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Ryaltris olopatadine hydrochloride and mometasone furoate 665 ug; 25 ug Spray, Metered — NDC 68462-0659-27 package photo

Ryaltris olopatadine hydrochloride and mometasone furoate 665 ug; 25 ug Spray, Metered

by Glenmark Pharmaceuticals Inc., USA · 12 CARTON in 1 BOX (68462-659-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY
NDC 68462-0659-27
🏷️ FDA NDC (as labeled) 68462-659-27 billing pads the product segment with a zero
This package
Contains240 spray, metered in 1 bottle, spray Cost per g$7.67 NADAC Pack sizes2 compare ↓
Also priced by: Part D plans $8.11/unit — full pricing hub ↓
Also comes in: 1 bottle 68462-0659-84
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Olopatadine Hydrochloride And Mometasone Furoate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 24, 2024 — Defective Delivery System: The dip tube is clogged causing the spray not to work. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0006-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 68462-659-27
Product NDC 68462-659
11-digit billing NDC 68462065927
NCPDP billing unit GM — per gram (weight)
RxCUI 2591806, 2591812
UNII 2XG66W44KF, MTW0WEG809
UPC 0368462659274
Application # NDA211746
SPL Set ID 406be932-f00e-4c66-9dd1-c142090fe822
Established class (EPC) Corticosteroid; Histamine-1 Receptor Antagonist; Histamine-1 Receptor In
Mechanism of action Corticosteroid Hormone Receptor Agonists; Histamine H1 Receptor Antagonists
Physiologic effect Decreased Histamine Release
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-13
Route NASAL
Dosage form SPRAY, METERED
Substance OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE
GCN Seq No 081937
GCN 49205
HICL code 047115
Ingredient (HICL) Olopatadine Hcl/Mometasone
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7O
Therapeutic class — specific (HIC3) Nasal Antihistamine And Anti-Inflam. Steroid Comb.
AHFS code 04:92.00.00
AHFS class Other Antihistamines
FDB label name RYALTRIS 665-25 MCG SPRAY
FDB brand name Ryaltris
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68462-659-27 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68462-0659-27. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, Glucocorticoids
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK SPECIALTY SA
FDA applicationNDA211746 (NDA)
Labeler code68462
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio343 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name RYALTRIS 665-25 MCG SPRAY Ingredient Olopatadine Hcl/Mometasone
📗 Our plain-language guide HelloPharmacist
  • Ryaltris is a bit more than a standard allergy spray. It combines two active ingredients: olopatadine, an antihistamine that blocks the histamine trigger behind sneezing and itchin...
  • What is Ryaltris actually for — is it just a regular allergy spray?
  • It can. Drowsiness was reported by some patients in clinical studies, so it's worth being cautious — especially the first few times you use it. Avoid driving or running heavy machi...
  • Shake the bottle well before every single use — that's important. Before you use it for the very first time, prime the pump by spraying 6 times into the air until a fine mist comes...
📖 Read our full Mometasone / Olopatadine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 70WT22SF4B
    A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $7.672 —
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $8.11 —
NADAC price history (per g) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Aug 2026 $7.689 $7.668
Flat over the last 4 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ryaltris 665 ug/1; 25 ug 59467-0700-27 HIKMA 1 bottle $7.671 — Availability likely —
Ryaltris 665 ug/1; 25 ugthis 68462-0659-27 Glenmark 1 bottle $7.671 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
First FDA approval
Jan 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2044
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 13, 2022 RLD RS ⏳ ~18.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10765686 — method of use (U-3295)
US 10758550 — method of use (U-3296)
US 10646500 — method of use (U-3297)
US 10548907 — method of use (U-3297)
US 11400101 — method of use (U-3297)
US 12064442 — method of use (U-3297)
US 10016443 — method of use (U-3297)
US 10517880 — method of use (U-3297)
US 9750754 — method of use (U-3297)
US 9078923 — method of use (U-3297)
US 12653833 — method of use (U-4564)
US 11679210 — drug product
US 10561672 — drug product
US 9370483 — drug product
US 10376526 — drug product
US 12303635 — drug substance
US 9937189 — drug product
Exclusivity NPP
2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042 2044
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (17)
PatentTypeUse codeExpires
US 10765686 ↗ Method of use U-3295 Sep 4, 2034
US 10758550 ↗ Method of use U-3296 Sep 4, 2034
US 10646500 ↗ Method of use U-3297 Sep 4, 2034
US 10548907 ↗ Method of use U-3297 Sep 4, 2034
US 11400101 ↗ Method of use U-3297 Sep 4, 2034
US 12064442 ↗ Method of use U-3297 Sep 4, 2034
US 10016443 ↗ Method of use U-3297 Sep 4, 2034
US 10517880 ↗ Method of use U-3297 Sep 4, 2034
US 9750754 ↗ Method of use U-3297 Sep 4, 2034
US 9078923 ↗ Method of use U-3297 Sep 4, 2034
US 12653833 ↗ Method of use U-4564 Nov 21, 2044
US 11679210 ↗ Drug product — Sep 3, 2038
US 10561672 ↗ Drug product — Sep 4, 2034
US 9370483 ↗ Drug product — Sep 4, 2034
US 10376526 ↗ Drug product — Sep 4, 2034
US 12303635 ↗ Drug substance — Apr 8, 2039
US 9937189 ↗ Drug product — Sep 4, 2034
FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationJul 7, 2029
Common questions
Is there a generic version of RYALTRIS 665-25 MCG SPRAY?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for RYALTRIS 665-25 MCG SPRAY. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2044 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ryaltris — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ryaltris. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.44M
Claims incl. refills
4.6K
Beneficiaries
3.7K
Spend / beneficiary
$390.43
Spend / claim
$314.17
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ryaltris (this brand).

