GLYCERYL TRINITATE Sublingual tablets Ref.[7277] Active ingredients: Glyceryl trinitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Macarthys Laboratories Ltd T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, RM3 8UG

Therapeutic indications

As a short-acting vasodilator:

  • Relief of angina pectoris.
  • Prophylaxis of angina pectoris.

Posology and method of administration

Posology

Adults and the elderly

Treatment of acute attacks of Angina Pectoris

One tablet to be allowed to dissolve slowly under the tongue. The treatment may be repeated at five minute intervals. If pain persists for more than 15 minutes medical care should be sought.

Prophylaxis of Angina Pectoris

Glyceryl trinitrate, 0.3 mg (one tablet), may be used prior to activity which is likely to precipitate angina pectoris.

The patient should preferably rest in the sitting position because of the risk of symptomatic postural hypotension. This is particularly important for elderly people.

Children

Not recommended for children.

Method of administration

For sublingual administration.

Overdose

Symptoms

Signs and symptoms encountered with overdose are generally similar to those events reported during treatment use although the magnitude and/or severity of the reactions may be more pronounced (see section 4.8). At very high doses an increase in intracranial pressure with cerebral symptoms may occur. Additional gastrointestinal effects such as colicky pain and diarrhoea have also been reported. Treatment:

In the case of overdose, the patient’s clinical status including vital signs and mental status should be assessed and supportive treatment of the cardiovascular and respiratory systems provided as clinically indicated or as recommended by the national poisons centre, where available. In the event of mild hypotension, passive elevation of the patient’s legs and/or lowering of the head may be effective.

Arterial blood gas estimation should be performed and if there is acidosis or the patient is clinically cyanosed, then severe methaemoglobinaemia must be assumed. Oxygen therapy should be given with 1 to 2 mg/kg bodyweight of I.V. Methylene Blue over five minutes unless the patient is known to have G-6-PD deficiency.

Shelf life

Shelf life

Unopened: 24 months.

After first opening: Discard 8 weeks after first opening.

Special precautions for storage

Store in a dry place below 25°C. Protect from light.

Nature and contents of container

Amber glass bottle with aluminium wadded cap packed in a cardboard carton along with a patient leaflet.

Pack size: 100 tablets.

Special precautions for disposal and other handling

  • After removing a tablet, close the cap tightly.
  • Do not transfer the tablets to another container.
  • Do not put any packing material into the bottle with the tablets.
  • If you do not use the tablets within 8 weeks of first opening the bottle, obtain a fresh supply and return the old tablets to the pharmacist for disposal.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.