Generic drug of Timoptol
Therapeutic class: Ophthalmology
active ingredients: Timolol
laboratory: Carl Zeiss Meditec Sas
Box of 60 single-dose containers of 0.4 ml
- Intraocular hypertonia.
- Chronic open angle glaucoma.
Dosage DIGAOL (1 mg / 0.4 ml) 0.25% Eye drops Box of 60 0.4 ml single dose containers
IN EYE INSTILLATION.
- It is recommended to start treatment by instillation into the sick eye of a drop of DIGAOL 0.25% twice daily.
- In case of insufficient efficacy, the higher concentration will be used at the rate of one drop of DIGAOL 0, 50%, twice a day in the sick eye.
In a small proportion of patients, one drop twice daily of 0.10% timolol in eye drops may be sufficient. If the clinical response is insufficient with the 0.10% solution, the concentration should be increased to 0.25% twice daily in the affected eye.
- The ophthalmologist may, if he deems it necessary, associate DIGAOL with one or more other antiglaucomatous treatments (locally and / or generally).
- However, the combination of two beta-blocking eye drops is not recommended (see section on warnings and precautions for use).
- The other eye drops should be given at least 15 minutes before DIGAOL.
- However, the normalization of the ocular tension by DIGAOL, in eye drops sometimes requires a few weeks, so the evaluation of the treatment must include a measurement of the intraocular tension after a period of treatment of about 4 weeks.
In a number of cases, daily administration of a single drop of DIGAOL may be sufficient, particularly when the intraocular pressure has been maintained at satisfactory levels.
- Substitution of previous treatment:
. When DIGAOL has to take over another antiglaucoma eye drops, this eye drops should be stopped at the end of a full day of treatment, and DIGAOL should be administered the next day at a dosage of 0.25% drop in the eye. sick eye twice a day.
. In case of insufficient efficacy, proceed to DIGAOL 0.50% at a rate of one drop in the sick eye, twice a day.
. If DIGAOL is to be substituted for multiple antiglaucoma drugs, deletions should be for one drug at a time.
. If DIGAOL substitutes for miotic eye drops, refraction may be required when the effects of miotics have disappeared.
- The medical prescription will be accompanied by the control of intraocular pressure, especially during the initiation of treatment.
The contraindications to systemically administered beta-blockers should be borne in mind, although the systemic effects of beta-blockers are only exceptionally observed after eye instillation :
- hypersensitivity to any of the components of the drug,
- asthma and obstructive chronic bronchopneumopathies,
- heart failure not controlled by treatment,
- cardiogenic shock,
- atrioventricular blocks of the second and third degrees not paired,
- angina of Prinzmetal,
- sinus disease (including sinoatrial block),
- bradycardia (<45-50 contractions per minute),
- Raynaud's disease and circulatory disorders,
- untreated pheochromocytoma,
- combination with floctafenine (see section interactions),
- association with sultopride (see interactions section).
NOT RECOMMENDED :
- This drug should generally not be combined with amiodarone, certain calcium antagonists (bepridil, verapamil, diltiazem) and beta-blockers used in heart failure (see section on interactions).
- The combination of two beta-blocking eye drops is not recommended.
- Use in children: this eye drops has not been the subject of clinical studies in premature infants, newborns and children. The use of this eye drops is not recommended in these patients.
- Breast-feeding: Beta-blockers are excreted in the milk. The risk of hypoglycaemia and bradycardia has been described for some beta-blockers with low plasma protein binding. As a result, breastfeeding is not recommended if treatment is needed.
Digaol side effects
As with all beta-blocker eye drops, it can be observed:
- a decrease of the lacrimal secretion (dry eye);
- symptoms of eye irritation:
. slight burning or stinging sensation at the beginning of treatment;
. conjunctival hyperemia, conjunctivitis, blepharitis, keratitis, corneal hypoesthesia;
- visual disturbances including changes in refraction (sometimes due to cessation of treatment by miotics), diplopia, ptosis;
- detachment of the choroid after surgical treatment of glaucoma (see section on warnings and precautions for use).
Linked to timolol maleate by the local route :
Other side effects reported with timolol maleate locally and may be adverse effects of DIGAOL are:
- Cardiovascular: arrhythmia, syncope, atrioventricular block, palpitation;
- Respiratory: dyspnea, coughing;
- General: headache, fatigue, chest pain;
- Cutaneous: alopecia;
- Nervous system / psychiatric effects: dizziness, increased signs and symptoms of myasthenia gravis;
- Digestive: dyspepsia, dry mouth;
- Urogenital: decreased libido, impotence;
- Immunological: systemic lupus erythematosus.
In addition, the adverse effects of systemically administered beta-blockers should be borne in mind, although they are only exceptionally observed after ocular instillation .
ON THE CLINICAL PLAN:
- The most frequently reported:
. cooling of the ends,
. bradycardia, severe if any,
. insomnia, nightmares or depression,
. digestive disorders (gastralgia, nausea, vomiting, diarrhea).
- Much more rarely:
. slowing of atrioventricular conduction or intensification of an existing atrioventricular block,
. heart failure,
. blood pressure drop,
. Raynaud's syndrome,
. worsening of existing intermittent claudication,
. skin manifestations including urticaria, anaphylaxis, angioedema (angioedema), rash, psoriasiform rash (see section on warnings and precautions for use).
ON 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.