Miochol-E (Acetylcholine Chloride)

MIOCHOL®-E

CIBA Vision

Acetylcholine Chloride – Electrolytes

Miotic

Action And Clinical Pharmacology: 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.

Indications And Clinical Uses: 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.

Contra-Indications: None known.

Manufacturers’ Warnings In Clinical States: Do not gas sterilize. If blister or peelable backing is damaged or broken, sterility of the enclosed bottle cannot be assured. Open under aseptic conditions only.

Precautions: General: In the reconstitution of the solution, as described under Directions for Using Univial, if the centre rubber plug seal in the univial does not go down or is down, do not use the vial.

If miosis is to be obtained quickly with Miochol-E, anatomical hindrances to miosis, such as anterior or posterior synechiae, must be released prior to administration. During cataract surgery, use Miochol-E only after delivery of the lens.

Aqueous solutions of acetylcholine 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.

Drug Interactions: Although clinical studies with acetylcholine 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 and carbachol have been ineffective when used in patients treated with topical nonsteroidal anti-inflammatory agents.

Children: Safety and effectiveness in children have not been established.

Adverse Reactions: 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.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Atropine sulfate (0.5 to 1 mg) should be given i.m. or i.v. and should be readily available to counteract possible overdosage. Epinephrine (0.1 to 1 mg s.c.) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.

Dosage And Administration: With a new needle of sturdy gauge, 18 to 20, draw all the solution into a dry, sterile syringe. Replace needle with a suitable atraumatic cannulae for intraocular irrigation.

The Miochol-E 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.

In cataract surgery, use Miochol-E only after delivery of the lens.

Aqueous solutions of acetylcholine 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.

Directions for using the univial: Sterile unless package open or broken.

1. Inspect univial while inside unopened blister. Diluent must be in upper chamber.

2. Peel open blister.

3. Aseptically transfer univial to sterile field. Maintain sterility of outer container duing preparation of solution.

4. Immediately before use, give plunger-stopper a quarter turn and press to force diluent and centre plug into lower chamber.

5. Shake gently to dissolve drug.

6. Discard univial and any unused solution.

SuppliedSupplied: Each univial (two chamber vial) contains: acetylcholine chloride 20 mg and mannitol 56 mg (lower chamber) and electrolyte diluent 2 mL (upper chamber). The reconstituted solution provides acetylcholine chloride 10 mg/mL. Nonmedicinal ingredients: calcium chloride dihydrate, magnesium chloride hexahydrate, mannitol, potassium chloride, sodium chloride and sterile water for injection. Store at controlled room temperature 15 to 30°C. Keep from freezing.

MIOCHOL®-E CIBA Vision Acetylcholine Chloride – Electrolytes Miotic

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