IYUZEH Latanoprost Ophthalmic Solution 0.005% 50 ug/mL Solution/ Drops, 30 pouches — NDC 82584-003-30 (Billing 82584-0003-30)
This is a package of 30 pouches of IYUZEH Latanoprost Ophthalmic Solution 0.005% 50 ug/mL Solution/ Drops from Thea Pharma Inc., marketed since Jul 2023 and currently FDA-listed; retail pharmacies pay about $10.12 per pouche (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 070724
- GCN: 34356
- GPI-14 (Medi-Span): 86330050002025
- HICL (First Databank): 040109
- AHFS class code: 52:40.28.00
- RxCUI (RxNorm): 314072
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Prostaglandin Analog class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- The evening timing is the recommended dosing schedule from clinical studies, and it's important to stick with it consistently. Using it at the same time every evening helps keep yo...
- Why do I have to use this at night? Can I use it in the morning instead?
- Yes, this is a real and well-documented effect of latanoprost. Over months to years, the iris (colored part of your eye) can gradually become more brown due to increased pigment. T...
- Will my eye color really change? Is that permanent?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $10.123 | $303.68 / 30 pouches |
| Medicaid paysCMS SDUD · 12 mo | $42.99 | $1,289.73 / 30 pouches |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 82584-0003-30 You're viewing this Main listing | 30 POUCH in 1 CARTON / .2 mL in 1 POUCH | 2023-07-14 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Latanoprost 50 ug/mL 24208-0463-25 | Bausch | 1 bottle | $1.575 | AT | Availability likely | save 84% |
| Latanoprost 50 ug/mL 25021-0001-02 | Sagent | 1 bottle | $1.575 | AT | Availability likely | save 84% |
| Latanoprost 50 ug/mL 42571-0499-06 | Micro | 1 bottle | $1.575 | AT | Availability likely | save 84% |
| Latanoprost 50 ug/mL 59762-0333-02 | Mylan | 1 bottle | $1.575 | AT | Availability likely | save 84% |
| Latanoprost 50 ug/mL 61314-0547-01 | Sandoz | 2.5 ml | $1.575 | AT | Availability likely | save 84% |
| Latanoprost 50 ug/mL 64980-0516-25 | Rising | 1 bottle | $1.575 | AT | Availability likely | save 84% |
| latanoprost 50 ug/mL 68462-0944-03 | GLENMARK | 1 bottle | $1.575 | AT | Availability likely | save 84% |
| Latanoprost 50 ug/mL 70069-0421-01 | Somerset | 1 bottle | $1.575 | AT | Availability likely | save 84% |
| Iyuzeh 50 ug/mLthis 82584-0003-30 | Thea | 30 pouches | $10.123 | — | Availability likely | — |
| Xalatan 50 ug/mL 58151-0419-35 | Viatris | 1 bottle | $108.342 | AT | Availability likely | +970% |
| Latanoprost 50 ug/mL 50090-1920-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Latanoprost 50 ug/mL 50090-7062-00 | A-S | 2.5 ml | — | AT | FDA listed | — |
| Latanoprost 50 ug/mL 65862-0872-25 | Aurobindo | 1 bottle | — | — | FDA listed | — |
| Latanoprost 50 ug/mL 68071-2376-02 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Latanoprost 50 ug/mL 68071-3884-02 | NuCare | 1 bottle | — | AT | FDA listed | — |
| latanoprost 50 ug/mL 68083-0609-01 | Gland | 1 bottle | — | AT | FDA listed | — |
| Latanoprost Ophthalmic Solution 50 ug/mL 70756-0680-00 | Lifestar | 1 bottle | — | — | FDA listed | — |
| Latanoprost 50 ug/mL 71205-0154-25 | Proficient | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8637054 ↗ | Method of use | U-446 | Jul 8, 2031 |
Is there a generic version of IYUZEH 0.005% EYE DROP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
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Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII HHT01ZNK31
Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
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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.
