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QUALITATIVE AND QUANTITATIVE COMPOSITION
ANGISED sublingual tablets contain either 0.5 mg (500 micrograms) or 0.6 mg (600 micrograms) glyceryl trinitrate.
PHARMACEUTICAL FORM Sublingual tablets.
ANGISED is indicated for the treatment of acute attacks of angina pectoris including variant angina and for the prophylaxis of such attacks. ANGISED may be used for the emergency treatment of pulmonary oedema.
Dosage and Administration
ANGISED must be placed under the tongue (administered sublingually) and retained in the mouth until dissolved or discarded. A local burning or tingling sensation may occur.
Treatment of acute attacks When angina starts, 0.5 mg or 0.6 mg glyceryl trinitrate (one tablet) should be taken every 3 minutes until cessation of pain or limiting side effects, such as headache or light-headedness supervene. The patient should preferably rest in the sitting position because of the risk of symptomatic postural hypotension.
0.5 mg or 0.6 mg ANGISED (one tablet) may be used prior to activity which is likely to precipitate angina pectoris.
In the treatment of pulmonary oedema doses ranging between 0.8 mg and 2.4 mg of ANGISED has been used at intervals of 5 to 10 minutes.
No data are available on the use of ANGISED in children.
Hypotension and syncope can be a particular problem with use of nitrates in the elderly. Patients should be advised to sit down whenever possible when taking sublingual ANGISED.
ANGISED is contraindicated in angina caused by hypertrophic obstructive cardiomyopathy as it may exaggerate outflow obstruction. ANGISED should not be used in patients with cerebral haemorrhage or head trauma. ANGISED is contraindicated in patients taking silde-nafil (see Interactions).
Warnings and Precautions
ANGISED should be used with caution in patients with cerebrovascular disease since symptoms may be precipitated by hypotension. ANGISED may worsen hypoxaemia in patients with lung disease or cor pulmonale. Arterial hypotension with bradycardia may occur in patients with myocardial infarction; this is thought to be reflexly mediated.
The use of ANGISED could theoretically compromise myocardial blood supply in patients with left ventricular hypertrophy associated with aortic stenosis because of the detrimental effects of tachycardia and decreased aortic diastolic pressure. Detailed haemodynamic studies in a small number of patients with valvular aortic stenosis with and without concomitant significant coronary artery disease studied in the supine position have not shown adverse effects with sublingual ANGISED. However it seems prudent to be cautious in treating ambulant patients with the combination of angina and moderate to severe valvular aortic stenosis.
The risk of hypotension and syncope wilh use of ANGISED may be enhanced by alcohol The possibility of tolerance to the effects of ANGISED should be considered when used in conjunction with long-acting nitrate preparations.
Consistent with its known effects on the nitric oxide/ cyclic guanosine monophosphate (cGMP) pathway, sildenafil has been shown to potentiate the hypo-tensive effects of nitrates, and its coadministration with ANGISED is therefore contraindicated (see Contraindications).
In vitro data suggest that St John's Wort (Hypericum perforatum) may induce cytochrome P450 3A4. There is a theoretical possibility therefore, that plasma levels of ANGISED trinitrate may be decreased during concomitant administration and increased upon withdrawal of St John's Wort.
Pregnancy and Lactation
In reproductive toxicity studies in animals, glyceryl trinitrate had no effects upon fertility, organogen-esis or peri- and post-natal development. However, the administration of ANGISED during pregnancyshould only be considered if the expected benefit tothe mother is greater than any possible risk to the foetus.
No data are available on the excretion of glyceryl trinitrate or its metabolites in human breast milk.
Effects on Ability to Drive and Use Machines Since dizziness and syncope have been reported following treatment with ANGISED, caution is recommended in patients performing skilled tasks.
The frequency estimations for these adverse reactions are unknown due to a lack of robust clinical trial data to accurately determine frequency estimates.
Blood and lymphatic system disorders: Methaemog lobi naemia
Psychiatric disorder: Restlessness
Nervous system disorders: Vascular headache, lighlheadedness, dizziness, syncope, cerebral ischaemia Headache and/or lighl-headedness persisting after relief of angina may be minimised by removing the ANGISED tablet before it has completely dissolved.
Cardiac disorders: Bradycardia, tachycardia, cyanosis
In the case of ingestion, all that is usually required is supportive treatment of the cardiovascular and respiratory systems. The patient should be nursed head-down if hypotensive. 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 2mg/kg bodyweight of intravenous Methylene Blue over 5 minutes.
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