Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: LABORATOIRES THEA, 12 RUE LOUIS BLERIOT, 63017 CLERMONT-FERRAND CEDEX 2, France
Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension.
Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if MONOPOST is administered in the evening.
The dosage of MONOPOST should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as normal.
No data are available with MONOPOST formulation.
Ocular use.
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 should be performed immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.
If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart.
A single-dose contains enough eye drops solution to treat both eyes.
For single use only.
This medicinal product is a sterile solution that does not contain a preservative. The solution from one individual single dose container is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single dose container is opened, any remaining contents must be discarded immediately after administration.
Patients should be instructed:
Apart from ocular irritation and conjunctival hyperaemia, no other ocular side effects are known if MONOPOST is overdosed.
If MONOPOST is accidentally ingested the following information may be useful: One single-dose container contains 10 micrograms latanoprost. More than 90% is metabolised during the first pass through the liver. Intravenous infusion of 3 micrograms/kg in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment and induced no symptoms, but a dose of 5.5-10 micrograms/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. In monkeys, latanoprost has been infused intravenously in doses of up to 500 micrograms/kg without major effects on the cardiovascular system.
Intravenous administration of latanoprost in monkeys has been associated with transient bronchoconstriction. However, in patients with moderate bronchial asthma, bronchoconstriction was not induced by latanoprost when applied topically on the eyes in a dose of seven times the clinical dose of MONOPOST.
If overdose with MONOPOST occurs, treatment should be symptomatic.
2 years in the outer packaging.
After first opening of the sachet, use the single-dose containers within 10 days.
After first opening of the single-dose container: use immediately and discard the single-dose container after use.
Store below 25°C.
For storage after first opening of the medicinal product, see section 6.3.
5 or 10 single-dose containers (LDPE) containing 0.2 ml of eye drops solution are packed in sachet (copolymers/aluminium/polyethylene/paper or PE/aluminium/polyethylene/PET).
A pack size contains 5 (1x5), 10 (2x5), 10 (1x10), 30 (6x5), 30 (3x10), 90 (18x5) or 90 (9x10) single-dose containers.
Not all pack sizes may be marketed.
No special requirements.
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