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UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
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UNII 7YC686GQ8F
A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
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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.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE IYUZEH ™ (latanoprost ophthalmic solution) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. IYUZEH is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. The dosage of IYUZEH should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including IYUZEH is not recommended.
It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. IYUZEH may be used concomitantly with other topical ophthalmic drug products to lower IOP.
In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with the preserved 0.005% latanoprost reference product. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to the administration of IYUZEH and may be reinserted 15 minutes after administration.
The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration. One drop in the affected eye(s) once daily in the evening.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution: opalescent, white to slightly yellow solution containing latanoprost 0.005% (50 mcg/mL). Ophthalmic solution containing latanoprost 0.005% (50 mcg/mL). ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Known hypersensitivity to latanoprost or any other ingredients in this product. Known hypersensitivity to latanoprost or any other ingredients in this product. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1 ) Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually, reversible. ( 5.2 )
5.1Pigmentation Topical latanoprost ophthalmic products, including IYUZEH have been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered.
The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation.
The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.
Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with IYUZEH can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
5.2Eyelash Changes Latanoprost ophthalmic products, including IYUZEH may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment.
5.3Intraocular Inflammation IYUZEH should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation because inflammation may be exacerbated.
5.4Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost ophthalmic products, including IYUZEH. IYUZEH should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
5.5Herpetic Keratitis Reactivation of herpes simplex keratitis has been reported during treatment with latanoprost. IYUZEH should be used with caution in patients with a history of herpetic keratitis. IYUZEH should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.
5.6Contact Lens Use Contact lenses should be removed prior to the administration of IYUZEH and may be reinserted 15 minutes after administration.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions have been reported with the use of topical latanoprost products and are discussed in greater detail in other sections of the label: Iris pigmentation changes [see Warnings and Precautions (5.1) ] Eyelid skin darkening [see Warnings and Precautions (5.1) ] Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2) ] Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3) ] Macular edema, including cystoid macular edema [see Warnings and Precautions (5.4) ] Most common adverse reactions (5% to 35%) for IYUZEH are: conjunctival hyperemia, eye irritation, eye pruritus, abnormal sensation in eye, foreign body sensation in eyes, vision blurred and lacrimation increased.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION. Revised: 03/2024
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. In the two clinical trials conducted with IYUZEH (latanoprost ophthalmic solution) 0.005% comparing it to XALATAN the preserved 0.005% latanoprost reference product, the most frequently reported ocular adverse reactions were conjunctival hyperemia and eye irritation ( Table 1 ).
Table 1. Ocular Adverse Reactions Reported by ≥ 1% of Subjects Receiving IYUZEH Symptom/Finding Adverse Reactions (incidence (%)) IYUZEH (n=378) XALATAN (n=358) Conjunctival hyperemia 129 (34) 133 (37) Eye irritation 72 (19) 112 (31) Eye pruritus 57 (15) 58 (16) Abnormal sensation in eye 51 (14) 52 (15) Foreign body sensation in eyes 44 (12) 36 (10) Vision blurred 28 (7) 30 (8) Lacrimation increased 19 (5) 14 (4) Photophobia 13 (3) 17 (5)
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of topical latanoprost products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ophthalmic latanoprost products, or a combination of these factors, include: Nervous System Disorders: Dizziness; headache; toxic epidermal necrolysis Eye Disorders: Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid skin darkening; localized skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva.
Respiratory, Thoracic and Mediastinal Disorders: Asthma and exacerbation of asthma; dyspnea Gastrointesting Disorders: Nausea; vomiting Skin and Subcutaneous Tissue Disorders: Pruritis Infections and Infestations: Herpes keratitis Cardiac Disorders: Angina; palpitations; angina unstable General Disorders and Administration Site Conditions: Chest pain
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The combined use of two or more prostaglandins, or prostaglandin analogs including IYUZEH is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of IYUZEH administration in pregnant women to inform drug-associated risks. In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses (equivalent to 1.3 – 324 times the maximum recommended human ophthalmic dose, on a mg/m 2 basis, assuming 100% absorption) (see Data ) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered latanoprost daily by IV injection on gestation days 6 through 18, to target the period of organogenesis.
