Aceclidine Hydrochloride

General

Aceclidine hydrochloride is available in the following dosage form(s) and strength(s):

Ophthalmic solution containing aceclidine 1.44% in a single-dose vial. 1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

Instill one drop in each eye, wait 2 minutes and instill a second drop in each eye once daily from the same single-dose vial. 1

Remove contact lenses prior to instillation; may re-insert 10 minutes after installation.1

Cautions ⬆ ⬇

Contraindications

None.1

Warnings/Precautions

Blurred Vision

Miotics may cause accommodative spasm.1 Do not drive or operate machinery if vision is not clear (e.g., blurred vision).1

Patients may experience temporary dim or dark vision.1 Exercise caution in night driving and other hazardous activities in poor illumination.1

Risk of Retinal Tear/Detachment

Rare cases of retinal tear and detachment have been reported with miotics when used in susceptible individuals and those with pre-existing retinal disease.1 Examination of the retina is advised in all patients prior to the initiation of treatment with aceclidine.1 Patients should be advised to seek immediate care with sudden onset of flashing lights, floaters, or vision loss.1

Iritis

Sequelae of ocular inflammation, i.e., adhesions (synechiae) between the iris and the lens, may be exacerbated with miotic use in patients with a known history of iritis.1

Hypersensitivity

Aceclidine is not recommended for use in patients with a known hypersensitivity to aceclidine ophthalmic solution or any other ingredient in the formulation.1

Use with Contact Lenses

Contact lenses should be removed prior to the instillation of aceclidine ophthalmic solution, and may be reinserted 10 minutes after instillation.1

Potential for Eye Injury or Contamination

To prevent eye injury or contamination, care should be taken to avoid touching the single-dose vial to the eye or to any other surface.1

Specific Populations

Pregnancy

There are no adequate and well controlled studies of aceclidine administration in pregnant women to inform a drug associated risk.1 In animal reproduction studies, oral administration of aceclidine to pregnant rats and rabbits throughout organogenesis and lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.1

Lactation

There is no information regarding the presence of aceclidine or its metabolite in human or animal milk, the effects on breastfed infants or the effects on milk production to inform the risk of aceclidine to an infant during lactation.1

Systemic levels of aceclidine and its metabolites following topical ocular administration are low, and it is not known whether measurable levels of aceclidine or its metabolites would be present in human milk following topical ocular administration. 1

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aceclidine and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.1

Pediatric Use

Presbyopia does not occur in the pediatric population.1

Geriatric Use

No overall differences in safety or effectiveness of aceclidine have been observed between patients 65 years of age and older and younger adult patients.1

Common Adverse Effects

The most common adverse reactions were instillation site irritation (20%), dim vision (16%), and headache (13%). 1

Drug Interactions ⬆ ⬇

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Other Information ⬆ ⬇

Actions

Mechanism of Action

Aceclidine is a cholinergic muscarinic agonist that stimulates muscarinic receptors located on smooth muscles.1 Aceclidine is a predominantly pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation.1 Aceclidine causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision.1

Advice to Patients

Advise patients that they may experience temporary dim or dark vision.1 Advise patients to exercise caution with night driving and when hazardous activities are undertaken in poor illumination. 1
Temporary problems when changing focus between near and distant objects may occur.1 Advise patients not to drive or use machinery if vision is not clear (e.g., blurred vision). 1
Advise patients to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss. 1
Advise patients to remove contact lenses prior to the instillation of aceclidine.1 Wait 10 minutes after instillation before reinserting their contact lenses. 1
Advise patients to avoid touching the tip of the single-dose vial to the eye or to any other surface in order to prevent eye injury or contamination.1 Advise patients to discard the opened single-dose vial and any remaining contents after use. 1
Advise patients if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart. 1

Additional Information

AHFS first Release^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations ⬆ ⬇

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.