Tafluprost Ophthalmic .0045 mg/.3mL Solution/ Drops — NDC 66993-429-30 (Billing 66993-0429-30)
This is a package of Tafluprost Ophthalmic .0045 mg/.3mL Solution/ Drops from Prasco Laboratories, marketed since Nov 2022 and currently FDA-listed; retail pharmacies pay about $2.45 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 66993-429-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 66993 labeler · 429 product · 30 package
- Package marketed since
- Nov 18, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0366993429816
- Medicaid fills, this package
- 901 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
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): 065587
- GCN: 27594
- GPI-14 (Medi-Span): 86330065002025
- HICL (First Databank): 036600
- AHFS class code: 52:40.28.00
- RxCUI (RxNorm): 1244611
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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
- It lowers high pressure inside your eye. Your doctor prescribes it for open-angle glaucoma or ocular hypertension.
- Put one drop in the affected eye(s) once a day in the evening. Don't use it more than once daily, since that can make it work less well. If your product is single-dose containers,...
- Take them out before the drop. You can put them back in 15 minutes later.
- Red eyes are the most common. You may also have stinging, itching, dry eye, or blurred vision. Your eyelashes may grow longer, thicker, or darker.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tafluprost — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 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 | $2.454 | $73.61 / 30 vials |
| Medicaid paysCMS SDUD · 12 mo | $11.65 | $349.46 / 30 vials |
| 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 Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- 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 |
|---|---|---|---|---|
| 66993-0429-30 You're viewing this Main listing | 3 POUCH in 1 CARTON / 10 VIAL, SINGLE-USE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-USE | 2022-11-18 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tafluprost .0045 mg/.3mL 00781-6184-87 | Sandoz | 6 pouches | $2.454 | AT | Availability likely | — |
| Tafluprost .015 mg/mL 50742-0339-30 | Ingenus | 6 pouches | $2.454 | AT | Availability likely | — |
| Tafluprost Ophthalmic .0045 mg/.3mLthis 66993-0429-30 | Prasco | 3 pouches | $2.454 | AT | Availability likely | — |
| Zioptan .015 mg/mL 82584-0609-30 | Thea | 3 pouches | $8.486 | AT | Availability likely | +246% |
| tafluprost .0045 mg/.3mL 42571-0264-26 | Micro | 1 pouch | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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 10864159 ↗ | Method of use | U-778 | May 28, 2029 |
| US 9999593 ↗ | Drug product | — | May 28, 2029 |
Is there a generic version of TAFLUPROST 0.0015% EYE DROP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 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.
🧪 Avoiding an ingredient? See Tafluprost Ophthalmic 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.
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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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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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.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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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 5QWK665956
A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
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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 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Prasco Laboratories labeler code 66993
- medroxyprogesterone acetate 150 mg/mL Injection, Suspension NDC 66993-370-25
- medroxyprogesterone acetate 150 mg/mL Injection, Suspension NDC 66993-371-79
- Phenytoin Infatabs 50 mg Tablet, Chewable NDC 66993-372-02
- Lanthanum carbonate 500 mg Tablet, Chewable NDC 66993-422-85
- Lanthanum carbonate 750 mg Tablet, Chewable NDC 66993-423-85
- Lanthanum carbonate 1000 mg Tablet, Chewable NDC 66993-424-85
- Prazosin Hydrochloride 1 mg Capsule NDC 66993-431-85
- Prazosin Hydrochloride 2 mg Capsule NDC 66993-432-85
- Prazosin Hydrochloride 5 mg Capsule NDC 66993-433-85
- Dapagliflozin 5 mg Tablet, Film Coated NDC 66993-456-30
- Dapagliflozin 10 mg Tablet, Film Coated NDC 66993-457-30
- Nisoldipine 8.5 mg Tablet, Film Coated, Extended Release NDC 66993-472-02
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Tafluprost Ophthalmic Solution 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Tafluprost Ophthalmic Solution 0.0015% is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dose is one drop of Tafluprost Ophthalmic Solution in the conjunctival sac of the affected eye(s) once daily in the evening. The dose should not exceed once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours.
Tafluprost Ophthalmic Solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart. 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 containing tafluprost 0.015 mg/mL. Ophthalmic solution containing tafluprost 0.015 mg/mL. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Pigmentation Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation is likely to be permanent. ( 5.1 ) Eyelash Changes Gradual changes to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 )
5.1Pigmentation Tafluprost Ophthalmic Solution has 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 tafluprost 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 tafluprost, 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 Tafluprost Ophthalmic Solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. [See Patient Counseling Information ( 17.3 )].
