Carteolol

There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic beta-blocker solution is administered concomitantly with oral calcium channel blockers, beta-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine.

Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.

Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta blockers may mask the signs and symptoms of acute hypoglycaemia.

Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.

Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud’s disease or Raynaud’s syndrome), untreated phaeochromocytoma and hypotension should be treated with caution.

Beta-blockers may also mask the signs of hyperthyroidism.

Beta-blockers should be administered with caution in patients with diabetic ketoacidosis or metabolic acidosis.

Patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal’s angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered.

Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions. Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.

Patients with myasthenia gravis should be treated with caution. Beta-adrenergic blockade may potentiate muscle weakness related to certain myasthenic symptoms, such as diplopia, ptosis and generalised weakness.

There are no adequate data for the use of carteolol in pregnant women. Carteolol should not be used during pregnancy unless clearly necessary.

Beta-blockers are excreted in breast milk. However, at therapeutic doses of carteolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant.

Fertility

Epidemiological studies have not revealed malformative effects but show a risk for intra uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of betablockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If carteolol is administered until delivery, the neonate should be carefully monitored during the first days of life.

Carteolol has minor influence on the ability to drive and use machines.

No studies on the effect of carteolol on the ability to drive have been conducted. While driving vehicles or operating different machines, it should be taken into account that occasionally visual disturbances may occur including refractive changes, diplopia, ptosis, frequent episodes of mild and transient blurred vision and occasional episodes of dizziness or fatigue.

Like other topically applied ophthalmic drugs, carteolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.

Immune system disorders: Systemic allergic reactions including angioedema, urticaria, localized and generalized rash, pruritus, anaphylactic reaction.

Metabolism and nutrition disorders: Hypoglycaemia.

Psychiatric disorders: Insomnia, depression, nightmares, memory loss.

Nervous system disorders: Syncope, cerebrovascular accident, cerebral ischemia, increases in signs and symptoms of myasthenia gravis, dizziness, malaise, paraesthesia, and headache.

Other: Discomfort, sinusitis.

Eye disorders: Signs and symptoms of ocular irritation (e.g. burning, stinging, itching, tearing, redness), sensation of foreign body, blepharitis, keratitis, sensitivity to light (photophobia), conjunctivitis, oedema, blurred vision and choroidal detachment following filtration surgery, decreased corneal sensitivity, dry eyes, corneal erosion, ptosis, conjunctival hyperaemia, diplopia.

Cardiac disorders: Bradycardia, chest pain, palpitations, oedema, arrhythmia, congestive heart failure, atrioventricular block, cardiac arrest, cardiac failure.

Vascular disorders: Hypotension, Raynaud’s phenomenon, cold hands and feet.

Respiratory, thoracic, and mediastinal disorders: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnoea, cough.

Gastrointestinal disorders: Dysgeusia, nausea, dyspepsia, diarrhoea, dry mouth, abdominal pain, vomiting.

Skin and subcutaneous tissue disorders: Alopecia, psoriasiform rash or exacerbation of psoriasis, skin rash.

Musculoskeletal and connective tissue disorders: Myalgia.

Reproductive system and breast disorders: Sexual dysfunction, decreased libido.

General disorders and administration site conditions: Asthenia/fatigue.

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.