DIGOXIN Tablets Ref.[6800] Active ingredients: Digoxin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

DIGOXIN TABLETS BP 125 micrograms.

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.

Qualitative and quantitative composition

Each tablet contains 125 micrograms Digoxin PhEur.

Active Ingredient Description
Digoxin

Digoxin increases contractility of the myocardium by direct activity. The primary action of digoxin is specifically to inhibit adenosine triphosphatase, and thus sodium-potassium (Na+ - K+) exchange activity, the altered ionic distribution across the membrane resulting in an augmented calcium ion influx and thus an increase in the availability of calcium at the time of excitation-contraction coupling. The potency of digoxin may therefore appear considerably enhanced when the extracellular potassium concentration is low, with hyperkalaemia having the opposite effect.

List of Excipients

Also contains:

Lactose
Magnesium stearate
Maize starch
Pregelatinised maize starch

Pack sizes and marketing

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 should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

  • Carton: Printed carton manufactured from white folding box board.
  • Blister pack: (i) 250ยตm white rigid PVC. (ii) Surface printed 20ยตm hard temper aluminium foil with 5-7g/Mยฒ PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250’s, 500’s, 1000’s

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 0142/0127

11.7.79
Renewed: 11.7.84; 16.4.93

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