Details for: JAMP-LATANOPROST/TIMOLOL
Company: JAMP PHARMA CORPORATION
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02453770 | JAMP-LATANOPROST/TIMOLOL | TIMOLOL (TIMOLOL MALEATE); LATANOPROST | 5 MG / ML; 50 MCG / ML | 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
JAMP-LATANOPROST/TIMOLOL is used to reduce eye pressure in patients with open angle glaucoma ocular hypertension. Both these conditions are related to an increase in pressure within the eye and eventually they may affect your eyesight.
What it does
JAMP-LATANOPROST/TIMOLOL is a combination of an ophthalmic prostaglandin drug (latanoprost) and an ophthalmic beta-blocking drug (timolol), both of which lower the pressure within the eye in different ways. The prostaglandin drug works by increasing the natural outflow of fluid from inside the eye. The beta- blocking drug works by decreasing the fluid production in the eye.
When it should not be used
What the medicinal ingredient is
Each millilitre (mL) contains 50 micrograms of latanoprost and 5 milligrams of timolol as timolol maleate.
What the non-medicinal ingredients are
Benzalkonium chloride (preservative), sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, water for injection, hydrochloric acid and sodium hydroxide.
What dosage form it comes in
JAMP-LATANOPROST/TIMOLOL is supplied in a 5 mL plastic ophthalmic dispenser bottle with a sterile under-cap dropper, and screw cap.
Warnings and precautions
Before using JAMP-LATANOPROST/TIMOLOL, talk to your doctor or pharmacist if:
Tell your doctor before you have an operation that you are using JAMP-LATANOPROST/TIMOLOL as Timolol Maleate may change effects of some medicines used during anaesthesia.
JAMP-LATANOPROST/TIMOLOL contains a preservative (benzalkonium chloride) that may be absorbed by contact lenses. The preservative may form a precipitate with an ingredient (thimerosal) present in several contact lens soaking solutions. If you wear contact lenses, remove them before using JAMPLATANOPROST/TIMOLOL. Wait 15 minutes after applying the eye drops before putting your lenses back in. If you are using more than one type of eye drop medication, wait at least 5 minutes between each different eye drop.
Interactions with this medication
JAMP-LATANOPROST/TIMOLOL can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes or other medicines including:
Proper use of this medication
Always use JAMP-LATANOPROST/TIMOLOL exactly as your
doctor has told you.
Usual adult dose:
One drop of JAMP-LATANOPROST/TIMOLOL should be
dropped into the affected eye(s) once daily.
Do not allow the dropper tip of the bottle to touch the eye or
other surrounding structures, because this could contaminate the
tip with common bacteria known to cause eye infections. Serious
damage to the eye with subsequent loss of vision may result if
you use eye drop solutions that have become contaminated. If
you experience any type of eye condition or have surgery,
immediately seek your doctor's advice concerning the continued
use of the bottle you are using.
If you forget to use your eye drops at the usual time, wait until it
is time for your next dose. If you put too many drops in your
eye(s), you may feel some slight irritation.
Follow these steps to help you use JAMPLATANOPROST/TIMOLOL properly:
The mixture (solution) should be inspected visually for clarity,
particulate matter, precipitation, discolouration, and leakage
prior to administration whenever solution and container permit.
Do not use product if solution shows haziness, particulate matter,
discolouration, or leakage.
- Before using this medicine for the first time, make sure the tamper evident ring is unbroken.
- Wash your hands and sit or stand comfortably. If you wear contact lenses, remove them before using your eye drops.
- Unscrew the protective cap.
- Remove the tamper evident ring from the bottle.
- Use your finger to gently pull down the lower eyelid of your affected eye.
- Place the tip of the bottle close to, but not touching your eye.
- Squeeze the bottle gently so that only one drop goes into your eye, then release the lower eyelid.
- After a drop of JAMP-LATANOPROST/TIMOLOL has fallen, close your eye and press a finger into the corner, by the nose for 2 minutes. This helps to stop JAMPLATANOPROST/TIMOLOL from getting on the rest of the body.
- Repeat in your other eye if your doctor has told you to do this.
- Put the protective inner cap back on the bottle.
JAMP-LATANOPROST/TIMOLOL is not recommended for use in children.
