Home › NDC Lookup › Ingredients › Olopatadine Hydrochloride › 63629-8434-01
olopatadine hydrochloride 665 ug Spray — NDC 63629-8434-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

olopatadine hydrochloride 665 ug Spray — NDC 63629-8434-1 (Billing 63629-8434-01)

by Bryant Ranch Prepack · 1 BOTTLE in 1 CARTON / 240 SPRAY in 1 BOTTLE

This is a package of olopatadine hydrochloride 665 ug Spray from Bryant Ranch Prepack, marketed since Jun 2017 and currently FDA-listed. It is this product's only package size.

NDC 63629-8434-01
🏷️ FDA NDC (as labeled) 63629-8434-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 63629-8434-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63629 labeler · 8434 product · 1 package
Package marketed since
Apr 28, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6362984341 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63629-8434-1
Product NDC 63629-8434
11-digit billing NDC 63629843401
NCPDP billing unit GM — per gram (weight)
RxCUI 1797895
UNII 2XG66W44KF
Application # ANDA202853
SPL Set ID 272e8f56-ee4e-456f-ab98-3e40f657c630
Established class (EPC) Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer
Mechanism of action Histamine H1 Receptor Antagonists
Physiologic effect Decreased Histamine Release
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-06-14
Route NASAL
Dosage form SPRAY
Substance OLOPATADINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 42401060102020
GPI class Olopatadine HCl
GCN Seq No 063890
GCN 99602
HICL code 012815
Ingredient (HICL) Olopatadine Hcl
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 Q7E
Therapeutic class — specific (HIC3) Nasal Antihistamine
AHFS code 52:02.00.00
AHFS class Antiallergic Agents
FDB label name OLOPATADINE 665 MCG NASAL SPRY
FDB brand name Olopatadine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063890
  • GCN: 99602
  • GPI-14 (Medi-Span): 42401060102020
  • HICL (First Databank): 012815
  • AHFS class code: 52:02.00.00
  • RxCUI (RxNorm): 1797895
Why two NDCs? The FDA registers this code as 63629-8434-1 — a 5-4-1 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 package segment → 63629-8434-01. 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 Histamine-1 Receptor Inhibitor class.

Pharmacologic class Histamine-1 Receptor Inhibitor, Histamine-1 Receptor Antagonist, Mast Cell Stabilizer
Drug family (ATC) Antiallergic agents, excl. corticosteroids, Other antiallergics
How it works Histamine H1 Receptor Antagonists
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.

Clinical

Label name OLOPATADINE 665 MCG NASAL SPRY Ingredient Olopatadine Hcl
📖 What it is MedlinePlus · NLM

Olopatadine nasal spray is used to relieve sneezing and a stuffy, runny or itchy nose caused by allergic rhinitis (hay fever). Olopatadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The eye drops relieve itchy eyes from allergies, and some products relieve redness too. The nasal spray relieves seasonal allergic rhinitis symptoms in adults and children 6 and ol...
  • It depends on the product. Some eye drops are twice daily, 6 to 8 hours apart, and others once daily. The nasal spray is twice daily. Follow your label or prescriber.
  • Take your lenses out before using the drops and wait at least 10 minutes before putting them back. Don't wear lenses if your eyes are red. These drops aren't for contact lens irrit...
  • With the nasal spray, a bitter taste, headache, nosebleeds and sore throat are common. It can also make you drowsy, so be careful driving and skip alcohol.
📖 Read our full Olopatadine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Olopatadine Hydrochloride — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Olopatadine Hydrochloride (3 interactions) — ranked by severity →
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.

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 $2.07 —
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63629-8434-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 240 SPRAY in 1 BOTTLE 2021-04-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
olopatadine hydrochloride 665 ug 45802-0104-01 Padagis 1 bottle $0.850 AB Availability likely —
Olopatadine Hydrochloride 665 ug 60505-0845-05 Apotex 1 bottle $0.850 AB Availability likely —
Olopatadine Hydrochloride 665 ug 65162-0890-23 Amneal 1 bottle $0.850 AB Availability likely —
olopatadine hydrochloride 665 ugthis 63629-8434-01 Bryant 1 bottle — AB FDA listed —
olopatadine hydrochloride 665 ug 72162-1390-02 Bryant 1 bottle — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2017
On the market since
Jun 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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.

🧪 Avoiding an ingredient? See Olopatadine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 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 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 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 GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • 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.

7 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.

Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA202853 (ANDA)
Labeler code63629
First marketedJun 2017
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 63629

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 67 words ▾

1 INDICATIONS AND USAGE Olopatadine hydrochloride nasal solution (nasal spray) is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. Olopatadine hydrochloride nasal solution (nasal spray) is an H 1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION For nasal use only. Recommended dosages: • Adults and Adolescents ≥ 12 Years : Two sprays per nostril (665 mcg per spray) twice daily ( 2.1 ). • Pediatric Patients 6 to 11 Years : One spray per nostril (665 mcg per spray) twice daily ( 2.2 ). • Priming Information : Prime olopatadine hydrochloride nasal solution (nasal spray) before initial use and when olopatadine hydrochloride nasal solution (nasal spray) has not been used for more than 7 days ( 2.3 ).

