Details for: APO-TRAVOPROST-TIMOP PQ
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02415305 | APO-TRAVOPROST-TIMOP PQ | TRAVOPROST; TIMOLOL (TIMOLOL MALEATE) | 0.004 % / W/V; 0.5 % / W/V | SOLUTION | OPHTHALMIC |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Increased pressure in the eye(s) is found in patients who have open-angle glaucoma or high pressure in the eyes (ocular hypertension). If left untreated, the increased pressure can lead to nerve damage within the eye, ultimately affecting eyesight.
APO-TRAVOPROST-TIMOP PQ is a fixed combination of two drugs, travoprost and timolol, that are used to lower the raised pressure in the eye(s) in adults with open-angle glaucoma or ocular hypertension.
What it does
APO-TRAVOPROST-TIMOP PQ lowers the pressure in your eye(s) through the action of:
- travoprost (a prostaglandin analogue) – works by increasing the flow of fluid out of the eye.
- timolol (a beta-blocker) – works by decreasing the amount of fluid produced by the eye.
When it should not be used
Do not use APO-TRAVOPROST-TIMOP PQ if you:
- have, or have ever had, an unusual or allergic reaction to travoprost, timolol or any other ingredient in APO-TRAVOPROST-TIMOP PQ (See What are the ingredients in APO-TRAVOPROST-TIMOP PQ)
- are pregnant or planning to become pregnant.
- have, or have had, a lung condition, such as asthma or chronic obstructive pulmonary disease (COPD).
- have certain types of a heart condition, heart disease, or heart problems, such as sick sinus syndrome, sino-atrial block, heart failure or low heart rate (bradycardia).
What the medicinal ingredient is
Medicinal ingredients: 0.04 mg/mL of travoprost and 5 mg/mL of timolol (as timolol maleate).
What the non-medicinal ingredients are
Non-medicinal ingredients: boric acid, mannitol, polyoxyl 40 hydrogenated castor oil, propylene glycol, polyquaternium-1 (a preservative), sodium chloride, sodium hydroxide and/or hydrochloric acid and water for injection.
What dosage form it comes in
APO-TRAVOPROST-TIMOP PQ is a sterile eye drop supplied as 2.5 mL or 5 mL fill size.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-TRAVOPROST-TIMOP PQ. Talk about any health conditions or problems you may have, including if you:
- have diabetes, low blood sugar (hypoglycemia), a thyroid condition (thyrotoxicosis) or kidney problems.
- have muscle weakness or have been diagnosed with myasthenia gravis (a condition causing abnormal weakness in some muscles)
- have heart disease, low blood pressure, circulation problems or problems with blood circulation to the brain.
- are breastfeeding or planning to breastfeed.
- are planning to have surgery.
- have had a severe allergic (anaphylactic) reaction.
- have had cataract surgery, an eye injury or eye inflammation.
- are using other beta- blockers or prostaglandin analogues.
STOP taking APO-TRAVOPROST-TIMOP PQ if you develop an allergic reaction. While using APO-TRAVOPROST-TIMOP PQ
Talk to your doctor if the following occurs while taking APO-TRAVOPROST-TIMOP PQ:
- you develop an eye or eyelid infection.
- you injure your eye(s).
- you plan to have surgery on your eye(s).
Pressure in your eye(s)
Your doctor should check the pressure in your eye(s) regularly.
Eye color and eyelash changes
Using APO-TRAVOPROST-TIMOP PQ may cause your eye color to become more brown or cause your eyelashes to become thicker, longer and darker. These changes may be permanent. If you are using APO-TRAVOPROST-TIMOP PQ in only one eye, your two eyes may look different. Your doctor should examine you regularly to make sure your medication is working and look for changes in eye colour. Your doctor may stop treatment if needed.
Contact lens wear
Do not wear contact lenses while using APO-TRAVOPROST-TIMOP PQ. Remove your contact lenses before applying APO-TRAVOPROST-TIMOP PQ and wait at least 15 minutes before putting them back in.
Skin contact
APO-TRAVOPROST-TIMOP PQ contains propylene glycol and polyoxyethylene hydrogenated castor oil, which can cause skin reactions. Avoid accidental contact with skin, eyes and mucous membranes. Wipe up any spills and rinse the contacted areas with water.
Driving and using machines
APO-TRAVOPROST-TIMOP PQ may cause you to become drowsy or your vision to become temporarily blurry. If any of these effects happen to you, wait until they go away before driving or using machines.
Not recommended to individuals under 18 years of age.