A no observed adverse effect level (NOAEL) was not established for rabbit developmental toxicity. Post-implantation loss due to late resorption was shown as doses ≥0.2 mcg/kg/day (equivalent to 1.3 times the maximum recommended human ophthalmic dose [RHOD], on a mg/m 2 basis, assuming 100% absorption). Spina bifida and abortion occurred at 5 mcg/kg/day (equivalent to 32 times the maximum RHOD).
Total litter loss due to early resorption was observed at doses ≥50 mcg/kg/day (324 times the maximum RHOD). Transient signs of maternal toxicity were observed after IV dosing (increased breathing, muscle tremors, slight motor incoordination) at 300 mcg/kg/day (1946 times the maximum RHOD). No maternal toxicity was observed at doses up to 50 mcg/kg/day.
Embryofetal studies were conducted in pregnant rats administered latanoprost daily by IV injection on gestation days 6 through 15, to target the period of organogenesis. A NOAEL for rat developmental toxicity was not established. Cleft palate was observed at 1 mcg/kg (equivalent to 3.2 times the maximum RHOD, on a mg/m 2 basis, assuming 100% absorption).
Brain porencephalic cyst(s) were observed ≥50 mcg/kg (162 times the maximum RHOD). Skeletal anomalies were observed at 250 mcg/kg (811 times the maximum RHOD). No maternal toxicity was detectable at 250 mcg/kg/day.
Prenatal and postnatal development was assessed in rats. Pregnant rats were administered latanoprost daily by IV injection from gestation day 15, through delivery, until weaning (lactation Day 21). No adverse effects on rat offspring were observed at doses up to 10 mcg/kg/day (32 times the maximum RHOD, on a mg/m2 basis, assuming 100% absorption).
At 100 mcg/kg/day (324 times the maximum RHOD), maternal deaths and pup mortality occurred.
8.2Lactation Risk Summary It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IYUZEH is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for IYUZEH and any potential adverse effects on the breastfed child from IYUZEH.
8.4Pediatric Use The safety and effectiveness of IYUZEH have not been established in pediatric patients.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of IYUZEH administration in pregnant women to inform drug-associated risks. In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses (equivalent to 1.3 – 324 times the maximum recommended human ophthalmic dose, on a mg/m 2 basis, assuming 100% absorption) (see Data ) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered latanoprost daily by IV injection on gestation days 6 through 18, to target the period of organogenesis.
A no observed adverse effect level (NOAEL) was not established for rabbit developmental toxicity. Post-implantation loss due to late resorption was shown as doses ≥0.2 mcg/kg/day (equivalent to 1.3 times the maximum recommended human ophthalmic dose [RHOD], on a mg/m 2 basis, assuming 100% absorption). Spina bifida and abortion occurred at 5 mcg/kg/day (equivalent to 32 times the maximum RHOD).
Total litter loss due to early resorption was observed at doses ≥50 mcg/kg/day (324 times the maximum RHOD). Transient signs of maternal toxicity were observed after IV dosing (increased breathing, muscle tremors, slight motor incoordination) at 300 mcg/kg/day (1946 times the maximum RHOD). No maternal toxicity was observed at doses up to 50 mcg/kg/day.
Embryofetal studies were conducted in pregnant rats administered latanoprost daily by IV injection on gestation days 6 through 15, to target the period of organogenesis. A NOAEL for rat developmental toxicity was not established. Cleft palate was observed at 1 mcg/kg (equivalent to 3.2 times the maximum RHOD, on a mg/m 2 basis, assuming 100% absorption).
Brain porencephalic cyst(s) were observed ≥50 mcg/kg (162 times the maximum RHOD). Skeletal anomalies were observed at 250 mcg/kg (811 times the maximum RHOD). No maternal toxicity was detectable at 250 mcg/kg/day.
Prenatal and postnatal development was assessed in rats. Pregnant rats were administered latanoprost daily by IV injection from gestation day 15, through delivery, until weaning (lactation Day 21). No adverse effects on rat offspring were observed at doses up to 10 mcg/kg/day (32 times the maximum RHOD, on a mg/m2 basis, assuming 100% absorption).
