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GLYTRIN SPRAY

Active substance(s): GLYCERYL TRINITRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Glytrin, 400 micrograms per metered dose, Sublingual Spray

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient
Glyceryl Trinitrate: 400 micrograms/metered dose
Excipients with known effect:
This product contains small amounts of ethanol (alcohol) less than 100mg per spray.
For the full list of excipients, see Section 6.1

3.

PHARMACEUTICAL FORM
Metered dose oromucosal (sublingual) spray solution.
Small aerosol canister

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Treatment of acute angina pectoris
Prevention of inducible angina (e.g. physical effort, emotional stress, exposure
to cold)
Route of Administration
Oromucosal (Sublingual)

4.2

Posology and method of administration

Oromucosal Dosage
Before using Glytrin for the first time, the patient should check that the spray is
working by pressing the pump button a few times until it produces a fine mist of
liquid. The patient should practice aiming the spray onto a tissue or similar item so
that they will be able to aim it correctly under the tongue when they need to use it. If
the patient does not need to use Glytrin very often, the spray should be checked
regularly to see that it still works properly.

Adults including the elderly
At the onset of an attack, one or two metered doses (400 to 800 micrograms
glyceryl trinitrate) to be sprayed under the tongue for the relief of anginal pain
while breath is held. No more than three doses are recommended at any one
time.
For the prevention of inducible angina (e.g. physical effort, emotional
stress, exposure to cold), one or two 400 microgram metered doses sprayed
under the tongue within 2 – 3 minutes of the event starting.
Children
Glytrin is not recommended for
children Administration
During application the patient should rest, ideally in the sitting position. The
canister should be held vertically with the valve head uppermost and the spray
orifice 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 top of the valve, in order to facilitate orientation, for
administration at night.

4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section
6.1.
Severe hypotension (systolic blood pressure lower than 90mm Hg).
Hypotensive shock, severe anaemia, constrictive pericarditis, extreme bradycardia,
Glucose-6-phosphate-Dehydrogenase-deficiency, cerebral haemorrhage and brain
trauma, aortic and/or mitral stenosis and angina caused by hypertrophic obstructive
cardiomyopathy.
Circulatory collapse, cardiogenic shock and toxic pulmonary oedema.

Concomitant use with phosphodiesterase inhibitors such as Sildenafil, Tadalafil or
Vardenafil.
Concomitant use with the soluble guanylate cyclase stimulator riociguat (see
section 4.5).

4.4.

Special warnings and precautions for use
Tolerance to this drug and cross-tolerance to other nitrates may occur.
Glytrin should be administered with particular caution in:





4.5

Pericardial tamponade
Low filling pressures (e.g. acute myocardial infarction, left ventricular
failure)
Tendancy to dysregulation of orthostatic blood pressure
Diseases accompanied by an increase in intracranial pressure (so far
further pressure has been observed solely in high doses of glyceryl
trinitrate). Alcohol should be avoided because of the hypotensive effect
and medical controls of the intraocular pressure of glaucoma patients are
advisable. Particular caution should also be exercised when using Glytrin
in patients with volume depletion from diuretic therapy, severe hepatic or
renal impairment and hypothyroidism.

Interaction with other medicinal products and other forms of interaction

Alcohol may potentiate the hypotensive effect.
Vasodilators, antihypertensives, ß-blockers, calcium antagonists, neuroleptics,
tricyclic antidepressants and diuretics can increase nitrate induced hypotension.
The hypotensive effects of nitrates are potentiated by the concurrent administration of
phosphodiesterase inhibitors, such as Sildenafil, Tadalafil or Vardenafil.
The use of a soluble guanylate cyclase stimulator such as riociguat is
contraindicated (see section 4.3) since concomitant use can cause hypotension.
The bioavailability of dihydroergotamine may be increased by concomitant use of
Glytrin, which can result in vasoconstriction since dihydroergotamine can antagonise
the effects of glyceryl trinitrate.
The concomitant administration of Glytrin and heparin can reduce the antithrombotic
effect of heparin. Regular monitoring of coagulation parameters and adjustments of
the heparin dose may be necessary.

In patients pretreated with organic nitrates a higher dose of glyceryl trinitrate may be
necessary to achieve the desired haemodynamic effect.
4.6

Fertility, pregnancy and lactation

Pregnancy
The safety of glyceryl trinitrate in human pregnancy, especially during the first trimester has
not been established.
Breastfeeding
It is not known whether glyceryl trinitrate is excreted into human breast milk. Glytrin should
only be used after weighing the benefit for the mother against possible risks for the child.
Nursing should be discontinued during treatment with this product.
Fertility
Preclinical data reveal no special hazard for humans based on conventional studies of
toxicity to reproduction (see section 5.3).

