APRACLONIDINE

). 5% w/v Eye Drops, Solution will be used with other ocular glaucoma therapies, an approximate five minute interval between instillation of each medication should be observed to prevent washout of the previous dose. Eye ointments should be administered last.

5% w/v Eye Drops, Solution does not remain in the eye, then the patient should repeat the dose by placing another drop in the eye. The maximum recommended duration of therapy is one month due to loss of effect over time (tachyphylaxis).

5% w/v Eye Drops, Solution for longer periods. There are no special precautions for administration to the elderly. 5% w/v Eye Drops, Solution in children has not been established. No data are available. Method of administration For ocular use only.

After cap is removed, if tamper evident snap collar is loose, remove before using product. Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended. This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic side effects

5% w/v Eye Drops, Solution the most common adverse reactions were ocular hyperaemia, eye pruritus, and conjunctivitis, occurring in approximately 12% to 23% of patients. The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. System Organ Classification MedDRA Preferred Term (v. 4). The mean onset time of these reactions was 44 days (range 1-127 days). 5% w/v Eye Drops, Solution was 15%.

The most commonly reported events leading to discontinuation included (in decreasing order of frequency) ocular hyperaemia, eye pruritus, lacrimation increased, ocular discomfort, eyelid oedema, dry mouth, and abnormal sensation in eye.

The possibility of bradycardia based on apraclonidine’s alpha-2-adrenergic agosnist effect should be considered. 5% w/v Eye Drops, Solution Eye Drops from clinical studies, occasional reports have been received through postmarketing surveillance.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

5% w/v Eye Drops, Solution had minimal effect on heart rate or blood pressure in clinical studies evaluating glaucoma patients including those with cardiovascular disease, the possibility of a vasovagal attack should be considered and caution should be exercised in patients with a history of such episodes.

5% w/v Eye Drops, Solution should be used with caution in patients with a history of angina, severe coronary insufficiency, recent myocardial infarction, overt cardiac failure, hypertension, cardiovascular disease, including apoplexy, cerebrovascular disease, Parkinson’s syndrome, chronic renal failure, Raynaud's disease or thromboangiitis obliterans.

Caution in and monitoring of depressed patients are advised since apraclonidine has been rarely associated with depression. 5% w/v Eye Drops, Solution therapy, treatment should be suspended. 5% w/v Eye Drops, Solution to delay surgery should have frequent follow-up examinations and treatment should be discontinued if the intraocular pressure rises significantly.

The loss of effect which occurs over time in most patients appears to be an individual occurrence with a variable time of onset and should be closely monitored. Furthermore, these patients should have their visual fields evaluated periodically.

No data are available on the topical use of apraclonidine in patients with renal or hepatic failure. 0 ng/ml. Nonetheless, monitoring of patients with impaired renal or hepatic function is advised. Close monitoring of cardiovascular parameters in patients with impaired liver function is also advised as the systemic dosage form of clonidine is partly metabolised in the liver.

8). 5% w/v Eye Drops, Solution therapy should be discontinued. Also, preclinical data suggest that there may be patients who develop a contact sensitization response with repeated use of the drug. Ocular intolerance responses are more common in patients treated for more than one month.

5% w/v Eye Drops, Solution is contraindicated in patients with a history of severe or unstable and uncontrolled cardiovascular disease including severe uncontrolled arterial hypertension. 5% w/v Eye Drops, Solution is contraindicated in children.

5% w/v Eye Drops, Solutionis contraindicated in patients with hypersensitivity to any component of the formulation or to systemic clonidine and in patients receiving monoamine oxidase inhibitors, systemic sympathomimetics or tricyclic antidepressants.