Consumer medicine information

1. Why am I using XALATAN?

XALATAN contains the active ingredient latanoprost. It is used to lower raised pressure in the eye in patients with open-angle glaucoma or ocular hypertension.
For more information, see Section 1. Why am I using XALATAN? in the full CMI.

2. What should I know before I use XALATAN?

Do not use if you have ever had an allergic reaction to XALATAN or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use XALATAN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with XALATAN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use XALATAN?

• The usual dose of XALATAN is one drop into the affected eye, or eyes, once daily. Use it until your doctor tells you to stop.

• If you are wearing soft contact lenses, remove them before putting the drops in your eye.

• While pulling down the lower eyelid and looking upwards with your head tilted back, gently squeeze the bottle to administer one drop. Release the eyelid and close your eye, without blinking or rubbing your eye. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes.

5. What should I know while using XALATAN?

6. Are there any side effects?

Common side effects of XALATAN include changes to the eye and the surrounding area. These complaints mainly relate to irritation of the eye and eyelid, but other common side effects include headache, muscle/joint pain, and painful/urgent or frequent urination. In addition to this, serious side effects may occur. These serious side effects include breathing difficulties, chest pain, strong/rapid/irregular heartbeats, dizziness, nausea/vomiting, swelling of the face/lips/mouth/tongue/throat, or developing white/cloudy deposits in the front of your eye.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Latanoprost.

2 Qualitative and Quantitative Composition

The active ingredient in Xalatan is latanoprost, a prostaglandin F_2α analogue.
Xalatan Eye Drops is a sterile, isotonic solution containing 50 microgram/mL of latanoprost in an aqueous buffer solution of pH 6.7.
Each 5 mL bottle contains 2.5 mL eye drop solution corresponding to a minimum of 80 drops of solution. One drop contains approximately 1.5 micrograms latanoprost.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye Drops, solution.
The solution is a clear and colourless liquid, filled in a polyethylene container.

4 Clinical Particulars

4.9 Overdose

Symptoms. Apart from ocular irritation and conjunctival or episcleral hyperaemia, the ocular effects of latanoprost administered at high doses are not known.
Treatment. If overdosage with Xalatan occurs, treatment should be symptomatic and supportive. If Xalatan is accidentally ingested the following information may be useful. One bottle contains 125 microgram latanoprost. More than 90% is metabolised during the first-pass through the liver. Intravenous infusion of 3 microgram/kg in healthy volunteers induced no symptoms but a dose of 5.5-10 microgram/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. In patients with bronchial asthma, bronchoconstriction was not induced by latanoprost when applied topically on the eyes in a dose of seven times the clinical dose of Xalatan.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Latanoprost was not mutagenic in gene mutation assays in bacteria and mouse lymphoma L5178Y cells and was negative in studies of unscheduled DNA synthesis. Chromosome aberrations were observed with human lymphocytes in vitro but latanoprost did not induce micronucleus formation in vivo.
Carcinogenicity. Latanoprost was not carcinogenic in either rats or mice when administered by oral gavage at doses up to 170 microgram/kg/day for 24 and 20 months respectively.
Animal toxicity. The ocular as well as systemic toxicity of latanoprost has been investigated in several animal species. Intravenous acute toxicity studies (2 mg/kg) and oral acute toxicity studies (50 mg/kg) in rats and mice resulted in no mortality. Latanoprost, 2-6 microgram/kg bodyweight, administered intravenously to unanaesthetised monkeys have been shown to increase the respiration rate, probably reflecting bronchoconstriction of short duration.
In animal studies latanoprost has not been found to have sensitising properties.
In the eye no significant toxic effects have been detected with doses of up to 100 microgram/eye/day in rabbits or monkeys (clinical dose is approximately 1.5 microgram/eye/day). In monkeys, however, latanoprost has been shown to induce increased pigmentation of the iris. The mechanism of increased pigmentation seems to be stimulation of melanin production in melanocytes of the iris with no proliferative changes observed. The change in iris colour may be permanent.
In chronic ocular toxicity studies, administration of latanoprost at 6 microgram/eye/day has also been shown to induce increased palpebral fissure. This effect is reversible and occurs at doses above the clinical dose level. The effect has not been seen in humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Latanoprost is a viscous oil which is practically insoluble in water, freely soluble in ethanol, ethyl acetate, isopropanol, methanol, acetone and octanol, and very soluble in acetonitrile.
Sixty four isomers of latanoprost are possible, however, for Xalatan, it is purified as a single isomer.
Chemical structure. The chemical name of latanoprost is isopropyl-(Z)-7[(1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenyl-1-pentyl]cyclopentyl]-5-heptenoate, according to IUPAC. Its molecular formula is C₂₆H₄₀O₅ and its molecular weight is 432.58. The structural formula is as follows:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLATANO.gif CAS number. 130209-82-4.

7 Medicine Schedule (Poisons Standard)

S4, Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/XALATAST.gif