At 100 mcg/kg/day (324 times the maximum RHOD), maternal deaths and pup mortality occurred.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of IYUZEH have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE Intravenous infusion of up to 3 mcg/kg of latanoprost in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment with latanoprost ophthalmic solution and no adverse reactions were observed. IV dosages of 5.5 to 10 mcg/kg caused abdominal pain, dizziness, fatigue, hot flushes, nausea, and sweating.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Latanoprost is a prostaglandin F 2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.
12.2Pharmacodynamics Reduction of the IOP in man starts about 3-4 hours after administration and maximum effect is reached after 8-12 hours. IOP reduction is present for at least 24 hours.
12.3Pharmacokinetics Absorption Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Distribution The distribution volume in humans is 0.16 ±
0.02L/kg. The acid of latanoprost can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration. Studies in man indicate that the peak concentration in the aqueous humor is reached about two hours after topical administration.
Elimination Metabolism Latanoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid β-oxidation. Excretion The elimination of the acid of latanoprost from human plasma is rapid (t 1/2 = 17 min) after both IV and topical administration.
Systemic clearance is approximately 7 mL/min/kg. Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys. Approximately 88% and 98% of the administered dose are recovered in the urine after topical and IV dosing, respectively.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Latanoprost is a prostaglandin F 2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING IYUZEH (latanoprost ophthalmic solution) is an opalescent, isotonic, white to slightly yellow solution of latanoprost 50 mcg/mL (0.005%) practically free from foreign particles. It is supplied as a sterile solution in translucent low-density polyethylene single-dose container packaged in foil pouches (5 single-dose containers per pouch). NDC 82584-003-30; Unit-of-Use Carton of 30 Storage: Store at 15°C to 25°C (59°F to 77°F).
Store in the original pouch. After the pouch is opened, the single-dose containers may be stored in the opened foil pouch for up to 30 days at room temperature 15°C to 25°C (59°F to 77°F). Patient should be advised to write down the date the foil pouch is opened in the space provided on the pouch.
Discard any unused containers 30 days after first opening the pouch.
📋 Description ▾
11 DESCRIPTION Latanoprost is a prostaglandin F 2α analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C 26 H 40 O 5 and its chemical structure is: Latanoprost is a colorless to yellow oil that is very soluble in acetonitrile and freely soluble in ethanol, ethyl acetate, and methanol.
It is practically insoluble in water and hexanes. IYUZEH (latanoprost ophthalmic solution) 0.005% is supplied as a sterile, isotonic, aqueous solution of latanoprost with a pH of approximately 7 and an osmolality of approximately 280 mOsmol/kg. Each mL of IYUZEH contains 50 mcg of latanoprost.
The inactive ingredients are: polyoxyl 40 hydrogenated castor oil, sorbitol, carbomer 974P, polyethylene glycol 4000, disodium edetate, sodium hydroxide (for pH-adjustment) and water for injections. One drop contains approximately 1.5 mcg of latanoprost. IYUZEH does not contain a preservative. chemstructure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Potential for Pigmentation Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of IYUZEH. Potential for Eyelash Changes Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with latanoprost ophthalmic solution.
These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. Handling the Container Advise patients that IYUZEH is a sterile solution that does not contain a preservative.
The drops are supplied in single-dose container. The solution from one individual container is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual container is opened, the remaining contents should be discarded immediately after administration.
Open a new single-dose container every time you use IYUZEH. When to Seek Physician Advice Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of IYUZEH. Contact Lens Use Advise patients that contact lenses should be removed prior to administration of the solution.
Lenses may be reinserted 15 minutes following administration of IYUZEH. Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. If a Dose is Missed Advise patients that if one dose is missed, treatment should continue with the next dose as normal.
Manufactured for: Thea Pharma Inc. Waltham, MA 02451. All rights reserved.
U.S. Patent N°. 8,637,054. ©2021, Laboratoires Théa.
