MIOCHOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MIOCHOL (MIOCHOL).
Miochol (acetylcholine chloride) is a direct-acting cholinergic agonist that binds to and activates muscarinic receptors, causing miosis (pupil constriction) and contraction of the ciliary muscle, thereby facilitating intraocular surgery.
| Metabolism | Acetylcholine is rapidly hydrolyzed by acetylcholinesterase at the synaptic cleft and in plasma. |
| Excretion | Miochol (acetylcholine chloride) is rapidly hydrolyzed by acetylcholinesterase in the blood and tissues; less than 1% is excreted unchanged in urine. No significant biliary or fecal elimination. |
| Half-life | Plasma half-life is approximately 2-3 minutes due to rapid enzymatic hydrolysis; clinical effect is brief and intraocular effect lasts only during the surgical procedure. |
| Protein binding | Negligible (<5%); binding to plasma proteins is minimal due to rapid hydrolysis. |
| Volume of Distribution | Not clinically applicable; drug is administered directly into aqueous humor and acts locally; systemic Vd not defined. |
| Bioavailability | Intraocular irrigation: 100% at site of application; systemic bioavailability negligible due to rapid hydrolysis. |
| Onset of Action | Intraocular irrigation: immediate (within seconds) miosis. |
| Duration of Action | Intraocular irrigation: miosis lasts 5-10 minutes in unprotected eyes; prolonged in eyes with compromised cholinesterase activity. |
Intraocular injection of 0.5 mL of a 1:100 (10 mg/mL) solution into the anterior chamber to achieve miosis within seconds.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required as systemic absorption is negligible. |
| Liver impairment | No dose adjustment required as systemic absorption is negligible. |
| Pediatric use | Same as adult dose; intraocular injection of 0.5 mL of 1:100 solution (10 mg/mL) into anterior chamber. |
| Geriatric use | Same as adult dose; no specific adjustments needed due to minimal systemic exposure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MIOCHOL (MIOCHOL).
| Breastfeeding | Systemic absorption following ocular administration is negligible, and acetylcholine is rapidly hydrolyzed by cholinesterases. It is not known if acetylcholine is excreted in human milk. Due to minimal systemic exposure, it is considered compatible with breastfeeding. M/P ratio not determined. |
| Teratogenic Risk | FDA Pregnancy Category C. No adequate and well-controlled studies in pregnant women. In animal studies, intraocular administration of acetylcholine chloride (the active ingredient in MIOCHOL) has not been shown to cause fetal harm. However, systemic absorption is minimal after ocular administration. Risk cannot be ruled out; use only if clearly needed. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to acetylcholine or any component of the formulation","Acute ocular infections or inflammatory conditions"]
| Precautions | ["Use with caution in patients with bradycardia, hypotension, asthma, or peptic ulcer disease.","Systemic effects (e.g., bradycardia, hypotension) may occur if absorbed systemically.","Do not inject subconjunctivally or intravenously.","Use only fresh solution; discard unused portion."] |
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| Fetal Monitoring | Monitor intraocular pressure post-administration. Observe for signs of systemic cholinergic effects (bradycardia, hypotension, bronchospasm) particularly in mothers with pre-existing conditions. Fetal monitoring not required due to minimal systemic absorption. |
| Fertility Effects | No known effects on fertility. Acetylcholine is a naturally occurring neurotransmitter and its intraocular use is not expected to impact reproductive function. No animal studies specifically evaluating fertility have been conducted with MIOCHOL. |