Top reported reactions

Device Delivery System Issue702
Drug Dose Omission By Device519
Device Issue159
Wrong Technique In Device Usage Process144
Device Occlusion133
Epistaxis125
Product Tampering70

Age at onset

Child2
Adolescent7
Adult76
Elderly29

Reporter sex

1,989 reports
Male · 31%
Female · 69%

Serious outcomes

Hospitalization78
Life-threatening14
Death12
Disabling10
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 778 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
68462-0659-27 You're viewing this 12 CARTON in 1 BOX (68462-659-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY $7.67 / g — 2026-01-13 Active
68462-0659-84 12 CARTON in 1 BOX (68462-659-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY — — 2026-01-13 Active

Pack size FAQ

What quantity is in NDC 68462-0659-27?
NDC 68462-0659-27 is listed by the FDA — 12 carton in 1 box / 1 bottle, spray in 1 carton / 240 spray, metered in 1 bottle, spray.
What NDC number is used to bill for this package of Ryaltris olopatadine hydrochloride and mometasone furoate 665 ug; 25 ug Spray, Metered?
Bill NDC 68462-0659-27 — the 11-digit billing format is 68462065927. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 66 words ▾

1 INDICATIONS AND USAGE RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older. RYALTRIS is a combination of olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid, indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • Recommended dosage: Adults and Pediatric Patients 12 years of age and older : 2 sprays in each nostril twice daily. ( 2.1 ) Pediatric patients 6 to 11 years of age : 1 spray in each nostril twice daily. ( 2.2 ) • Administration Instructions: For intranasal use only.

Prime before initial use by releasing 6 sprays or until a fine mist appears and when it has not been used for 14 or more days by releasing 2 sprays or until a fine mist appears. (2.3 )

2.1Recommended Dosage for Adults and Pediatric Patients 12 Years of Age and Older The recommended dosage of RYALTRIS is 2 sprays (2 sprays deliver a total of 1,330 mcg of olopatadine hydrochloride and 50 mcg of mometasone furoate) in each nostril twice daily.

2.2Recommended Dosage for Pediatric Patients 6 Years to 11 Years of Age The recommended dosage of RYALTRIS is 1 spray (1 spray delivers a total of 665 mcg of olopatadine hydrochloride and 25 mcg of mometasone furoate) in each nostril twice daily.

2.3Administration Information • Administer RYALTRIS by intranasal route only. • Shake the bottle well before each use. • Prime RYALTRIS before initial use by releasing 6 sprays or until a fine mist appears. When RYALTRIS has not been used for 14 or more days, re-prime by releasing 2 sprays or until a fine mist appears. • Avoid spraying RYALTRIS into the eyes or mouth.

