Nitral

Nitral
Glyceryl trinitrate

Composition
Nitral 500 mcg tablet:
Each tablet contains 500 mcg Glyceryl trinitrate

Mode of action 
Pharmacodynamic properties
Glyceryl trinitrate is a vasodilator and is used for angina of effort

Pharmacokinetic properties
Glyceryl trinitrate is readily absorbed from the oral mucosa, but rapidly metabolized so that it only has a fleeting duration of action.
Glyceryl trinitrate is also readily absorbed from the gastrointestinal tract, but owing to extensive first pass metabolism in the liver its bioavailability is reduced (short plasma half-life).
Glyceryl trinitrate is metabolised by hydrolysis to dinitrates and the mononitrate, which is the main urinary metabolite.

Indication
As a short acting vasodilator in the prophylaxis and continued treatment of: Angina pectoris.

Posology
1 tablets 0.5 mg should be placed under the tongue and allowed to dissolve slowly; this dose should be repeated as required. Dosage should be adjusted according to the response obtained by the individual patient and the severity of the anginal pain. Tablet should not be swallowed.

NB: Tolerance may develop with daily use, but withdrawal for a week re-establishes the original sensitivity.

Contraindications
Glyceryl trinitrate should not be used in patient with marked anaemia, head trauma, cerebral haemorrhage or closed angle glaucoma.
Glyceryl trinitrate is also contraindicated in patients with coronary thrombosis or in those who are sensitive to nitrates.
Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.
Hypersensitivity to Nitrates, Hypotensive conditions and hypovolaemia, hypertropic obstructive cardiomyopathy, aortic stenosis, cardica tamponade, constrictive paricarditis, mitral stenosis.

Interactions
Some effects of glyceryl trinitrate are enhanced by alcohol. The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil.
Patients receiving antihypertensive drugs/ β - adrenergic blockers/ phenothiazines and nitrates should be observe for possible additive hypotension.

Side effects
Side effects are predominantly headache and facial flushing. Other side effects include dizziness, weakness and tachycardia.
Syncope due to Nitrate vasodilation, flushing drug rush and exfoliative dermatitis has been reported.

Precautions

• Nitroglycerine should be used with caution in patient with severely impaired renal or hepatic function, hypothyroidism, malnutrition or hypothermia.
• The safety and effectiveness of Nitroglycerine in pediatric patients have not been established.
• Nitrate therapy may aggravate the angina caused by hypertropic cardiomyopathy.
• The drug should be discontinued if blurring of vision or drying of the mouth occurs. Exclusive dosage of Nitroglycerine may produce severe headache.

Pregnancy and lactation
There is no, or inadequate, evidence of safety of nitrates in human pregnancy or lactation; nitrates should not be administered in pregnancy or lactation unless considered essential.

Overdose
Toxic effects of glyceryl trinitrate include vomiting, restlessness, hypotension, syncope, cyanosis and methaemoglobinaemia; coldness of the skin, impairment of respiration, bradycardia and psychosis may ensue.
Overdosage should be treated with gastric aspiration and lavage, plus attention to any respiratory and circulatory symptoms. Oxygen may prove additional useful.
Effects of hypotension may be minimized by treating the patient in the recumbent position with the head lowered. Methaemoglobinaemia may be treated with methylene blue intravenously 1-4 mg/kg body weight. The circulation may be maintained with infusions of plasma or suitable electrolyte solutions.

Presentation
Nitral500 mcg sub lingual tablet:
Available in bottle of 30 sub lingual tablets.

Storage
Store below 25° C in a dry place, protect from light.

Reg. No. :DKL0505513574A1

HARUS DENGAN RESEP DOKTER

Manufactured by
PT Actavis Indonesia, Jakarta
(Actavis Group, Iceland)

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