RECTOGESIC Rectal ointment Ref.[7280] Active ingredients: Glyceryl trinitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, UK

Product name and form

Rectogesic 4 mg/g Rectal Ointment.

Pharmaceutical Form

Rectal ointment.

Off-white smooth opaque ointment formulation.

Qualitative and quantitative composition

Glyceryl trinitrate: 4 mg/g.

One gram of rectal ointment contains 4 mg Glyceryl trinitrate (GTN). The delivered dose from 375 mg of this formulation is approximately 1.5 mg GTN.

Excipient(s) with known effect:

The ointment also contains 36 mg Propylene Glycol, and 140 mg Lanolin, per gram rectal ointment.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Glyceryl trinitrate

Glyceryl trinitrate is a vasodilator and is used for angina of effort. Vasodilation is achieved by the releasing of free redical nitric oxide which activates guanylate cyclase and increases synthesis of guanosine 3′ and 5′-monophosphate with resultant effects on the phosphorylation of proteins in smooth muscle. If taken in excess, its vasodilatory effect can cause headache.

List of Excipients

Propylene glycol
Lanolin
Sorbitan sesquioleate
Hard paraffin
White soft paraffin

Pack sizes and marketing

30 g.

Aluminium tubes with white polyethylene non-piercing screw caps.

Marketing authorization holder

Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, UK

Marketing authorization dates and numbers

PL 16508/0037

28/08/2009

Drugs

Drug Countries
RECTOGESIC Cyprus, Estonia, Spain, Finland, France, Ireland, Israel, New Zealand, Singapore, Turkey, United Kingdom

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