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MONOPROST is a brand name for Latanoprost, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Optimal effect is obtained when MONOPROST® is administered in the evening. Recommended Dose and Dosage Adjustment Recommended dosage for adults – including the elderly (>65 years of age) – is one drop in the affected eye(s) once daily.
The dose of MONOPROST® should not exceed once daily as it has been shown that more frequent administration decreases the IOP lowering effect. Reduction of IOP in humans starts about 3 to 4 hours after treatment and maximum effect is reached after 8 to 12 hours.
Pressure reduction is maintained for at least 24 hours. Missed Dose If one dose is missed, treatment should continue with the next dose as scheduled. Administration MONOPROST® is for ocular use only. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute.
This step should be performed immediately following the instillation of MONOPROST®. Contact lenses should be removed before instillation of MONOPROST®. Contact lenses may be reinserted 15 minutes after instillation. For single use only.
The single-dose container provides enough solution to treat both eyes once. Use one drop to treat one eye. Use one drop in each eye if treating both eyes. Discard unused portion even if treating one eye. Patients should be instructed to: • avoid contact between the dropper tip and the eye or eyelids; • use the eye drops solution immediately after first opening the single-dose container; and • discard the single-dose container after use.
Use in combination with other drugs MONOPROST® may be used concomitantly with other topical ophthalmic products to further lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
OVERDOSAGE For management of a suspected drug overdose, particularly accidental oral ingestion, contact your regional Poison Control Centre. MONOPROST® Product Monograph Page 11 of 30 Apart from ocular irritation and conjunctival or episcleral hyperemia, no other ocular adverse event of latanoprost administered at high doses in humans are known.
Intravenous infusion of up to 3 μg/kg latanoprost in healthy volunteers – mean plasma concentrations 200 times higher than that observed during clinical treatment – did not result in observed adverse events. 5 to 10 μg/kg resulted in observed adverse events of abdominal pain, dizziness, fatigue, hot flushes, nausea, and sweating.
Hepatic/Biliary/Pancreatic Latanoprost has not been studied in patients with hepatic impairment. Caution is advised if using MONOPROST® in patients with hepatic impairment. Ophthalmologic Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost.
These reports have mainly occurred in aphakic patients, in pseudophakic patients with torn posterior lens capsule, or in patients with known risk factors for macular edema. Caution is advised if using MONOPROST® in patients who do not have an intact posterior capsule or who have known risk factors for macular edema.
Latanoprost may gradually increase the pigmentation of the iris. , blue-brown, grey-brown, green-brown or yellow-brown). This change may not be noticeable for several months to years. During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant colour change may be permanent.
Eyelid skin darkening, which may be reversible, has been reported in association with the use of latanoprost. Latanoprost may gradually change eyelashes and vellus hair in the treated eye; these changes can include increased length, thickness, pigmentation, and number of lashes or hairs, as well as misdirected growth of eyelashes.
Eyelash changes are usually reversible upon discontinuation of treatment. There is no experience with latanoprost in patients with inflammatory ocular conditions, inflammatory glaucoma, neovascular glaucoma, or congenital glaucoma, and only limited experience with pseudophakic and/or pigmentary glaucoma patients.
, iritis/uveitis). Caution is advised if using MONOPROST® in patients with a history of intraocular inflammation. Latanoprost is not recommended in patients with active herpes simplex keratitis or a history or recurrent herpetic keratitis specifically associated with prostaglandin analogues.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In monkeys, latanoprost has been infused intravenously in doses of up to 500 μg/kg without major adverse effects on the cardiovascular system. Intravenous administration in monkeys has been associated with transient bronchoconstriction.
In patients with bronchial asthma, bronchoconstriction was not induced by latanoprost when administered topically to the eyes at a dose 7 times the recommended clinical dose. If overdosage with MONOPROST® occurs, treatment should be symptomatic.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action MONOPROST®, a prostaglandin F2α (13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α isopropyl ester) analogue, is a selective prostanoid FP receptor agonist that reduces intraocular pressure by increasing the outflow of aqueous humour.
, decrease in outflow resistance) has also been reported in humans. Pharmacodynamics Reduction of intraocular pressure following a single dose in humans starts approximately 3 to 4 hours following topical administration, with maximum effect reached after 8 to 12 hours.