5.2Eyelash Changes Tafluprost Ophthalmic Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
5.3Intraocular Inflammation Tafluprost Ophthalmic Solution should be used with caution in patients with active intraocular inflammation (e.g., iritis/uveitis) because the inflammation may be exacerbated.
5.4Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2α analogs. Tafluprost Ophthalmic Solution 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common ocular adverse reaction is conjunctival hyperemia (range 4% to 20%). ( 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.
6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Preservative-containing or preservative-free tafluprost 0.0015% was evaluated in 905 patients in five controlled clinical studies of up to 24-months duration. The most common adverse reaction observed in patients treated with tafluprost was conjunctival hyperemia which was reported in a range of 4% to 20% of patients.
Approximately 1% of patients discontinued therapy due to ocular adverse reactions. Ocular adverse reactions reported at an incidence of ≥2% in these clinical studies included ocular stinging/irritation (7%), ocular pruritus including allergic conjunctivitis (5%), cataract (3%), dry eye (3%), ocular pain (3%), eyelash darkening (2%), growth of eyelashes (2%) and vision blurred (2%). Nonocular adverse reactions reported at an incidence of 2% to 6% in these clinical studies in patients treated with tafluprost 0.0015% were headache (6%), common cold (4%), cough (3%) and urinary tract infection (2%).
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of tafluprost. Because postapproval adverse 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. Respiratory disorders: exacerbation of asthma, dyspnea Eye disorders: iritis/uveitis In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Use in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. ( 8.4 )
8.1Pregnancy Pregnancy Category C. Teratogenic effects: In embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. Tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats.
Tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. In rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on C max . In rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the clinical exposure based on C max .
At the no-effect dose in rabbits (0.01 mcg/kg/day), maternal plasma levels of tafluprost acid were below the lower level of quantification (20 pg/mL). In a pre- and postnatal development study in rats, increased mortality of newborns, decreased body weights and delayed pinna unfolding were observed in offsprings. The no observed adverse effect level was at a tafluprost intravenous dose of 0.3 mcg/kg/day which is greater than 3 times the maximum recommended clinical dose based on body surface area comparison.
There are no adequate and well-controlled studies in pregnant woman. Although animal reproduction studies are not always predictive of human response, Tafluprost Ophthalmic Solution should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Women of childbearing age/potential should have adequate contraceptive measures in place.
8.3Nursing Mothers A study in lactating rats demonstrated that radio-labeled tafluprost and/or its metabolites were excreted in milk. 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 Tafluprost Ophthalmic Solution is administered to a nursing woman.
8.4Pediatric Use Use in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.
8.5Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. Teratogenic effects: In embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. Tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats.
Tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. In rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on C max . In rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the clinical exposure based on C max .
At the no-effect dose in rabbits (0.01 mcg/kg/day), maternal plasma levels of tafluprost acid were below the lower level of quantification (20 pg/mL). In a pre- and postnatal development study in rats, increased mortality of newborns, decreased body weights and delayed pinna unfolding were observed in offsprings. The no observed adverse effect level was at a tafluprost intravenous dose of 0.3 mcg/kg/day which is greater than 3 times the maximum recommended clinical dose based on body surface area comparison.
There are no adequate and well-controlled studies in pregnant woman. Although animal reproduction studies are not always predictive of human response, Tafluprost Ophthalmic Solution should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Women of childbearing age/potential should have adequate contraceptive measures in place.
🧒 Pediatric Use ▾
8.4Pediatric Use Use in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Tafluprost acid, a prostaglandin analog is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.
12.3Pharmacokinetics Absorption Following instillation, tafluprost is absorbed through the cornea and is hydrolyzed to the biologically active acid metabolite, tafluprost acid. Following instillation of one drop of the 0.0015% solution once daily into each eye of healthy volunteers, the plasma concentrations of tafluprost acid peaked at a median time of 10 minutes on both Days 1 and 8. The mean plasma C max of tafluprost acid were 26 pg/mL and 27 pg/mL on Day 1, and Day 8, respectively.
The mean plasma AUC estimates of tafluprost acid were 394 pg*min/mL and 432 pg*min/mL on Day 1 and 8, respectively. Metabolism Tafluprost, an ester prodrug, is hydrolyzed to its biologically active acid metabolite in the eye. The acid metabolite is further metabolized via fatty acid β-oxidation and phase II conjugation.
