MIOSTAT Solution for injection Ref.[10040] Active ingredients: Carbachol

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.

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.

Use only if the container is undamaged.

There are no adequate and well-controlled studies in pregnant women. MIOSTAT (carbachol intraocular solution, USP) 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman.

Safety and efficacy in pediatric patients have not been established.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.