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Drug overview for RYALTRIS (olopatadine hcl/mometasone furoate):
Generic name: olopatadine HCl/mometasone furoate (OH-loe-PAT-a-deen/moe-MET-a-sone)
Drug class: Nasal Antihistamines
Therapeutic class: Respiratory Therapy Agents
Mometasone furoate is a synthetic nonfluorinated corticosteroid. Olopatadine hydrochloride is a relatively selective histamine H1-receptor antagonist; the drug also shares many of the pharmacologic effects of mast-cell stabilizers.
No enhanced Uses information available for this drug.
Generic name: olopatadine HCl/mometasone furoate (OH-loe-PAT-a-deen/moe-MET-a-sone)
Drug class: Nasal Antihistamines
Therapeutic class: Respiratory Therapy Agents
Mometasone furoate is a synthetic nonfluorinated corticosteroid. Olopatadine hydrochloride is a relatively selective histamine H1-receptor antagonist; the drug also shares many of the pharmacologic effects of mast-cell stabilizers.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for RYALTRIS (olopatadine hcl/mometasone furoate) have been approved by the FDA:
Indications:
Allergic rhinitis
Seasonal allergic rhinitis
Professional Synonyms:
Intermittent allergic rhinitis
Periodic runny nose
Seasonal allergy
Indications:
Allergic rhinitis
Seasonal allergic rhinitis
Professional Synonyms:
Intermittent allergic rhinitis
Periodic runny nose
Seasonal allergy
The following dosing information is available for RYALTRIS (olopatadine hcl/mometasone furoate):
Dosage of olopatadine hydrochloride is expressed in terms of olopatadine.
Dosage adjustment for olopatadine nasal spray is not necessary in patients with hepatic or renal impairment.
Dosage adjustment for olopatadine nasal spray is not necessary in patients with hepatic or renal impairment.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| RYALTRIS 665-25 MCG SPRAY | Maintenance | Adults spray 2 sprays in each nostril by intranasal route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for RYALTRIS (olopatadine hcl/mometasone furoate):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Radioactive Iodide/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(2) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(3) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1) |
ADREVIEW, JEANATOPE, MEGATOPE, SODIUM IODIDE I-123 |
| Sodium Iodide I 131/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1,2) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1,2) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1,2) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(3) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(4) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1,2) |
HICON, SODIUM IODIDE I-131 |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Mometasone/Selected CYP3A4 Inhibitors SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: CYP3A4 inhibitors may inhibit the metabolism of mometasone.(1-14,17) CLINICAL EFFECTS: Concurrent use of CYP3A4 inhibitors may result in increased systemic exposure to and effects from mometasone, including Cushing's syndrome and adrenal suppression.(1-14,17) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Use caution when using concurrent therapy with mometasone and CYP3A4 inhibitors. Alternative corticosteroids that are less affected by CYP3A4 inhibitors should be considered, like beclomethasone and prednisolone.(14) If concurrent therapy is warranted, patients should be closely monitored for systemic effects. The corticosteroid may need to be discontinued. DISCUSSION: In a study in 24 healthy subjects, inhaled mometasone furoate (400 mcg delivered by a dry powder inhaler twice daily for 9 days) with ketoconazole (200 mg on Days 4 to 9) increased systemic mometasone furoate concentrations from <150 pg/mL on Day 3 prior to coadministration of ketoconazole to a peak plasma concentrations of mometasone furoate >200 pg/mL on Day 9 (211-324 pg/mL).(14) There have been several case reports of Cushing's syndrome in patients treated concurrently with ritonavir and nasal fluticasone and mometasone.(15) A review of corticosteroid use patients on protease inhibitors detailed the interactions that can result in accumulation of corticosteroids, leading to adrenal suppression and Cushing's syndrome.(16) Selected CYP3A4 inhibitors linked to this monograph include: atazanavir, boceprevir, ceritinib, cobicistat, darunavir, fosamprenavir, idelalisib, indinavir, lenacapavir, lonafarnib, lopinavir, mibefradil, nelfinavir, nirmatrelvir, paritaprevir, saquinavir, telaprevir, tipranavir, and tucatinib.(17) |
APTIVUS, ATAZANAVIR SULFATE, DARUNAVIR, EVOTAZ, FOSAMPRENAVIR CALCIUM, GENVOYA, KALETRA, LOPINAVIR-RITONAVIR, PAXLOVID, PREZCOBIX, PREZISTA, REYATAZ, STRIBILD, SUNLENCA, SYMTUZA, TUKYSA, TYBOST, VIRACEPT, ZOKINVY, ZYDELIG, ZYKADIA |
The following contraindication information is available for RYALTRIS (olopatadine hcl/mometasone furoate):
Drug contraindication overview.
Known hypersensitivity to mometasone furoate or any ingredient in the formulation.
Known hypersensitivity to mometasone furoate or any ingredient in the formulation.
There are 0 contraindications.
There are 8 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Nasal septal perforation |
| Nasal septal ulcers |
| Nasal trauma |
| Ocular herpes simplex |
| Ocular hypertension |
| Open angle glaucoma |
| Operation on nose |
| Severe infection |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Adrenocortical insufficiency |
| Cataracts |
| Epistaxis |
| Inactive tuberculosis |
| Nasal septal ulcers |
| Parasitic infection |
The following adverse reaction information is available for RYALTRIS (olopatadine hcl/mometasone furoate):
Adverse reaction overview.