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS AND STRENGTHS Nasal spray: 665 mcg of olopatadine hydrochloride and 25 mcg of mometasone furoate in each spray Nasal spray: 665 mcg of olopatadine hydrochloride and 25 mcg of mometasone furoate in each spray. ( 3 )

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS RYALTRIS is contraindicated in patients with known hypersensitivity to any ingredients of RYALTRIS. Hypersensitivity reactions, including wheezing, has occurred after nasal administration of mometasone furoate [see Warnings and Precautions ( 5.4 )]. Patients with known hypersensitivity to any ingredients of RYALTRIS, including mometasone furoate. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Epistaxis, nasal ulcerations, nasal septal perforations, impaired wound healing, and Candida albicans infection: Monitor patients periodically for signs of adverse reactions on the nasal mucosa. ( 5.1 ) • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery when taking RYALTRIS. ( 5.2 ) • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with RYALTRIS because additional reductions in alertness and additional impairment of CNS performance may occur.

( 5.2 ) • Glaucoma and cataracts: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. ( 5.3 ) • Hypersensitivity Reactions: Hypersensitivity reactions can occur with RYALTRIS. Hypersensitivity reactions including wheezing, have occurred after the nasal administration of mometasone furoate.

Discontinue RYALTRIS if such reactions occur. ( 5.4 ) • Immunosuppression and Risk of Infections: Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients: Use caution in patients with the above because of the potential for worsening of these infections.

( 5.5 ) • Hypercorticism and adrenal suppression with misuse or use of higher-than-recommended dosages or at the regular dosage in susceptible patients at risk for such effects ( 5.6 ) • Potential reduction in growth velocity in children: Routinely monitor the growth in pediatric patients receiving RYALTRIS. ( 5.7 , 8.4 )

5.1Local Nasal Adverse Reactions Epistaxis Epistaxis was observed in 1% of patients treated with RYALTRIS and 0.6% of patients who received placebo in 2-week studies in patients with seasonal allergic rhinitis [see Adverse Reactions ( 6.1 )]. Nasal Ulceration and Nasal Septal Perforation Instances of nasal ulceration and nasal septal perforation have occurred in patients following the nasal application of antihistamines such as RYALTRIS. Monitor patients periodically for signs of adverse effects on the nasal mucosa.

Impaired Nasal Wound Healing Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should avoid use of RYALTRIS until healing has occurred. Local Candida Infection Localized infections of the nose and pharynx with Candida albicans have occurred from nasal administration of mometasone furoate. When such an infection occurs, discontinue RYALTRIS and institute appropriate local or systemic therapy.

Patients using RYALTRIS over several months or longer should be examined periodically for evidence of Candida infection.

5.2Somnolence and Impaired Mental Alertness Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after administration of RYALTRIS. Concurrent use of RYALTRIS with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur. Somnolence was reported in 0.3% of patients treated with RYALTRIS and none of the patients who received placebo in 2-week studies in patients with seasonal allergic rhinitis [see Adverse Reactions ( 6.1 )] .

5.3Glaucoma and Cataracts Nasal and inhaled corticosteroids including RYALTRIS can result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

5.4Hypersensitivity Reactions Hypersensitivity reactions can occur with RYALTRIS. Hypersensitivity reactions including wheezing, have occurred after the nasal administratio…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Local Nasal Adverse Reactions [see Warnings and Precautions ( 5.1 )] • Somnolence and Impaired Mental Alertness [see Warnings and Precautions ( 5.2 )] • Glaucoma and Cataracts [see Warnings and Precautions ( 5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.5 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.4 )] • Effect on Growth [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (≥1% incidence) are dysgeusia, epistaxis, nasal discomfort, and headache.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared with rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults and Pediatric Patients 12 Years of Age and Older The pooled RYALTRIS safety population reflects exposure to RYALTRIS at 2 sprays (2 sprays deliver a total of 1,330 mcg of olopatadine hydrochloride and 50 mcg of mometasone furoate) in each nostril twice daily in a total of 1189 patients from Studies 1 and 2 [see Clinical Studies ( 14 )] and from three additional placebo and/or active-controlled studies in patients with allergic rhinitis.

One placebo controlled study was a 52-week safety study. In this study, 393 patients were exposed to RYALTRIS for one year, and no new safety signals were observed. The RYALTRIS safety population described below reflects exposure to RYALTRIS at 2 sprays (2 sprays deliver a total of 1,330 mcg of olopatadine hydrochloride and 50 mcg of mometasone furoate) in each nostril twice daily for two weeks duration in a total of 789 patients, including 596 patients from Studies 1 and 2 [see Clinical Studies ( 14 )], and 36 and 157 from two additional placebo and active-controlled studies in patients with seasonal allergic rhinitis.

