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Miochol® -E
(acetylcholine chloride) Intraocular Solution
Miochol® -E (acetylcholine chloride intraocular solution) is a parasympathomimetic preparation for intraocular use. It is packaged in a blister pack containing one vial and one ampoule. The vial contains 20 mg acetylcholine chloride and 56 mg mannitol. The accompanying ampoule contains 2 mL of a modified diluent of sodium acetate trihydrate, potassium chloride, magnesium chloride hexa-hydrate, calcium chloride dihydrate and sterile water for injection.
The reconstituted liquid will be a sterile isotonic solution (275–330 milliosmoles/Kg) containing 20 mg acetylcholine chloride (1:100 solution) and 2.8% mannitol. The pH range is 5.0–8.2. Mannitol is used in the process of lyophilizing acetylcholine chloride, and is not considered an active ingredient.
The chemical name for acetylcholine chloride, C7H16ClNO2 , is Ethanaminium, 2-(acetyloxy)-N,N,Ntrimethyl-, chloride and is represented by the following chemical structure:
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To obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required.
Miochol® -E (acetylcholine chloride intraocular solution) is instilled into the anterior chamber before or after securing one or more sutures.
Instillation should be gentle and parallel to the iris face and tangential to pupil border.
If there are no mechanical hindrances, the pupil starts to constrict in seconds and the peripheral iris is drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis must be released to permit the desired effect of the drug. In most cases, 0.5 to 2 mL produces satisfactory miosis. Note that the syringe filter supplied with Miochol-E has a priming volume of 0.6 mL (approximately).
In cataract surgery, use Miochol-E only after delivery of the lens.
Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution which is not clear and colorless. Discard any solution that has not been used.
Discard the filter appropriately after use.
Do not reuse the syringe filter.
Do not aspirate and inject through the same filter.
Miochol® -E (acetylcholine chloride intraocular solution)............................NDC 24208-539-20
One blister pack containing the following components:
One 0.2 micron sterile filter
Store at 4°–25°C (39°–77°F).
Distributed by: Bausch & Lomb Incorporated Rochester, NY 14609. Revised: Mar 2007
Infrequent cases of corneal edema, corneal clouding, and corneal decompensation have been reported with the use of intraocular acetylcholine.
Adverse reactions have been reported rarely which are indicative of systemic absorption. These include bradycardia, hypotension, flushing, breathing difficulties and sweating.
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with topical nonsteroidal anti-inflammatory agents.
DO NOT GAS STERILIZE. If blister or peelable backing is damaged or broken, sterility of the enclosed vial and ampoule cannot be assured. Open under aseptic conditions only.
If miosis is to be obtained quickly with Miochol® -E (acetylcholine chloride intraocular solution), anatomical hindrances to miosis, such as anterior or posterior synechiae, must be released, prior to administration of Miochol-E. During cataract surgery, use Miochol-E only after delivery of the lens.
Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution which is not clear and colorless. Discard any solution that has not been used.
Safety and effectiveness in pediatric patients have not been established.
Atropine sulfate (0.5 to 1 mg) should be given intramuscularly or intravenously and should be readily available to counteract possible overdosage. Epinephrine (0.1 to 1 mg subcutaneously) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.
Miochol® -E (acetylcholine chloride intraocular solution) is contraindicated in persons with a known hypersensitivity to any component of this product.
Acetylcholine is a naturally occurring neurohormone which mediates nerve impulse transmission at all cholinergic sites involving somatic and autonomic nerves. After release from the nerve ending, acetylcholine is rapidly inactivated by the enzyme acetylcholinesterase by hydrolysis to acetic acid and choline.
Direct application of acetylcholine to the iris will cause rapid miosis of short duration. Topical ocular instillation of acetylcholine to the intact eye causes no discernible response as cholinesterase destroys the molecule more rapidly than it can penetrate the cornea.
No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
