MIOSTAT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MIOSTAT (MIOSTAT).
MIOSTAT (carbachol intraocular solution) is a cholinergic agent that mimics the effects of acetylcholine, causing miosis (pupil constriction) by stimulating muscarinic receptors on the sphincter muscle of the iris.
| Metabolism | Primarily metabolized by plasma cholinesterases; renal excretion of metabolites |
| Excretion | Primarily via intraocular metabolism; systemic absorption minimal. No significant renal or biliary excretion. |
| Half-life | Intraocular half-life approximately 1-2 hours; systemic half-life negligible due to rapid metabolism. |
| Protein binding | Minimal due to low systemic exposure; not clinically characterized. |
| Volume of Distribution | Not applicable; drug acts locally in the eye; systemic Vd negligible. |
| Bioavailability | Not applicable via oral route; only intraocular administration is relevant. |
| Onset of Action | Intraocular: within 2-3 minutes after intracameral injection. |
| Duration of Action | Intraocular: miosis persists for 20-30 minutes; clinical effect sufficient for cataract surgery. |
Intracameral injection of 0.01 mg (0.5 mL of 0.02 mg/mL solution) as a single dose during surgery.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required based on GFR; drug is locally administered with minimal systemic absorption. |
| Liver impairment | No dose adjustment required based on Child-Pugh class; drug is locally administered with minimal systemic absorption. |
| Pediatric use | Safety and efficacy not established; no recommended pediatric dose. |
| Geriatric use | No specific dose adjustment; use same dose as adults due to local administration and minimal systemic exposure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MIOSTAT (MIOSTAT).
| Breastfeeding | Not systemically absorbed after ocular use; thus, transfer into breast milk is negligible. M/P ratio is not applicable. Compatible with breastfeeding. |
| Teratogenic Risk | Miostat (carbachol intraocular solution) is not systemically absorbed after ocular administration. No fetal risks are anticipated from topical ophthalmic use. However, no controlled human studies exist. The drug is classified as FDA Pregnancy Category C. First trimester: theoretical risk only if systemic absorption occurs. Second/third trimesters: no known risks. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to carbachol or any component","Iritis","Acute inflammatory conditions of the anterior chamber"]
| Precautions | ["Corneal edema","Retinal detachment","Iritis","Hypersensitivity reactions","Use with caution in patients with asthma, bradycardia, hyperthyroidism, peptic ulcer, or urinary tract obstruction"] |
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| Fetal Monitoring |
| No systemic exposure; routine ophthalmic monitoring only. No maternal or fetal monitoring required beyond standard obstetric care. |
| Fertility Effects | No known effects on fertility due to lack of systemic absorption. Animal studies not relevant for ocular route. |