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Careful Administration: This product should be administered with special caution in the following patients: Patients with right heart failure due to pulmonary hypertension. [These symptoms may be exacerbated by negative chronotropic/inotropic effects due to β-receptor blockade.]
Patients with congestive heart failure. [These symptoms may be exacerbated by negative chronotropic/inotropic effects due to β-receptor blockade.]
Patients with diabetic ketoacidosis or metabolic acidosis. [This product may exacerbate the reduction of the myocardial contractile force due to acidosis.]
Patients with poorly controlled diabetes. [Blood glucose levels should be monitored because this product may mask symptoms of hypoglycemia.]
Aphakic patients, pseudophakic patients with a torn posterior lens capsule. [By administering latanoprost, macular edema, including cystoid macular edema and the decreased visual acuity associated with macular edema, have been reported.]
Patients with intraocular inflammation (iritis/uveitis). [By administering latanoprost, elevated intraocular pressure (IOP) has been reported.]
Patients potentially with latent herpes virus infection. [By administering latanoprost, herpetic keratitis has been reported.]
Pregnant, parturient, nursing women [see Use in Pregnancy & Lactation].
Important Precautions: Because this product is a combination ophthalmic solution containing 50 μg of latanoprost and 6.83 mg of timolol maleate (equivalent to timolol 5 mg) in the 1 mL, adverse reactions to both latanoprost and timolol maleate may occur. Hence, appropriate use of this product should be considered.
It should be noted that this product may be absorbed systemically, and an adverse reaction similar to that caused by systemic administration of β-blockers may occur.
When this product is administered, the iris pigmentation may occur (due to increased melanin content). Before using this product, patients who receive treatment should be well informed of the possibility of the iris pigmentation and the change in iris color. It is reported that pigmentation by administration of latanoprost is expected to increase gradually and stops after discontinuation of treatment. However, the resultant pigmentation is likely to be permanent. In addition, iris color change due to the iris pigmentation may occur. In particular, the treatment of one eye may cause iris color difference between the right and left eyes. The pigmentation of the iris has been reported predominantly in patients with brown-based irises. The change in iris color is mild and may not be detected clinically (see Clinically Significant Adverse Reactions under Adverse Reactions).
Corneal epithelium disorder (superficial punctate keratitis, filamentary keratitis, corneal erosion) may occur during administration of this product. The patients should be adequately instructed to immediately consult a doctor if the subjective symptoms of eye stinging, itching, and eye pain persist.
This product should be administered with special caution in the patients with angle-closure glaucoma due to an insufficient clinical experience.
When switching from miotic to timolol maleate preparation, refractive adjustments may be required due to the disappearance of miotic action. Caution should be exercised when administering this product.
Since blurred vision may temporarily occur after administration of the product, patients should be advised to refrain from operating machinery or driving a car until the symptoms disappear.
Other Precautions: Intravenously administered latanoprost at a dose (2 μg/kg) in monkeys induced increases in transient airway resistance. However, it has been reported that instillation of latanoprost in 11 patients with moderate bronchial asthma at seven times the recommended clinical dose (recommended dose is 1.5 μg/eye) had no effect on lung function.
Use in Children: The safety of this product in pediatric patients has not been established. (No sufficient clinical data.)
Use in the Elderly: Generally elderly patients have declined physiological functions and this product should be administered with caution.
