Medicinal Products

BETOPTIC 025% Ophthalmic solution box of 60 ¼ mL single-dose containers

Generic drug of the therapeutic class: Ophthalmology
active ingredients: Betaxolol
laboratory: Alcon

Ophthalmic suspension
All forms

Indication

- Chronic open angle glaucoma.
- Intraocular hypertonia.

Dosage BETOPTIC 025% Ophthalmic solution box of 60 ¼ mL single-dose containers

- Chronic open angle glaucoma.
- Intraocular hypertonia.

Against indications

CONTRAINDICATED:
The contraindications to systemically administered beta-blockers should be borne in mind, although the systemic effects of beta-blockers after ocular instillation are observed only exceptionally :
- Hypersensitivity to betaxolol, or any other product or treatment that has previously caused anaphylactic reaction.
- Heart failure not controlled by treatment.
- Cardiogenic shock.
- Atrioventricular blocks of second and third degrees not paired.
- Sinus disease (including sinoatrial block).
- Bradycardia (<45 to 50 contractions per minute).
NOT RECOMMENDED :
- Use in children: this suspension has not been studied in clinical studies in premature infants, newborns and children.
- Breast-feeding: Beta-blockers are excreted in the milk. The risk of hypoglycaemia and bradycardia has not been evaluated: therefore, as a precaution, breastfeeding is not recommended during the course of treatment.

Betoptic side effects

EYES :
- Possibility of :
. slight uncomfortable feeling of short duration,
. decrease of lacrimal secretion,
. corneal hypoesthesia.
- More rarely :
. lacrimation,
. conjunctival hyperemia,
. superficial punctate keratitis,
. photophobia,
. anisocoria.
GENERAL
The side effects of systemically administered beta-blockers should be borne in mind, although they are only exceptionally observed after ocular instillation .
CLINICAL PLAN: - The most frequently reported:. asthenia,
. cooling of the ends,
. bradycardia, severe if any,
. insomnia, nightmares,
. digestive disorders (gastralgia, nausea, vomiting),
. dry eye.
- Much more rarely:
. slowing of atrioventricular conduction or intensification of an existing atrioventricular block,
. heart failure,
. blood pressure drop,
. bronchospasm,
. hypoglycemia,
. Raynaud's syndrome,
. worsening of existing intermittent claudication,
. various skin manifestations including psoriasiform eruptions.
AT THE BIOLOGICAL PLAN:
In rare cases, it has been possible to observe the appearance of antinuclear antibodies which only exceptionally accompany clinical manifestations such as lupus syndrome and cede at the end of treatment.

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