All rights reserved. IYUZEH ™ is a trademark of Laboratoires Théa.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Distribution The distribution volume in humans is 0.16 ±
0.02L/kg. The acid of latanoprost can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration. Studies in man indicate that the peak concentration in the aqueous humor is reached about two hours after topical administration.
Elimination Metabolism Latanoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid β-oxidation. Excretion The elimination of the acid of latanoprost from human plasma is rapid (t 1/2 = 17 min) after both IV and topical administration.
Systemic clearance is approximately 7 mL/min/kg. Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys. Approximately 88% and 98% of the administered dose are recovered in the urine after topical and IV dosing, respectively.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Reduction of the IOP in man starts about 3-4 hours after administration and maximum effect is reached after 8-12 hours. IOP reduction is present for at least 24 hours.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Elevated Baseline IOP In randomized, controlled clinical trials of patients with open angle glaucoma or ocular hypertension with mean baseline IOP of 19 - 24 mmHg, IYUZEH lowered IOP by 3 – 8 mmHg versus 4 – 8 mmHg by latanoprost ophthalmic solution preserved with benzalkonium chloride. Latanoprost ophthalmic solution preserved with benzalkonium chloride was approximately 1 mmHg more effective than IYUZEH.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 mcg/kg/day (approximately 2800 times the recommended maximum human dose) for up to 20 and 24 months, respectively. Mutagenesis Latanoprost was not mutagenic in bacteria, in mouse lymphoma, or in mouse micronucleus tests. Chromosome aberrations were observed in vitro with human lymphocytes.
Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were negative. Impairment of Fertility Latanoprost has not been found to have any effect on male or female fertility in rat studies at IV doses up to 250 mcg/kg/day (811 times the maximum RHOD, on a mg/m 2 basis, assuming 100% absorption).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 mcg/kg/day (approximately 2800 times the recommended maximum human dose) for up to 20 and 24 months, respectively. Mutagenesis Latanoprost was not mutagenic in bacteria, in mouse lymphoma, or in mouse micronucleus tests. Chromosome aberrations were observed in vitro with human lymphocytes.
Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were negative. Impairment of Fertility Latanoprost has not been found to have any effect on male or female fertility in rat studies at IV doses up to 250 mcg/kg/day (811 times the maximum RHOD, on a mg/m 2 basis, assuming 100% absorption).
📄 Patient Package Insert ▾
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 12/2022 PATIENT INFORMATION IYUZEH ™ (eye yoo’ zeh) (latanoprost ophthalmic solution) 0.005% For topical ophthalmic use What is IYUZEH? IYUZEH is a prescription sterile eye drop solution which does not contain a preservative.
IYUZEH is used to lower the pressure in the eye (intraocular pressure) in people with open-angle glaucoma or ocular hypertension when their eye pressure is too high. IYUZEH belongs to a group of medicines called prostaglandin analogs. It is not known if IYUZEH is safe and effective in children.
Do not use IYUZEH if you are allergic to latanoprost or any of the ingredients in IYUZEH. See the end of this Patient Information leaflet for a complete list of ingredients in IYUZEH. Before you use IYUZEH, tell your doctor if you: have or have had eye problems including any surgery on your eye or eyes are using any other eye medicines have any other medical problems are pregnant or plan to become pregnant.
It is not known if IYUZEH will harm your unborn baby. If you become pregnant while using IYUZEH talk to your doctor right away. are breastfeeding or plan to breastfeed. It is not known if IYUZEH passes into your breast milk.
Talk to your doctor about the best way to feed your baby if you use IYUZEH. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take.
Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take IYUZEH? Read the Instructions for Use at the end of this Patient Information leaflet for additional instructions about the right way to use IYUZEH.
Use 1 drop of IYUZEH in your eye (or eyes) each evening. Talk to your doctor or pharmacist if you are not sure how to use IYUZEH. Your IYUZEH may not work as well if you use it more than 1 time each evening.
