MIOCHOL-E
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MIOCHOL-E (MIOCHOL-E).
Cholinergic agonist: mimics acetylcholine at muscarinic receptors, causing contraction of the sphincter muscle of the iris (miosis) and ciliary muscle (accommodation).
| Metabolism | Rapidly hydrolyzed by plasma cholinesterases. |
| Excretion | Renal (primarily as unchanged drug and metabolites via glomerular filtration and tubular secretion) ~90%; fecal ~10%. |
| Half-life | Terminal elimination half-life of acetylcholine is approximately 1-2 minutes due to rapid hydrolysis by acetylcholinesterase; in the eye, the miotic effect lasts about 4-6 hours. |
| Protein binding | Acetylcholine is not significantly protein-bound (<10%); binding proteins not clinically relevant. |
| Volume of Distribution | Vd is very small (approximately 0.1-0.2 L/kg) due to rapid hydrolysis and limited distribution; reflects extracellular fluid volume. |
| Bioavailability | Intraocular (topical to eye surface): Not applicable; intraocular irrigation: 100% (directly administered to site of action). |
| Onset of Action | Intraocular: Immediate (seconds to minutes) after intraocular irrigation; cataract surgery: within seconds. |
| Duration of Action | Miosis persists for approximately 4-6 hours after intraocular administration; complete recovery of pupil size may take longer. |
Intracameral injection: 0.5 mL of reconstituted solution (containing 1:100 acetylcholine chloride) instilled into the anterior chamber of the eye after lens delivery and before wound closure. Single dose per procedure; repeat if necessary, but not within 24 hours.
| Dosage form | FOR SOLUTION |
| Renal impairment | No specific dose adjustment recommended based on GFR; systemic absorption is negligible after intracameral administration. |
| Liver impairment | No specific dose adjustment recommended based on Child-Pugh score; systemic absorption is negligible after intracameral administration. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; no specific pediatric dosing guidelines available. |
| Geriatric use | No specific dose adjustment required; use same dose as for adults with monitoring for potential age-related ocular conditions. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MIOCHOL-E (MIOCHOL-E).
| Breastfeeding | Not systemically absorbed; not expected to be excreted into breast milk. M/P ratio not applicable. Generally considered compatible with breastfeeding. |
| Teratogenic Risk | Miochol-E (acetylcholine chloride intraocular solution) is not systemically absorbed; therefore, fetal exposure is negligible. No teratogenic effects reported. No controlled human studies; animal studies incomplete. Trimester 1-3: No known risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to acetylcholine or any component (e.g., mannitol).","Acute cardiac failure or significant bradycardia.","Active bronchial asthma or COPD."]
| Precautions | ["Do not use if solution is discolored or contains precipitate.","Risk of corneal edema or endothelial damage due to hyperosmolarity (contains mannitol).","Avoid excessive irrigation; use only volume needed for miosis.","May cause systemic effects (bradycardia, hypotension, bronchospasm) if absorbed systemically."] |
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| Monitor intraocular pressure, corneal clarity, anterior chamber depth during ophthalmic surgery. No systemic fetal monitoring required. |
| Fertility Effects | No known effects on fertility. Not systemically absorbed; reproductive function unaffected. |