The demographics of the RYALTRIS-treated patients were 12 to 81 years of age (mean age of 40 years; 67% female; 81% White, 15% Black/African American and 3% Other). Table 1 lists adverse reactions from the safety population reported with frequencies ≥1% and more frequently than placebo in patients treated with RYALTRIS. Somnolence was reported in <1% (2 of 789) of patients treated with RYALTRIS and no patients treated with placebo.

Table 1: Adverse Reactions with ≥1% Incidence that Were Reported More Frequently with RYALTRIS than Placebo in the Safety Population in Adult and Pediatric Patients 12 Years of Age and Older with Seasonal Allergic Rhinitis RYALTRIS N=789 n (%) Olopatadine HCl Nasal Spray * N=751 n (%) Mometasone Furoate Nasal Spray * N=746 n (%) Placebo N=776 n (%) Dysgeusia 24 (3.0) 16 (2.1) 0 (0) 2 (0.3) Epistaxis 8 (1.0) 11 (1.5) 6 (0.8) 5 (0.6) Nasal discomfort 8 (1.0) 4 (0.5) 4 (0.5) 6 (0.8) * Non-US approved drugs Adverse Reactions in Pediatric Patients 6 Years to 11 Years of Age The safety data of RYALTRIS in pediatric patients 6 years to11 years of age with seasonal allergic rhinitis was based on 225 patients who received RYALTRIS in a 2-week, double-blind, randomized, parallel-group, placebo-controlled study [see Clinical Studies (14)] .

Patients in the study received 1 spray per nostril of RYALTRIS, twice daily. The adverse reactions observed in pediatric patients 6 years to 11 years of age were similar to the adults and pediatric patients 12 years of age and older. Additionally, headache was reported in 1% of pediatric patients 6 years to 11 years of age treated with RYALTRIS and 0.5% of pediatric patients 6 years to 11 years of ag…

🔄 Drug Interactions 163 words ▾

7 DRUG INTERACTIONS No formal drug-drug interaction studies have been performed with RYALTRIS. The drug interactions of the combination are expected to reflect those of the individual components [see Clinical Pharmacology ( 12.3 )] .

7.1Central Nervous System Depressants Concurrent use of RYALTRIS with alcohol or other central nervous system depressants should be avoided because somnolence and impairment of central nervous system performance may occur [see Warnings and Precautions ( 5.2 )] .

7.2Inhibitors of Cytochrome P450 3A4 Studies have shown that mometasone furoate, a component of RYALTRIS, is primarily and extensively metabolized to multiple metabolites. In vitro studies have confirmed the primary role of cytochrome P450 (CYP) 3A4 in the metabolism of this compound. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the mometasone furoate plasma concentration and potentially increase the risk for adverse reactions.

Caution should be exercised when considering the coadministration of RYALTRIS with strong CYP3A4 inhibitors [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on RYALTRIS or mometasone furoate use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Postmarketing experience with antihistamines, with similar mechanism of action to olopatadine, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are no published human data specific to olopatadine.

Animal reproduction studies have not been conducted with RYALTRIS. However, animal reproduction studies are available for olopatadine hydrochloride and mometasone furoate. Oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 120 and 1600 times the maximum recommended human daily intranasal dose (MRHDID) on a mg/m 2 basis, respectively (see Data) .

In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1 to 16 times the MRHDID on a mcg/m 2 or AUC basis (see Data) . However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No reproductive toxicology studies were conducted with RYALTRIS; however, studies are available for olopatadine hydrochloride and mometasone furoate, as described below.

Olopatadine hydrochloride In an oral embryo-fetal development study, pregnant rats were dosed throughout the period of organogenesis at doses up to 600 mg/kg/day. Maternal toxicity, producing death and reduced maternal body weight gain was observed at 600 mg/kg/day (approximately 1200 times the MRHDID on a mg/m 2 basis). Olopatadine produced cleft palate at 60 mg/kg/day (approximately 120 times the MRHDID on a mg/m 2 basis) and decreased embryo-fetal viability and reduced fetal weight in rats at 600 mg/kg/day (approximately 1200 times the MRHDID on a mg/m 2 basis).

