Lanoxin 125 Tablets (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Aspen |
|---|---|
| Διεύθυνση | 12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland |
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Name of the medicinal product
Lanoxin 125 Tablets.
Qualitative and quantitative composition
Digoxin Ph Eur 0.125 mg/tablet
Pharmaceutical form
Tablet.
Therapeutic indications
Lanoxin is indicated in the management of chronic cardiac failure where the dominant problem is systolic dysfunction. Its therapeutic benefit is greatest in those patients with ventricular dilatation. ...
Posology and method of administration
The dose of Lanoxin for each patient has to be tailored individually according to age, lean body weight and renal function. Suggested doses are intended only as an initial guide. The difference in bioavailability ...
Contraindications
Lanoxin is contra-indicated in intermittent complete heart block or second degree atrioventricular block, especially if there is a history of Stokes-Adams attacks. Lanoxin is contra-indicated in arrhythmias ...
Special warnings and precautions for use
Arrhythmias may be precipitated by digoxin toxicity, some of which can resemble arrhythmias for which the drug could be advised. For example, atrial tachycardia with varying atrioventricular block requires ...
Interaction with other medicinal products and other forms of interaction
Interactions may arise from effects on the renal excretion, tissue binding, plasma protein binding, distribution within the body, gut absorptive capacity and sensitivity to Lanoxin. Consideration of the ...
Pregnancy and lactation
No data are available on whether or not digoxin has teratogenic effects. There is no information available on the effect of digoxin on human fertility. The use of digoxin in pregnancy is not contra-indicated, ...
Effects on ability to drive and use machines
Since central nervous system and visual disturbances have been reported in patients receiving Lanoxin, patients should exercise caution before driving, using machinery or participating in dangerous activities. ...
Undesirable effects
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10,000 ...
Overdose
The symptoms and signs of toxicity are generally similar to those described in the Undesirable Effects section but may be more frequent and can be more severe. Signs and symptoms of digoxin toxicity become ...
Pharmacodynamic properties
Mode of Action:- Digoxin increases contractility of the myocardium by direct activity. This effect is proportional to dose in the lower range and some effect is achieved with quite low dosing; it occurs ...
Pharmacokinetic properties
Absorption Intravenous administration of a loading dose produces an appreciable pharmacological effect within 5 to 30 minutes; this reaches a maximum in 1 to 5 hours. Upon oral administration, digoxin ...
Preclinical safety data
No data are available on whether or not digoxin has mutagenic or carcinogenic effects.
List of excipients
Lactose Ph Eur Starches Ph Eur Hydrolysed Starch HSE Magnesium Stearate Ph Eur
Incompatibilities
None known.
Ημερομηνία λήξης
Amber glass bottle: 60 months. Blister packs: 36 months.
Special precautions for storage
Store below 25°C
Nature and contents of container
Amber glass bottle with low-density polyethylene snap-fit closure Pack sizes: 28, 50, 500 tablets Amber glass bottle with a clic-loc child resistant closure Pack size: 56 tablets White opaque PVC/aluminium ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Aspen Pharma Trading Limited 12/13 Exchange Place I.F.S.C Dublin 1 Ireland
Marketing authorization number(s)
PL 39699/0009
Date of first authorization / renewal of the authorization
24 April 2003
Date of revision of the text
10 March 2012