4.7.

Effects on ability to drive and use machines
The ability to react may be diminished because of the side effects or
interactions due to the nitrates. This effect is potentiated by alcohol
consumption. Therefore, driving and/or using machines should be avoided
during treatment with Glytrin.

4.8

Undesirable effects

The following adverse reactions have been reported:
System Organ
Class

Very
Common
Common
(≥1/100 to <
(≥1/10)
1/10)

Nervous

Headache Vertigo

System

Uncommon

Rare

(≥ 1,000 to < (≥1/10,000
(1/100)
to < 1,000)

Very Rare
(<1/10,000)

Syncope

Dizziness

Disorders
Skin and
Subcutaneous

Allergic
Dermatitis*

Tissue
Disorders
Vascular
Disorders

Facial
Flushing

Orthostatic
hypotension

Exfoliative
dermatitis

Circulatory
collapse
General
Administration

Application
site
discomfort
including

Site Conditions

Burning

Disorders and

Asthenia

Sensation
And
Stinging
Gastrointestinal
Disorders

Nausea

Tongue
blistering

Cardiac

Tachycardia

Disorders

Bradycardia
Angina
pectoris
aggravated

Investigations

Blood
pressure
decreased

*symptoms which are known in conjunction with hypersensitivity reactions
Use of Glytrin may give rise to transient hypoxaemia and, in patients with coronary
heart disease, ischaemia as a result of a relative redistribution of the bloodstream,
which is to hypoventilated alveolar areas.
Tolerance development and the occurrence of crossed tolerance of other nitro
compounds have been found in chronic, continuous treatment using high doses. To
avoid a decrease in efficacy or a loss of efficacy, high continuous doses should be
avoided.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9.

Overdose
Signs and symptoms

Flushing, severe headache, vertigo, tachycardia, a feeling of suffocation,
hypotension, fainting 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.
Treatment
Recovery often occurs without special treatment. Hypotension may be
corrected by elevation of the legs to promote venous return.
Methaemoglobinaemia should be treated by intravenous methylthioninium
chloride and / or toluidine blue. Symptomatic treatment should be given for
respiratory and circulatory defects in more serious cases.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Vasodilators used in cardiac diseases,
organic nitrates
ATC-Code: C0IDA02
Glyceryl trinitrate acts on vascular smooth muscles to produce arterial and venous
vasodilation. The vasodilation results in a reduction of venous return and an
improvement in myocardial perfusion with the result of a reduction in the work
performed by the heart and hence reduced oxygen demand.

5.2.

Pharmacokinetic Properties
Glyceryl trinitrate is rapidly absorbed through the buccal and sublingual
mucosa, and in man peak concentrations in plasma are observed within four
minutes of sublingual administration.
The absolute bioavailability after sublingual administration is approximately
39%. After sublingual administration the plasma levels have shown a wide
range of intra and inter-individual variability.
The compound is extensively metabolised by liver enzymes and has a plasma
half life of 1-3 minutes. The principle mechanism of metabolism involves
denitration.

5.3.

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity,
carcinogenic potential, or toxicity to reproduction.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Peppermint oil
Propellant HFC 134A (1,1,1.2 Tetrafluoroethane)
Ethanol BP

6.2.

Incompatibilities
None.

6.3

Shelf life

3 years

6.4.

Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.

6.5.

Nature and Content of Containers
Internally lacquered monobloc aluminium pressurised container sealed with a
metered spray valve.
The product is presented in packs with one metered dose spray.
One metered dose spray (= one aluminium container) contains 1760.0mg of
solution (according to 11400.0mg of solution and propellant) providing 200
single metered doses.

6.6.

Special precautions for disposal
Glytrin is an aerosol spray and contains a pressurised liquid. Do not expose to
temperature higher than 50°C, and do not pierce the canister, even when
empty It should not be sprayed at a naked flame or any incandescent material.

Patients, especially those who smoke should be warned not to use Glytrin near
a naked flame.

7

MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU

8.

MARKETING AUTHORISTATION HOLDER
PL 16431/0017

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/09/2006

10

DATE OF REVISION OF THE TEXT
21/12/2017

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