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Olopatadine and mometasone: Drug information

Olopatadine and mometasone: Drug information
(For additional information see "Olopatadine and mometasone: Pediatric drug information" and see "Olopatadine and mometasone: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ryaltris
Pharmacologic Category
  • Corticosteroid, Nasal;
  • Histamine H1 Antagonist;
  • Histamine H1 Antagonist, Second Generation;
  • Piperidine Derivative
Dosing: Adult
Allergic rhinitis, seasonal

Allergic rhinitis, seasonal: Intranasal: 2 sprays (olopatadine 1,330 mcg/mometasone 50 mcg) in each nostril twice daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturing labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; drug accumulation of mometasone may increase with liver impairment.

Dosing: Pediatric

(For additional information see "Olopatadine and mometasone: Pediatric drug information")

Allergic rhinitis, seasonal

Allergic rhinitis, seasonal: Olopatadine 665 mcg and mometasone 25 mcg per spray:

Children ≥12 years and Adolescents: Intranasal: 2 sprays per nostril twice daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; mometasone concentrations appear to increase with the severity of hepatic impairment; use with caution.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Nasal:

Ryaltris: Olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg/actuation (29 g) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80]

Generic Equivalent Available: US

No

Administration: Adult

Intranasal: For intranasal administration only. Prime pump (press 6 times and until a fine spray appears) prior to first use. If ≥14 days have elapsed since last use, reprime the pump with 2 sprays or until fine mist appears. Shake before using. Blow nose to clear nostrils. Insert applicator into the nostril, tilt head slightly forward, keeping bottle upright, and close off the other nostril. Breathe in through the nose. While inhaling, press pump to release spray and exhale through the mouth. After each use, wipe the spray tip with a clean tissue or cloth and replace cap. Avoid spraying directly into the nasal septum, eyes or mouth. Discard after 240 medicated sprays have been used, even if the bottle is not completely empty.

Administration: Pediatric

Intranasal: Shake well prior to each use. Before first use, prime by pressing pump 6 times until a fine mist appears. If ≥14 days have elapsed since last use, the delivery system should be reprimed with 2 sprays or until a fine spray appears. Blow nose to clear nostrils before each use. Keep head tilted downward while spraying. Insert applicator into nostril keeping bottle upright, and close off the other nostril. Angle applicator slightly toward outside of the nose (towards cheek), away from the center of the nose. Breathe in through nose while pressing the pump to release spray, then breathe out through mouth. Repeat procedure to complete full dose (2 sprays each nostril). Do not blow nose for ≥15 minutes after administration. Do not spray into eyes or mouth. After each use, wipe the spray tip with a clean tissue or cloth. Discard after labeled number of doses has been used, even if bottle is not completely empty.

Use: Labeled Indications

Allergic rhinitis, seasonal: Treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients ≥12 years of age.

Medication Safety Issues
Sound-alike/look-alike issues:

Ryaltris may be confused with Rybelsus.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults. Also see individual agents.

1% to 10%:

Gastrointestinal: Dysgeusia (3%)

Respiratory: Epistaxis (1%), nasal discomfort (1%)

<1%: Nervous system: Drowsiness

Frequency not defined: Respiratory: Nasal mucosa ulcer, nasal septum perforation

Contraindications

Hypersensitivity to olopatadine, mometasone, or any component of the formulation.

Documentation of allergenic cross-reactivity for corticosteroids is limited; however, the possibility of cross-sensitivity cannot be ruled out with certainty because of similarities in chemical structure and/or pharmacologic actions.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: When recommended doses are exceeded, or in extremely sensitive individuals, mometasone may cause hypercortisolism or suppression of the hypothalamic-pituitary-adrenal axis. Reports of hypercortisolism are rare with topical corticosteroids. Withdrawal and discontinuation of a corticosteroids should be done slowly and carefully. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid exposure needed to treat patients having trauma, surgery, or infections.

• CNS depression: Olopatadine may cause drowsiness in some patients; instruct patients to use caution when driving or operating machinery. Effects may be additive with ethanol ingestion and/or other CNS depressants.

• Delayed wound healing: Avoid nasal corticosteroids (eg, mometasone) in patients with nasal septal ulcers, recent nasal surgery, or trauma until healing has occurred.

• Hypersensitivity: Hypersensitivity reactions, including rash, pruritus, angioedema, and wheezing, have been reported.

• Immunosuppression: Prolonged use of corticosteroids (eg, mometasone) may increase the incidence of secondary infections, mask acute infections (including fungal infections), prolong or exacerbate viral infections, or limit the response to vaccines. Avoid exposure to chicken pox and/or measles if not immunized.

• Local nasal effects: May cause epistaxis, nasal ulceration, or septal perforation.

Disease-related concerns:

• Infections: Use with caution or avoid use in patients with active or latent tuberculosis interaction of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Do not use in untreated localized infection involving the nasal mucosa; local Candida infections of the nose and throat have occurred from nasal administration of mometasone.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use of mometasone.

Special populations:

• Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

CNS Depressants: Olopatadine (Nasal) may enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Mometasone (Nasal). Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Nasal). Risk C: Monitor therapy

Pregnancy Considerations

Refer to individual monographs

Breastfeeding Considerations

Refer to individual monographs.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Growth (adolescents and children); signs/symptoms of hypothalamic-pituitary-adrenal access suppression/adrenal insufficiency, glaucoma and/or cataracts, especially in patients with a change in vision; adverse nasal effects (eg, nasal septal perforation, nasal ulceration, irritation, epistaxis); infections of nose or throat.

Mechanism of Action

Olopatadine: Selective histamine H1-antagonist; olopatadine inhibits release of histamine from mast cells.

Mometasone: Mometasone may depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins). Leukocytes and macrophages may have to be present for the initiation of responses mediated by the above substances. Mometasone inhibits the margination and subsequent cell migration to the area of injury, and also reverses the dilation and increased vessel permeability in the area resulting in decreased access of cells to the sites of injury.

Pharmacokinetics

Also see individual agents.

Onset: Symptom improvement noted within 15 minutes following the initial dose.

Half-life elimination: Mean: Mometasone: 18 hours; olopatadine: 9 hours.

Time to peak, plasma: Median: 1 hour.

Pricing: US

Suspension (Ryaltris Nasal)

665-25 mcg/ACT (per gram): $10.30

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Ryaltris (AT, AU, CZ, DK, GB, NL, PL)


For country code abbreviations (show table)
  1. Ryaltris (olopatadine/mometasone) [prescribing information]. Columbus, OH: Hikma Specialty USA Inc; July 2022.
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