2.1Adults and Adolescents Twelve Years of Age and Older The recommended dosage is two sprays per nostril twice daily.

2.2Pediatric Patients Six to Eleven Years of Age The recommended dosage is one spray per nostril twice daily.

2.3Administration Information Administer olopatadine hydrochloride nasal solution (nasal spray) by the nasal route only. Priming : Before initial use, prime olopatadine hydrochloride nasal solution (nasal spray) by releasing 5 sprays or until a fine mist appears. The correct amount of medication cannot be assured before the initial priming.

Re-priming (as needed): When olopatadine hydrochloride nasal solution (nasal spray) has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying olopatadine hydrochloride nasal solution (nasal spray) into the eyes. Discard Instructions : Discard nasal device after 240 sprays (enough for 30 days of dosing) have been used even though the bottle is not completely empty.

The correct amount of medication cannot be assured after 240 sprays have been used.

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS Nasal spray: 665 mcg olopatadine hydrochloride per spray supplied in a white plastic bottle with a metered-dose manual spray pump, a white nasal applicator, a blue overcap and a blue clip. Nasal spray: 665 mcg of olopatadine hydrochloride in each spray ( 3 ).

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 ).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Epistaxis, Nasal Ulceration, and Nasal Septal Perforation : Monitor patients periodically for signs of adverse effects on the nasal mucosa. Discontinue if ulcerations or perforations occur. Avoid use in patients with nasal disease other than allergic rhinitis ( 5.1 ). • Avoid engaging in hazardous occupations requiring complete mental alertness and coordination, such as driving or operating machinery when taking olopatadine hydrochloride nasal solution (nasal spray) ( 5.2 ). • Avoid concurrent use of alcohol or other central nervous system depressants with olopatadine hydrochloride nasal solution (nasal spray) ( 5.2 ).

5.1Local Nasal Effects Epistaxis and Nasal Ulceration In placebo-controlled clinical trials (vehicle nasal spray) of 2 weeks to 12 months duration, epistaxis and nasal ulcerations were reported [ see Adverse Reactions 6.1 ]. Nasal Septal Perforation Three placebo-controlled long term (12 months) safety trials (vehicle nasal spray) were conducted. In the first safety trial, patients were treated with an investigational formulation of olopatadine hydrochloride nasal solution (nasal spray) containing povidone (not the commercially marketed formulation) or a vehicle nasal spray containing povidone.

Nasal septal perforations were reported in one patient treated with the investigational formulation of olopatadine hydrochloride nasal solution (nasal spray) and 2 patients treated with the vehicle nasal spray. In the second safety trial with olopatadine hydrochloride nasal solution (nasal spray), which does not contain povidone, there were no reports of nasal septal perforation. In the third safety trial, one patient exposed to the 3.7 pH vehicle nasal spray (containing no povidone) reported a nasal septal perforation [ see Adverse Reactions ( 6.1 ) ].

Before starting olopatadine hydrochloride nasal solution (nasal spray), conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Perform nasal examinations periodically for signs of adverse effects on the nasal mucosa and consider stopping olopatadine hydrochloride nasal solution (nasal spray) if patients develop nasal ulcerations.

5.2Somnolence and Impaired Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking olopatadine hydrochloride nasal solution (nasal spray) [ see Adverse Reactions ( 6.1 ) ]. 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 olopatadine hydrochloride nasal solution (nasal spray). Concurrent use of olopatadine hydrochloride nasal solution (nasal spray) with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most clinically significant adverse reactions described in other sections of labeling include: • Epistaxis, Nasal Ulceration, and Nasal Septal Perforation [ see Warnings and Precautions ( 5.1 ) ] • Somnolence and Impaired Mental Alertness [ see Warnings and Precautions ( 5.2 ) ] The most common (>1%) adverse reactions, included bitter taste, headache, epistaxis, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection in patients 12 years of age and older and epistaxis, headache, upper respiratory tract infection, bitter taste, pyrexia, and rash in patients 6 to 11 years of age ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure to olopatadine hydrochloride nasal solution (nasal spray) in 2770 patients with seasonal or perennial allergic rhinitis in 10 controlled clinical trials of 2 weeks to 12 months duration.

Olopatadine hydrochloride nasal solution (nasal spray) is not indicated for use in patients with perennial allergic rhinitis. The safety data from adults and adolescents are based upon 6 placebo-controlled clinical trials (3.7 pH vehicle nasal spray or 7.0 pH vehicle nasal spray) in which 1834 patients with seasonal or perennial allergic rhinitis (652 males and 1182 females) 12 years of age and older were treated with olopatadine hydrochloride nasal solution (nasal spray) two sprays per nostril twice daily. There were 1180 patients (olopatadine hydrochloride nasal solution (nasal spray), 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration.

