1. Name Of The Medicinal Product
SUSCARD BUCCAL TABLETS 2MG
SUSCARD BUCCAL TABLETS 3MG
SUSCARD BUCCAL TABLETS 5MG
2. Qualitative And Quantitative Composition
Each tablet contains 2mg, 3mg or 5mg glyceryl trinitrate as Diluted Nitroglycerin USP.
3. Pharmaceutical Form
Prolonged release muco-adhesive buccal tablet.
4. Clinical Particulars
4.1 Therapeutic Indications
Management and treatment of angina pectoris. This product may also be of benefit in the in-patient management of unstable angina.
Acute and congestive cardiac failure.
4.2 Posology And Method Of Administration
For buccal administration
Dosage
Adults and Elderly Patients:
Angina:
Administration of Suscard Tablets should start with the 2mg strength. If angina occurs while the tablet is in place, the dosage strength used should be increased to 3mg where necessary. The 5mg dosage strength should be reserved for patients with severe angina pectoris refractory to treatment with the lower dosage strengths.
Suggested dosage frequency in angina:
A) For patients suffering only occasional angina pectoris – the tablets may be administered on a p.r.n. basis to relieve the acute attack.
B) For patients suffering angina pectoris in response to known stimuli - the tablet may be administered a few minutes prior to encountering the angina-precipitating stimulus.
C) For patients in whom chronic therapy is indicated - the tablet should be administered on a thrice daily basis or as dictated by the dissolution rate of the tablet in an individual patient. If angina occurs during the period between the disappearance of one tablet and the time the next tablet is due to be put in place, dosage frequency should be increased.
Note that if an acute attack of angina pectoris is suffered while a tablet is in place, an additional tablet may be positioned on the opposite side of the mouth.
Unstable Angina:
Dosage should be rapidly titrated upwards in order to relieve and prevent symptoms. Suscard Tablets may be used in addition to pre-existing anti-anginal therapy, where considered appropriate.
As indicated in the above section the higher 5mg dosage strength may be required to achieve a satisfactory therapeutic response in patients exhibiting severe symptoms. Unstable angina is a serious condition managed under hospitalised conditions and involving continuous monitoring of ECG changes with frequent monitoring of appropriate haemodynamic variables. In common with other nitrate therapy a fall in systolic blood pressure, of 10-15mm hg may occur.
Acute heart failure:
Administer 5mg, repeated as indicated by the patient response until the symptoms abate.
Congestive cardiac failure:
Dosage should commence with the 5mg strength, administered three times daily. In moderately severe or severe cases, particularly where patients have not responded to standard therapy (digitalis/diuretics), the dosage may need to be increased to 10mg (2 x 5mg tablets) t.i.d. over a period of three or four days. In such instances one tablet should be placed between the upper lip and the gum, on each side of the front teeth.
Method of Administration
Suscard is for buccal administration. The Suscard Tablet is placed high up between the upper lip and gum to either side of the front teeth.
The onset of action of Suscard Tablets is extremely rapid and the tablets may be substituted for sublingual glyceryl trinitrate tablets in the treatment of acute angina pectoris. The duration of action of the Suscard Tablet, once in place correlates with the dissolution time of the tablet. This is normally 3-5 hours. However, the first few doses may dissolve more rapidly until the patient is used to the presence of the tablet.
During the dissolution period the tablet will soften and adhere to the gum; in practice the presence of the tablet is not noticeable to the patient after a short time.
Patients should be instructed as to the correct placement of the tablet and should note the following points
A) The tablet should not be moved about the mouth with the tongue, as this will cause it to dissolve more rapidly.
B) A slight stinging sensation (as for sublingual glyceryl trinitrate) may be felt for a few minutes after placement of the tablet.
C) If a tablet is accidentally swallowed it may be replaced by a further tablet.
D) In patients who wear dentures, the tablet may be placed in any comfortable position between the lip and the gum.
