Miochol E
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
History
There is currently no drug history available for this drug.
Other Information
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 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, C7H16ClNO2, is Ethanaminium, 2-(acetyloxy)-N,N,N-trimethyl-, chloride and is represented by the following chemical structure:
Sources
Miochol E Manufacturers
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Novartis Pharmaceuticals Corporation
![Miochol E (Acetylcholine Chloride) Kit [Novartis Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Miochol E | Novartis Pharmaceuticals Corporation
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.
DIRECTIONS FOR PREPARING MIOCHOL®-E:
STERILE UNLESS PACKAGE OPEN OR BROKEN
Inspect the unopened blister, vial and ampoule to ensure that they are all intact. Peel open the blister under a sterile field. Maintain sterility of the outer containers of the vial and ampoule during preparation of solution.
Aseptically attach a sterile 18-20 gauge, beveled needle to the luer tip of a sterile disposable syringe with a twisting motion to assure a secure fit.
Break open the ampoule containing the diluent. The One Point Cut (OPC) ampoule must be opened as follows: Hold the bottom part of the ampoule with the thumb pointing to the colored dot. Grasp the top of the ampoule with the other hand, positioning the thumb at the colored dot, and press back to break at the existing cut under the dot.
Remove the needle protector and withdraw the diluent from the ampoule into the syringe. Discard the ampoule.
Remove and discard the cap from the top of the vial.
Insert the needle through the center of the vial stopper, and transfer the diluent from the syringe to the vial. Shake gently to dissolve the powder.
Slowly withdraw the solution from the vial through the needle into the syringe. Discard the needle.
Aseptically open the syringe filter pouch, and attach the filter onto the luer tip of the syringe with a twisting motion to assure a secure fit.
Aseptically attach a sterile blunt tip irrigation cannula to the male luer of the filter prior to intraocular irrigation.Discard the filter appropriately after use.
Do not reuse the syringe filter.
Do not aspirate and inject through the same filter.
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Bausch & Lomb Incorporated
Miochol E | Bausch & Lomb Incorporated
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.
9214900
AB53920
2074024 US
![Miochol E (Acetylcholine Chloride) Kit [Bausch & Lomb Incorporated]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e701ef07-9499-4b56-931f-f4eb3eedbe24&name=d2d98a73-3056-4eb2-b8e8-9660403dcd0c-02.jpg)
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