SOTALOL Tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Sotalol 40mg Tablets.
Qualitative and quantitative composition
Each tablet contains 40mg Sotalol hydrochloride. For excipients: see 6.1.
Pharmaceutical form
Tablet. Round, white to off-white, flat bevelled edged tablets.
Therapeutic indications
Sotalol 40mg Tablets are indicated for: Ventricular arrhythmias:Treatment of life-threatening ventricular tachyarrhythmias; Treatment of symptomatic non-sustained ventricular tachyarrhythmias. Supraventricular ...
Posology and method of administration
Posology As with other antiarrhythmic agents, it is recommended that Sotalol 40mg Tablets be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm. The dosage must ...
Contraindications
Sotalol should not be used where there is evidence of: Sick sinus syndrome. Second and third degree AV heart block unless a functioning pacemaker is present Congenital or acquired long QT syndromes. Torsades ...
Special warnings and precautions for use
Abrupt Withdrawal Hypersensitivity to catecholamines is observed in patients withdrawn from beta-blocker therapy. Occasional cases of exacerbation of angina pectoris, arrhythmias, and in some cases, myocardial ...
Interaction with other medicinal products and other forms of interaction
Contraindicated combinations Class 1a antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other antiarrhythmic drugs such as amiodarone and bepridil are not recommended as concomitant ...
Pregnancy and lactation
Pregnancy Animal studies with sotalol hydrochloride have shown no evidence of teratogenicity or other harmful effects on the foetus. Although there are no adequate and well-controlled studies in pregnant ...
Effects on ability to drive and use machines
There are no data available, but the occasional occurrence of side effects such as dizziness and fatigue should be taken into account (see 4.8 Undesirable effects).
Undesirable effects
Sotalol is well tolerated in the majority of patients, with the most frequent adverse effects arising from its beta-blockade properties. Adverse effects are usually transient in nature and rarely necessitate ...
Overdose
Intentional or accidental overdose with sotalol has rarely resulted in death. Haemodialysis results in a large reduction of plasma levels of sotalol. Symptoms and treatment of overdose The most common ...
Pharmacodynamic properties
Pharmacotherapeutic group: beta blocking agents, non-selective ATC Code: C07AA07 D,l-sotalol is a non-selective hydrophilic β-adrenergic receptor blocking agent, devoid of intrinsic sympathomimetic activity ...
Pharmacokinetic properties
The bioavailability of oral sotalol is essentially complete (greater than 90%). After oral administration, peak levels are reached in 2.5 to 4 hours, and steady-state plasma levels are attained within ...
Preclinical safety data
No further particulars.
List of excipients
Calcium hydrogen phosphate dihydrate Maize starch Povidone K30 Sodium starch glycollate (Type A) Talc Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Do not store above 25°C. Store in original package.
Nature and contents of container
The tablets are packed in 14-tablets blisters constituted from PVC/PVdC and aluminium foil. Pack sizes: 28 and 56 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
Marketing authorization number(s)
PL16363/0175
Date of first authorization / renewal of the authorization
18<sup>th</sup> July 2005
Date of revision of the text
21/02/2019
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