ZIOPTAN- tafluprost solution/ drops

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

TAFLUPROST (UNII: 1O6WQ6T7G3) (TAFLUPROST - UNII:1O6WQ6T7G3)

Dostępny od:

Thea Pharma Inc.

Droga podania:

OPHTHALMIC

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. None. 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, ZIOPTAN ® 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. 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 ZIOPTAN ® is administered to a nursing woman. Use in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. Read these Instructions for Use before using your ZIOPTAN ® 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: - ZIOPTAN ® is for the eye only. Do not swallow ZIOPTAN ® . - ZIOPTAN ® single-use containers are packaged in a foil pouch. - Do not use the ZIOPTAN ® 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 ZIOPTAN ® : - If your doctor has told you to use ZIOPTAN ® drops in both eyes, repeat Steps 7 to 10 for your other eye. - There is enough ZIOPTAN ® in one single-use container for both of your eyes. - Throw away the opened single-use container with any remaining ZIOPTAN ® right away. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Rx only Manufactured for : Thea Pharma Inc. Waltham, MA 02451 Made in France © 2023. Thea Pharma Inc. All rights reserved The ZIOPTAN trademark is owned by Merck Sharp & Dohme Corp. and is used under license. Revised: 05/2023 N10260U30USA/0423 Revised: 3/2024 Thea Pharma Inc.

Podsumowanie produktu:

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 82584-609-30; Unit-of-Use Carton of 30. Storage: Store refrigerated at 2° to 8°C (36° to 46°F). During shipment ZIOPTAN ® 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.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

ZIOPTAN- TAFLUPROST SOLUTION/ DROPS
THEA PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIOPTAN (TAFLUPROST
OPHTHALMIC SOLUTION) 0.0015% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
ZIOPTAN
.
ZIOPTAN (TAFLUPROST OPHTHALMIC SOLUTION) 0.0015%
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
ZIOPTAN
(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
One drop in the affected eye(s) once daily in the evening. ( 2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing tafluprost 0.015 mg/mL ( 3)
CONTRAINDICATIONS
None. ( 4)
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)
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.
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)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
®
®
®
®
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pigmentation
5.2 Eyelash Changes
5.3 Intraocular Inflammation
5.4 Macular Edema
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
1