There were 2840 patients (olopatadine hydrochloride nasal solution (nasal spray), 1247; 3.7 pH vehicle nasal spray, 1251; 7.0 pH vehicle nasal spray, 342) that participated in 3 long-term clinical trials of 1-year duration. The racial distribution of adult and adolescent patients receiving olopatadine hydrochloride nasal solution (nasal spray) was 77% white, 9% black, and 14% other. The incidence of discontinuation due to adverse reactions in these controlled clinical trials was comparable for olopatadine hydrochloride nasal solution (nasal spray) and vehicle nasal spray.

Overall, 4.7% of the 1834 adult and adolescent patients across all 6 studies treated with olopatadine hydrochloride nasal solution (nasal spray), 3.5% of the 1844 patients treated with 3.7 pH vehicle nasal spray discontinued due to adverse reactions, and 2.9% of the 342 patients treated with 7.0 pH vehicle nasal spray discontinued due to adverse reactions. The safety data from pediatric patients 6 to 11 years of age are based upon 3 clinical trials in which 870 children with seasonal allergic rhinitis (376 females and 494 males) were treated with olopatadine hydrochloride nasal solution (nasal spray) one or two sprays per nostril twice daily for 2 weeks.

The racial distribution of pediatric patients receiving olopatadine hydrochloride nasal solution (nasal spray) was 68.6% white, 16.6% black, and 14.8% other. The incidence of discontinuation due to adverse reactions in these controlled clinical trials was comparable for olopatadine hydrochloride nasal solution (nasal spray) and vehicle nasal spray. Overall, 1.4% of the 870 pediatric patients across all 3 studies treated with olopatadine hydrochloride nasal solution (nasal spray) and 1.3% of the 872 pediatric patients treated with vehicle nasal spray discontinued due to adverse reactions.

Adults and Adolescents 12 Years of Age and Older in Short-Term (2-week) Trials There were 1180 patients 12 years of age and older (olopatadine hydrochloride nasal solution (n… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 56 words ▾

7 DRUG INTERACTIONS Formal drug-drug interaction studies were not conducted for olopatadine hydrochloride nasal solution (nasal spray). Drug interactions with inhibitors of liver enzymes are not anticipated because olopatadine is eliminated predominantly by renal excretion. Drug interactions involving P450 inhibition and plasma protein binding are also not expected. [ See Clinical Pharmacology ( 12.3 ) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published data from postmarketing experience with antihistamines, with similar mechanism of action to olopatadine hydrochloride nasal solution (nasal spray), 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 hydrochloride nasal solution (nasal spray). In animal reproductive studies, oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 110 and 1460 times the maximum recommended human daily intranasal dose (MRHDID) on a mg/m 2 basis, respectively (see Data) .

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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively.

Data Animal Data 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 (1460 times the MRHDID, on a mg/m 2 basis). 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 1100 times the MRHDID on a mg/m 2 basis). Olopatadine produced cleft palate at 60 mg/kg/day (approximately 110 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 1100 times the MRHDID on a mg/m 2 basis). In peri-/postnatal 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 110 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.

8.2Lactation Risk Summary There are no data on the presence of olopatadine in human milk, the effects on the breastfed infant, or the effects on milk production. Although orally administered olopatadine is present in rat milk, there is no information about nasally administered olopatadine. It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for olopatadine hydrochloride nasal solution (nasal spray) and any potential adverse effects on the breast fed infant from olopatadine hydrochloride nasal solution (nasal spray) or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of olopatadine hydrochloride nasal solution (nasal spray) for the relief of symptoms of seasonal allergic rhinitis have been established in pediatric patients aged 6 years and older. The safety and effectiveness of olopatadine hydrochloride nasal solution (nasal spray) in pediatric patients 6 to 11 years of age are supported by 3 vehicle-controlled 2-week studies in 870 patients [ see Adverse Reactions ( 6.1 ) ]. Doses studied included one and two sprays per nostril twice daily.

One of these studies evaluated the safety of olopatadine hydrochloride n… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Published data from postmarketing experience with antihistamines, with similar mechanism of action to olopatadine hydrochloride nasal solution (nasal spray), 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 hydrochloride nasal solution (nasal spray). In animal reproductive studies, oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 110 and 1460 times the maximum recommended human daily intranasal dose (MRHDID) on a mg/m 2 basis, respectively (see Data) .

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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively.

Data Animal Data 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 (1460 times the MRHDID, on a mg/m 2 basis). 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 1100 times the MRHDID on a mg/m 2 basis). Olopatadine produced cleft palate at 60 mg/kg/day (approximately 110 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 1100 times the MRHDID on a mg/m 2 basis). In peri-/postnatal 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 110 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.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of olopatadine hydrochloride nasal solution (nasal spray) for the relief of symptoms of seasonal allergic rhinitis have been established in pediatric patients aged 6 years and older. The safety and effectiveness of olopatadine hydrochloride nasal solution (nasal spray) in pediatric patients 6 to 11 years of age are supported by 3 vehicle-controlled 2-week studies in 870 patients [ see Adverse Reactions ( 6.1 ) ]. Doses studied included one and two sprays per nostril twice daily.