In an oral embryo-fetal development study, pregnant rabbits were dosed throughout the period of organogenesis at doses up to 400 mg/kg/day. A decrease in the number of live fetuses was observed at 400 mg/kg/day (approximately 1600 times the MRHDID on a mg/m 2 basis). In peri-/post-natal toxicity studies, pregnant rats received oral doses of olopatadine up to 600 mg/kg/day during late gestation and throughout the lactation period.

Olopatadine produced decreased neonatal survival at 60 mg/kg/day (approximately 120 times the MRHDID on a mg/m 2 basis) and reduced body weight gain in pups at 4 mg/kg/day (approximately 7 times the MRHDID on a mg/m 2 basis). These effects appeared attributable to exposure of pups via the milk as demonstrated in a cross-fostered study in which pups of untreated dams cross-fostered to dams treated with 60 mg/kg/day olopatadine orally during the lactation period exhibited decreased body weight gain. Mometasone furoate In an embryo-fetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose approximately equivalent to the MRHDID (on a mcg/m 2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 4 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 180 mcg/kg).

No toxicity was observed with a dose that produced an…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no available data on RYALTRIS or mometasone furoate use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Postmarketing experience with antihistamines, with similar mechanism of action to olopatadine, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are no published human data specific to olopatadine.

Animal reproduction studies have not been conducted with RYALTRIS. However, animal reproduction studies are available for olopatadine hydrochloride and mometasone furoate. Oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 120 and 1600 times the maximum recommended human daily intranasal dose (MRHDID) on a mg/m 2 basis, respectively (see Data) .

In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1 to 16 times the MRHDID on a mcg/m 2 or AUC basis (see Data) . However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No reproductive toxicology studies were conducted with RYALTRIS; however, studies are available for olopatadine hydrochloride and mometasone furoate, as described below.

Olopatadine hydrochloride In an oral embryo-fetal development study, pregnant rats were dosed throughout the period of organogenesis at doses up to 600 mg/kg/day. Maternal toxicity, producing death and reduced maternal body weight gain was observed at 600 mg/kg/day (approximately 1200 times the MRHDID on a mg/m 2 basis). Olopatadine produced cleft palate at 60 mg/kg/day (approximately 120 times the MRHDID on a mg/m 2 basis) and decreased embryo-fetal viability and reduced fetal weight in rats at 600 mg/kg/day (approximately 1200 times the MRHDID on a mg/m 2 basis).

In an oral embryo-fetal development study, pregnant rabbits were dosed throughout the period of organogenesis at doses up to 400 mg/kg/day. A decrease in the number of live fetuses was observed at 400 mg/kg/day (approximately 1600 times the MRHDID on a mg/m 2 basis). In peri-/post-natal toxicity studies, pregnant rats received oral doses of olopatadine up to 600 mg/kg/day during late gestation and throughout the lactation period.

Olopatadine produced decreased neonatal survival at 60 mg/kg/day (approximately 120 times the MRHDID on a mg/m 2 basis) and reduced body weight gain in pups at 4 mg/kg/day (approximately 7 times the MRHDID on a mg/m 2 basis). These effects appeared attributable to exposure of pups via the milk as demonstrated in a cross-fostered study in which pups of untreated dams cross-fostered to dams treated with 60 mg/kg/day olopatadine orally during the lactation period exhibited decreased body weight gain. Mometasone furoate In an embryo-fetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose approximately equivalent to the MRHDID (on a mcg/m 2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 4 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 180 mcg/kg).

No toxicity was observed with a dose that produced an exposure approximately one-hal…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of RYALTRIS for the treatment of symptoms of seasonal allergic rhinitis have been established in pediatric patients 6 years of age and older. Use of RYALTRIS for this indication is supported by evidence with the following: • an adequate and well-controlled 2-week study in pediatric patients 6 years to 11 years of age [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14 )] . • adequate and well-controlled studies in adult and pediatric patients 12 years and older [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14 ), Pharmacokinetics ( 12.3 )] .

The safety and effectiveness of RYALTRIS in pediatric patients below the age of 6 years have not been established. Effect on Growth Controlled clinical studies have shown that nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.

The long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving nasal corticosteroids, including RYALTRIS, should be monitored routinely (e.g., via stadiometry).

