Miochol-E system pak

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:

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.

None known.

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.

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.