Adverse effects occurring in 5% or more of patients receiving mometasone furoate for the treatment of allergic rhinitis include headache, viral infection, pharyngitis, epistaxis/blood-tinged mucus, coughing, and upper respiratory tract infection; in addition, dysmenorrhea, musculoskeletal pain, and sinusitis (in patients 12 years of age or older) and vomiting (in patients 3-11 years of age). Adverse effects occurring in 5% or more of patients receiving mometasone furoate for the treatment of nasal polyposis and more frequently than with placebo include epistaxis.
Adverse effects occurring in 5% or more of patients receiving mometasone furoate for the treatment of allergic rhinitis include headache, viral infection, pharyngitis, epistaxis/blood-tinged mucus, coughing, and upper respiratory tract infection; in addition, dysmenorrhea, musculoskeletal pain, and sinusitis (in patients 12 years of age or older) and vomiting (in patients 3-11 years of age). Adverse effects occurring in 5% or more of patients receiving mometasone furoate for the treatment of nasal polyposis and more frequently than with placebo include epistaxis.
There are 23 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Viral infection |
Asthma Bronchitis Chest pain Dysmenorrhea Earache Nasal septal perforation Nasal septal ulcers Sinusitis Upper respiratory infection |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Cataracts Dysgeusia Glaucoma Impaired wound healing Increased creatine kinase level Lesion of nasal mucosa Migration of implant Nasal candidiasis Nasal septal perforation Oral candidiasis Parosmia |
There are 33 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Conjunctivitis Cough Dysgeusia Epistaxis Headache disorder Otitis Pharyngitis Upper respiratory infection |
Arthralgia Cough Diarrhea Dyspepsia Headache disorder Myalgia Nausea Presyncope Rhinitis Sneezing Urinary tract infection |
| Rare/Very Rare |
|---|
|
Depression Dizziness Drowsy Fatigue Flu-like symptoms Influenza Loss of sense of smell Nasal pain Nasal passage irritation Parosmia Pharyngitis Sore throat Vomiting Xerostomia |
The following precautions are available for RYALTRIS (olopatadine hcl/mometasone furoate):
Safety and efficacy of intranasal mometasone furoate not established in children younger than 2 years of age for the treatment of allergic rhinitis or younger than 18 years of age for the treatment of nasal polyposis, respectively. Intranasal corticosteroids, including mometasone furoate, may cause a reduction in growth velocity in pediatric patients. (See General Precautions: Systemic Corticosteroid Effects, in Cautions.)
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Reproduction studies in rats and rabbits receiving oral olopatadine dosages of 600 or 400 mg/kg daily, respectively (i.e., 93,750 or 62,500 times the maximum recommended human ocular dosage, respectively, based on a drop size of 40 mcL, and approximately 1000 or 1400 times the maximum recommended human dose, respectively, for adults on a mg/m2 basis), have not revealed evidence of teratogenicity. However, a decrease in the number of live fetuses was observed in rabbits and rats receiving oral olopatadine dosages of 25 and 60 mg/kg (approximately 88 and 100 times the maximum recommended human dose, respectively, for adults on a mg/m2 basis) or higher. In rats receiving an oral olopatadine dose of 60 mg/kg (approximately 100 times the maximum recommended human dose for adults on a mg/m2 basis), viability and body weights of pups were reduced on day 4 postpartum; however, no effect on viability was observed at a dose of 20 mg/kg (approximately 35 times the maximum recommended human dose for adults on a mg/m2 basis).
There are no adequate and well-controlled studies to date using olopatadine in pregnant women, and the drug should be used during pregnancy only if the potential benefits justify the possible risks to the embryo or fetus. Category C. (See Users Guide.) Administration of corticosteroids during pregnancy may result in hypoadrenalism in the infant.
There are no adequate and well-controlled studies to date using olopatadine in pregnant women, and the drug should be used during pregnancy only if the potential benefits justify the possible risks to the embryo or fetus. Category C. (See Users Guide.) Administration of corticosteroids during pregnancy may result in hypoadrenalism in the infant.
Olopatadine is distributed into milk in rats following oral administration. It is not known whether topical ophthalmic administration of olopatadine could result in sufficient systemic absorption to produce detectable quantities in milk; therefore, olopatadine ophthalmic solutions should be used with caution in nursing women. Olopatadine nasal spray should be used in nursing women only if the potential benefits to the woman outweigh the potential risks to the infant.
Not known whether mometasone furoate is distributed in milk. Caution is advised if the drug is administered in nursing women.
Not known whether mometasone furoate is distributed in milk. Caution is advised if the drug is administered in nursing women.
No substantial differences in safety and efficacy relative to younger adults.
The following prioritized warning is available for RYALTRIS (olopatadine hcl/mometasone furoate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for RYALTRIS (olopatadine hcl/mometasone furoate)'s list of indications:
| Allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J30.5 | Allergic rhinitis due to food |
| J30.8 | Other allergic rhinitis |
| J30.81 | Allergic rhinitis due to animal (cat) (dog) hair and dander |
| J30.89 | Other allergic rhinitis |
| J30.9 | Allergic rhinitis, unspecified |
| Seasonal allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
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