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Olopatadine Hydrochloride 665 ug Spray, Metered — NDC 60505-0845-05 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, Metered — NDC 60505-0845-5 (Billing 60505-0845-05)

by Apotex Corp. · 1 BOTTLE in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE

This is a package of Olopatadine Hydrochloride 665 ug Spray, Metered from Apotex Corp., marketed since Oct 2014 and currently FDA-listed; retail pharmacies pay about $0.8495 per g (NADAC). It is this product's only package size.

NDC 60505-0845-05
🏷️ FDA NDC (as labeled) 60505-0845-5 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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 60505-0845-5 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60505 labeler · 0845 product · 5 package
Package marketed since
Oct 27, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6050508455 5
Medicaid fills, this package
4,438 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60505-0845-5
Product NDC 60505-0845
11-digit billing NDC 60505084505
NCPDP billing unit GM — per gram (weight)
Application # ANDA091572
SPL Set ID 3aa27224-7b72-38eb-0c21-b8d73525ee85
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 2014-10-27
Route NASAL
Dosage form SPRAY, METERED
Substance OLOPATADINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

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
  • HICL (First Databank): 012815
  • AHFS class code: 52:02.00.00
Why two NDCs? The FDA registers this code as 60505-0845-5 — 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 → 60505-0845-05. 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.

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 gPer package
Retail pharmacies payNADAC · weekly $0.850 —
Medicaid paysCMS SDUD · 12 mo $1.17 —
Medicare drug plans payPart D · Q2 2026 $2.07 —
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.247 $0.850
▼ Down 31% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
60505-0845-05 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE 2014-10-27 — 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 ugthis 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 ug 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

🏛️
2014
On the market since
Oct 2014
📍
2026
Currently FDA-listed
12 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

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA091572 (ANDA)
Labeler code60505
First marketedOct 2014
Product typeHuman Prescription Drug
Portfolio306 products on file

More NDCs from Apotex Corp. labeler code 60505

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 66 words ▾

1 INDICATIONS AND USAGE Olopatadine hydrochloride 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 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 ( 1 ).

⏱️ 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 spray before initial use and when olopatadine hydrochloride 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 spray by the nasal route only. Priming : Before initial use, prime olopatadine hydrochloride 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 spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying olopatadine hydrochloride 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 48 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, safety clip and a translucent overcap. 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 spray ( 5.2 ). Avoid concurrent use of alcohol or other central nervous system depressants with olopatadine hydrochloride 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 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 spray and 2 patients treated with the vehicle nasal spray. In the second safety trial with olopatadine hydrochloride 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 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 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 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 spray. Concurrent use of olopatadine hydrochloride 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 Apotex Corp. at 1-800-706-5575 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 spray in 2,770 patients with seasonal or perennial allergic rhinitis in 10 controlled clinical trials of 2 weeks to 12 months duration. Olopatadine hydrochloride 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 1,834 patients with seasonal or perennial allergic rhinitis (652 males and 1,182 females) 12 years of age and older were treated with olopatadine hydrochloride nasal spray two sprays per nostril twice daily. There were 1,180 patients (olopatadine hydrochloride nasal spray, 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration.

There were 2,840 patients (olopatadine hydrochloride nasal spray, 1,247; 3.7 pH vehicle nasal spray, 1,251; 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 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 spray and vehicle nasal spray.

Overall, 4.7% of the 1,834 adult and adolescent patients across all 6 studies treated with olopatadine hydrochloride nasal spray, 3.5% of the 1,844 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 spray one or two sprays per nostril twice daily for 2 weeks.

