Acetylcholine

Acetylcholine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Acetylcholine is a neurotransmitter that is FDA approved for the treatment of for temporary relief of chest congestion with mild constriction, indigestion, drowsiness, headache, forgetfulness, and general fatigue. Common adverse reactions include corneal edema, corneal clouding, and corneal decompensation have been reported with the use of intraocular acetylcholine.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• For temporary relief of chest congestion with mild constriction, indigestion, drowsiness, headache, forgetfulness, and general fatigue.
• 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
• 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acetylcholine in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetylcholine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Acetylcholine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acetylcholine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetylcholine in pediatric patients.

Contraindications

• It is contraindicated in persons with a known hypersensitivity to any component of this product.

Warnings

• If pregnant or breast-feeding, ask a health care professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Acetylcholine in the drug label.

Postmarketing Experience

• 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.

Drug Interactions

There is limited information regarding Acetylcholine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Acetylcholine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Acetylcholine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Acetylcholine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Acetylcholine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Acetylcholine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Acetylcholine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Acetylcholine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Acetylcholine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Acetylcholine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Acetylcholine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Acetylcholine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral
• Anterior chamber instillation

Monitoring

There is limited information regarding Monitoring of Acetylcholine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Acetylcholine in the drug label.

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.

Pharmacology

Mechanism of Action

• 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.

Structure

• Acetylcholine chloride 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 hexa-hydrate, 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:

Pharmacodynamics

• 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.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Acetylcholine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Acetylcholine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Acetylcholine in the drug label.

How Supplied

• Miochol®-E (acetylcholine chloride intraocular solution)

• NDC 24208-539-20

One blister pack containing the following components:

• Vial of 20 mg acetylcholine chloride powder for intraocular solution
• Ampoule 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.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Acetylcholine in the drug label.

Precautions with Alcohol

• Alcohol-Acetylcholine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• MIOCHOL E®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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