Miochol-E

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Miochol-E uses


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

Miochol-E is contraindicated in persons with a known hypersensitivity to any component of this product.

WARNINGS

DO NOT GAS STERILIZE. If blister or peelable backing is damaged or broken, sterility of the enclosed vial and ampule cannot be assured. Open under aseptic conditions only.

PRECAUTIONS

General

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 Miochol-E 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 Miochol-E chloride and animal studies with Miochol-E or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that Miochol-E 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.

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ADVERSE REACTIONS

Infrequent cases of corneal edema, corneal clouding, and corneal decompensation have been reported with the use of intraocular Miochol-E.

Adverse reactions have been reported rarely, which are indicative of systemic absorption. These include bradycardia, hypotension, flushing, breathing difficulties, and sweating.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

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 Miochol-E chloride are unstable. Prepare solution immediately before use. Do not use solution that is not clear and colorless. Discard any solution that has not been used.

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DIRECTIONS FOR PREPARING MIOCHOL -E:

STERILE UNLESS PACKAGE OPEN OR BROKEN

  • Inspect the unopened blister, vial, and ampule 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 ampule 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 ampule containing the diluent. The One Point Cut (OPC) ampule must be opened as follows: Hold the bottom part of the ampule with the thumb pointing to the colored dot. Grasp the top of the ampule 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 ampule into the syringe. Discard the ampule.
  • 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.

HOW SUPPLIED

Miochol -E

(acetylcholine chloride intraocular solution)............................NDC 24208-539-20

One blister pack containing the following components:

  • Vial of 20 mg Miochol-E chloride powder for intraocular solution
  • Ampule of 2 mL diluent

One 0.2 micron sterile filter

  • Priming volume 0.6 mL (approximately)

Storage

Store at 4°-25°C (39°-77°F)

KEEP FROM FREEZING

KEEP OUT OF REACH OF CHILDREN

Manufactured for:

Bausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Manufactured by:

Sanofi S.p. A.

Via Valcanello, 4

03012 ANAGNI (FR)

Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.

©Bausch & Lomb Incorporated

Rev. 05/2017

9214903

AB53920

NDC 24208-539-20

Miochol -E

(acetylcholine chloride

intraocular solution)

20 mg/2 mL (10 mg/mL)

Sterile

1:100 with Electrolyte

Diluent

FOR INTRAOCULAR

USE ONLY

Rx Only

Contents:

One Blister Pack containing:

-20mg vial

-2 mL diluent ampule

One 0.2 micron sterile filter

BAUSCH + LOMB

carton.jpg

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Miochol-E pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Miochol-E available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Miochol-E destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Miochol-E Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Miochol-E pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."MIOCHOL E (ACETYLCHOLINE CHLORIDE) KIT [BAUSCH & LOMB INCORPORATED]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "acetylcholine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "acetylcholine". http://www.drugbank.ca/drugs/DB0312... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Miochol-E?

Depending on the reaction of the Miochol-E after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Miochol-E not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Miochol-E addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Miochol-E, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Miochol-E consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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