This is a combination product containing two different medications: Latanoprost and Timolol. Latanoprost belongs to a class of medications called prostaglandin analogs. It works to reduce the pressure in the eye by allowing fluid in the eye to flow better. Timolol belongs to a class of medications called beta-adrenergic receptor blockers (also known as "beta-blockers"). Latanoprost - timolol solution is available in an eye-drop form. It is used to reduce the pressure inside the eye for people with open-angle Glaucoma or intraocular hypertension (increased pressure in the eye).

This medication is intended to be used by people with chronic open-angle glaucoma or by people with ocular hypertension who do not get a complete response to treatment with only one medication and are considered appropriate candidates for combination therapy. The combined effect of these two medications results in a larger decrease in pressure compared to either medication alone. However, Xalacom is not to be used as initial treatment.

Fluid is constantly being formed and drained out of the eye. When this fluid does not drain out of the eye properly, pressure inside the eye increases. Latanoprost - timolol works by reducing the amount of fluid produced by the eye and by increasing the flow of fluid out of the eye.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of Xalacom may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Xalacom may not be used for all of the conditions discussed here.

Your doctor may have suggested Xalacom for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given Xalacom, speak to your doctor. Do not stop using Xalacom without consulting your doctor.

Do not give Xalacom to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use Xalacom if their doctor has not prescribed it.

The recommended dose of latanoprost - timolol is one drop to the affected eye(s) once daily.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

To use the eye drops:

1. Wash your hands before using the eye drops.
2. Remove the cap and place it in a clean location. To avoid possible contamination, keep the tip of the container away from contact with any surface.
3. Tilt the head back and look towards the ceiling.
4. With your index finger, gently pull the lower eyelid down and away from the eye to form a pouch.
5. Apply one drop into the pouch but do not allow the tip of the container to touch the eye or areas around the eye.
6. Gently apply pressure to the inner corner of the eye (at the bridge of the nose) for about 30 seconds (this is called nasolacrimal occlusion), or close the eyes for 2 minutes. This prevents the medication from dripping down through the tear duct and entering the bloodstream, which could cause you to experience some side effects.
7. Repeat with the other eye, if prescribed by your physician.
8. Wash your hands again to remove any medication.

Do not allow the dropper tip of the bottle to touch the eye or other surrounding structures. This can contaminate the tip with common bacteria known to cause Eye Infections. Serious damage to the eye, possibly leading to loss of vision may result if you use eye drop solutions that have become contaminated.

If you use other eye drops as well, wait at least 5 minutes before using them.

If you wear contact lenses, remove them before instilling latanoprost - timolol into your eye. You may put your contact lenses back in 15 minutes after using the medication.

It is important to use Xalacom exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular schedule. Do not instill a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store unopened containers of eye drops in the refrigerator (2°C to 8°C), out of direct light. Once the bottle has been opened, keep the eye drops at room temperature up to 25°C and away from light. Keep Xalacom out of the reach of children. Latanoprost - timolol eye drops must be used within 10 weeks after opening the container.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Xalacom. If you are concerned about side effects, discuss the risks and benefits of Xalacom with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Dry Mouth
• dryness of eye
• feeling of something in the eye
• headache
• irritation, burning, or stinging of the eye when medication is applied
• itching eyes
• redness of the eyelid
• temporary blurred vision after putting in the eye drop
• temporary eye redness
• watery eye

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• back pain
• blurred vision
• coughing
• cloudiness of the eyeball
• darkening of eyelid skin colour
• Depression
• difficulty sleeping
• dizziness
• eye pain
• flu or cold-like symptoms
• hair loss
• increased blood pressure
• increased blood sugar
• increased brown colour in coloured part (iris) of eye
• increased tearing
• longer, thicker, and darker eyelashes
• muscle or joint pain
• muscle weakness
• prolonged blurred vision or other change in vision
• sensitivity of eye to light
• sinus pain and inflammation
• slowed heartbeat
• swelling, irritation, or inflammation of the eye or eyelid
• unusual fatigue

Stop taking the medication and seek immediate medical attention if any of the following occur:

• Angina pectoris or other chest pain
• symptoms of an allergic reaction (e.g., difficulty breathing, Hives, itchy skin rash, or swelling of the mouth and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Xalacom.

Each 1 mL of sterile, clear, colourless aqueous solution contains 50 µg of latanoprost and 5 mg of timolol. Each drop contains approximately 1.5 µg of latanoprost and 150 µg of timolol. Nonmedicinal ingredients: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, water for injection, and benzalkonium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (acidity).

