Apraclonidine

Dosage Forms & Strengths

ophthalmic solution

• 0.5%
• 1%

Inhibition of Perioperative Intraocular Pressure (IOP) Increase

1 gtt of a 1% solution onto the eye undergoing surgery 1 hour before surgery & repeated immediately upon completion of surgery

Glaucoma

1-2 gtt of a 0.5% solution in the affected eye(s) q8hr

Safety & efficacy not established

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take apraclonidine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to apraclonidine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Not for injection or oral ingestion. FOR TOPICAL OPHTHALMIC USE ONLY.

In clinical studies the overall discontinuation rate related to Apraclonidine Ophthalmic Solution was 15%. The most commonly reported events leading to discontinuation included (in decreasing order of frequency) hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation.

The following adverse reactions (incidences) were reported in clinical studies of Apraclonidine Ophthalmic Solution as being possibly, probably, or definitely related to therapy:

Ocular: The following adverse reactions were reported in 5 to 15% of the patients: discomfort, hyperemia, and pruritus.

The following adverse reactions were reported in 1 to 5% of the patients: blanching, blurred vision, conjunctivitis, discharge, dry eye, foreign body sensation, lid edema, and tearing.

The following adverse reactions were reported in less than 1% of the patients: abnormal vision, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival follicles, corneal erosion, corneal infiltrate, corneal staining, edema, irritation, keratitis, keratopathy, lid disorder, lid erythema, lid margin crusting, lid retraction, lid scales, pain, photophobia.

Nonocular: Dry mouth occurred in approximately 10% of the patients.

The following adverse reactions were reported in less than 3% of the patients: abnormal coordination, asthenia, arrhythmia, asthma, chest pain, constipation, contact dermatitis, depression, dermatitis, dizziness, dry nose, dyspnea, facial edema, headache, insomnia, malaise, myalgia, nausea, nervousness, paresthesia, parosmia, peripheral edema, pharyngitis, rhinitis, somnolence, and taste perversion.

Clinical practice: The following events have been identified during post-marketing use of Apraclonidine Ophthalmic Solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Apraclonidine Ophthalmic Solution, or a combination of these factors, include: bradycardia.

• Alpha2 Agonist, Ophthalmic

Hypersensitivity to apraclonidine, clonidine, or any component of the formulation; concomitant use with MAO inhibitors.

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling; monitor cardiovascular parameters closely.

MAO Inhibitors: May enhance the adverse/toxic effect of Apraclonidine. MAO Inhibitors may increase the serum concentration of Apraclonidine. Avoid combination

Mianserin: May diminish the therapeutic effect of Alpha2-Agonists (Ophthalmic). Avoid combination

Mirtazapine: May diminish the antihypertensive effect of Alpha2-Agonists. Management: Consider avoiding concurrent use. If the combination cannot be avoided, monitor for decreased effects of alpha2-agonists if mirtazapine is initiated/dose increased, or increased effects if mirtazapine is discontinued/dose decreased. Consider therapy modification

Tricyclic Antidepressants: May diminish the therapeutic effect of Alpha2-Agonists (Ophthalmic). Monitor therapy