Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Recordati Ireland Ltd, Raheens East, Ringaskiddy, Co. Cork, Ireland Τel.: +353 21 4379 400, Fax: +353 21 4379 264
Hypertension. Logimax can be used when treatment with beta-blockers or calcium antagonists of the dihydropyridine type in monotherapy has not produced an adequate effect.
One Logimax 5/50 tablet once daily, if needed the dose may be doubled to two Logimax 5/50 tablets once daily.
Patients with renal impairment
Dose adjustment is not needed in patients with impaired renal function.
Dose adjustment is normally not needed in patients suffering from liver cirrhosis because metoprolol has a low protein binding (5-10%). When there are signs of serious impairment of liver function (e.g. shunt-operated patients) doses higher than Logimax 5/50 mg should not be given.
One Logimax prolonged-release tablet once dailyis usually sufficient. If required, the dose may be increased to two Logimax prolonged-release tablets per day.
Logimax should not be used in children due to lack of clinical experience.
Abrupt interruption of the medication is to be avoided. If possible, a dose reduction of Logimax should be performed and/or administration every second day over a period of 10-14 days.
During this period, in particular, patients with known ischaemic disease should be closely monitored since the risk for myocardial infarction and sudden death may be increased during withdrawal of Logimax or other medicinal products containing a βeta-blocker.
Due to the properties of Logimax, omission of isolated doses is without consequences.
The prolonged-release tablets are given once daily, in the morning. The prolonged-release tablets must be swallowed with liquid, and must not be divided, crushed or chewed. The prolonged-release tablets may be taken on an empty stomach or together with a light low fat, low carbohydrate meal.
10 mg in a 2-year-old caused mild intoxication. 150-200 mg in a 17-year-old and 250 mg in an adult caused mild to moderate intoxication. Probably a more pronounced effect on the peripheral circulation than on the heart, compared with other drugs in the group.
7.5 g in an adult caused fatal intoxication. 100 mg in a 5-year-old caused no symptoms after gastric lavage. 450 mg in a 12-year-old and 1.4 g in an adult caused moderate intoxication, 2.5 g in an adult caused severe intoxication, 7.5 g in an adult caused extremely severe intoxication.
In cases of intoxication with prolonged-release preparations, the onset of symptoms may be delayed for 12-16 hours, and severe symptoms may occur after several days.
Overdose with felodipine may cause excessive peripheral vasodilatation with marked hypotension and sometimes bradycardia. Other: AV block, AV dissociation, VES, ventricular fibrillation, asystole. Dizziness, headache, impaired consciousness, coma, convulsions. Dyspnoea, pulmonary oedema (non-cardiac) and apnoea. Possibly ARDS (Adult Respiratory Distress Syndrome). Acidosis, hypokalaemia, hyperglycaemia, possibly hypocalcaemia. Flushing, hypothermia. Nausea and vomiting.
Overdose of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness/coma, nausea, vomiting and cyanosis. In some cases, especially in children and adolescents, CNS symptoms and respiratory depression may predominate.
Poor peripheral blood perfusion, respiratory depression, apnoea. Fine tremors, convulsions, perspiration, paraesthesia, possibly oesophageal spasm, hypoglycaemia (especially in children), or hyperglycaemia, hyperkalaemia. Effects on the kidneys. Transient myasthenic syndrome. Concomitant ingestion of alcohol, antihypertensive drugs, quinidine or barbiturates may aggravate the patient’s condition.
The first signs of overdose may be seen 20 minutes to 2 hours after ingestion.
Charcoal, if necessary gastric lavage, in some cases even at a late stage. If severe hypotension occurs, symptomatic treatment should be instituted. The patient should be placed supine with the legs elevated. NOTE! Atropine (0.25-0.5 mg intravenously for adults, 10-20 micrograms/kg for children) should be given before gastric lavage (owing to the risk of vagal stimulation). ECG monitoring. Respirator on wide indication. Correction of acid-base and electrolyte status. In cases of concomitant bradycardia and block: Atropine 0.5-1 mg intravenously for adults (20-50 micrograms/kg for children), possibly repeated, or isoprenaline initially 0.05-0.1 micrograms/kg/minute. Pacemaker at an early stage in severe cases. If this is not enough, increase plasma volume by intravenous infusion of e.g. glucose, saline or dextran, or calcium glubionate (9 mg Ca/ml) 20(-30) ml intravenously over a period of 5 minutes for adults (3-5 mg Ca/kg for children) initially and repeated if required, or as an infusion, adrenaline or dopamine if required. In severe cases glucagon may be administered.
Sympathomimetics with predominant effect on the α1-adrenoceptor may be given if treatment as above is not sufficient.
In cases of circulatory arrest in connection with overdose, resuscitation should be instituted and may have to be continued for several hours. Diazepam for convulsions. Other symptomatic treatment.
Charcoal, gastric lavage if required. NOTE! Atropine (0.25-0.5 mg intravenously for adults, 10-20 micrograms/kg for children) should be given before gastric lavage (on account of the risk of vagal stimulation). Intubation and respirator treatment should be carried out on very wide indication. Adequate volume expansion. Glucose infusion. ECG monitoring.
Atropine 1.0-2.0 mg intravenously, possibly repeated (especially in cases of vagal symptoms). In the presence of severe hypotension, bradycardia and impending heart failure, administer a β1- agonist intravenously at 2-5 minutes intervals or as continuous infusion until the desired effect is achieved. Where a selective β1-agonist is not available, dopamine or atropine sulphate i.v. may be used in order to block the vagus nerve. If a satisfactory effect is not achieved, other sympathomimetic agents such as dobutamine or noradrenaline may be given.
For myocardial depression: infusion of dobutamine or dopamine and calcium glubionate 9 mg/ml, 10-20 ml. Glucagon 50-150 micrograms/kg intravenously over a period of 1 minute followed by infusion may also be administered, as may amrinone. In some cases, the addition of epinephrine (adrenaline) has been effective. Infusion of sodium (chloride or bicarbonate) in cases of widening QRS-complex and arrhythmias. Possibly pacemaker.
To combat bronchospasm, a β-agonist can be given intravenously.
In cases of circulatory arrest in connection with overdose, resuscitation for several hours may be justified. For bronchospasms, possibly terbutaline (via injection or inhalation). Symptomatic therapy.
Observe that the dosages of drugs (antidotes) needed to treat overdose of b-blockade are much higher than the recommended therapeutic dosages, because the b-receptors are occupied by the b-blockade.
3 years.
Do not store above 30°C.
PVC/PVDC blister packs.
28 tablets.
Not applicable.
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