Overdose:
Missed Dose:
If you forget one dose of JAMP-LATANOPROST/TIMOLOL, continue with the next dose as normal. Do not double dose.
Side effects and what to do about them
In some patients, JAMP-LATANOPROST/TIMOLOL may
cause a gradual change in eye color by increasing the amount of
brown pigment in the iris (the colored part of the eye). This
change may not be noticeable for several months to years. This
effect may be more noticeable in patients with eye colors that are
mixtures of green and brown, blue/gray and brown, or yellow
and brown. The brown pigment may gradually spread outward
toward the outside edge of the iris.
However, the entire iris or parts of it may become more
brownish in appearance. This change may be more noticeable if
you are only treating one eye. Therefore, there is the potential for
permanent difference in the colour between the treated and the
untreated eyes. Your doctor will examine you regularly to make
sure that your medication is working and look for changes in eye
color. If you should experience any changes in eye color, your
doctor can stop treatment. However, any color change that has
already occurred may be permanent, even after the medication is
stopped.
JAMP-LATANOPROST/TIMOLOL may also cause your eye
lashes to darken, appear thicker and longer than they usually do.
A very small number of people may notice their eye lid skin
looks darker after using JAMP-LATANOPROST/TIMOLOL for
some time. These changes may be more noticeable if you are
only treating one eye. JAMP-LATANOPROST/TIMOLOL may
also cause your eye lashes to become ingrown.
JAMP-LATANOPROST/TIMOLOL may cause iris cyst (small
cyst appearing in the colored part of the eye).
When using JAMP-LATANOPROST/TIMOLOL, you might
feel as if there is something in your eye(s). Your eye(s) might
water and become red. As with other eye drops, if your vision is
blurred when you first put your drops in, wait until this wears off
before you drive or operate machinery. A few people using
JAMP-LATANOPROST/TIMOLOL have developed a skin rash.
A few people may experience changes in their vision, sometimes
in combination with a red and sore/painful eye. These changes
do not always occur right after administering the drops, and if
they occur, you may find that reading and seeing fine details
more difficult. Although unlikely, if you experience any of these
changes, stop using JAMP-LATANOPROST/TIMOLOL and
contact your doctor immediately.
JAMP-LATANOPROST/TIMOLOL may cause the following
side effects as well.
Common side effects: eye irritation, including burning and
stinging, inflammation of the eye lid and eye pain, upper
respiratory tract infection.
Effects on the body: headache and skin rash, loss of appetite,
muscle pain, joint pain, chest pain, heart palpitations, asthma,
low blood sugar in diabetics, dry eyes, nervous system effects
including anxiety, nervousness, dizziness, confusion,
disorientation, insomnia, hallucinations.
Be sure to tell your doctor (or pharmacist) if you notice any
other unwanted side effects.
Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking the drug and seek emergency medical assistance |
---|---|---|---|
Rare | |||
Heart effects such as irregular heartbeat, high blood pressure and low blood pressure | ✔ | ||
Severe respiratory reactions has been reported with administration of timolol | ✔ | ||
Allergic reactions with symptoms such as swelling of the mouth, and throat, difficulty breathing, hives, itching, rash. | ✔ | ||
Beta adrenergic blockers (e.g. timolol) have been reported to cause muscle weakness in those with myasthenia gravis or similar conditions | ✔ |
How to store
Always keep medicine well out of the reach of children.
Before JAMP-LATANOPROST/TIMOLOL is first opened, keep
it in a fridge (between 2°C and 8°C), out of direct light.
Once the bottle has been opened, JAMPLATANOPROST/TIMOLOL can be kept at normal room
temperature up to 25°C, out of direct light. JAMPLATANOPROST/TIMOLOL must be used within 10 weeks
after opening the bottle. Discard the bottle and/or unused
contents after 10 weeks. JAMP-LATANOPROST/TIMOLOL
should not be used after the expiry date on the bottle.
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/healthcanada/services/drugs-health-products/medeffectcanada/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
This document plus the full product monograph, prepared for
health professionals can be found by contacting the sponsor,
JAMP Pharma Corporation, at: 1-866-399-9091.
This leaflet was prepared by
JAMP Pharma Corporation
1310 Nobel Street
Boucherville, Québec
J4B 5H3 .
Date of revision: January 21, 2019