Miostat - Product Information
|Condition:||Glaucoma, Intraocular Hypertension, Production of Miosis|
|Class:||Ophthalmic glaucoma agents|
|Ingredients:||sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, trisodium citrate dihydrate, sodium hydroxide, hydrochloric acid, water|
Summary Product Information
|Clinically Relevant Nonmedicinal
|Intraocular injection||Intraocular Solution/
For a complete listing see Dosage Forms, Composition and Packaging section.
Indications and Clinical Use
MIOSTAT* (Carbachol Intraocular Solution,USP)is indicated for:
- Intraocular use for obtaining miosis during surgery
- Reduction of the intensity of intraocular pressure elevation in the first 24 hours after cataract surgery
Pediatrics (<18 Years of Age)
The safety and effectiveness of MIOSTAT* have not been established in pediatric patients.
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the prescribing information.
Warnings and Precautions
For single-dose intraocular use only. Discard unused portion.
MIOSTAT* should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, gastrointestinal spasm, urinary tract obstruction and Parkinson’s disease.
The use of MIOSTAT* may increase surgically induced intraocular inflammation.
The vial stopper contains natural rubber (latex), which may cause severe allergic reactions.
Carcinogenesis and Mutagenesis
Studies in animals to evaluate the carcinogenic potential have not been conducted.
Driving and Using Machinery
Miosis may cause blurred vision and difficulty in dark adaptation. If temporary blurred vision occurs following surgery where MIOSTAT*was used, the patient must wait until vision clears before driving or using machinery.
Pregnant Women: There are no adequate and well-controlled studies in pregnant women. MIOSTAT* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Women: It is not known if carbachol is excreted in breast milk. Exercise caution when administering MIOSTAT* to a nursing woman.
Pediatrics (<18 Years of Age): The safety and effectiveness of MIOSTAT* in pediatric patients have not been established.
Adverse reactions that have been reported following use of MIOSTAT*, either in clinical trials or via spontaneous post-market reporting, include the following
Eye disorders: corneal clouding or opacity, persistent bulbous keratopathy, retinal detachment, post-operative iritis following cataract extraction, intraocular pressure increased, visual impairment, corneal degeneration, anterior chamber inflammation, corneal edema, eye inflammation, drug effect prolonged (miosis), vision blurred, eye pain, ocular hyperaemia
Gastrointestinal disorders: vomiting
Nervous system disorders: headache
Systemic reactions, such as flushing, sweating, epigastric distress, abdominal cramps and tightness in urinary bladder have been reported with topical or systemic application of carbachol.
No clinically relevant drug interactions have been described
Dosage and Administration
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.
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.
Each mL contains:
Medicinal ingredient: carbachol 0.01%w/v
Non-medicinal ingredients: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate dihydrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection
MIOSTAT* is available in 1.5 mL sterile glass vials packaged twelve to a carton.