E) The patient may alternate the placement of successive tablets on the right and left sides of the front teeth.
The tablets should not be placed under the tongue, chewed or intentionally swallowed.
4.3 Contraindications
As for glyceryl trinitrate. Suscard Tablets should not be used in patients with marked anaemia, head trauma, cerebral haemorrhage or close angle glaucoma.
Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.
4.4 Special Warnings And Precautions For Use
Rarely, prolonged use in susceptible individuals with poor dental hygiene and associated plaque may lead to an increased risk of dental caries. Patients should, therefore be instructed to alternate the site of application and careful attention should be paid to dental hygiene, particularly in those areas where the tablet is applied. In conditions where xerostomia (dry mouth) may occur, e.g. during concomitant medication with drugs having anticholinergic effects, patients should be instructed to moisten the buccal mucosa with the tongue, or with a little water, prior to insertion of Suscard.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil.
4.6 Pregnancy And Lactation
There is no information on the safety of nitrates in pregnancy and lactation. Nitrates should not be administered to pregnant women and nursing mothers unless considered essential by the physician.
4.7 Effects On Ability To Drive And Use Machines
None known
4.8 Undesirable Effects
Side effects are predominantly headache, dizziness, facial flushing and postural hypotension. In the unlikely event of severe side effects, the tablet may simply be removed from the mouth. Blisters of the tongue and oral mucosa have been associated with glyceryl trinitrate treatment.
4.9 Overdose
Toxic effects of glyceryl trinitrate include vomiting, restlessness, cyanosis, methaemoglobinaemia and syncope. Overdosage (i.e. if large numbers of tablets have been swallowed) should be treated with gastric aspiration and lavage plus attention to the respiratory and circulatory systems.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The principal action of glyceryl trinitrate is relaxation of vascular smooth muscle producing a vasodilator effect on both peripheral arteries and veins. Dilation of the post-capillary vessels, including large veins, promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure (preload). Arteriolar relaxation reduces systemic vascular resistance and arterial pressure (afterload). Myocardial oxygen consumption or demand for a given level of exercise is decreased by both the arterial and venous effects of nitroglycerin. Dilatation of the large epicardial coronary arteries by nitroglycerin contributes to the relief of exertional angina.
5.2 Pharmacokinetic Properties
Bioavailability:
relative to sublingual GTN 107%.
Mean plasma levels:
0.7ng/ml obtained with 5mg Buccal Tablet over 5 hours compared with 0.4ng/ml over 30 minutes with 0.4mg sublingual GTN.
Maximum plasma concentration:
1.7ng/ml following 5mg Buccal compared with 0.9ng/ml following 0.4mg sublingual GTN.
Time to maximum plasma concentration:
1.52 hours following Buccal GTN compared with 6 minutes following sublingual GTN.
Apparent elimination half-life:
1.30 hours for Buccal GTN compared with an elimination half-life of 5 minutes following sublingual GTN.
Pharmacodynamic studies have shown a dose-related response with a rapid onset equivalent to sublingual GTN together with a prolonged duration of activity of 4-5 hours.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose hydrous
Hypromellose
Purified Water
Peppermint flavour
Spearmint flavour
Stearic acid
Silica gel
6.2 Incompatibilities
None stated
6.3 Shelf Life
3 years
6.4 Special Precautions For Storage
Do not store above 25°C
6.5 Nature And Contents Of Container
Aluminium foil blister strips in cartons of 30, 50, 60, 90 and 100 tablets.
Professional sample pack size of 10 tablets.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
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8. Marketing Authorisation Number(S)
Suscard Buccal Tablets 2mg: 0108/0069
Suscard Buccal Tablets 3mg: 0108/0073
Suscard Buccal Tablets 5mg: 0108/0071
9. Date Of First Authorisation/Renewal Of The Authorisation
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10. Date Of Revision Of The Text
March 2010
11. Legal Category
P
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