Elimination Mean plasma tafluprost acid concentrations were below the limit of quantification of the bioanalytical assay (10 pg/mL) at 30 minutes following topical ocular administration of tafluprost 0.0015% ophthalmic solution.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tafluprost acid, a prostaglandin analog is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Tafluprost Ophthalmic Solution 0.0015% is supplied as a sterile solution in translucent low density polyethylene single-use containers packaged in foil pouches (10 single-use containers per pouch). Each single-use container has 0.3 mL solution corresponding to 0.0045 mg tafluprost. NDC 66993-429-30; Unit-of-Use Carton of 30.
Storage: Store refrigerated at 2° to 8°C (36° to 46°F). During shipment Tafluprost Ophthalmic Solution may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 2 days. Mail-order prescriptions received after two days of the dispensing date noted in the prescribing label should not be used.
Store in the original pouch. After the pouch is opened, the single-use containers may be stored in the opened foil pouch for up to 30 days at room temperature 20° to 25°C (68° to 77°F). Protect from moisture.
Write down the date you open the foil pouch in the space provided on the pouch. Discard any unused containers 30 days after first opening the pouch.
📦 Storage and Handling ▾
Storage: Store refrigerated at 2° to 8°C (36° to 46°F). During shipment Tafluprost Ophthalmic Solution may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 2 days. Mail-order prescriptions received after two days of the dispensing date noted in the prescribing label should not be used.
Store in the original pouch. After the pouch is opened, the single-use containers may be stored in the opened foil pouch for up to 30 days at room temperature 20° to 25°C (68° to 77°F). Protect from moisture.
Write down the date you open the foil pouch in the space provided on the pouch. Discard any unused containers 30 days after first opening the pouch.
📋 Description ▾
11 DESCRIPTION Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is 1-methylethyl ( 5Z )-7-{( 1R , 2R , 3R , 5S )-2-[( 1E )-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost is C 25 H 34 F 2 O 5 and its molecular weight is 452.53.
Its structural formula is: Tafluprost is a colorless to light yellow viscous liquid that is practically insoluble in water. Tafluprost Ophthalmic Solution 0.0015% is supplied as a sterile solution of tafluprost with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmo/kg. Tafluprost Ophthalmic Solution contains Active: tafluprost 0.015 mg/mL; Inactives: glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection.
Tafluprost Ophthalmic Solution does not contain a preservative. Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling ( Patient Information ).
17.1Nightly Application Advise patients to not exceed once daily dosing since more frequent administration may decrease the intraocular pressure lowering effect of Tafluprost Ophthalmic Solution.
17.2Handling the Single-Use Container Advise patients that Tafluprost Ophthalmic Solution is a sterile solution that does not contain a preservative. 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.
17.3Potential for Pigmentation Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Also inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of Tafluprost Ophthalmic Solution.
17.4Potential for Eyelash Changes Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with Tafluprost 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.
17.5When to Seek Physician Advice Advise patients that if they develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, 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 Tafluprost Ophthalmic Solution.
17.6Use with Other Ophthalmic Drugs If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications.
17.7Storage Information Instruct patients on proper storage of cartons, unopened foil pouches, and opened foil pouches [see How Supplied/Storage and Handling ( 16 )] . Recommended storage for cartons and unopened foil pouches is to store refrigerated at 2° to 8°C (36° to 46°F). After the pouch is opened, the single-use containers may be stored in the opened foil pouch for up to 30 days at room temperature 20° to 25°C (68° to 77°F).
Protect from moisture. Manufactured for: Prasco Laboratories Mason, OH 45040 USA Made in France Rev. 06/22
🍼 Nursing Mothers ▾
8.3Nursing Mothers A study in lactating rats demonstrated that radio-labeled tafluprost and/or its metabolites were excreted in milk. 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 Tafluprost Ophthalmic Solution is administered to a nursing woman.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Following instillation, tafluprost is absorbed through the cornea and is hydrolyzed to the biologically active acid metabolite, tafluprost acid. Following instillation of one drop of the 0.0015% solution once daily into each eye of healthy volunteers, the plasma concentrations of tafluprost acid peaked at a median time of 10 minutes on both Days 1 and 8. The mean plasma C max of tafluprost acid were 26 pg/mL and 27 pg/mL on Day 1, and Day 8, respectively.
The mean plasma AUC estimates of tafluprost acid were 394 pg*min/mL and 432 pg*min/mL on Day 1 and 8, respectively. Metabolism Tafluprost, an ester prodrug, is hydrolyzed to its biologically active acid metabolite in the eye. The acid metabolite is further metabolized via fatty acid β-oxidation and phase II conjugation.