Pressure reduction is maintained for at least 24 hours. Pharmacokinetics The pharmacokinetics of latanoprost from MONOPROST® and XALATANTM were assessed in a phase II controlled clinical study conducted in 30 patients newly diagnosed with open-angle glaucoma or ocular hypertension1.
0 pg/mL) was similar between groups; except at 5 min after instillation. Cmax was marginally lower and tmax marginally higher after MONOPROST® suggesting MONOPROST® absorption is marginally slower than XALATANTM; however, this difference is not considered to be clinically relevant.
MONOPROST® Product Monograph Page 12 of 30 Table 3:
Latanoprost plasma pharmacokinetic parameters following administration of MONOPROST® and XALATANTM ophthalmic solution, 50 μg/mL in patients following 6 weeks of treatment Treatment Cmax (pg/mL) Tmax (min) AUC0-30min (pg•min/mL) t1/2 (min) Latanoprost (MONOPROST®) 46 (20, 140) 11 (5, 15) 992 (600, 2874) NA Latanoprost (XALATANTM) 62 (20, 198) 7 (5, 10) 1203 (600, 3341) NA Limit of Quantification (LOQ) was 40 pg/mL; Samples below LOQ were assigned a value of 20 pg/ml – trend consistent at assigned values of 0, 20, and 39 pg/mL; Pharmacokinetic parameters are presented as geometric means; Values in parentheses are (minimum, maximum) values for respective parameter.
t1/2 was not calculated as too many values were missing (values below the LOQ).
Absorption:
Latanoprost is an isopropyl ester prodrug that is well absorbed through the cornea, and upon entering the aqueous humour, is rapidly and completely hydrolysed to the biologically active acid. Studies in humans indicate that the peak concentration in the aqueous humour is reached about 2 hours after topical administration.
, 40 pg/mL).
Distribution:
Following topical administration in monkeys, latanoprost is primarily distributed in the anterior segment of the eye, including the conjunctiva and eyelids, while minute quantities are detected in the posterior segment. Metabolism: […]
Caution is advised if using MONOPROST® in patients with a history of herpetic keratitis. Contact lenses should be removed prior to the administration of latanoprost, and may be reinserted 15 minutes after administration. Renal Latanoprost has not been studied in patients with renal impairment.
Caution is advised if using MONOPROST® in patients with renal impairment. Respiratory There is limited experience with latanoprost in patients with asthma or chronic obstructive pulmonary disease; however, rare cases of exacerbation of asthma and/or dyspnoea were reported from post MONOPROST® Product Monograph Page 5 of 30 marketing experience.
Caution is advised if using MONOPROST® in patients with asthma or chronic obstructive pulmonary disease. (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions).
Special Populations Pregnant Women:
Reproduction studies have been performed in rats and rabbits. In rabbits an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest non-embryocidal dose in rabbits was approximately 15 times the maximum human dose (see TOXICOLOGY).
Caution is advised if using MONOPROST® in pregnant women.
Nursing Women:
Latanoprost and its metabolites may pass into breast milk. Caution is advised if using MONOPROST® in nursing women.
Pediatrics (<18 years of age):
The safety and efficacy of latanoprost has not been established in children. ADVERSE REACTIONS Adverse Drug Reaction Overview Ocular adverse events in either MONOPROST® or XALATANTM groups were primarily considered by the investigators to be of mild intensity and did not require treatment intervention.
One adverse event of ocular discomfort was classified as severe in a patient treatment with MONOPROST®. No ocular adverse event was considered serious. Ocular adverse events infrequently caused drug withdrawal, regardless of treatment group.
The most common adverse events in the MONOPROST® group from clinical trials were blepharitis, conjunctival hyperemia, instillation site pain and instillation site pruritus. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 5 years) with a history of elevated intraocular pressure. MONOPROST®, in contrast to the positive control XALATANTM (lataonoprost ophthalmic solution) 50 μg/mL, does not contain the preservative benzalkonium chloride (BAK).
MONOPROST® was administered to 213 patients at a dose of one drop daily in the evening for up to 3 months. The most frequent adverse events observed in the clinical trial are provided in Table 1. 1) General disorders and administration site […]