Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Laboratories Thea, 12 Rue Louis Blรฉriot, 63017, Clermont-Ferrand Cedex 2, France
The carteolol eye drops are contraindicated in patients with:
Like other topically applied ophthalmic agents carteolol is absorbed systemically. Due to beta-adrenergic component, carteolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur.
Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see 4.2.
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 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.
Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic betablockers. Teoptic should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.
Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as betablockers may mask the signs and symptoms of acute hypoglycaemia.
Beta-blockers should be administered with caution in patients with diabetic ketoacidosis or metabolic acidosis.
Beta-blockers may also mask the signs of hyperthyroidism
Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.
In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil with a miotic.
Carteolol has little or no effect on the pupil. When carteolol is used to reduce intraocular pressure in angle-closure glaucoma it must be used with a miotic and not alone.
The effect on intra-ocular pressure or the known effects of systemic betablockade may be potentiated when carteolol is given to the patients already receiving a systemic beta-blocking agent.
The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.5).
While taking beta-blockers, patients with history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures. Surgical anaesthesia ฮฒ-blocking ophthalmological preparations may block systemic ฮฒ-agonist effects e.g. of adrenaline. The anaesthetist should be informed when the patient is receiving carteolol.
Severe prolonged hypotension has been observed in some patients after administration of systemic beta-blockers during anaesthesia.
Patients with myasthenia gravis should be treated with caution. Betaadrenergic blockade may potentiate muscle weakness related to certain myasthenic symptoms, such as diplopia, ptosis and generalised weakness.
The carteolol eye drops contain benzalkonium chloride as a preservative. Therefore, the medicament should not be used while wearing soft contact lenses. The lenses must be removed before application of the drops and not reinserted earlier than 15 minutes after use.
No interaction studies have been performed.
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.
If a supplementary ophthalmic medication is used, there must be an interval of at least five minutes between the administration of the two products.
There are no adequate data for the use of carteolol in pregnant women. Carteolol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see 4.2.
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 Teoptic 1% w/v Eye Drops, Solution is administered until delivery, the neonate should be carefully monitored during the first days of life.
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. To reduce the systemic absorption, see 4.2.
As with any other eye medication, should a patient experience any disturbance of vision, dizziness or syncope following instillation of carteolol eye drops, driving and the operation of machinery must be avoided until vision has returned to normal.
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 (see 4.4 Special warnings and precautions for use), 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.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
Not applicable.
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