Elimination Mean plasma tafluprost acid concentrations were below the limit of quantification of the bioanalytical assay (10 pg/mL) at 30 minutes following topical ocular administration of tafluprost 0.0015% ophthalmic solution.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES In clinical studies up to 24 months in duration, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 23 to 26 mmHg who were treated with Tafluprost Ophthalmic Solution dosed once daily in the evening demonstrated reductions in intraocular pressure at 3 and 6 months of 6 to 8 mmHg and 5 to 8 mmHg, respectively.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Tafluprost was not carcinogenic when administered subcutaneously daily for 24 months at doses up to 30 mcg/kg/day in rats and for 18 months at doses up to 100 mcg/kg/day in mice (over 1600 and 1300 times, respectively, the maximum clinical exposure based on plasma AUC). Tafluprost was not mutagenic or clastogenic in a battery of genetic toxicology studies, including an in vitro microbial mutagenesis assay, an in vitro chromosomal aberration assay in Chinese hamster lung cells, and an in vivo mouse micronucleus assay in bone marrow.
In rats, no adverse effects on mating performance or fertility were observed with intravenous dosing of tafluprost at a dose of 100 mcg/kg/day (over 14000 times the maximum clinical exposure based on plasma C max or over 3600 times based on plasma AUC).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Tafluprost was not carcinogenic when administered subcutaneously daily for 24 months at doses up to 30 mcg/kg/day in rats and for 18 months at doses up to 100 mcg/kg/day in mice (over 1600 and 1300 times, respectively, the maximum clinical exposure based on plasma AUC). Tafluprost was not mutagenic or clastogenic in a battery of genetic toxicology studies, including an in vitro microbial mutagenesis assay, an in vitro chromosomal aberration assay in Chinese hamster lung cells, and an in vivo mouse micronucleus assay in bone marrow.
In rats, no adverse effects on mating performance or fertility were observed with intravenous dosing of tafluprost at a dose of 100 mcg/kg/day (over 14000 times the maximum clinical exposure based on plasma C max or over 3600 times based on plasma AUC).
📄 Patient Package Insert ▾
PATIENT INFORMATION TAFLUPROST OPHTHALMIC Solution 0.0015% (ta-floo-prost) Read this Patient Information before you start using Tafluprost Ophthalmic Solution and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is Tafluprost Ophthalmic Solution? Tafluprost Ophthalmic Solution is a prescription sterile eye drop solution. Tafluprost Ophthalmic Solution 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.
Tafluprost Ophthalmic Solution belongs to a group of medicines called prostaglandin analogs. Tafluprost Ophthalmic Solution is not for use in children. What should I tell my doctor before using Tafluprost Ophthalmic Solution ?
Before you use Tafluprost Ophthalmic Solution , 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 Tafluprost Ophthalmic Solution will harm your unborn baby. You should use an effective method of birth control while you use Tafluprost Ophthalmic Solution.
If you become pregnant while using Tafluprost Ophthalmic Solution talk to your doctor right away. are breastfeeding or plan to breastfeed. It is not known if Tafluprost Ophthalmic Solution passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Tafluprost Ophthalmic Solution.
Tell your doctor about all the medicines you take, including prescription and nonprescription 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 Tafluprost Ophthalmic Solution ? Read the Instructions for Use at the end of this Patient Information leaflet for additional instructions about the right way to use Tafluprost Ophthalmic Solution. Use 1 drop of Tafluprost Ophthalmic Solution in your eye (or eyes) each evening.
Talk to your doctor or pharmacist if you are not sure how to use Tafluprost Ophthalmic Solution. Your Tafluprost Ophthalmic Solution may not work as well if you use it more than 1 time each evening. If you use other medicines in your eye, wait at least 5 minutes between using Tafluprost Ophthalmic Solution and your other eye medicines.
Use your Tafluprost Ophthalmic Solution right away after opening. Each Tafluprost Ophthalmic Solution single-use container is sterile and is to be used 1 time then thrown away. Do not save any Tafluprost Ophthalmic Solution that may be left over after you use your medicine.
Using Tafluprost Ophthalmic Solution that is not sterile may cause other eye problems. What are the possible side effects of Tafluprost Ophthalmic Solution ? Tafluprost Ophthalmic Solution may cause serious side effects including: changes in the color of your eye (iris).
