|
|
Beta-Ophtiole, Metipranolol hydrochloride QUALITATIVE
AND QUANTITATIVE COMPOSITION Active substance:
PHARMACEUTICAL FORM AND CONTENT
PHARMACOTHERAPEUTIC
CLASS MARKETING
AUTHORIZATION HOLDER THERAPEUTIC
INDICATIONS This therapy is indicated for certain special kinds of glaucoma such as: capsular glaucoma, pigmentary glaucoma, juvenile glaucoma and hemorrhagic glaucoma. CONTRAINDICATIONS
AND SIDE EFFECTS DRUG
INTERACTIONS AND OTHER FORMS OF INTERACTION The application of collyria containing adrenaline or pilocarpine, intensify the ocular hypotensive effect of metipranolol. The simultaneous systemic application of beta-blockers, may originate potential additive effects of beta-blockage, both at the systemic level or at intraocular pressure level. It may occur an increment of hypotension and/or bradycardia if metipranolol is administered together with calcium antagonists, catecholamine depletion substances or with beta-blockers. SPECIAL
PRECAUTIONS FOR USE Like with any other glaucoma treatment, it is recommended the regular monitoring of intraocular pressure (IOP) and of the cornea every 4-6 weeks. Observation: The sudden discontinuation of beta-blockers may cause feed-back phenomena! Newborns: There is no data on the use of metipranolol in these ages Children: There is no data on metipranolol. Elderly: The dosage with metipranolol should be administered in a gradual way, in patients with angina pectoris and hypertension, in order to prevent complications. Keep away from the reach of children. EFFECTS
ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND
PATIENTS WITH SPECIAL PATHOLOGIES EFFECTS
ON THE ABILITY TO DRIVE AND USE MACHINES LIST
OF EXCIPIENTS USUAL
POSOLOGY, WITH REFERENCE TO MAXIMUM DOSE INDICATION
OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE DURATION
OF THE AVERAGE TREATMENT WHEN IT SHOULD BE LIMITED
INDICATION OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION
CAUSES WITHDRAWAL EFFECTS MEASURES
TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY SYMPTOMS
AND ANTIDOTES Cardiodepressive effects combined with the inhibition of heart beat (bradycardia, atrioventricular blockage of degree I-III), as well as cardiac contractility (decrease of blood pressure, peripheral cyanosis, oliguria, acidosis). Additionally, it may occur central level effects if blood-brain barrier is easily crossed: sedation (drowsiness, vertigo, dizziness, also possible states of unconsciousness, ataxia, hypopnoea), or excitement (vomit anxiety, spasms and possibly hallucinations), dyspnoea due to bronchospasms. Cases of hypoglycaemia occurred specially in children. Manifestations of intoxication only occur after 12 h. Increase of toxicity in combination with ether (possibly also with alcohol?). Treatment of intoxication: For the deintoxication, the antidote used is 0.5-1.0 mg of orciprenaline sulphate slowly administered by IV or IM route. In order to improve cardiac output, it is initially used 0.2 mg/Kg BW of Glucagon as a brief intravenous infusion, then 0.5 mg/Kg BW for a period of 12 hour after the previous administration of 1 vial of metoclopramide hydrochloride or 10-20 mg of triflupromazine as antiemetic. The compensation of acidosis is made with sodium bicarbonate, possibly also with furosamide, atropine (if bradycardia remains), possibly high doses of dopamine or dobutamine, treatment with pace-maker, bronchospasmolitic agents, artificial breathing and oxygen. ADVICE
TO THE PATIENT Always keep medicines out of reach and sight of children. SPECIAL
PRECAUTIONS FOR STORAGE AND INDICATION OF VISIBLE SIGNS OF DETERIORATION
IF THEY EXIST After the 1st opening it is valid for 6 weeks. DATE OF THE REVISION OF THE LEAFLET: February 2004. |