MIOCHOL-E (Novartis Ophthalmics)
(acetylcholine chloride intraocular solution)
1:100 with Electrolyte Diluent

Description

MIOCHOL -E (acetylcholine chloride intraocular solution) is a parasympathomimetic preparation for intraocular use packaged in a vial of two compartments; the lower chamber containing acetylcholine chloride 20 mg and mannitol 56 mg; the upper chamber containing 2 mL of a modified diluent of sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, 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, C 7 H 16 ClNO 2 , is Ethanaminium, 2-(acetyloxy)- N,N,N -trimethyl-, chloride and is represented by the following chemical structure:

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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 Usage

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.

Contraindications

None known.

Warnings

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 center 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 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.

Drug Interactions

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.

Pediatric Use:   Safety and effectiveness in pediatric patients 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.

Overdosage

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.

Dosage and Administration

With a new needle of sturdy gauge, 18-20, 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 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.

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 during preparation of solution.
  4. Immediately before use, give plunger-stopper a quarter turn and press to force diluent and center plug into lower chamber.
  5. Shake gently to dissolve drug.
  6. Discard univial and any unused solution.

How Supplied

MIOCHOL -E with Novartis Ophthalmics Steri-Tags™: NDC 58768-773-52

One MIOCHOL -E 2 mL sterile univial

One pack Novartis Ophthalmics Steri-Tags sterile labels

MIOCHOL -E System Pak™: NDC 58768-773-53

One MIOCHOL -E 2 mL sterile univial

One pack Novartis Ophthalmics Steri-Tags sterile labels

One B-D 3 mL sterile syringe

One Dynagard™ 0.2 micron sterile filter

Store at 4°-25°C (39°-77°F).

KEEP FROM FREEZING.

Rx Only

Mfd. by OMJ Pharmaceuticals, Inc.,

San Germ[aacute]n, P.R., 00683 for:

Novartis Ophthalmics6110-D

Duluth, GA 30097May 2001

INSTRUCTIONS FOR USING THE
SYRINGE TIP FILTER

Injection Procedure:

  1. Pre-fill syringe with MIOCHOL -E.
  2. Aseptically open Syringe Filter pouch.
  3. Aseptically attach filter onto luer of syringe with twisting motion to assure secure fit.
  4. Aseptically attach sterile needle or cannula to male luer of filter.
  5. After use discard appropriately.

Precautions

  • Do not exceed 50 psi pressure on the inlet side to avoid resultant decrease in flow rates.
  • Change filter when pressure buildup makes syringe operation difficult.
  • Aspiration through the filter is not recommended.
    However, if utilized, discard needle and syringe filter to prevent recontamination of fluids during injection.

Contraindications

  • Chemically resistant to aqueous solutions, dilute acids, bases, and aliphatic and aromatic hydrocarbons.
    Not recommended for use with aldehydes, esters, ketones, alcohols, halogenated hydrocarbons or their derivatives.

Mfd. for:

Novartis Ophthalmics, Inc.

Duluth, GA 30097

 

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