DailyMed Label: tafluprost

DailyMed Label: tafluprost

2022

DailyMed Prescription

tafluprost

tafluprost opthalmic

Micro Labs Limited

NDC: 42571-264

NDC: 42571-264

NDC: 42571-264

NDC: 42571-264

NDC: 42571-264

NDC: 42571-264

Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is 1-methylethyl (5 Z )-7-{(1 R , 2 R , 3 R , 5 S )-2-[(1 E )-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 mOsmol/kg. Tafluprost ophthalmic solution contains Active: tafluprost 0.015 mg/mL; Inactives: edetate disodium, glycerin, monobasic sodium phosphate dihydrate, polysorbate 80,  hydrochloric acid and sodium hydroxide (to adjust pH) and water for injection. Tafluprost ophthalmic solution does not contain a preservative.

Tafluprost ophthalmic solution, 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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.

Ophthalmic solution containing tafluprost 0.015 mg/mL.

None.

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 )

Use in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. ( 8.4 )

Tafluprost ophthalmic solution 0.0015% is supplied as 0.3 mL sterile solution in translucent low density polyethylene single-dose containers packaged in foil pouches (15 single-dose containers per pouch). Each single-dose container has 0.3 mL solution corresponding to 0.0045 mg tafluprost. Unit-of-Use Carton of 15           NDC 42571-264-26 Unit-of-Use Carton of 30           NDC 42571-264-73 Unit-of-Use Carton of 90           NDC 42571-264-74 Storage: Store refrigerated at 2º to 8°C (36º to 46°F). During shipment tafluprost ophthalmic solution may be maintained at temperatures up to 40ºC (104ºF) for a period not exceeding 2 days. Mail-order prescriptions received after two days of the dispensing date noted on the prescribing label should not be used. 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 20º to 25°C (68º 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.

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.

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).

In clinical studies up to 24 months in duration, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 23 to 26 mm Hg who were treated with tafluprost 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.

Tafluprost (TA-floo-prost) Ophthalmic Solution, 0.0015% 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 talks to your doctor right away. are breastfeeding or plan to breastfeed. It is not known if tafluprost 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 non-prescription 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-dose 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 m ay 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 infection Tell your doctor if you have any new eye problems while using tafluprost ophthalmic solution 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 general use: worsening of asthma shortness of breath Tell your doctor if you have any other side effects that bother you. These are not all the possible side effects of tafluprost ophthalmic solution. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store tafluprost ophthalmic solution? Important Information for Mail-Order Patients: Do not use if prescription is not received within two days of dispensing date. Keep the foil pouches and tafluprost ophthalmic solution single-dose containers dry. Before opening the foil pouches: Store the unopened foil pouches in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not open the pouch containing tafluprost ophthalmic solution until you are ready to use the eye drops. After opening the foil pouch: Store the opened foil pouch at room temperature, between 68°F to 77°F (20°C to 25°C), for up to 30 days. Throw away all unused tafluprost ophthalmic solution single-dose containers in the opened foil pouch after 30 days. Keep the tafluprost ophthalmic solution single-dose containers in their original foil pouch. After opening the foil pouch, refrigeration is not required. Keep tafluprost ophthalmic solution a nd all medicines out of the reach of children. General information about the safe and effective use of tafluprost ophthalmic solution. Do not use tafluprost ophthalmic solution for a condition for which it was not prescribed. Do not give tafluprost ophthalmic solution to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about tafluprost ophthalmic solution. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about tafluprost ophthalmic solution that is written for health professionals. What are the ingredients in tafluprost ophthalmic solution? Active ingredients: tafluprost Inactive  ingredients:  edetate disodium, glycerin, monobasic sodium phosphate dihydrate, polysorbate 80, hydrochloric acid and sodium hydroxide (to adjust pH) and water for injection. 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 i s for the eye only. Do not swallow tafluprost ophthalmic solution. Tafluprost ophthalmic solution single-dose containers are packaged in a foil pouch. Do not use the tafluprost ophthalmic solution 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. Every time you use tafluprost ophthalmic solution: Step 1. Wash your hands. Step 2. Take the strip of single-dose containers from the foil pouch. Step 3. Pull off one single-dose container from the strip. Step 4. Put the remaining strip of single-dose containers back in the foil pouch and fold the edge to close the pouch. Step 5. Hold the single-dose container upright. Make sure that your tafluprost ophthalmic solution medicine is in the bottom part of the single-dose container. See Figure A.    Figure A Step 6. Open the single-dose container by twisting off the tab. See Figure B.   Figure B Step 7. Step 8. Tilt your head backwards. If you are unable to tilt your head, lie down.   Place the tip of the single-dose container close to your eye. Be careful not to touch your eye with the tip of the single-dose container. See Figure C.   Figure C Step 9. Step 10. Pull your lower eyelid downwards and look up.   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.   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-dose container for both of your eyes. Throw away the opened single-dose 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 by: Micro Labs Limited Bangalore – 560099, INDIA.   Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev. 05/2022

Tafluprost Ophthalmic Solution 0.0015% 0.3 mL Container label For use in the eye Rx Only Rx Only NDC 42571-264-93 Tafluprost Ophthalmic Solution 0.0015% For Topical Application in the Eye 15 Single-dose Containers (0.3 mL each) Single-dose Containers Perservative-Free, Sterile NDC 42571-264-26 Rx Only Tafluprost Ophthalmic Solution 0.0015% For Topical Application in the Eye REFRIGERATE (2° to 8°C or 36° to 46°F) Single-dose Containers Perservative-Free, Sterile 15 Single-dose Containers (0.3 mL each)