One of these studies evaluated the safety of olopatadine hydrochloride nasal solution (nasal spray) at doses of one and two sprays per nostril twice daily in 1,188 patients, of which 298 patients were exposed to olopatadine hydrochloride nasal solution (nasal spray) 1 spray and 297 patients were exposed to vehicle 1 spray. In this study, the incidence of epistaxis with olopatadine hydrochloride nasal solution (nasal spray) use was 5.7% [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14 )]. The safety and effectiveness of olopatadine hydrochloride nasal solution (nasal spray) in pediatric patients aged 12 years and older are supported by 3 randomized, double blind, parallel group, multicenter, placebo-controlled clinical trials of 2 weeks duration in adult and adolescent patients [see Clinical Studies ( 14 )] .

In these studies, the incidence of epistaxis with olopatadine hydrochloride nasal solution (nasal spray) use in 587 patients was 3.2% [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of olopatadine hydrochloride nasal solution (nasal spray) have not been established in pediatric patients under 6 years of age. The safety of olopatadine hydrochloride nasal solution (nasal spray) at a dose of one spray per nostril twice daily was evaluated in one 2-week vehicle-controlled study in 132 pediatric patients 2 to 5 years of age with allergic rhinitis.

In this trial, 66 patients were exposed to olopatadine hydrochloride nasal solution (nasal spray). The most common (greater than 1.0%) adverse reactions reported were diarrhea (9.1%), epistaxis (6.1%), rhinorrhea (4.5%), bitter taste (3.0%) and wheezing (3.0%). Diarrhea was reported more frequently (9.1%) in patients 2 to 5 years of age than 6 to 11 year old age group (< 1%).

🧓 Geriatric Use 79 words ▾

8.5Geriatric Use Clinical studies of olopatadine hydrochloride nasal solution (nasal spray) did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage 66 words ▾

10 OVERDOSAGE Symptoms of antihistamine overdose may include drowsiness in both adults and children. Agitation and restlessness followed by drowsiness may also occur in children. There is no known specific antidote to olopatadine hydrochloride nasal solution (nasal spray).

Should overdose occur, symptomatic or supportive treatment is recommended, taking into account any concomitantly ingested medications. For additional information about overdose treatment, call a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Olopatadine is a histamine H 1 receptor antagonist. The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans.

12.2Pharmacodynamics Cardiac Electrophysiology In a placebo-controlled cardiovascular safety study, 32 healthy volunteers received 20 mg oral solution of olopatadine twice daily for 14 days (8-fold greater daily dose than the recommended daily nasal dose). The mean QTcF (QT corrected by Fridericia’s correction method for heart rate) change from baseline was -2.7 msec and -3.8 msec for olopatadine, and placebo, respectively. In this study, 8 subjects treated with olopatadine had a QTcF change from baseline of 30-60 msec, 1 subject had a QTcF change from baseline greater than 60 msec, and no subjects had QTcF values greater than 500 msec.

Eight subjects treated with placebo had a QTcF change from baseline of 30-60 msec, no subjects had a QTcF change from baseline greater than 60 msec, and no subjects had QTcF values greater than 500 msec. In a 12-month study in 429 perennial allergic rhinitis patients treated with olopatadine hydrochloride nasal solution (nasal spray) two sprays per nostril twice daily, no evidence of any effect of olopatadine hydrochloride on QT prolongation was observed.

12.3Pharmacokinetics The pharmacokinetic properties of olopatadine were studied after administration by the nasal, oral, intravenous, and topical ocular routes. Olopatadine exhibited linear pharmacokinetics across the routes studied over a large dose range. Absorption Healthy Subjects: Olopatadine was absorbed with individual peak plasma concentrations observed between 30 minutes and 1 hour after twice daily intranasal administration of olopatadine hydrochloride nasal solution (nasal spray).

The mean ( ± SD) steady-state peak plasma concentration (C max ) of olopatadine was 16.0 ± 8.99 ng/mL. Systemic exposure as indexed by area under the curve (AUC 0-12 ) averaged 66.0 ± 26.8 ng·h/mL. The average absolute bioavailability of intranasal olopatadine is 57%.

The mean accumulation ratio following multiple intranasal administration of olopatadine hydrochloride nasal solution (nasal spray) was about 1.3. Seasonal Allergic Rhinitis Patients: Systemic exposure of olopatadine in seasonal allergic rhinitis SAR patients after twice daily intranasal administration of olopatadine hydrochloride nasal solution (nasal spray) was comparable to that observed in healthy subjects. Olopatadine was absorbed with peak plasma concentrations observed between 15 minutes and 2 hours.

The mean steady-state C max was 23.3 ± 6.2 ng/mL and AUC 0-12 averaged 78.0 ± 13.9 ng·h/mL. 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 was bound predominately to human serum albumin.

