ISOSORBIDE DINITRATE Tablet Ref.[7872] Active ingredients: Isosorbide dinitrate

Posology

Adults

Angina: 30-120mg daily in divided doses according to individual requirements. Dosage should be gradually increased to minimise the possibility of nitrate headache and/or tolerance.

Congestive cardiac failure: In severe congestive cardiac failure doses of 40-160mg, daily in divided doses may be employed depending on individual requirements. The optimum dosage is best determined by continuous haemodynamic monitoring. The use of isosorbide dinitrate tablets in severe congestive cardiac failure should be regarded as an adjunctive therapy to more conventional treatment (eg cardiac glycosides, diuretics).

The maximum daily dose should not exceed 240mg in divided doses.

Elderly

Dosage may be reduced in the elderly especially where there is impairment of renal or hepatic function.

Method of Administration

For oral administration

Gastric lavage may be performed if within four hours of ingestion, otherwise treatment is symptomatic. Hypotension may be treated by elevating the legs to promote venous return and giving intravenous fluids.

Shelf-life: Three years from the date of manufacture.

Shelf-life after dilution/reconstitution: Not applicable.

Shelf-life after first opening: Not applicable.

Store below 25°C in a dry place.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool.

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

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 56s, 60s, 84s, 90s, 100s, 112s, 1000s.

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.

Not applicable.