Medicinal Products

DIGAOL (1 mg / 0.4 ml) 0.25%

Generic drug of Timoptol
Therapeutic class: Ophthalmology
active ingredients: Timolol
laboratory: Carl Zeiss Meditec Sas

eyewash
Box of 60 single-dose containers of 0.4 ml
All forms

Indication

- 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

Local way.
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.

Against indications

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 :
CONTRAINDICATED:
- 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,
- hypotension,
- 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

EYES :
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).
GENERAL
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:
. asthenia,
. 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,
. bronchospasm,
. hypoglycemia,
. 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.

Popular Posts

Category Medicinal Products, Next Article