Elimination The plasma elimination half-life of olopatadine is 8 to 12 hours. 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. Metabolism Olopatadine is not extensively metabolized. Based on plasma metabolite profiles following oral administration of [ 14 C] olopatadine, at least six minor metabolites circulate in human plasma.

Olopatadine accounts for 77% of peak plasma total radioactivity and all metabolites amounted to <6% combined. Two of these have been identified as the olopatadine N-oxide and N-desmethyl olopatadine. In in vitro studies with cDNA-expressed human cytochrome P450 isoenzymes (CYP) and flavin-containing monooxygenases (FMO), N-desmethyl olopatadine (Ml) formation was catalyzed mainly by CYP3A4, while olopatadine N-oxide (M3) was primar… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 27 words ▾

12.1Mechanism of Action Olopatadine is a histamine H 1 receptor antagonist. The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans.

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Olopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 mcg is supplied in a white plastic bottle with a metered-dose manual spray pump, a white nasal applicator, a blue overcap and a blue clip in a box of 1 (NDC 63629-8434-1). Each trade size bottle contains 30.5 g of clear, colorless liquid and will provide 240 metered sprays. After priming [ see Dosage and Administration (2.3) ], each spray delivers a fine mist containing 665 mcg of olopatadine hydrochloride in 100 µL of formulation through the nozzle.

Net content 30.5 g, 240 sprays: NDC 63629-8434-1 (trade size) Storage Store olopatadine hydrochloride nasal solution (nasal spray) at room temperature between 4°C to 25°C (39°F to 77°F). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 166 words ▾

11 DESCRIPTION Olopatadine hydrochloride nasal solution (nasal spray), 665 mcg is a metered-spray solution for nasal administration. Olopatadine hydrochloride, the active component of olopatadine hydrochloride nasal solution (nasal spray), is a white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride.

It has a molecular weight of 373.88 g/mol, and its molecular formula is C 21 H 23 NO 3 • HCl with the following chemical structure: Olopatadine hydrochloride nasal solution (nasal spray) contains 0.6% w/v olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 µL of the aqueous solution containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [ see Dosage Forms and Strengths ( 3 ) ] .

Olopatadine hydrochloride nasal solution (nasal spray) also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Local Nasal Effects and Other Common Adverse Reactions Inform patients that treatment with olopatadine hydrochloride nasal solution (nasal spray) may lead to adverse reactions, which include epistaxis and nasal ulcerations [ see Warnings and Precautions ( 5.1 ) ]. Other common adverse reactions reported with use of olopatadine hydrochloride nasal solution (nasal spray) include bitter taste, headache, and pharyngolaryngeal pain [ see Adverse Reactions ( 6 ) ].

Somnolence and Impaired Mental Alertness Somnolence has been reported in some patients taking olopatadine hydrochloride nasal solution (nasal spray). Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as driving or operating machinery after administration of olopatadine hydrochloride nasal solution (nasal spray) [ see Warnings and Precautions ( 5.2 ) ]. Concurrent Use of Alcohol and Other Central Nervous System Depressants Advise patients that concurrent use of olopatadine hydrochloride nasal solution (nasal spray) with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [ see Warnings and Precautions ( 5.2 ) ].

Keep Spray Out of Eyes Inform patients to avoid spraying olopatadine hydrochloride nasal solution (nasal spray) in their eyes [ see Dosage and Administration ( 2.3 ) ]. Made in Israel Manufactured by Perrigo Yeruham, Israel Distributed By Perrigo Allegan, MI 49010 ● www.perrigorx.com Rev 06-21 4S000 RC J3

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic properties of olopatadine were studied after administration by the nasal, oral, intravenous, and topical ocular routes. Olopatadine exhibited linear pharmacokinetics across the routes studied over a large dose range. Absorption Healthy Subjects: Olopatadine was absorbed with individual peak plasma concentrations observed between 30 minutes and 1 hour after twice daily intranasal administration of olopatadine hydrochloride nasal solution (nasal spray).

The mean ( ± SD) steady-state peak plasma concentration (C max ) of olopatadine was 16.0 ± 8.99 ng/mL. Systemic exposure as indexed by area under the curve (AUC 0-12 ) averaged 66.0 ± 26.8 ng·h/mL. The average absolute bioavailability of intranasal olopatadine is 57%.

The mean accumulation ratio following multiple intranasal administration of olopatadine hydrochloride nasal solution (nasal spray) was about 1.3. Seasonal Allergic Rhinitis Patients: Systemic exposure of olopatadine in seasonal allergic rhinitis SAR patients after twice daily intranasal administration of olopatadine hydrochloride nasal solution (nasal spray) was comparable to that observed in healthy subjects. Olopatadine was absorbed with peak plasma concentrations observed between 15 minutes and 2 hours.

The mean steady-state C max was 23.3 ± 6.2 ng/mL and AUC 0-12 averaged 78.0 ± 13.9 ng·h/mL. 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 was bound predominately to human serum albumin.

Elimination The plasma elimination half-life of olopatadine is 8 to 12 hours. 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. Metabolism Olopatadine is not extensively metabolized. Based on plasma metabolite profiles following oral administration of [ 14 C] olopatadine, at least six minor metabolites circulate in human plasma.

