Lacoma T

Indications

Lacoma T is indicated for the treatment of Glaucoma & ocular hypertension

Adverse Effects

Latanoprost Most common adverse reactions (5-15%) from clinical trials are blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate keratitis Timolol In clinical trials with timolol maleate ophthalmic solutions, common adverse effects aobserved were transient blurred vision upon instillation of the drop, burning and stinging upon instillation, Blepharitis, conjunctivitis, crusting, discomfort, foreign body sensation, hyperemia, pruritus and tearing.

Drug Interactions

Timolol: Some products that may interact with this drug include: oral beta-blockers (such as propranolol), clonidine, certain antidepressants (including SSRIs such as fluoxetine), digoxin, epinephrine, fingolimod, methyldopa, quinidine Latonoprost: Definitive drug interaction data are not available. There have been reports of paradoxical elevations in IOP following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins, prostaglandin analogues or prostaglandinderivatives is not recommended

Mechanism of Action

Lacoma-T consists of two components: latanoprost and timolol maleate. These two components decrease elevatedintraocular pressure (IOP) by different mechanisms of action and the combined effect results in additional IOP reductioncompared to either compound administered alone. Latanoprost, a prostaglandin F 2α analogue, is a selective prostanoid FP receptor agonist that reduces the IOP byincreasing the outflow of aqueous humour. The main mechanism of action is increased uveoscleral outflow. Additionally,some increase in outflow facility (decrease in trabecular outflow resistance) has been reported in man. Latanoprost hasno significant effect on the production of aqueous humour, the blood-aqueous barrier or the intraocular blood circulation.Chronic treatment with latanoprost in monkey eyes, which had undergone extracapsular lens extraction did not affect theretinal blood vessels as determined by fluorescein angiography. Latanoprost has not induced fluorescein leakage in theposterior segment of pseudophakic human eyes during short term treatment. Timolol is a beta-1 and beta-2 (non-selective) adrenergic receptor blocking agent that has no significant intrinsicsympathomimetic, direct myocardial depressant or membrane-stabilising activity. Timolol lowers IOP by decreasing theformation of aqueous in the ciliary epithelium.

Pharmacokinetics

The half life of Latanoprost in Lacoma T is 17 minutes, half life of Timolol in Lacoma T is not applicable since the plasma concentration of Timolol is negligible

Absorption, Distribution, Metabolism & Excretion

Latanoprost Latanoprost is an isopropyl ester prodrug which per se is inactive, but after hydrolysis to the acid of latanoprost becomes biologically active. The prodrug is well absorbed through the cornea and all drug that enters the aqueous humour is hydrolysed during the passage through the cornea. Studies in man indicate that the peak concentration in the aqueous humour is reached about two hours after topical administration. After topical application in monkeys, latanoprost is distributed primarily in the anterior segment, the conjunctivae and the eyelids. Only minute quantities of the drug reach the posterior segment. There is practically no metabolism of the acid of latanoprost in the eye. The main metabolism occurs in the liver. The half life in plasma is 17 minutes in man. The main metabolites, the 1,2-dinor and 1,2,3,4-tetranor metabolites, exert no or only weak biological activity in animal studies and are excreted primarily in the urine. Timolol Absorption The onset of reduction in intra-ocular pressure can be detected within one-half hour after a single dose. The maximum effect occurs in one or two hours; significant lowering of IOP can be maintained for as long as 24 hours with a single dose. In some cases, a decreased therapeutic effect has been observed in long-term treatment.

Drug Use in Pregnancy

Pregnancy Latanoprost There are no adequate data from the use of latanoprost in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Timolol There are no adequate data for the use of timolol in pregnant women. Timolol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption. Epidemiological studies have not revealed malformative effects, but show a risk for intra uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If Latanoprost / Timolol 50 micrograms / ml + 5 mg / ml Eye Drops, Solution is administered until delivery, the neonate should be carefully monitored during the first days of life. Consequently Latanoprost / Timolol 50 micrograms / ml + 5 mg / ml Eye Drops, Solution should not be used during pregnancy (see section 5.3). Breastfeeding Beta- blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. To reduce the systemic absorption, see section 4.2. Latanoprost and its metabolites may pass into breast milk. Latanoprost / Timolol 50 micrograms / ml + 5 mg / ml Eye Drops, Solution should not be used in women who are breast-feeding.

Drug Use in Pediatric Population

Paediatric population The safety and efficacy of Lacoma T in children and adolescents has not been established.

Drug Use in Geriatric Population

Adults (including the elderly) Recommended therapy is one eye drop in the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop inthe affected eye(s) daily.