Acetylcholine chloride

Name: Acetylcholine chloride

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:

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.

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.

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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