Indication:
ZIOPTAN (tafluprost ophthalmic solution) 0.0015%
Initial U.S. Approval: 2012
Drug Name- Zioptan
Active Ingredient - Tafluprost
For reducing elevated intraocular pressure in patients with open-angle
glaucoma or ocular hypertension
Indication-
For reducing elevated intraocular pressure in patients with open-angle
glaucoma or ocular hypertension
Approved by FDA on 10-2-2012 (Ref- FDA Approved List- 2012)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Tafluprost Eye drops 21-10-2011
0.0015%w/v
For the reduction of Elevated Traocular Pressure in Open Angle
Glaucoma and Ocular Hypertension
Adverse Reaction:
Most common ocular adverse reaction is conjunctival hyperemia (range 4% -20%).
Contra-Indications:
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Pigmentation-
Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes
can occur. Iris pigmentation is likely to be permanent.
Eyelash Changes-
Gradual changes to eyelashes including increased length, thickness
and number of lashes. Usually reversible.
Dosages/ Overdosage Etc:
Indication-
For reducing elevated intraocular pressure in patients with open-angle
glaucoma or ocular hypertension
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.
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening.
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing tafluprost 0.015 mg/mL.
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information).
1. Nightly Application
Advise patients, not to exceed once daily dosing since more frequent administration
may decrease the intraocular pressure lowering effect of ZIOPTAN
2. Handling the Single-Use Container
Advise patients that ZIOPTAN 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.
3. Potential 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 ZIOPTAN
4. Potential for Eyelash Changes
Inform patients of the possibility of eyelash and vellus hair changes in the treated
eye during treatment with ZIOPTAN. 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.
5. When 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 ZIOPTAN.
6. Use 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.
Pharmacology/ Pharmacokinetics:
1. Mechanism 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.
2. Pharmacokinetics
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 Cmax 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.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1.Pregnancy
Pregnancy Category C.
Teratogenic effects: In embryo-fetal development studies in rats and rabbits, tafluprost
administered intravenously was teratogenic.
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.
2. Nursing 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 ZIOPTAN is administered to a nursing woman.
3. Pediatric Use
Use in pediatric patients is not recommended because of potential safety concerns
related to increased pigmentation following long-term chronic use.
4. Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between
elderly and other adult patients
Manufacturer Details