Interactions with this medication
No specific drug interaction studies were done using APO-TRAVOPROST-TIMOP PQ.
Tell your doctor about all the drugs you are taking, recently took or are planning to take, including any prescription or non-prescription drugs.
Drugs that may interact with APO-TRAVOPROST-TIMOP PQ include:
- Digitalis (used to treat congestive heart failure and heart rhythm problems).
- Calcium antagonists.
- Catecholamine-depleting drugs, e.g. reserpine (used to treat high blood pressure).
- Quinidine (an antiarrhythmic).
- Injectable epinephrine (used to treat severe allergic reactions).
- Central nervous system depressants.
- Tricyclic antidepressants.
- Other beta-blocking drugs.
Proper use of this medication
Usual adult dose
Use one drop of APO-TRAVOPROST-TIMOP PQ in the affected eye(s) once daily, either morning or evening.
How to use APO-TRAVOPROST-TIMOP PQ:
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 |
- Get the APO-TRAVOPROST-TIMOP PQ bottle and a mirror.
- Wash your hands.
- Open the bottle being careful not to touch the dropper tip.
- Hold the bottle, pointing down, between your thumb and fingers.
- Tilt your head back. Pull down your eyelid with a clean finger, until there is a 'pocket' between the eyelid and your eye. The drop will go in there (see Picture 1).
- Bring the bottle tip close to the eye. Use the mirror if it helps.
- Don't touch your eye or eyelid, surrounding areas or other surfaces with the bottle tip. It could contaminate the drops.
- Gently squeeze the bottle to release one drop of APO-TRAVOPROST-TIMOP PQ (see Picture 2). After using APO-TRAVOPROST-TIMOP PQ, press a finger into the corner of your eye, by the nose (see Picture 3). This helps to stop APO-TRAVOPROST-TIMOP PQ from getting into the rest of the body.
- If a drop misses your eye, wipe with a tissue and try again.
- If you take drops in both eyes, repeat the steps for your other eye.
- Close the bottle cap firmly immediately after use.
- Wash your hands after use.
If you are using more than one eye drop, wait at least 5 minutes between APO-TRAVOPROST-TIMOP PQ and the other drop(s).
Avoid unnecessary contact with the skin.
Missed Dose
If you miss a dose, wait until it is time for your next dose. Do not double dose to make up for a missed dose.
Overdose
In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control centre, even if there are no symptoms.
If you use more APO-TRAVOPROST-TIMOP PQ than you should, rinse it all out with warm tap water. Using too many drops may cause your eyes to become red and irritated. Do not put in any more drops until it's time for your next regular dose.
If you accidentally ingest APO-TRAVOPROST-TIMOP PQ, contact your doctor or pharmacist for advice.
Side effects and what to do about them
Like all medicines, APO-TRAVOPROST-TIMOP PQ may cause side effects, although not everybody gets them. They can be unpleasant, but most of them soon pass. You can usually keep taking the drops, unless the effects are serious. If you're worried, talk to your doctor or pharmacist.
Side effects in the eye(s) include: redness, itching, dryness, pain, sensitivity to light, abnormal sensation in eye or other eye irritations, blurred vision, temporary reduction of vision, tearing, growth of eyelashes and eyebrows hair, abnormally positioned eyelashes, eye swelling, discomfort (burning and stinging), changes in vision, itching, swollen, heavy, painful or irritated eyelids, inflammation of the eyelid glands, increased eye pressure, and eyelid crusting, sunken eyes (eyes appear more inset), changes in the color of the iris (colored part of the eye), skin darkening (around the eye).
Side effects in other areas of the body include: headache, postnasal drip, thirst, cough or throat pain or irritation, a change in blood pressure or heart rate, disturbance in attention, dizziness, nervousness, skin infection or irritation, skin reaction, skin redness, ear infections, pain in arms or legs, shortness of breath, difficulty breathing, fatigue, discomfort inside the nose, a change in urine color, bad taste in the mouth, strained talking or swelling in the limbs, rash.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Unknown | |||
| Allergic reaction Symptoms include swelling or inflammation of the eye, trouble breathing |
✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-TRAVOPROST-TIMOP PQ, contact your doctor of pharmacist.
How to store
Keep these eye drops in a safe place out of the reach and sight of children.
Store between 2ºC and 25ºC. No refrigeration is required. Discard 120 days after opening.
Do not use this medicine after the expiry date on the bottle or carton.
Reporting side effects
Reporting Side Effects You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APO-TRAVOPROST-TIMOP PQ:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); Find the Patient Medication Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: February 26, 2020