NITROLINGUAL Sublingual spray Ref.[7281] Active ingredients: Glyceryl trinitrate

Posology

Adults and older people

At the onset of an attack or prior to a precipitating event: one or two 400 microgram metered doses sprayed under the tongue. If symptoms do not resolve, this may be repeated at five minute intervals for a total of three doses. If symptoms have not resolved after a total of three doses, the patient should seek prompt medical attention.

For the prevention of exercise induced angina or in other precipitating conditions: one or two 400 microgram metered doses sprayed under the tongue immediately prior to the event.

Paediatric population

No data are available on the use of glyceryl trinitrate in children.

Method of administration

Precautions to be taken before handling or administering the medicinal product:

The bottle should be held vertically with the valve head uppermost. If the pump is new, or has not been used for a week or more, the first actuation should be released into the air. The spray orifice should then be placed as close to the mouth as possible. The dose should be sprayed under the tongue and the mouth should be closed immediately after each dose. The spray should not be inhaled.

Patients should be instructed to familiarise themselves with the position of the spray orifice, which can be identified by the finger rest on the top of the valve, in order to facilitate orientation for administration at night. During application the patient should rest, ideally in the sitting position because of the risk of symptomatic postural hypotension. Hypotension and syncope can be a particular problem with the use of nitrates in the elderly.

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 Adverse Reactions).

Flushing, severe headache, a feeling of suffocation, hypotension, fainting, restlessness, blurred vision, impairment of respiration, bradycardia and rarely, cyanosis and methaemoglobinaemia may occur. In a few patients there may be a reaction comparable to shock with nausea, vomiting, weakness, sweating and syncope.

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 min unless the patient is known to have G-6-PD deficiency.

Shelf life: 3 years.

Do not store above 25°C.

Glass bottle with or without red plastic coating, fitted with metering pump. Each bottle contains 6.3 g, 12.1 g, 13.2 g, 15.4 g solution (equivalent to about 75, 180, 200 or 250 doses). Nitrolingual Pumpspray Duo pack contains a 6.3 g and a 15.4 g bottle.

Not all pack sizes may be marketed.

See ‘Administration’ section.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.