Momelo(25 mcg+600 mcg)/Spray

Momelo is a fixed-dose combination nasal spray indicated for the relief of symptoms of seasonal allergic rhinitis (such as sneezing, nasal itching, rhinorrhea, and nasal congestion) in adults and pediatric patients 6 years of age and older.

• FDA-approved use: Symptomatic treatment of seasonal allergic rhinitis in patients aged 6 years and above.
• Guideline-supported use: Commonly used as therapy for moderate-to-severe or treatment-resistant allergic rhinitis, combining an intranasal corticosteroid with an intranasal antihistamine for more complete symptom control than either agent alone.
• Off-label use: Sometimes used for perennial allergic rhinitis, although this is not an FDA-approved indication and evidence is less robust.

Momelo is not indicated for the treatment of non-allergic rhinitis, sinusitis, or nasal polyps.

Each metered actuation of Mometasone Furoate + Olopatadine Hydrochloride nasal spray delivers 665 mcg of olopatadine hydrochloride and 25 mcg of mometasone furoate, formulated as an aqueous suspension for intranasal administration.

Momelo is a fixed-dose combination intranasal spray that combines a topical corticosteroid (mometasone furoate) with a topical antihistamine/mast-cell stabilizer (olopatadine hydrochloride) in a single formulation. This combination provides both anti-inflammatory and antihistaminic action directly at the nasal mucosa, offering more comprehensive relief of allergic rhinitis symptoms than either component used alone. It is applied directly into the nostrils using a metered-dose spray pump.

Momelo belongs to the therapeutic class of intranasal corticosteroid and antihistamine combination agents, used in the management of allergic rhinitis.

Mometasone Furoate + Olopatadine Hydrochloride combines two complementary mechanisms of action:

• Mometasone furoate is a synthetic corticosteroid with potent local anti-inflammatory activity. It inhibits the release of inflammatory mediators, reduces mucosal edema, and suppresses the recruitment of eosinophils and other inflammatory cells to the nasal mucosa, thereby reducing nasal congestion, itching, and rhinorrhea.
• Olopatadine hydrochloride is a selective histamine H1-receptor antagonist that also inhibits the release of histamine from mast cells. It blocks the action of histamine at H1 receptors in the nasal mucosa, providing rapid relief of sneezing, itching, and rhinorrhea.

Together, the two components of Mometasone Furoate + Olopatadine Hydrochloride act on both the early (histamine-mediated) and late (inflammatory) phases of the allergic response, resulting in comprehensive and rapid symptom control with predominantly local action and low systemic absorption.

Momelo is for intranasal use only. Blow the nose gently to clear the nostrils before use. Tilt the head slightly forward, insert the nozzle into one nostril, close the other nostril, and spray while breathing in gently through the nose. Repeat in the other nostril as directed. Avoid contact with the eyes. Do not swallow.

Momelo has the following clinically significant interactions:

• CNS depressants and alcohol: Concomitant use with alcohol or other central nervous system depressants may increase the risk of somnolence due to the antihistamine component; concurrent use should be avoided.
• Strong CYP3A4 inhibitors: Co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole) may increase systemic exposure to mometasone furoate and should be used with caution, as this may increase the risk of systemic corticosteroid effects.

The most commonly reported side effects of Momelo include:

• Dysgeusia (altered/bitter taste)
• Epistaxis (nosebleed)
• Nasal discomfort or irritation
• Headache
• Somnolence (drowsiness), reported in a small proportion of patients

Less common but more serious effects can include nasal septal perforation, nasal ulceration, localized Candida (fungal) infection of the nose or throat, and hypersensitivity reactions. See Precautions and Warnings for further detail.

Pregnancy: There are no adequate data on the use of Momelo in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under medical supervision.

Lactation: There is no data on whether Momelo or its components pass into human breast milk. Because therapeutic intranasal doses generally result in low systemic exposure, risk to a breastfed infant is expected to be low, but a physician should be consulted before use during breastfeeding.

The following precautions apply to the use of Momelo:

• Nasal effects: May cause nasal irritation, epistaxis, or, rarely, nasal septal ulceration or perforation, particularly with prolonged use. Avoid use in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.
• CNS effects: May cause somnolence; avoid alcohol and other CNS depressants, and use caution when driving or performing tasks requiring mental alertness.
• Ocular effects: Long-term use of intranasal corticosteroids has been associated with glaucoma and cataracts; patients with a history of these conditions should be monitored.
• Immunosuppression and infection risk: The corticosteroid component may increase susceptibility to infections and can mask signs of infection; caution is advised in patients with active or latent tuberculosis, or untreated fungal, bacterial, or viral infections.
• Localized fungal infection: Candida infection of the nose and pharynx may occur, particularly with prolonged use.
• Growth effects in children: Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients; growth should be monitored periodically in children on long-term therapy.
• Hypersensitivity: Discontinue immediately if signs of a hypersensitivity reaction occur.

There is limited clinical experience with overdose of Momelo. Excessive use may lead to drowsiness (and, in children, initial agitation or restlessness followed by drowsiness) due to the antihistamine component, and chronic excessive use of the corticosteroid component may lead to symptoms of hypercorticism. In case of suspected overdose or accidental ingestion, seek immediate medical attention or contact a poison control center. Treatment should be supportive and symptomatic.

Store Momelo nasal spray upright at room temperature (20°C to 25°C / 68°F to 77°F). Do not freeze or refrigerate. Keep out of reach of children.

Pediatric use: Safety and efficacy of Momelo have been established in children 6 years of age and older for seasonal allergic rhinitis. Safety and efficacy have not been established in children below 6 years of age. Growth velocity should be monitored in pediatric patients receiving long-term therapy.

Geriatric use: Clinical experience in patients 65 years and older is limited; no overall differences in safety or effectiveness have been identified compared with younger adults, but caution is advised.

Renal and hepatic impairment: No specific dose-adjustment data are established for Momelo in renal or hepatic impairment given its predominantly local action and low systemic absorption; use with caution and physician guidance.

The duration of treatment with Momelo should be determined by a physician based on symptom severity and response. It is generally used for the duration of seasonal allergen exposure. Long-term continuous use should be periodically reviewed by a physician, with attention to nasal examination and, in children, growth monitoring.

Mometasone Furoate + Olopatadine Hydrochloride is classified as an intranasal corticosteroid and antihistamine (H1-receptor antagonist) fixed-dose combination.

Mometasone Furoate + Olopatadine Hydrochloride works through dual mechanisms: mometasone furoate exerts potent local anti-inflammatory action by suppressing multiple inflammatory mediators and cells involved in the allergic response, while olopatadine hydrochloride selectively blocks histamine H1 receptors and stabilizes mast cells, preventing further histamine release. This dual action addresses both the immediate histamine-driven symptoms and the underlying nasal inflammation of allergic rhinitis.

Momelo is approved for use in children 6 years of age and older for the treatment of seasonal allergic rhinitis, with a lower dose (1 spray per nostril twice daily) recommended for children aged 6 to 11 years compared with patients 12 years and older. Safety and efficacy have not been established in children younger than 6 years, and use in this age group is not recommended. Because intranasal corticosteroids may reduce growth velocity, growth should be monitored regularly in children receiving long-term treatment with Momelo.