The racial distribution of pediatric patients receiving olopatadine hydrochloride 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 spray and vehicle nasal spray. Overall, 1.4% of the 870 pediatric patients across all 3 studies treated with olopatadine hydrochloride 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 1,180 patients 12 years of age and older (olopatadine hydrochloride nasal spray, 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration. Table 1 presents the most common adverse reactions (0.9% or greater in patients treated with olopatad… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 52 words ▾

7 DRUG INTERACTIONS Formal drug-drug interaction studies were not conducted for olopatadine hydrochloride 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 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 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 spray and any potential adverse effects on the breast fed infant from olopatadine hydrochloride nasal spray or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of olopatadine hydrochloride 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 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 spray at doses of one and two sprays per nostril twice daily in 1,188 patients, of which 298 patients were exposed to olopatadi… [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 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 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 ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of olopatadine hydrochloride 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 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 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 spray 1 spray, and 297 patients were exposed to vehicle 1 spray. In this study, the incidence of epistaxis with olopatadine hydrochloride nasal spray use was 5.7% [see Adverse Reactions (6.1), Clinical Studies (14)]. The safety and effectiveness of olopatadine hydrochloride 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 spray use in 587 patients was 3.2% [see Adverse Reactions (6.1)]. The safety and effectiveness of olopatadine hydrochloride nasal spray have not been established in pediatric patients under 6 years of age. The safety of olopatadine hydrochloride 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 spray. The most common (greater than 1%) adverse reactions reported were diarrhea (9.1%), epistaxis (6.1%), rhinorrhea (4.5%), bitter taste (3%) and wheezing (3%). 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 77 words ▾

8.5Geriatric Use Clinical studies of olopatadine hydrochloride 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 64 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 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 spray 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 to 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 to 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 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 spray.

The mean (± SD) steady-state peak plasma concentration (C max ) of olopatadine was 16 ± 8.99 ng/mL. Systemic exposure as indexed by area under the curve (AUC 0-12 ) averaged 66 ± 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 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 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 ± 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… [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 116 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Olopatadine hydrochloride nasal spray, 665 mcg is supplied in a white, opaque HDPE cylindrical bottle with a metered-dose spray pump, a white actuator, safety clip and a translucent overcap in a box of 1 (NDC 60505-0845-5). 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 microliters of formulation through the nozzle.

Net content 30.5 g, 240 sprays: NDC 60505-0845-5 (trade size) Storage Store olopatadine hydrochloride nasal spray at room temperature between 4°C to 25°C (39°F to 77°F).

📋 Description 161 words ▾

11 DESCRIPTION Olopatadine Hydrochloride Nasal Spray, 665 micrograms (mcg) is a metered-spray for nasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Spray, is a white to off-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, and its molecular formula is C 21 H 23 NO 3 • HCl with the following chemical structure: Olopatadine Hydrochloride Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous spray with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous spray containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [see Dosage Forms and Strengths ( 3 )] .

Olopatadine Hydrochloride Nasal Spray also contains anhydrous dibasic sodium phosphate, benzalkonium chloride (0.01%), edetate disodium dihydrate, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water. Olopatadine-HCl

💬 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 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 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 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 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 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 spray in their eyes [see Dosage and Administration ( 2.3 )]. APOTEX INC. OLOPATADINE HYDROCHLORIDE NASAL SPRAY Manufactured by Manufactured for Apotex Inc.

Apotex Corp. Toronto, Ontario Weston, FL Canada M9L 1T9 33326 Revision: 01

🧬 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 spray.

The mean (± SD) steady-state peak plasma concentration (C max ) of olopatadine was 16 ± 8.99 ng/mL. Systemic exposure as indexed by area under the curve (AUC 0-12 ) averaged 66 ± 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 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 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 ± 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 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 hydrochloride nasal spray is warranted in patients with renal impairment.… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 175 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology In a placebo-controlled cardiovascular safety study, 32 healthy volunteers received 20 mg oral spray 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 to 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 to 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 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 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 1,598 patients (556 males, and 1,042 females) 12 years of age and older.

In these 3 trials, 587 patients were treated with olopatadine hydrochloride nasal spray 0.6%, 418 patients were treated with olopatadine hydrochloride 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 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 Change From Difference From Placebo Study No. Treatment N Baseline Baseline Estimate 95% CI p-value Study 1 Olopatadine Hydrochloride Nasal Spray 0.6% 183 8.71 -3.63 -0.96 (-1.42, -0.51) <0.0001 Olopatadine Hydrochloride 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 Spray 0.6% 220 9.17 -2.90 -0.98 (-1.37, -0.59) <0.0001 Olopatadine Hydrochloride 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 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 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 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 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 of olopatadine hydrochloride nasal spray was evaluated in 2 of the 3 trials.

