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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

DIGOXIN Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

DIGOXIN TABLETS BP 125 micrograms.

Qualitative and quantitative composition

Each tablet contains 125 micrograms Digoxin PhEur.

Pharmaceutical form

White uncoated tablets. White, circular, flat bevelled-edge, uncoated tablets impressed C on one face and the identifying letters DF on the reverse.

Therapeutic indications

Digoxin is indicated for the treatment of congestive cardiac failure. Digoxin may be used for certain supraventricular dysrhythmias, particularly atrial fibrillation.

Posology and method of administration

The following schedules are intended as an initial guide but each patient has to be tailored individually according to age, lean body weight and renal function for his/her needs: Suggested doses are intended ...

Contraindications

Patients known to be hypersensitive to digoxin, other digitalis glycosides or any of the excipients. Patients with arrhythmias caused by cardiac glycoside intoxication. Patients with hypertrophic obstructive ...

Special warnings and precautions for use

Monitoring Patients receiving digoxin should have their serum electrolytes and renal function (serum creatinine concentration) assessed periodically; the frequency of assessments will depend on the clinical ...

Interaction with other medicinal products and other forms of interaction

These may arise from effects on the renal excretion, tissue binding, plasma protein binding, distribution within the body, gut absorptive capacity and sensitivity to digoxin. Consideration of the possibility ...

Fertility, pregnancy and lactation

Pregnancy 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 ...

Effects on ability to drive and use machines

Neurological adverse effects and visual disturbances have been reported in patients receiving digoxin. Patients should make sure they are not affected before they drive or operate machinery.

Undesirable effects

The adverse effects produced by digoxin are frequently due to the narrow margin between therapeutic and toxic doses. Plasma levels in excess of 2nmol.L<sup>-1</sup> indicate that the patient is at special ...

Overdose

Symptoms and signs The symptoms and signs of toxicity are generally similar to those described in Section 4.8, but may be more frequent and can be more severe. Signs and symptoms of digoxin toxicity become ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cardiac therapy, cardiac glycosides, digitalis glycosides ATC code: C01AA05 Cardiac glycosides Mechanism of action Digoxin increases contractility of the myocardium by direct ...

Pharmacokinetic properties

Absorption The T<sub>max</sub> following IV administration is approximately 1 to 5 hours, while the Tmax for oral administration is 2 to 6 hours. Upon oral administration, digoxin is absorbed from the ...

Preclinical safety data

Carcinogenesis, mutagenesis Digoxin showed no genotoxic potential in in vitro studies (Ames test and mouse lymphoma). No data are available on the carcinogenic potential of digoxin.

List of excipients

Also contains: Lactose Magnesium stearate Maize starch Pregelatinised maize starch

Incompatibilities

None known.

Shelf life

Shelf life PVC Blister packs: Four years from the date of manufacture. Polypropylene or polyethylene tablet containers with polyethylene lids: Three years from the date of manufacture. Amber glass bottles ...

Special precautions for storage

Store below 25°C in a dry place.

Nature and contents of container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad and snap-on polyethylene lids; in case any supply difficulties ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization number(s)

PL 0142/0127

Date of first authorization / renewal of the authorization

11.7.79 Renewed: 11.7.84; 16.4.93

Date of revision of the text

20/02/2019

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