INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NITRADISC® 5 ADHESIVE PADS
NITRADISC® 10 ADHESIVE PADS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

NITRADISC® 5 ADHESIVE PADS
NITRADISC® 10 ADHESIVE PADS

COMPOSITION:
NITRADISC 5 contains a 16 mg nitroglycerin impregnated polymer which releases 5 mg
nitroglycerin per 24 hours.
NITRADISC 10 contains a 32 mg nitroglycerin impregnated polymer which releases 10 mg nitroglycerin per 24 hours.

Nitroglycerin is more commonly referred to as
glyceryl trinitrate.

PHARMACOLOGICAL CLASSIFICATION:
A 7.7.4 Vasodilators - Coronary and other medicines for angina pectoris.

PHARMACOLOGICAL ACTION:
NITRADISC provides constant and controlled drug delivery over a uniform skin surface area for 24 hours. Absorption from the skin surface will vary among individuals. When NITRADISC is applied to the skin, nitroglycerin is absorbed continuously through the skin into the systemic circulation. This results in active drug reaching the target organs (heart and peripheral vasculature) before being inactivated by the liver. Nitroglycerin is a smooth muscle relaxant with vascular effects predominantly by venous dilation and pooling. The major beneficial effect of nitroglycerin in angina pectoris is due to a reduction in myocardial oxygen consumption secondary to vascular smooth muscle relaxation and consequent reduced cardiac preload and afterload. The relative importance of preload and afterload reduction remains undefined. Transdermal absorption of nitroglycerin from NITRADISC occurs in a continuous and well-controlled manner for up to 24 hours. Plasma levels reach a plateau within approximately one hour after the application of the pad and remain in the same range for 24 hours. Plasma levels of nitroglycerin may still be detectable 30 minutes after removal of the system.

INDICATIONS:
NITRADISC is indicated for the prevention of angina pectoris due to coronary artery disease.

CONTRA-INDICATIONS:
NITRADISC (nitroglycerin) is contra-indicated in patients known to be intolerant of organic nitrate drugs. NITRADISC should not be used in patients with marked anaemia, increased intraocular pressure or increased intracranial pressure.

WARNINGS:
In patients with acute myocardial infarction or congestive heart failure, NITRADISC should be used under constant clinical and/or haemodynamic monitoring. NITRADISC is not intended for immediate relief of anginal attacks. For this purpose, occasional use of sublingual preparations may be necessary.

Pregnancy: Safety in pregnancy and lactation has not been established.

Tolerance (as measured by exercise stress) has been reported to develop to the haemodynamic and antianginal effects of organic nitrates following either oral or topical administration. Therefore, patients receiving long-term nitrate therapy must be monitored carefully for signs of tolerance (see Dosage and Directions for Use). In terminating treatment of patients with angina, both the dosage and frequency of application must be gradually reduced over a period of 4 to 6 weeks to prevent potential withdrawal reactions, which are characteristic of all vasodilators in the nitrate class.

DOSAGE AND DIRECTIONS FOR USE:
Follow the instructions below. NITRADISC should be applied to an intact skin site free of hair and not subject to excessive movement. It should not be applied to the distal parts of the extremities. The chest or the inner side of the upper arm are recommended. A suitable area should be shaved free of hair if necessary. The application site should be changed slightly each time to avoid undue skin irritation. A new NITRADISC should be applied if the product loosens.
The optimal dosage regimen should be selected based upon the clinical response, the side effects, and the effects of therapy upon blood pressure and heart rate. It is recommended that therapy be initiated with NITRADISC 5 and that NITRADISC 10 be utilized when a greater response is desired. In the event that higher doses are necessary, multiple discs may be applied.
Although some well controlled clinical trials using exercise tolerance testing have shown maintenance of effectiveness when patches are worn continuously, the large majority of such controlled trials have shown the development of tolerance (i.e. complete loss of effect) within the first 24 hours after therapy was initiated. Dose adjustment, even to levels much higher than generally used, did not restore efficacy.
Intermittent schedules of administration have been reported to overcome the phenomenon of tolerance development. Although the minimum nitrate-free interval has not been precisely defined, data show that a nitrate-free interval of 10-12 hours is sufficient. The dosing schedule for NITRADISC should include a daily patch-on period of 12-14 hours and a daily patch-off period of 10-12 hours.

Application:
{Illustrated here}
Gently separate silver foil from foam at thumb cut. Complete pulling Nitradisc apart where silver foil disc and foam pad separates most easily.
Apply foam pad to site free of hair on chest or on inner arm.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Headache is the most common side-effect, especially when higher doses of the drug are used. These headaches should be treated with mild analgesics while NITRADISC therapy is continued. When such headaches are unresponsive to treatment, the nitroglycerin dosage should be reduced or use of the product discontinued (see Warnings).
Adverse reactions reported less frequently include hypotension, increased heart rate, faintness, flushing, dizziness, nausea, vomiting and dermatitis. With the exception of dermatitis, these symptoms are attributable to the known pharmacological effects of nitroglycerin, but may be symptoms of overdosage. When they persist, NITRADISC dose should be reduced or use discontinued (see Warnings).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Hypotension, increased heart rate, faintness, flushing, dizziness, nausea and vomiting, are symptoms attributable to the known pharmacologic effects of nitroglycerin and may be symptoms of overdosage. When they occur and persist, the Nitradisc dosage should be reduced or use discontinued (see Warnings).

IDENTIFICATION:
Nitradisc incorporates a patented Microseal Drug Delivery system consisting of a solid, nitroglycerin-impregnated polymer bonded to a flexible, non-sensitizing adhesive bandage.
NITRADISC 5 adhesive pads are circular-shaped discs approximately 65 mm in diameter.
NITRADISC 10 adhesive pads are circular-shaped discs approximately 80 mm in diameter.
Both sizes are tan-coloured on one side and metallic silver on the reverse with a slightly raised cup in the centre.

PRESENTATION:
NITRADISC 5 adhesive pads are packed in cardboard cartons of 30 units.
NITRADISC 10 adhesive pads are packed in cardboard cartons of 30 units.

STORAGE INSTRUCTIONS:
Store at a controlled room temperature of 15 °C - 30 °C.
Extremes of temperature and/or humidity should be avoided.
Do not refrigerate.
Keep out of reach of children.

REGISTRATION NUMBER:
NITRADISC 5:
P/7.1.4/220
NITRADISC 10: P/7.1.4/221

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
G.D. Searle (South Africa) (Pty) Ltd
14 Mandy Road
Reuven
Johannesburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 October 1982

® 1994, G.D. Searle (South Africa) (Pty) Ltd.
        Rosside 24329        Code 4275 [IMA 7690 (R1)]-3-9/94

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