(and dosage form):
Each tablet contains quinidine gluconate 324 mg in a tablet matrix specially designed for the prolonged (8 or 12 hour interval) release of the medicine in the gastro-intestinal tract.
Quinidine gluconate contains 62,3% of the anhydrous quinidine alkaloid, whereas quinidine sulphate contains 82,86%. In prescribing Quinaglute Dura-Tabs, this factor should be considered.
A. 6.2 Cardiac depressants.
The antiarrhythmic activity of quinidine consists of two basic actions: (a) prolongation of effective refractory period of the atrial or ventricular muscle which leads to termination of arrhythmia; (b) decrease in excitability of ectopic foci of the heart. The action is not limited to these two properties on the heart. In addition, quinidine (c) blocks vagal innervation and (d) facilitates conduction in the atrioventricular junction. In the treatment of cardiac arrhythmia, quinidine is administered in a dose that will exert actions (a) and (b) with a minimal effect on (c) and (d).
For the prevention of premature atrial, nodal or ventricular contractions. For maintenance of normal sinus rhythm following conversion by other techniques of atrial, nodal or ventricular tachycardia, atrial flutter and fibrillation (paroxysmal or chronic).
Aberrant impulses and abnormal rhythms due to escape mechanisms should not be treated with quinidine.
Partial A-V or complete heart block, or intraventricular conduction defects, especially those exhibiting a marked grade of QRS widening.
Renal disease resulting in significant azotemia, or those developing cardiotoxic effects such as conduction defects, ventricular premature beats, ventricular tachycardia or flutter while on the medicine.
Marked cardiac enlargement, particularly with congestive failure, poor renal function and especially renal tubular acidosis.
Idiosyncrasy or hypersensitivity to quinidine.
As with other quinidine products, Quinaglute Dura-Tabs should not be used during pregnancy.
During the treatment of atrial flutter, reversion to sinus rhythm may be preceded by a progressive reduction in the degree of A-V block to a 1:1 ratio resulting in an extremely rapid ventricular rate.
DOSAGE AND DIRECTIONS FOR USE
The dosage varies considerably depending upon the general condition and cardiovascular state of the patient. The quantity and frequency of administration of Quinaglute Dura-Tabs which will achieve the desired clinical results must be determined for each patient.
The ideal dosage is the minimum amount of total dose and frequency of daily administration that will prevent premature contractions, paroxysmal tachycardias, and maintain normal sinus rhythm.
Prevention of premature atrial, nodal or ventricular contractions: 1-2 tablets every 12 or 8 hours.
Maintenance of normal sinus rhythm following conversion of atrial fibrillation, tachycardia, or flutter: 2 tablets every 12 hours or 1½ to 2 tablets every 8 hours are usually required.
Some patients may be maintained in normal rhythm on a dosage of 1 tablet every 12 or 8 hours; other patients may require larger doses or more frequent administration (ie every 6 hours) than the usually recommended schedule. Such increased dosage should be instituted only after careful clinical and laboratory evaluation of the patient (including serial electrocardiograms and plasma quinidine levels).
Quinaglute Dura-Tabs are well tolerated with few gastrointestinal disturbances which, if they occur, may be minimised by administering the medicine with food.
It is frequently desirable to determine if a patient can tolerate maintenance quinidine therapy prior to electrical conversion of atrial fibrillation or flutter. Therefore, maintenance therapy may be initiated 2 to 3 days before electrical conversion is attempted. Quinaglute Dura-Tabs are well suited for such a programme and can be administered at the maintenance dose felt necessary for a given patient as indicated above.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
The patient should be advised to report immediately to the physician any symptoms of cinchonism including tinnitus, decreased auditory acuity, vertigo, headache, blurred vision, colour perception disturbances, photophobia, diplopia, night blindness, scotomata, reduced visual fields, mydriasis, hypotension, respiratory distress and gastro-intestinal disturbances.
Where such symptoms develop, or if evidence of hypotension appears, the medicine should be discontinued. Gastro-intestinal disturbances have only rarely been reported. If they occur, they may be minimised by administering the medicine with food. If they persist, dosage should be decreased.
The precautions to be observed include all those applicable to quinidine. A preliminary test dose of a single tablet of quinidine sulphate should be administered to determine if the patient has an idiosyncrasy to quinidine. Signs of idiosyncrasy include febrile reactions, skin eruptions, thrombocytopenic purpura and respiratory embarrassment. Hypersensitivity to quinidine, although rare, should constantly be considered, especially during the first weeks of therapy.
Quinidine in large doses may reduce the contractile force of the heart, therefore, extreme caution should be exercised in using the medicine in patients with severe heart disease and congestive heart failure, with digitalis intoxication, or renal insufficiency.
It should be administered cautiously, if at all, to senile patients.
Hospitalisation for close clinical observations, electrocardiographic monitoring, and possibly plasma quinidine levels, is indicated when large doses are used, or with patients who present an increased risk.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See "Side effects and special precautions".
White to yellowish white, slightly mottled biconvex discs, having a waxy odour and an impressed clock insignia on one surface, and an embossed "C" in an impressed conical flask on the other.
Amber bottles of 100 tablets.
Store at room temperature (25°C). Protect from light. Keep out of reach of children. For shelf-life see imprint on label.
G.2855 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
P O Box 5278
Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Sole S A agent for:
Berlex Laboratories Inc
300 Fairfield Road Wayne
New Jersey 07470
Updated on this site: April 2003
Source: Pharmaceutical Industry
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