The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risk/benefits of non-corticosteroid treatment alternatives. The potential of mometasone furoate nasal spray 50 mcg to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out.

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use There were 20 patients 65 years of age and older treated with RYALTRIS in the clinical studies for seasonal allergic rhinitis [see Clinical Studies ( 14 )] . Of the RYALTRIS-treated patients in these studies, 16 (2.7%) were between 65 to 75 years of age, while 4 (0.7%) were 75 years of age and older. Clinical studies of RYALTRIS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

🆘 Overdosage 78 words ▾

10 OVERDOSAGE RYALTRIS contains both olopatadine hydrochloride and mometasone furoate; therefore, the risks associated with overdosage for the individual components described below apply to RYALTRIS. Olopatadine Hydrochloride: Symptoms of antihistamine overdose may include drowsiness in adults and children. Agitation and restlessness, followed by drowsiness in children.

Should overdose occur, symptomatic or supportive treatment is recommended. Mometasone Furoate: Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism [see Warnings and Precautions ( 5.6 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action RYALTRIS contains both olopatadine hydrochloride and mometasone furoate. The mechanisms of action described below for the individual components apply to RYALTRIS. Olopatadine Hydrochloride Olopatadine is a histamine-1 (H1) receptor inhibitor.

The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans. Mometasone Furoate Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on allergic rhinitis is not known.

Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

12.2Pharmacodynamics Cardiac Electrophysiology A study specifically designed to evaluate the effect of RYALTRIS on the QT interval has not been conducted. In a 12-month study, 429 patients treated with olopatadine hydrochloride two sprays per nostril (665 mcg per spray) twice daily, no evidence of any effect of olopatadine hydrochloride on QT prolongation has been observed. HPA Axis Effect A study specifically designed to evaluate the effect of RYALTRIS on the HPA axis has not been conducted.

In one study, daily nasal doses of 200 and 400 mcg of mometasone furoate and oral dose of 10 mg prednisone were compared to placebo in 64 patients (22 to 44 years of age) with allergic rhinitis. Adrenal function before and after 36 consecutive days of treatment was assessed by measuring plasma cortisol levels following a 6-hour cosyntropin infusion and by measuring 24-hour urinary free cortisol levels. Mometasone furoate at both the 200- and 400-mcg dose, was not associated with a statistically significant decrease in mean plasma cortisol levels post-cosyntropin infusion or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo.

A statistically significant decrease in the mean plasma cortisol levels post-cosyntropin infusion and 24-hour urinary free cortisol levels was detected in the prednisone treatment group compared to placebo.

12.3Pharmacokinetics Absorption After repeated nasal administration of 2 sprays per nostril of RYALTRIS (2660 mcg of olopatadine hydrochloride and 100 mcg of mometasone furoate) twice daily in patients with seasonal allergic rhinitis, the mean (± standard deviation) peak plasma exposure (C max ) was 19.80 ± 7.01 ng/mL for olopatadine and 9.92 ± 3.74 pg/mL for mometasone furoate, and the mean exposure over the dosing regimen (AUC tau ) was 88.77 ± 23.87 ng/mL*hr for olopatadine and 58.40 ± 27.00 pg/mL*hr for mometasone furoate.

The median time to peak exposure from a single dose was 1 hour for both olopatadine and mometasone furoate. Distribution The protein binding of olopatadine was moderate at approximately 55% in human serum and independent of drug concentration over the range of 0.1 to 1000 ng/mL. Olopatadine binds predominately to human serum albumin.

The in vitro protein binding for mometasone furoate was reported to be 98% to 99% in concentration range of 5 to 500 ng/mL. Elimination Following single‑dose nasal administration of a combination of olopatadine and mometasone furoate, the mean elimination half-lives of olopatadine and mometasone furoate were 9 and 18 hours, respectively. Olopatadine is mainly eliminated through urinary excretion.

Approximately 70% of a [ 14 C] olopatadine hydrochloride oral dose was recovered in urine with 17% in the feces. Of the drug‑related material recovered within the first 24 hours in the urine, 86% was unchanged olopatadine, with the balance comprised of olopatadine N-oxide and N-desmethyl olopatadine. Any absorbed drug is excreted as metabolites mostly via the bile, and to a limited extent, into the urine.