If you miss a dose of IYUZEH, skip the missed dose and take the next dose at your regular time. If you use other medicines in your eye, wait at least 5 minutes between using IYUZEH and your other eye medicines. Contact lenses should be taken out before using IYUZEH and you should wait at least 15 minutes after giving the dose of IYUZEH before putting the contact lenses back into your eyes.
Use your IYUZEH right away after opening. Each IYUZEH single-dose container is sterile and is to be used 1 time then thrown away. Do not save any IYUZEH that may be left over after you use your medicine.
Using IYUZEH that is not sterile may cause other eye problems. What are the possible side effects of IYUZEH? IYUZEH may cause serious side effects including: changes in the color of your eye (iris).
Your iris may become more brown in color while using IYUZEH. This color change may not go away when you stop using IYUZEH. If IYUZEH is used in 1 eye only, the color of that eye may always be a different color from the color of your other eye. darkening of the color of the skin around your eye (eyelid).
These skin changes usually go away when you stop using IYUZEH. increasing the length, thickness, color, or number of your eyelashes. These eyelash changes usually go away when you stop using IYUZEH. hair growth on your eyelids. This hair growth usually goes away when you stop using IYUZEH.
The most common side effects of IYUZEH include: redness of and around the eye (conjunctival hyperemia) eye irritation eye itching abnormal sensation in the eye foreign body sensation in the eye blurry vision increase of tears in the eye (increased lacrimation) Tell your doctor right away if you have any new eye problems while using IYUZEH, including: an eye injury an eye infection a sudden loss of vision eye surgery swelling and redness of and around your eye (conjunctivitis) problems with your eyelids Additionally, the following side effects have been reported in other latanoprost medicines like IYUZEH, when used in the eye (topical use): dizzin… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions for Use Read these Instructions for Use before using your IYUZEH™ and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
Important: IYUZEH is for the eye. Do not swallow IYUZEH. IYUZEH single-dose containers are packaged in a foil pouch.
Do not dose the IYUZEH single-dose containers if the foil pouch is opened. Write down the date you open the foil pouch in the space provided on the pouch. Do not open the IYUZEH single-dose container until you are ready to use the eye drops.
Please follow these instructions to use IYUZEH: Step 1. Wash your hands and sit or stand comfortably. Step 2.
Open the foil pouch containing a strip of 5 single-dose containers. Write down the date of first opening on the foil pouch. Step 3.
Take the strip of single-dose containers from the foil pouch Break off one single-dose container from the strip Place the unopened single-dose containers back in the foil pouch and fold the edge to close the pouch. Step 4. Hold the single-dose container upright.
Make sure that your IYUZEH medicine is in the bottom part of the single-dose container. Twist open the top of the single-dose container as shown. Do not touch the tip after opening the container.
Step 5. Tilt your head backwards. If you are unable to tilt your head, lie down.
Use your finger to gently pull down the lower eyelid of your affected eye. Step 6. Place the tip of the single-dose container close to, but not touching your eye.
Step 7. Squeeze the single-dose container gently so that only one drop goes into your eye, then release the lower eyelid. If the drop misses your eye completely, try again.
If your doctor has told you to use IYUZEH drops in both eyes, repeat Steps 5 to Step 7 for your other eye. Each single-dose container contains enough solution for both eyes. Throw away the single-dose container after use.
Do not keep it to use it again. To lessen the chance of an infection, a new single-dose container must be opened each time you are ready to use IYUZEH. Place the unopened foil pouch with the unopened single-dose containers back in the carton.
The unopened single-dose containers must be used within 30 days after opening the foil pouch. Rx Manufactured for: Thea Pharma Inc. Waltham, MA 02451.
All rights reserved. U.S. Patent N°.
8,637,054. ©2021, Laboratoires Théa. All rights reserved. IYUZEH™ is a trademark of Laboratoires Théa.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Approved: 12/2022 Figure A Figure A Figure A Figure A
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 82584-003-30 IYUZEH™ (latanoprost ophthalmic solution) 0.005% 30 single-dose containers (0.2 mL each) For Topical Ophthalmic Use - Rx only Sterile Contains no preservatives Théa PRINCIPAL DISPLAY PANEL