Glyceryl Trinitrate 400mcg Spray

UGX42,200.00

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1. Name of the medicinal product

Glyceryl Trinitrate Spray 400 micrograms/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 Glyceryl Trinitrate Spray 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 Glyceryl Trinitrate Spray 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 the 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

Glyceryl Trinitrate Spray 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 the 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 anemia, constrictive pericarditis, extreme bradycardia, Glucose-6-phosphate-Dehydrogenase-deficiency, cerebral hemorrhage, and brain trauma, aortic and/or mitral stenosis and angina caused by hypertrophic obstructive cardiomyopathy.

Circulatory collapse, cardiogenic shock, and toxic pulmonary edema.

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.

Glyceryl Trinitrate Spray should be administered with particular caution in:

– pericardial tamponade

– low filling pressures (e.g. acute myocardial infarction, left ventricular failure)

– the tendency to dysregulation of orthostatic blood pressure

– diseases accompanied by an increase in intracranial pressure (so far further pressure increase has been observed solely in high doses of glyceryl trinitrate).

Alcohol should be avoided because of the hypotensive effect.

Medical controls of the intraocular pressure of glaucoma-patients are advisable.

Particular caution should also be exercised when using Glyceryl Trinitrate Spray in patients with volume depletion from diuretic therapy, severe hepatic or renal impairment and hypothyroidism.

4.5 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 Glyceryl Trinitrate Spray, which can result in vasoconstriction since dihydroergotamine can antagonize the effects of glyceryl trinitrate.

The concomitant administration of Glyceryl Trinitrate Spray 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 hemodynamic 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. Glyceryl Trinitrate Spray 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.

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 Glyceryl Trinitrate Spray.

4.8 Undesirable effects

The following adverse reactions have been reported:

System Organ Class Very Common

(≥1/10)

Common

(≥1/100 to < 1/10)

Uncommon

(≥ 1,000 to < (1/100)

Rare

(≥1/10,000 to < 1,000)

Very Rare

(<1/10,000)

Nervous System Disorders Headache Vertigo

Dizziness

Syncope
Skin and Subcutaneous Tissue Disorders Allergic Dermatitis* Exfoliative dermatitis
Vascular Disorders Facial Flushing Orthostatic hypotension

Circulatory collapse

General Disorders and Administration Site Conditions Asthenia Application site discomfort including Burning Sensation And Stinging
Gastrointestinal Disorders Nausea Tongue blistering
Cardiac Disorders Tachycardia

Bradycardia

Angina pectoris aggravated

Investigations Blood pressure decreased

*symptoms which are known in conjunction with hypersensitivity reactions

Use of Glyceryl Trinitrate Spray may give rise to transient hypoxemia and, in patients with coronary heart disease, ischemia 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 authorization 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 methemoglobinemia 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.

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