Your iris may become more brown in color while using Tafluprost Ophthalmic Solution. This color change may not go away when you stop using Tafluprost Ophthalmic Solution. If Tafluprost Ophthalmic Solution 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 Tafluprost Ophthalmic Solution. increasing the length, thickness, color, or number of your eyelashes. These eyelash changes usually go away when you stop using Tafluprost Ophthalmic Solution. hair growth on your eyelids. This hair growth usually goes away when you stop using Tafluprost Ophthalmic Solution.
The most common side effects of Tafluprost Ophthalmic Solution include: redness, stinging or itching of your eye cataract formation dry eye eye pain blurred vision headache common cold cough urinary tract infect… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions for Use Read these Instructions for Use before using your Tafluprost Ophthalmic Solution 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: Tafluprost Ophthalmic Solution is for the eye only. Do not swallow Tafluprost Ophthalmic Solution . Tafluprost Ophthalmic Solution single-use containers are packaged in a foil pouch.
Do not use the Tafluprost Ophthalmic Solution single-use containers if the foil pouch is opened. Write down the date you open the foil pouch in the space provided on the pouch. Every time you use Tafluprost Ophthalmic Solution: Step 1.
Wash your hands. Step 2. Take the strip of single-use containers from the foil pouch.
Step 3. Pull off one single-use container from the strip. Step 4.
Put the remaining strip of single-use containers back in the foil pouch and fold the edge to close the pouch. Step 5. Hold the single-use container upright.
Make sure that your Tafluprost Ophthalmic Solution medicine is in the bottom part of the single-use container. See Figure A. Figure A Step 6.
Open the single-use container by twisting off the tab. See Figure B. Figure B Step 7.
Tilt your head backwards. If you are unable to tilt your head, lie down. Figure C Step 8.
Place the tip of the single-use container close to your eye. Be careful not to touch your eye with the tip of the single-use container. See Figure C.
Step 9. Pull your lower eyelid downwards and look up. Figure D Step 10.
Gently squeeze the container and let 1 drop of Tafluprost Ophthalmic Solution fall into the space between your lower eyelid and your eye. If a drop misses your eye, try again. See Figure D.
If your doctor has told you to use Tafluprost Ophthalmic Solution drops in both eyes, repeat Steps 7 to 10 for your other eye. There is enough Tafluprost Ophthalmic Solution in one single-use container for both of your eyes. Throw away the opened single-use container with any remaining Tafluprost Ophthalmic Solution right away.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Rx only Manufactured for: Prasco Laboratories Made in France Rev.
06/22 Figure A Figure B Figure C Figure D
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Text for Container Label: Tafluprost Ophthalmic Solution 0.0015% Mfd. for: Prasco Laboratories Rx only Label
Principal Display Panel Text for pouch Label: NDC 66993-429-81 Tafluprost Ophthalmic Solution 0.0015% For Topical Application in the Eye Single-use Containers Preservative-Free, Sterile Contains: Active: Tafluprost 0.0015% (4.5 mcg per single-use container). Inactive ingredients: Glycerol, Sodium Dihydrogen Phosphate Dihydrate, Disodium Edetate, Polysorbate 80, Water for Injection, Hydrochloric Acid and/or Sodium Hydroxide are added to adjust pH. STORAGE: Store refrigerated at 2° to 8°C (36° to 46°F).
Store in original pouch. After the pouch is opened, the single-use containers may be stored in the opened foil pouch for up to 30 days at room temperature 20° to 25°C (68° to 77°F). Protect from moisture.
Write down the date the pouch is opened here: ____________ USUAL DOSAGE: One drop in the affected eye(s) once daily in the evening. The solution from one single-use container is to be used immediately after opening for administration to one or both eyes. ATTENTION: Use the eye drops immediately after opening the container.
Discard the opened container with any remaining contents immediately after use. pouch
Principal Display Panel Text for Carton Label: NDC 66993-429-30 Tafluprost Ophthalmic Solution 0.0015% For Topical Application in the Eye REFRIGERATE (2° to 8°C or 36° to 46°F) Single-use Containers Preservative-Free, Sterile Contains: Active: Tafluprost 0.0015% (4.5 mcg per single-use container). Inactive ingredients: Glycerol, Sodium Dihydrogen Phosphate Dihydrate, Disodium Edetate, Polysorbate 80, Water for Injection, Hydrochloric Acid and/or Sodium Hydroxide are added to adjust pH. Rx only 30 Single-use Containers: 3 pouches x 10 single-use containers (0.3 mL each) Carton