Metabolism Olopatadine is not extensively metabolized. Based on pl…

🧬 Mechanism of Action 107 words ▾

12.1Mechanism of Action RYALTRIS contains both olopatadine hydrochloride and mometasone furoate. The mechanisms of action described below for the individual components apply to RYALTRIS. Olopatadine Hydrochloride Olopatadine is a histamine-1 (H1) receptor inhibitor.

The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans. Mometasone Furoate Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on allergic rhinitis is not known.

Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

📦 How Supplied / Storage and Handling 147 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING RYALTRIS (NDC 68462-659-27) is supplied in a white plastic bottle fitted with a metered‑dose spray nozzle unit. Each bottle contains a net fill weight of 31 g and will deliver 240 metered sprays in addition to six (6) initial priming sprays [see Description ( 11 )] . The bottle should be discarded after 240 sprays have been used.

Each spray delivers a volume of 0.1 mL suspension as a fine mist, containing 665 mcg of olopatadine hydrochloride equivalent to 600 mcg of olopatadine (base) and 25 mcg of mometasone furoate monohydrate (on the anhydrous basis). Storage Store RYALTRIS upright with the purple dust cap on at room temperature (see USP Controlled Room Temperature, between 20°C and 25°C, or between 68°F and 77°F, with excursions permitted between 15°C to 30°C or between 59°F to 86°F). Do not store in a freezer or refrigerator.

📋 Description ~1 min read ▾

11 DESCRIPTION RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride.

It has a molecular weight of 373.88, and its molecular formula is C 21 H 23 NO 3 •HCl with the following chemical structure: Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure: Mometasone furoate monohydrate is a white powder, with an empirical formula of C 27 H 30 C l2 O 6 •H 2 O and a molecular weight of 539.45.

It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis).

After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, glycerin, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling ( 16 )] . structureolopatadine structuremometasone

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Information Instruct patients to use RYALTRIS by intranasal route only. Patients should be instructed to shake the bottle well before each use and prime RYALTRIS before initial use by releasing 6 sprays or until a fine mist appears.

When RYALTRIS has not been used for 14 days or more, patients should re-prime with 2 sprays or until a fine mist appears. Patients should be instructed to avoid spraying RYALTRIS into their eyes [see Dosage and Administration ( 2.3 )]. Local Nasal Adverse Reactions Nasal antihistamines are associated with epistaxis, nasal ulceration, and nasal septal perforation.

Nasal corticosteroids are associated with epistaxis, nasal septal perforation, Candida albicans infection, and impaired wound healing [see Warnings and Precautions ( 5.1 )] . Somnolence and Impaired Mental Alertness Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of RYALTRIS [see Warnings and Precautions ( 5.2 )] . Somnolence has been reported in some patients (2 of 789 patients) taking RYALTRIS in controlled clinical studies in seasonal allergic rhinitis [see Adverse Reactions ( 6.1 )] .

Concurrent Use of Alcohol and Other Central Nervous System Depressants Patients should be advised to avoid concurrent use of RYALTRIS with alcohol or other CNS depressants because additional reductions in alertness and additional impairment of CNS performance may occur [see Warnings and Precautions ( 5.2 )] . Glaucoma and Cataracts Patients should be informed that nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts [see Warnings and Precautions ( 5.3 )] .

Hypersensitivity Reactions Hypersensitivity reactions can occur with RYALTRIS. Hypersensitivity reactions including wheezing, have occurred after the nasal administration of mometasone furoate. Discontinue RYALTRIS if such reactions occur [see Contraindications ( 4 ) and Warnings and Precautions ( 5.4 )] .

Immunosuppression and Risk of Infections Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and patients should also be advised that if they are exposed, medical advice should be sought without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions ( 5.5 )] . Effect on Growth Inform patients that nasal corticosteroids, including RYALTRIS, may cause reduction in growth velocity when administered to pediatric patients.

Healthcare providers should closely follow the growth of pediatric patients using corticosteroids [see Warnings and Precautions ( 5.7 )]. Potential Drug Interactions Patients should be advised to be cautious if RYALTRIS is co-administered with ketoconazole or other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Drug Interactions ( 7.2 )] . Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 RYALTRIS and the RYALTRIS logo are registered trademarks of Glenmark Specialty SA Revised: July 2026 logo1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68462-0657-29 · Glenmark 68462-0672-95 · Glenmark →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.