Each mL contains: Latanoprost 50 μg, Timolol Maleate equivalent to Timolol 5 mg.
Excipients/Inactive Ingredients: Preservative: Benzalkonium Chloride 0.02%.
Pharmacology: Latanoprost and Timolol Maleate decrease elevated intraocular pressure (IOP) by different mechanisms of action and the combined effects results in additional IOP reduction compared to either compound administered alone.
Latanoprost: The active substance Latanoprost, a prostaglandin F2α analogue, is a selective prostanoid FP receptor agonist that reduces the IOP by increasing the outflow of aqueous humor. The main mechanism of action is increased uveoscleral outflow.
Latanoprost has no significant effects on the production of aqueous humour, the blood-aqueous barrier or the intraocular blood circulation.
Latanoprost has not induced fluorescein leakage in the posterior segment of pseudophakic human eyes during short term treatment.
Timolol Maleate: Timolol is a beta-1 and beta-2 (non-selective) adrenergic receptor blocking agent that has no significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. Timolol lowers IOP by decreasing the formation of aqueous in the ciliary epithelium. The precise mechanism of action is not clearly established but inhibition of increased cyclic AMP synthesis caused by endogenous beta-adrenergic stimulation is probable. Timolol has not been found to significantly affect the permeability of the blood-aqueous barrier to plasma proteins.
LANOSAN PLUS are indicated as a reduction of intraocular pressure (IOP). In patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to Timolol or and Latanoprost.
Recommended dosage for adults (including the eldery): One eye drop in the affected eye(s) once daily in the morning. If the dose is missed, treatment should continue with the next dose as planned.
The dose should not exceed one drop in the affected eye(s) daily.
Administration: If more than one topical ophthalmic drug being used, they should be administered five minutes apart.
Use in children and adolescents: Safety and effectiveness in children and adolescents has not been established.
No data are available in humans with regards to overdose with LANOSAN PLUS.
Hypersensitivity to drug components.
Heart failure, second or third degree cardiac arrhythmias with AV blockade, bradycardia, cardiogenic shock, bronchial asthma, chronic airway obstruction with a predisposition to bronchial spasm or a history of bronchial spasm; hypersensitivity to timolol maleate and benzalkonium chloride.
Special warning and special precaution for use: Benzalkonium Chloride, which is commonly used as preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since this drug contains Benzalkonium Chloride, close monitoring is required in frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Contact lenses: Patients should be advised not to wear contact lenses if their eye is red. This drug should not be used to treat contact lenses-related irritation. The preservative in this drug, Benzalkonium Chloride, may be absorbed by contact lenses. Patients who wear contact lenses and whose eyes are not red should be instructed to wait at least 10 minutes after instilling this drug before they insert their contact lenses.
Before starting treatment, the patient should be informed of possible eye color changes; observe eye color changes; aphakia or pseudophakia with a tear in the posterior lens capsule or anterior lens space; risk factors for cystoid macular edema; severe or recurrent asthma; should not be used within 5 minutes after using preparations containing thyomersal; pregnancy.
Should not be used in women who are breastfeeding.
The potential for heterochromia exists in patients receiving a single treatment.
Should not be used in women who are breastfeeding.
Brown pigmentation, especially in patients with mixed iris colors; inflammation of the eyelids, ocular irritation and pain; eyelashes lengthen, grow darker and thicker; conjunctival hyperaemia; transient punctate epithelial erosion; skin rash; less often eyelid edema and rash; rarely dyspnoea, more severe asthma, iritis, uveitis, local edema, darkened palpebral skin.
Specific medical product interaction studies have not been performed with this product.
The effect on intraocular pressure or the known effects of systemic beta-blokade may be potentiated when Latanoprost-Timolol is given to patients already receiving an oral beta-adrenergic blocking agent, and the use of two or more topical beta-adrenergic blocking agent is not recommended.
There have been reports of paradoxical elevations in IOP following the concomitant ophthalmic administration of two prostaglandin analogs. Therefore, the use of two or more prostaglandins, prostaglandins analogs, or prostaglandin derivatives is not recommended.
Mydriasis has occasionally been reported when Timolol was given with Epinephrine.
There is a potential for additive effects resulting in hypotension and/or marked bradycardia when eye drops with Timolol are administered concomitantly with oral calcium channel blockers, guanethidine or beta-blocking agents, antiarrhythmics, digitalis glycosides or parasympathomimetics.
The hypertensive reaction to sudden withdrawal of Clonidine can be potentiated when taking beta-blockers.
Beta-blockers may increase the hypoglycemic effect of antidiabetic agents. Beta-blockers can mask the signs and symptoms of hypoglycemia (see PRECAUTIONS).
Store between 2°c and 8°C, away from light.
After opening, store below 25°C and use within 4 weeks.
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Lanosan Plus Eye Drops
(dropper-tip bottle) 2.5 mL x 1's (Rp132,350/boks)
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