drug-drug interactions with Momelo. Interactions are expected to align with those of its individual components.

Central Nervous System Depressants: It is advisable to avoid using Momelo in conjunction with alcohol or other CNS depressants, as this may lead to drowsiness and impaired cognitive function.

Cytochrome P450 3A4 Inhibitors: Mometasone furoate is primarily metabolized by cytochrome P450 (CYP) 3A4. Co-administration of CYP3A4 inhibitors may impede the metabolism of mometasone furoate, potentially elevating plasma levels and increasing the risk of adverse effects. Caution is recommended when considering concurrent use with potent CYP3A4 inhibitors.

Contraindications

Momelo nasal spray should not be used by individuals with a known hypersensitivity to any of its components. Hypersensitivity reactions, including wheezing, have been reported following nasal administration of mometasone furoate.

Side Effects

Clinically significant adverse reactions may include:

• Local nasal reactions
• Drowsiness and decreased mental alertness
• Glaucoma and cataracts
• Hypersensitivity reactions
• Immunosuppression and heightened infection risk
• Hypercorticism and adrenal suppression

Pregnancy & Lactation

Data on the use of mometasone furoate in pregnant women are lacking, making it difficult to assess risks associated with major birth defects, miscarriage, or other adverse outcomes for mothers and infants. There is also no information regarding the presence of olopatadine or mometasone furoate in breast milk or their effects on breastfeeding infants or milk production. Other corticosteroids similar to mometasone furoate have been found in human milk. However, since plasma concentrations after nasal therapeutic doses are low, it is likely that corresponding concentrations in breast milk are also low.

Precautions & Warnings

Monitor patients periodically for signs of nasal mucosa-related adverse reactions, such as epistaxis, nasal ulcers, perforations of the nasal septum, impaired wound healing, and Candida albicans infections.

Somnolence: Patients should refrain from activities requiring full mental alertness and coordination, such as driving or operating machinery, while using this nasal spray.

CNS Depressants: Concurrent use of alcohol or other CNS depressants should be avoided, as it may lead to increased drowsiness and impairment.

Ocular Health: Patients experiencing vision changes or with a history of elevated intraocular pressure, glaucoma, or cataracts should be monitored closely.

Hypersensitivity Reactions: Monitor for hypersensitivity reactions, including wheezing, after nasal administration of mometasone furoate. Discontinue use if such reactions occur.

Infection Risk: There is a potential risk of worsening existing tuberculosis, or fungal, bacterial, viral, or parasitic infections, including ocular herpes simplex. Susceptible patients may experience more severe courses of chickenpox or measles. Use caution in patients with a history of these conditions.

Growth Monitoring in Children: Regularly assess growth in pediatric patients using this nasal spray, as there may be a reduction in growth velocity.

Storage Conditions

Store the spray upright at room temperature (20°C to 25°C) with the purple dust cap on. Do not freeze or refrigerate.