Do not use latanoprost - timolol eye drops if you:

• are allergic to latanoprost, timolol, benzalkonium chloride, or any ingredients of the medication
• have Asthma or have had asthma in the past
• have any of certain heart diseases or conditions:
• cardiogenic shock (heart cannot provide enough oxygen to the body)
• second-degree or third-degree atrioventricular (AV) block (electrical problems)
• sinus bradycardia (slow heartbeat)
• uncontrolled heart failure (heart cannot pump effectively)
• have severe COPD (Chronic Obstructive Pulmonary Disease) (COPD; e.g., emphysema, chronic Bronchitis)

There may be an interaction between latanoprost - timolol and any of the following:

• Abiraterone acetate
• Aldesleukin
• alpha blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• Amiodarone
• angiotensin converting enzyme inhibitors (ACEIs; e.g., Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., candasartan, Irbesartan, Losartan)
• anti-psychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, olanzepine, Quetiapine, Risperidone)
• barbiturates (e.g., butalbital, pentobarbital, Phenobarbital)
• beta-adrenergic blockers in eye-drop or tablet form (e.g., betaxolol, Levobunolol, timolol, Propranolol)
• beta-2 agonists (e.g., salbutamol, formoterol, salmeterol, terbutaline)
• Bimatoprost
• brimonidine
• Bromocriptine
• Bupropion
• Cabergoline
• calcium channel blockers (e.g., Nifedipine, Diltiazem, Verapamil, Amlodipine)
• Celecoxib
• chloroquine
• Clobazam
• Clonidine
• Cinacalcet
• Cobicistat
• Darifenacin
• diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Nateglinide, Rosiglitazone)
• Digoxin
• Diphenhydramine
• Dipyridamole
• Disopyramide
• diuretics (e.g., Amiloride, Furosemide, Hydrochlorothiazide)
• Donepezil
• Dronedarone
• Epinephrine
• ergot alkaloids (e.g., Dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• Galantamine
• grass pollen extract
• Guanfacine
• HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, saquinavir, tipranavir)
• isoniazid
• Methotrimeprazine
• methyldopa
• nonsteroidal anti-inflammatory medications (e.g., Diclofenac, Ibuprofen, Ketoprofen, Naproxen)
• quinidine
• monoamine oxidase inhibitors (M.O.S. e.g., Phenelzine, Tranylcypromine, Selegiline)
• opiate medications (e.g., Codeine, Hydrocodone, Morphine)
• nitrates (e.g., isosorbide dinitrate, Nitroglycerin)
• Octreotide
• quinidine
• rifampin
• rifapentine
• Riociguat
• ritonavir
• Rivastigmine
• selective serotonin reuptake inhibitors (SSRI; e.g., Fluoxetine, Paroxetine, Sertraline)
• Stiripentol
• Theophylline
• Ticlopidine
• Tizanidine
• tofactitinb
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Nortriptyline)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Xalacom. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xalacom.

Allergy: If you are allergic to other prostaglandin analogues or beta-adrenergic receptor blockers, discuss the risks and benefits of using Xalacom with your doctor.

Asthma and respiratory disease: Although Xalacom is intended to be used as a topical (surface only) treatment for the eyes, it may be absorbed into the bloodstream and affect breathing if you have a history of breathing problems or difficulty breathing. If you have asthma or another respiratory condition, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Choroidal detachment: If you have chronic or recurrent choroidal detachment, talk to your doctor about further use of the eye drops.

Contact lenses: Contact lenses should be removed before latanoprost - timolol eye drops are applied and should not be reinserted for 15 minutes after application of the drops.

Depression: People with clinical depression should discuss with their doctor how Xalacom may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed. You may need to visit your doctor more often to ensure that Xalacom is not making your condition worse.

Diabetes: Although Xalacom is intended to be used as a topical treatment for the eyes, it may be absorbed into the bloodstream and affect blood sugar control if you have diabetes. People with diabetes should discuss with their doctor how Xalacom may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed. You may need to test your blood sugar more often while you are using Xalacom.

Drowsiness/reduced alertness: This medication may cause drowsiness and temporary blurring of your vision. Do not drive, operate machinery, or engage in any potentially hazardous activities until you determine how Xalacom affects you.

Eye changes: Latanoprost may gradually change the colour of the eye, increasing the amount of brown pigment in the iris (coloured part of the eye). The long-term effects on the eye and the chances of injury to the eye are currently unknown. The change in colour may be permanent and occurs slowly, and may not be noticeable for several months or years. Latanoprost has also been reported to cause darkening, thickening, and lengthening of eyelashes. Talk to your doctor if you have any concerns.

Eye conditions: If you have frequent or chronic inflammation of the eye, discuss with your doctor how Xalacom may affect your medical condition, howyour medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Heart disease: Although Xalacom is intended to be used as a treatment applied directly to the eyes, it may be absorbed into the bloodstream and have an effect on heart disease or circulation problems such as Raynaud’s disease. If you have heart disease or circulation problems, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Kidney or liver disease: If you have decreased kidney or liver function, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Myasthenia Gravis: If you have myasthenia gravis, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Thimerosal: Any eye medication containing thimerosal should not be used within 5 minutes before or after using latanaprost, as solid particles may develop as a result of the two medications mixing together.

Thyroid disease: If you have thyroid disease, discuss with your doctor how Xalacom may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalacom, and whether any special monitoring is needed.

Pregnancy: Xalacom should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Xalacom, contact your doctor immediately.

Breast-feeding: Xalacom may pass into breast milk. If you are a breast-feeding mother and are taking latanoprost - timolol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Xalacom have not been established for children.