Patient Medication Information: uses, side effects, how to take - Miostat Ophthalmic Liq 0.01%

ABOUT THIS MEDICATION

What the medication is used for:

MIOSTAT* is used to:

Constrict the pupil (miosis) during eye surgery
Reduce the level of intraocular pressure (IOP) increase during the first 24 hours following cataract surgery

What it does:

MIOSTAT* contains carbachol, which constricts the iris (part of the eye which controls the pupil size) and the ciliary body (part of the eye that controls the shape of the lens) of the eye, thereby lowering the pressure in the eye (IOP).

When it should not be used:

Do not use MIOSTAT* if you are allergic (hypersensitive) to carbachol, natural rubber (latex) or any of the other ingredients of this medicine (see What the important nonmedicinal ingredients are).

What the medicinal ingredient is:

Carbachol, 0.01% w/v

What the important nonmedicinal ingredients are:

Calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, sodium citrate dihydrate, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection.

What dosage forms it comes in:

MIOSTAT* is a sterile salt-balanced solution and is available in 1.5 mL glass vials.

WARNINGS AND PRECAUTIONS

BEFORE you use MIOSTAT* talk to your doctor or pharmacist if you:

Have heart problems
Have asthma
Have a urinary tract obstruction (e.g. difficultly urinating)
Have stomach ulcers (peptic ulcers)
Have an overactive thyroid (hyperthyroidism)
Have painful stomach cramping sensations
Parkinson’s disease
Are allergic to natural rubber (latex). The vial stopper contains latex.
MIOSTAT* may increase eye inflammation following eye surgery.
Driving and Using Machinery
MIOSTAT* may cause blurred vision and difficulty in seeing in low light. Do not drive or use machinery until these effects have worn off.
Pregnancy and Breastfeeding
If you are pregnant, may be pregnant, are breastfeeding, or planning to breastfeed , talk to your doctor before using MIOSTAT*.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about all the drugs you are using or planning to use, including those without a prescription. No drug interaction studies have been done for MIOSTAT*.

PROPER USE OF THIS MEDICATION

Usual adult dose:

MIOSTAT* is for injection into the eye and should only be administered by your doctor.

Overdose:

If excess MIOSTAT* is given, your doctor may need to give you an injection of an anticholinergic agent to control symptoms.

Symptoms of an overdose may include: headache, excess saliva, fainting, slow heart rate, a drop in blood pressure, abdominal cramps, vomiting, asthma and diarrhea.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, MIOSTAT* can cause side effects, although not everybody gets them.

Side effects include:

Headache, flushing, sweating, stomach cramps, vomiting, bladder tightness (e.g. pressure in the bladder, feeling the need to urinate)
Visual impairment (some difficulty in seeing), clouding of the eye surface, eye inflammation, blurred vision, eye swelling, eye pain, eye redness, increased eye pressure, decrease in pupil size

This is not a complete list of side effects. For any unexpected effects while taking MIOSTAT^*, contact your doctor or pharmacist.

HOW TO STORE IT

Your doctor or another healthcare professional will store MIOSTAT*at controlled room temperature (15^oC to 30^oC), and keep it out of the reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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$ Report online at www.healthcanada.gc.ca/medeffect
$ Call toll-free at 1-866-234-2345
$ Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
  Health Canada
  Postal Locator 0701D
  Ottawa, Ontario
  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full prescribing information, prepared for health professionals can be found at:

http://www.alcon.ca

or by contacting the sponsor, Alcon Canada Inc. at:

1-800-613-2245

Last revised: May 13, 2015

*a trademark of Novartis

Rx or OTC	Prescription (Rx)?
DIN	00042544
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Carbachol 0.01 %
Dosage form(s)	Solution
Route(s) of administration	Intraocular
Drug class (WHO ATC)	S Sensory organ drugs S01 Ophthalmologicals S01E Antiglaucoma preparations and miotics S01EB Parasympathomimetics, antiglaucoma preparations and miotics S01EB02 Carbachol
Company	ALCON CANADA INC
Current status	Marketed
Current status date	December 31, 1980

Miostat Ophthalmic Liq 0.01%: Uses, Side Effects and Dosage