Keeping intraocular pressure in check
Apraclonidine 1% w/v has a well-documented safety profile, with commonly reported ocular adverse events and specific contraindications and precautions outlined for clinical use.1
Adverse Events
In clinical trials, common adverse events include dry mouth (5.6% of patients), eyelid retraction and mydriasis (approximately 3% to 4% of patients). All other drug reactions occurred in fewer than 2% of patients.1
| System Organ Classification | Common Adverse Events (≥1/100 to <1/10) | Uncommon Adverse Events (≥1/1,000 to <1/100) |
|---|---|---|
| Nervous System Disorders | Dysgeusia | Syncope vasovagal, paraesthesia, libido decreased, irritability, dizziness postural, headache |
| Eye Disorders | Ocular hyperaemia, mydriasis, dry eye, abnormal sensation in eye, eyelid retraction, eye disorder (conjunctival blanching) | Conjunctival haemorrhage, eye inflammation, eyelid disorder (upper lid elevation), hypotony of eye, visual acuity reduced (dim vision), vision blurred, eye allergy, eye pruritus, dry eye, eye irritation, ocular discomfort, punctate keratitis |
| Cardiac Disorders | - | Heart rate irregular, bradycardia, palpitations |
| Psychiatric Disorders | - | Insomnia, abnormal dreams |
| Respiratory, Thoracic and Mediastinal Disorders | Nasal dryness | - |
| Vascular Disorder | - | Orthostatic hypotension |
| Gastrointestinal Disorders | Dry mouth | Diarrhoea, vomiting, abdominal pain, stomach discomfort, nausea |
| General Disorders and Administration Site Conditions | Fatigue | - |
For rare side effects, or those with an unknown frequency, please refer to the Summary of Product Characteristics.1
Contraindications
Apraclonidine 1% w/v is contraindicated in:1
- Patients with a history of severe or unstable and uncontrolled cardiovascular disease.
- Children.
- Patients receiving monoamine oxidase inhibitor therapy, systems sympathomimetic agents or tricyclic antidepressants.
- Patients with hypersensitivity to the active substances (clonidine or apraclonidine) or to any of the excipients; sodium acetate, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.
Warnings
- Minimal impact on heart rate and blood pressure has been observed with two drops of Apraclonidine 1% during anterior segment laser surgery, but vasovagal episodes remain possible, particularly in those with a history of such events.1
- Use with caution in patients with: angina or severe coronary insufficiency, recent myocardial infarction, overt cardiac failure, cerebrovascular disease, chronic renal failure, Raynaud's disease, thromboangiitis obliterans.1
- Caution in and monitoring of depressed patients are advised since apraclonidine has been rarely associated with depression.1
Precautions
- Patients with impaired liver function should have cardiovascular parameters closely monitored due to partial hepatic metabolism of clonidine.1
- No data exist for use in patients with renal or hepatic failure; although systemic absorption is low, monitoring is recommended in these groups.1
- Because apraclonidine strongly reduces intraocular pressure, patients showing an excessive response should be observed closely.1
Please consult the Summary of Product Characteristics for full safety information.1