Olopatadine accounts for 77% of peak plasma total radioactivity and all metabolites amounted to <6% combined. Two of these have been identified as the olopatadine N-oxide and N-desmethyl olopatadine. In in vitro studies with cDNA-expressed human cytochrome P450 isoenzymes (CYP) and flavin-containing monooxygenases (FMO), N-desmethyl olopatadine (Ml) formation was catalyzed mainly by CYP3A4, while olopatadine N-oxide (M3) was primarily catalyzed by FMO1 and FMO3.

Olopatadine at concentrations up to 33,900 ng/mL did not inhibit the in vitro metabolism of specific substrates for CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4. The potential for olopatadine and its metabolites to act as inducers of CYP enzymes has not been evaluated. Specific Populations Patients with Hepatic Impairment No specific pharmacokinetic study examining the effect of hepatic impairment was conducted.

Since metabolism of olopatadine is a minor route of elimination, no adjustment of the dosing regimen of olopatadine hydrochloride nasal solution (nasal spray) is warranted in patients with hepatic impairment. Patients with Renal Impairment The mean C max values for olopatadine following single nasal doses were not markedly different between healthy subjects (18.1 ng/mL) and patients with mild, moderate and severe renal impairment (range 15.5 to 21.6 ng/mL). The mean plasma AUC 0-12 was 2-fold higher in patients with severe impairment (creatinine clearance <30 mL/min/1.73 m 2 ).

In these patients, peak steady-state plasma concentrations of olopatadine are approximately 10-fold lower than those observed after higher 20 mg oral doses, twice daily, which were well-tolerated. These findings indicate that no adjustment of the dosing regimen of olopatadine hyd… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 173 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology In a placebo-controlled cardiovascular safety study, 32 healthy volunteers received 20 mg oral solution of olopatadine twice daily for 14 days (8-fold greater daily dose than the recommended daily nasal dose). The mean QTcF (QT corrected by Fridericia’s correction method for heart rate) change from baseline was -2.7 msec and -3.8 msec for olopatadine, and placebo, respectively. In this study, 8 subjects treated with olopatadine had a QTcF change from baseline of 30-60 msec, 1 subject had a QTcF change from baseline greater than 60 msec, and no subjects had QTcF values greater than 500 msec.

Eight subjects treated with placebo had a QTcF change from baseline of 30-60 msec, no subjects had a QTcF change from baseline greater than 60 msec, and no subjects had QTcF values greater than 500 msec. In a 12-month study in 429 perennial allergic rhinitis patients treated with olopatadine hydrochloride nasal solution (nasal spray) two sprays per nostril twice daily, no evidence of any effect of olopatadine hydrochloride on QT prolongation was observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Adult and Adolescent Patients 12 Years of Age and Older The efficacy and safety of olopatadine hydrochloride nasal solution (nasal spray) were evaluated in 3 randomized, double blind, parallel group, multicenter, placebo-controlled clinical trials (vehicle nasal spray) of 2 weeks duration in adult and adolescent patients, 12 years of age and older with symptoms of seasonal allergic rhinitis. The 3 clinical trials were conducted in the United States and included 1598 patients (556 males, and 1042 females) 12 years of age and older.

In these 3 trials, 587 patients were treated with olopatadine hydrochloride nasal solution (nasal spray) 0.6%, 418 patients were treated with olopatadine hydrochloride nasal solution (nasal spray) 0.4%, and 593 patients were treated with vehicle nasal spray. Assessment of efficacy was based on patient recording of 4 individual nasal symptoms (nasal congestion, rhinorrhea, itchy nose, and sneezing) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) as reflective or instantaneous scores.

Reflective scoring required patients to record symptom severity over the previous 12 hours; the instantaneous scoring required patients to record symptom severity at the time of recording. The primary efficacy endpoint was the difference from placebo in the percent change from baseline in the average of morning and evening reflective total nasal symptom score (rTNSS) averaged for the 2-week treatment period. In all 3 trials, patients treated with olopatadine hydrochloride nasal solution (nasal spray), two sprays per nostril, twice-daily, exhibited statistically significantly greater decreases in rTNSS compared to vehicle nasal spray.

Results for the rTNSS from 2 representative trials are shown in Table 3. Table 3: Mean Reflective Total Nasal Symptom Score (rTNSS) in Adult and Adolescent Patients With Seasonal Allergic Rhinitis Study No. Treatment N Baseline Change from Baseline Difference from Placebo Estimate 95% CI p-value Study 1 Olopatadine Hydrochloride Nasal Solution (Nasal Spray) 0.6% 183 8.71 -3.63 -0.96 (-1.42, -0.51) <0.0001 Olopatadine Hydrochloride Nasal Solution (Nasal Spray) 0.4% 188 8.90 -3.38 -0.71 (-1.17, -0.26) 0.0023 Vehicle Nasal Spray 191 8.75 -2.67 Study 2 Olopatadine Hydrochloride Nasal Solution (Nasal Spray) 0.6% 220 9.17 -2.90 -0.98 (-1.37, -0.59) <0.0001 Olopatadine Hydrochloride Nasal Solution (Nasal Spray) 0.4% 228 9.26 -2.63 -0.72 (-1.11, -0.33) 0.0003 Vehicle Nasal Spray 223 9.07 -1.92 Abbreviation: CI, confidence interval.

