VERAPAMIL Oral solution (2022)
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Περιεχόμενα
Name of the medicinal product
Verapamil 40mg/5ml Oral Solution.
Qualitative and quantitative composition
Verapamil Hydrochloride 40mg/5ml. <u>Excipients with known effect:</u> Propylene glycol (E1520): 500mg/5ml Liquid Maltitol (E965): 2500mg/5ml Ethanol: 2.1mg/5ml Benzoic acid (E210): 5mg/5ml For the full ...
Pharmaceutical form
Oral Solution.
Therapeutic indications
1. Treatment of mild to moderate hypertension. 2. Treatment and prophylaxis of chronic stable angina, vasospastic angina and unstable angina. 3. Treatment and prophylaxis of paroxysmal supraventricular ...
Posology and method of administration
Adults <u>Hypertension:</u> Initially 120mg b.d. increasing to 160mg b.d. when necessary. In some cases, dosages of up to 480mg daily, in divided doses, have been used. A further reduction in blood pressure ...
Contraindications
Hypersensitivity to verapamil or any of the excipients listed in Section 6.1. Cardiogenic shock. Acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure. ...
Special warnings and precautions for use
Since verapamil is extensively metabolised in the liver, careful dose titration of verapamil is required in patients with liver disease. Although the pharmacokinetics of verapamil in patients with renal ...
Interaction with other medicinal products and other forms of interaction
<em>In vitro</em> metabolic studies indicate that verapamil hydrochloride is metabolised by cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. Verapamil has been shown to be an inhibitor of CYP3A4 ...
Fertility, pregnancy and lactation
Pregnancy Although animal studies have not shown any teratogenic effects, verapamil should not be given during the first trimester of pregnancy unless, in the clinicians judgement, it is essential for ...
Effects on ability to drive and use machines
Depending on individual susceptibility, the patients ability to drive a vehicle or operate machinery or work under hazardous conditions may be impaired. This is particularly true in the initial stages ...
Undesirable effects
Verapamil is generally well tolerated. Side effects are usually mild and transient and discontinuation of therapy is rarely necessary. <u>Immune System Disorders:</u> Allergic reactions (e.g. erythema, ...
Overdose
The course of symptoms in verapamil intoxication depends on the amount taken, the point in time at which detoxification measures are taken and myocardial contractility (age-related). The main symptoms ...
Pharmacodynamic properties
Verapamil is a calcium antagonist which blocks the inward movement of calcium ions in cardiac muscle cells, in smooth muscle cells of the coronary and systemic arteries and in the cells of the intracardiac ...
Pharmacokinetic properties
Absorption Over 90% of verapamil is absorbed following administration with peak plasma concentrations occurring between 1 and 2 hours and does not appear to be affected markedly by food. Distribution, ...
Preclinical safety data
Verapamil is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
List of excipients
Propylene glycol Benzoic acid Liquid maltitol Dill water concentrate (contains ethanol) Liquorice flavour Citric acid monohydrate Sodium citrate Purified water
Incompatibilities
Not applicable.
Shelf life
36 months. 3 months once open.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
<u>Bottle:</u> Amber (Type III) glass. <u>Closure:</u> HDPE, EPE wadded, tamper evident, child resistant closure. <u>Pack Size:</u> 150ml.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Essential Pharma Ltd, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, UK
Marketing authorization number(s)
PL 41871/0021
Date of first authorization / renewal of the authorization
23 May 2001 / 23 Feb 2007
Date of revision of the text
27/10/2022
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