MIOSTAT .1 mg/mL
carbachol · SOLUTION · Alcon Laboratories, Inc.
Miostat is a prescription eye drop containing carbachol that is used during eye surgery to reduce eye pressure and constrict the pupil. It works by stimulating certain muscles in the eye to help with surgical procedures.
Key Facts
- Brand Name
- MIOSTAT
- Generic Name
- carbachol
- NDC Code (Product)
0065-0023- Manufacturer
- Alcon Laboratories, Inc.
- Strength
- .1 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA016968
- Marketing Start
- 04/15/1974
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT* (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP elevation in the first 24 hours after cataract surgery.
Dosage & Administration
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 milliliter 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.
Warnings
WARNINGS: For single-dose intraocular use only. Discard unused portion. Intraocular carbachol 0.01% should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, G.I. spasm, urinary tract obstruction and Parkinson's disease. The vial stopper contains natural rubber (latex) which may cause severe allergic reactions.
Contraindications
CONTRAINDICATIONS: Should not be used in those persons showing hypersensitivity to any of the components of this preparation.
Adverse Reactions
ADVERSE REACTIONS: Ocular: Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported. Systemic: Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, and headache have been reported with topical or systemic application of carbachol. The following additional reactions have been identified during post-approval use of MIOSTAT (carbachol intraocular solution, USP) 0.01% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to MIOSTAT, or a combination of these factors, include: corneal edema, drug effect prolonged (miosis), eye inflammation, eye pain, intraocular pressure increased, ocular hyperemia, vision blurred, visual impairment, and vomiting.
Frequently Asked Questions
What is MIOSTAT used for?
Miostat is a prescription eye drop containing carbachol that is used during eye surgery to reduce eye pressure and constrict the pupil. It works by stimulating certain muscles in the eye to help with surgical procedures.
Is MIOSTAT a controlled substance?
MIOSTAT is not classified as a controlled substance by the DEA.
What is the generic name for MIOSTAT?
The generic name for MIOSTAT is carbachol. There are 1 other brand versions of carbachol.
What is the NDC code for MIOSTAT .1 mg/mL?
The NDC (National Drug Code) for MIOSTAT .1 mg/mL is 0065-0023, listed by Alcon Laboratories, Inc..