Itchy eyes and watery eyes were evaluated as secondary endpoints but eye redness was not evaluated. In 2 of the studies, patients treated with olopatadine hydrochloride nasal solution (nasal spray) had significantly greater decreases in reflective symptom scores for itchy eyes and watery eyes, compared to vehicle nasal spray. In the 2-week seasonal allergy trials, onset of action was also evaluated by instantaneous TNSS assessments twice-daily after the first dose of study medication.

In these trials, onset of action was seen after 1 day of dosing. Onset of action was evaluated in 3 environmental exposure unit studies with single doses of olopatadine hydrochloride nasal solution (nasal spray). In these studies, patients with seasonal allergic rhinitis were exposed to high levels of pollen in the environmental exposure unit and then treated with either olopatadine hydrochloride nasal solution (nasal spray) or vehicle nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly as instantaneous scores for the subsequent 12 hours.

Olopatadine hydrochloride nasal solution (nasal spray) 0.6% was found to have an onset of action of 30 minutes after dosing in the environmental exposure unit. Pediatric Patients 6 to 11 Years of Age There were 3 clinical trials of 2 weeks duration with olopatadine nasal spray in patients 6 to 11 years of age with seasonal allergic rhinitis. Efficacy… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 157 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Olopatadine demonstrated no tumorigenic potential in mice at oral doses up to 500 mg/kg/day (approximately 460 times the MRHDID on a mg/m 2 basis) for 78 weeks or in rats at oral doses up to 200 mg/kg/day (approximately 370 times the MRHDID on a mg/m 2 basis) for 104 weeks. Mutagenesis No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test.

Impairment of Fertility Olopatadine administered at an oral dose of 400 mg/kg/day, (approximately 730 times the MRHDID for adults on an mg/m 2 basis) produced toxicity in male and female rats, and resulted in a decrease in the fertility index and reduced implantation rate. No effects on reproductive function were observed at 50 mg/kg/day (approximately 90 times the MRHDID on a mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 154 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Olopatadine demonstrated no tumorigenic potential in mice at oral doses up to 500 mg/kg/day (approximately 460 times the MRHDID on a mg/m 2 basis) for 78 weeks or in rats at oral doses up to 200 mg/kg/day (approximately 370 times the MRHDID on a mg/m 2 basis) for 104 weeks. Mutagenesis No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test.

Impairment of Fertility Olopatadine administered at an oral dose of 400 mg/kg/day, (approximately 730 times the MRHDID for adults on an mg/m 2 basis) produced toxicity in male and female rats, and resulted in a decrease in the fertility index and reduced implantation rate. No effects on reproductive function were observed at 50 mg/kg/day (approximately 90 times the MRHDID on a mg/m 2 basis).

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert PATIENT INFORMATION Olopatadine Hydrochloride (oh-loe-PA-ta-deen HYE-droe-KLOR-ide) Nasal Solution (Nasal Spray), 665mcg/spray for intranasal use What is olopatadine hydrochloride nasal solution (nasal spray)? Olopatadine hydrochloride nasal solution (nasal spray) is a prescription nasal spray that contains an antihistamine. Olopatadine hydrochloride nasal solution (nasal spray) is used to treat seasonal allergy symptoms in adults and children 6 years of age and older.

It is not known if olopatadine hydrochloride nasal solution (nasal spray) is safe and effective in children under 6 years of age. Before using olopatadine hydrochloride nasal solution (nasal spray), tell your healthcare provider about all of your medical conditions, including if you: • have nose problems, such as nose bleeds, or sores in the nose. • are pregnant or planning to become pregnant. It is not known if olopatadine hydrochloride nasal solution (nasal spray) will harm your unborn baby. • are breastfeeding or plan to breastfeed.

It is not known if olopatadine passes into your breast milk. You and your healthcare provider should decide if you will use olopatadine hydrochloride nasal solution (nasal spray) if you plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Olopatadine hydrochloride nasal solution (nasal spray) and other medicines may affect each other and cause side effects. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider or pharmacist when you get a new medicine.

How should I use olopatadine hydrochloride nasal solution (nasal spray)? • See the “Instructions for Use” at the end of this Patient Information leaflet for information about the right way to use olopatadine hydrochloride nasal solution (nasal spray). • Olopatadine hydrochloride nasal solution (nasal spray) is for use in your nose only. Do not spray it in your eyes or mouth. • Use olopatadine hydrochloride nasal solution (nasal spray) exactly as your healthcare provider tells you to use it. • Do not use more than your healthcare provider tells you. • If you use too much olopatadine hydrochloride nasal solution (nasal spray), call your healthcare provider or pharmacist right away • Throw away olopatadine hydrochloride nasal solution (nasal spray) after 240 sprays (about 30 days) after the first priming.

Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it. What should I avoid while using olopatadine hydrochloride nasal solution (nasal spray)? • Olopatadine hydrochloride nasal solution (nasal spray) can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how olopatadine hydrochloride nasal solution (nasal spray) affects you. • Do not drink alcohol or take any medicines that may cause you to feel sleepy while using olopatadine hydrochloride nasal solution (nasal spray).

It may make your sleepiness worse. What are the possible side effects of olopatadine hydrochloride nasal solution (nasal spray)? Olopatadine hydrochloride nasal solution (nasal spray) may cause serious side effects, including: • nosebleeds. • sores in the nose. • hole in the cartilage between the nose (nasal septum perforation).

A whistling sound when you breathe may be a symptom of nasal septum perforation. • sleepiness or drowsiness. The most common side effects of olopatadine hydrochloride nasal solution (nasal spray) in people 12 years of age and older include: • bad or bitter taste • headache • throat pain • nose congestion • cough • urinary tract infection The most common side effects of olopatadine hydrochloride nasal solution (nasal spray) in people 6 to 11 years of age include: • headache • upper respiratory tract infection • bad or bitter taste • fever • rash Tell your healthcare provider… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use INSTRUCTIONS FOR USE Olopatadine Hydrochloride (oh-loe-PA-ta-deen HYE-droe-KLOR-ide) Nasal Solution (Nasal Spray), 665mcg/spray for intranasal use This Instructions for Use contains information on how to use olopatadine hydrochloride nasal solution (nasal spray). Read this Instructions for Use that comes with olopatadine hydrochloride nasal solution (nasal spray) before you start using it and each time you get a refill. There may be new information.

This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Olopatadine hydrochloride nasal solution (nasal spray) is for use in your nose only. Do not spray olopatadine hydrochloride nasal solution (nasal spray) in your eyes or mouth.

Important information you need to know before using olopatadine hydrochloride nasal solution (nasal spray) • Use olopatadine hydrochloride nasal solution (nasal spray) exactly how your healthcare provider tells you to use it. • Your olopatadine hydrochloride nasal solution (nasal spray) bottle must be shaken and primed before you use it for the first time and when you have not used it for more than 7 days. • Throw away olopatadine hydrochloride nasal solution (nasal spray) after 240 sprays after the first priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.

Using olopatadine hydrochloride nasal solution (nasal spray) Step 1. Remove the blue plastic cap and the blue clip (see Figure A ). Figure A Step 2.

Hold the bottle and press down on the shoulders of the nasal applicator with your forefinger and middle finger. • Support the bottom of the bottle with your thumb (see Figure B ). Prime the bottle by pressing and releasing the shoulders of the bottle down firmly 5 times or until you see a fine mist come out of the nasal applicator. • Now your pump is primed and ready to use. • If you do not use olopatadine hydrochloride nasal solution (nasal spray) for more than 7 days, you will need to prime the bottle again by pressing and releasing the shoulders of the bottle down firmly 2 times or until you see a fine mist come out of the nasal applicator.

Figure B Step 3. Gently blow your nose to clear your nostrils. Hold 1 nostril closed with a finger.

Tilt your head down (chin toward chest) and insert the nasal applicator into a nostril. Hold the bottle upright with the nasal applicator tip pointing away from the center of the nose (see Figure C ). Step 4.

Breathe in gently through your nose. While breathing in, press firmly and quickly on the nasal applicator shoulders to release the spray into your nostril (see Figure C ). Step 5.

Breathe out through your mouth. Do not tilt your head back or blow your nose right after using olopatadine hydrochloride nasal solution (nasal spray). This may cause you to get a bitter taste in your mouth.

Step 6. Repeat Steps 3 through 5 above to deliver a spray in your other nostril. Step 7.

If your healthcare provider tells you to use 2 sprays in each nostril, repeat Steps 3 through 5 for the second spray in each nostril. Figure C Step 8. Wipe the nasal applicator with a clean tissue and replace the plastic cap and clip (see Figure D ).

Figure D Cleaning the olopatadine hydrochloride nasal solution (nasal spray) nasal applicator Step 9. To clean the nasal applicator, remove the plastic cap and clip (see Figure E ). If the nasal applicator becomes clogged, do not try to clear it using a pointed object.

Figure E Step 10. Gently pull the nasal applicator up to remove it from the bottle (see Figure F ). Figure F Step 11.

With the nasal applicator pointing downwards, wash it by running warm tap water into the nasal applicator for about 1 minute (see Figure G ). Step 12. Shake the nasal applicator to remove any water and put the nasal applicator back on the bottle.

Step 13. Prime the bottle again by pressing the shoulders of the bottle down firmly and releasing the should… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 8 words ▾

Olopatadine Hcl 665 mcg Nasal Spray, #240 Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63629-8409-01 · Bryant 63629-8436-01 · Bryant →
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.