olopatadine intranasal/mometasone, intranasal (Rx)

Brand and Other Names:Ryaltris
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

olopatadine/mometasone

intranasal spray

  • (665mcg/25mcg)/spray

Seasonal Allergic Rhinitis

Indicated for symptoms of seasonal allergic rhinitis

2 sprays per nostril BID

Dosage Modifications

Hepatic impairment

  • Not studied; however, increasing concentrations of mometasone have been reported with severity of hepatic impairment

Renal impairment

  • Mometasone: Not studied
  • Olopatadine
    • Mild, moderate, or severe (single dose): No change in peak plasma concentration for single dose
    • Severe (CrCl <30 mL/min/1.73 m2) at steady-state: AUC 2-fold higher and peak plasma concentration ~10-fold higher

Dosage Forms & Strengths

olopatadine/mometasone

intranasal spray

  • (665mcg/25mcg)/spray

Seasonal Allergic Rhinitis

Indicated for symptoms of seasonal allergic rhinitis in adult and pediatric patients aged ≥12 years

<12 years: Safety and efficacy not established

≥12 years: 2 sprays per nostril BID

Dosage Modifications

Hepatic impairment

  • Not studied; however, increasing concentrations of mometasone have been reported with severity of hepatic impairment

Renal impairment

  • Mometasone: Not studied
  • Olopatadine
    • Mild, moderate, or severe (single dose): No change in peak plasma concentration for single dose
    • Severe (CrCl <30 mL/min/1.73 m2) at steady-state: AUC 2-fold higher and peak plasma concentration ~10-fold higher
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Interactions

Interaction Checker

and olopatadine intranasal/mometasone, intranasal

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            Adverse Effects

            1-10%

            Dysgeusia (3%)

            Epistaxis (1%)

            Nasal discomfort (1%)

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            Warnings

            Contraindications

            Hypersensitivity to any ingredients of nasal spray

            Cautions

            May cause somnolence; avoid operating heavy machinery or engaging in tasks that require mental alertness and coordination; caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination (eg, operating machinery, driving a motor vehicle) after administration

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

            Glaucoma and/or cataracts may develop; closely monitor patients with vision changes or history of increased intraocular pressure, glaucoma, and/or cataracts

            Hypersensitivity reactions, including wheezing, have occurred after nasal administration of mometasone; discontinue therapy if such reactions occur

            Nasal corticosteroids may cause reduction in growth velocity when administered to pediatric patients; routinely monitor growth of pediatric patients; safety and efficacy not established in pediatric patients aged <12 years; not indicated for use in this population

            Hypercorticism and adrenal suppression may occur when nasal corticosteroids are misused by taking higher-than-recommended dosages or in patients at risk for such effects

            Local nasal adverse reactions

            • Epistaxis, nasal ulceration, and nasal septal perforation reported
            • Periodically monitor for signs of adverse effects on nasal mucosa
            • Corticosteroids may impair wound healing; avoid use in patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma until resolved
            • Localized Candida infections of the nose and pharynx have occurred from mometasone intranasal; if infection occurs, discontinue therapy, and treat appropriately; examine periodically for evidence of Candida infection if use is over several months or longer

            Immunosuppression and risk of infections

            • Immunosuppressive drugs (eg, corticosteroids) may increase susceptibility to infection
            • Chickenpox and measles may be more serious or even fatal in susceptible children or adults using corticosteroids
            • Risk of developing an infection based on therapy (ie, dose, duration, route), underlying disease, and/or prior corticosteroid use is unknown
            • If exposed to chickenpox, prophylaxis with varicella zoster immune globulin may be indicated; if exposed to measles, prophylaxis with pooled IM immunoglobulin may be indicated; if chickenpox develops, consider treating with antiviral agents
            • Use with caution in active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex

            Drug interaction overview

            • CNS depressants
              • Avoid coadministration
              • Alcohol and other CNS depressants may potentiate somnolence and CNS depression
            • Strong CYP3A4 inhibitors
              • Use with caution
              • Strong CYP3A4 inhibitors may inhibit metabolism of, and increase mometasone furoate plasma concentration, and potentially increase risk for adverse reactions
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            Pregnancy & Lactation

            Pregnancy

            Data are unavailable on use in pregnant females to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

            Animal data

            • Olopatadine: Oral administration of olopatadine to pregnant rats and rabbits caused a decrease in number of live fetuses at maternal doses 120x and 1600x the maximum recommended human daily intranasal dose (MRHDID) on a mg/m2 basis, respectively
            • Mometasone: Administration of mometasone to pregnant rats and rabbits caused increased fetal malformations and decreased fetal survival and growth at doses that produced exposures 1-16x the MRHDID on a mcg/m2 or AUC basis

            Lactation

            Data are unavailable on presence of drug in human milk, effects on breastfed children, or on milk production

            Other corticosteroids are excreted in human milk

            Olopatadine has been identified in milk of nursing rats following oral administration; unknown whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Olopatadine: Antihistamine (H1 antagonist); inhibits release of histamine from mast cells

            Mometasone: Corticosteroid with potent anti-inflammatory properties; elicits effects on various cells, including mast cells and eosinophils; also elicits effects on inflammatory mediators (eg, histamine, eicosanoids, leukotrienes, cytokines)

            Absorption

            Peak plasma time: 1 hr

            Peak plasma concentration

            • Olopatadine: 19.8 ng/mL
            • Mometasone: 9.92 pg/mL

            AUC

            • Olopatadine: 88.77 ng·hr/mL
            • Mometasone: 58.4 pg·hr/mL

            Distribution

            Protein bound

            • Olopatadine: 55% (binds primarily to serum albumin)
            • Mometasone: 98-99%

            Metabolism

            Olopatadine

            • Not extensively metabolized
            • Metabolites: Olopatadine N-oxide and N-desmethyl olopatadine; at least 6 minor metabolites circulate in human plasma

            Mometasone

            • Metabolized by CYP3A4
            • Metabolites: No major metabolites detectable in plasma; 6ß-hydroxy-mometasone furoate (minor metabolite)

            Elimination

            Half-life

            • Olopatadine: 9 hr
            • Mometasone: 18 hr

            Excretion

            • Olopatadine: 70% (urine [86% unchanged]); 17% (feces)
            • Any absorbed drug is excreted as metabolites mostly via the bile, and to a limited extent, into the urine
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            Administration

            Intranasal Preparation

            Priming

            • Shake bottle gently before each use
            • Prime bottle before initial use by releasing 6 sprays
            • Reprime bottle if unused for >14 days by spraying 2 sprays or until fine mist appears

            Intranasal Administration

            Gently blow nose to clear nostrils

            Administer by intranasal route only

            Hold 1 nostril closed with finger and insert spray pump tip into other nostril, pointing it slightly toward outside of nose, away from nasal septum

            Avoid spraying into eyes or mouth

            Do not blow nose for at least 15 minutes after administration

            Storage

            Store upright with dust cap on at room temperature (20-25ºC [68-77ºF]; excursions permitted at 15-30ºC [59-86ºF])

            Do not freeze or refrigerate

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            Patient Handout

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.