Tafluprost

Dosage Forms & Strengths

ophthalmic solution

• 0.0015% (0.015mg/mL)

Elevated Intraocular Pressure

Indicated for reducing elevated IOP in patients with open-angle glaucoma or ocular hypertension

Instill 1 drop in affected eye(s) once daily in the evening

Administration

Instill into conjunctival sac of affected eye(s)

Do not exceed once daily dosing regimen; more frequent administration of prostaglandin analogs may lessen the IOP lowering effect

Reduction of intraocular pressure starts approximately 2 - 4 hours after first administration with maximum effect reached after 12 hr

If other topical ophthalmics are prescribed, each should be administered 5 minutes apart

Preservative free product; use immediately after opening one unit-dose for administration; sterility cannot be maintained after opening

Not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use

Dosage Forms And Strengths

Ophthalmic solution containing tafluprost 0.015 mg/mL.

Storage And Handling

ZIOPTAN (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 0006-3931-30; Unit-of-Use Carton of 30.
NDC 0006-3931-54; Unit-of-Use Carton of 90.

Store refrigerated at 2-8°C (36-46°F). 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 28 days at room temperature: 2025°C (68-77°F). Protect from moisture. Write down the date you open the foil pouch in the space provided on the pouch. Discard any unused containers 28 days after first opening the pouch.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Laboratoire Unither ZI de la Guerie F-50211 COUTANCES Cedex France . Revised: 2012

Tafluprost may be found in some form under the following brand names:

• Zioptan

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• any other eyedrops
• bematoprost (Lumigan, Latisse)
• latanoprost (Xalatan)

This is not a complete list of tafluprost drug interactions. Ask your doctor or pharmacist for more information.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of tafluprost there are no specific foods that you must exclude from your diet when receiving tafluprost.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about tafluprost, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about tafluprost. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using tafluprost.

Review Date: October 4, 2017

For ophthalmic use only. Wash hands before use. Avoid touching the tip of the single-use container to eye or other surfaces. Each single-use container has adequate solution to treat both eyes (if applicable); discard immediately after use. If more than one topical ophthalmic drug is being used, administer the drugs at least 5 minutes apart.

Store unopened foil pouches refrigerated at 2°C to 8°C (36°F to 46°F). During shipping, may be stored at temperatures up to 40°C (104°F) for no more than 2 days; do not use if mail-order prescriptions arrive after 2 days of the dispensing date. Upon opening the foil pouch, store the single-dose containers at 20°C to 25°C (68°F to 77°F) in the foil pouch; discard unused containers after 30 days. Discard opened single-dose containers immediately after use. Protect from moisture.

Intraocular pressure; regularly examine patients who develop increased iris pigmentation

Adverse events have been observed in animal reproduction studies. Effective contraception during treatment is recommended for women of childbearing potential.

Applies to tafluprost ophthalmic: ophthalmic solution

Along with its needed effects, tafluprost ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tafluprost ophthalmic:

• Blurred vision
• burning, dry, or itching eyes
• decreased vision
• eye discharge or excessive tearing
• eye pain
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Some side effects of tafluprost ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• stinging or irritation of the eye

• Cough
• darker color of the eyelashes
• dry eyes
• increased growth of the eyelashes

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Women of childbearing potential should use effective contraception methods.

Animal studies have revealed reproductive toxicity. Additionally, studies have shown increased incidence of vertebral skeletal abnormalities, malformations of the skull, brain, and spine. There are no adequate studies in pregnant women. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.