One of the 2 trials that showed efficacy was a randomized, double blind, parallel group, multicenter, placebo (vehicle nasal… [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 ▾

INSTRUCTIONS FOR USE Olopatadine Hydrochloride (OH-loe-PA-ta-deen HYE-droe-KLOR-ide) nasal spray, for intranasal use This Instructions for Use contains information on how to use olopatadine hydrochloride nasal spray. Read this Instructions for Use that comes with olopatadine hydrochloride 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 spray is for use in your nose only. Do not spray olopatadine hydrochloride nasal spray in your eyes or mouth.

Important information you need to know before using olopatadine hydrochloride nasal spray Use olopatadine hydrochloride nasal spray exactly how your healthcare provider tells you to use it. Your olopatadine hydrochloride 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 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 spray Step 1. Remove the plastic cap (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 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 ). 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 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. Step 8. Wipe the nasal applicator with a clean tissue and replace the plastic cap (see Figure D ).

Figure D Cleaning the olopatadine hydrochloride nasal spray nasal applicator Step 9. To clean the nasal applicator, remove the plastic cap (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 shoulders 2 times or until you see a fine mist come out of the white nasal applicator. Repeat Steps 11 and 12 above if the nasal applicator is still clogged.

Figure G How should I store olopatadine hydrochloride nasal spray ? Store olopatadine hydrochloride nasal spray at room temperature between 39°F to 77°F… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 57 words ▾

PRINCIPAL DISPLAY PANEL - Bottle Olopatadine Hydrochloride Nasal Spray 665 mcg FOR INTRANASAL USE ONLY Rx Only 240 Metered Sprays Net Fill Weight 30.5g Apotex Corp. NDC 60505-0845-5 bottle.jpg olop-carton.jpg

PRINCIPAL DISPLAY PANEL - Carton Olpatadine Hydrochloride Nasal Spray, 665mcg FOR INTRANASAL USE ONLY Rx Only 240 Metered Sprays Net Fill Weight 30.5g Apotex Corp. NDC 60505-0845-5

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.4K
Units reimbursed last 4 qtrs
148.2K
Gross reimbursed last 4 qtrs
$173.9K
Avg / prescription
$39.19
Avg / unit
$1.1732
Latest quarter Q1 2026
1KRx
Medicaid pays / g
$1.1732
gross reimbursed
vs
NADAC / g
$0.8495
acquisition cost
=
Spread
+$0.3237
+38% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
52% FFS 48% MCO
Fee-for-service · 2,304 Rx Managed care · 2,134 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 46,238 units · 236 per 100k residents NY Vermont: no data reported VT New Hampshire: 763 units · 54.4 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 7,198 units · 224 per 100k residents IA Illinois: 13,725 units · 109 per 100k residents IL Indiana: 2,471 units · 36.0 per 100k residents IN Ohio: 26,596 units · 226 per 100k residents OH Pennsylvania: 5,460 units · 42.1 per 100k residents PA New Jersey: 641 units · 6.9 per 100k residents NJ Massachusetts: no data reported MA California: 11,499 units · 29.5 per 100k residents CA Utah: no data reported UT Colorado: 641 units · 10.9 per 100k residents CO Nebraska: no data reported NE Missouri: 48 units · 0.8 per 100k residents MO Kentucky: 2,044 units · 45.2 per 100k residents KY West Virginia: 7,320 units · 414 per 100k residents WV Virginia: 1,403 units · 16.1 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 9,760 units · 137 per 100k residents TN North Carolina: 8,845 units · 81.6 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 49 units · 1.0 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 3,538 units · 11.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.8414
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 414 /100k
2 New York 236 /100k
3 Ohio 226 /100k
4 Iowa 224 /100k
5 Tennessee 137 /100k
6 Illinois 109 /100k
7 North Carolina 81.6 /100k
8 New Hampshire 54.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 60505-0833-05 · Apotex 60505-0953-03 · Apotex →
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.