Aseptically remove the sterile vial from the blister package by peeling the backing paper and dropping the vial onto a sterile tray. Withdraw the contents into a dry sterile syringe, and replace the needle with an atraumatic cannula prior to intraocular instillation.
No more than one-half millimeter should be gently instilled into the anterior chamber for the production of satisfactory miosis. It may be instilled before or after securing sutures. Miosis is usually maximal within two to five minutes after application.
OVERDOSAGE In case of overdose, symptoms of toxicity may include headache, salivation, syncope, bradycardia, hypotension, abdominal cramps, vomiting, asthma and diarrhea. Treatment of overdose is supportive. In cases of severe systemic toxicity, therapy with anticholinergic may be necessary.
For management of a suspected drug overdose, contact your regional Poison Control Centre. ACTION AND CLINICAL PHARMACOLOGY Carbachol is a potent cholinergic (parasympathomimetic) agent, which produces constriction of the iris and ciliary body resulting in a reduction in intraocular pressure (IOP).
The exact mechanism by which carbachol lowers IOP is not precisely known. STORAGE AND STABILITY Store at controlled room temperature (15oC – 30oC). Keep out of the reach and sight of children. DOSAGE FORMS, COMPOSITION AND PACKAGING MIOSTAT* is a sterile balanced salt solution of carbachol for intraocular injection.
5 mL sterile glass vials packaged twelve to a carton.
IMPORTANT:
PLEASE READ 131-MIOSTAT-Prescribing Information-non-annotated Page 6 of 7 PART III: CONSUMER INFORMATION Pr MIOSTAT* Carbachol Intraocular Solution, USP This leaflet is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about MIOSTAT*.
Contact your doctor or pharmacist if you have any questions about the drug.
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). 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.
5 mL glass vials. 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.
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.
IMPORTANT:
PLEASE READ 131-MIOSTAT-Prescribing Information-non-annotated Page 7 of 7 HOW TO STORE IT Your doctor or another healthcare professional will store MIOSTAT*at controlled room temperature (15oC to 30oC), 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 […]