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Logo LENOPREL INJECTION 0,2 mg/mL [discontinued]

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

LENOPREL INJECTION 0,2 mg/mL [discontinued]

COMPOSITION:
Each 1 mL ampoule contains 0,2 mg
Isoprenaline Hydrochloride, and 0,1% m/v sodium metabisulphite as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A5.1 Adrenomimetics (sympathomimetics)

PHARMACOLOGICAL ACTION:
Lenoprel exerts its action on all ß-receptors and almost no action on alpha-receptors. The main actions of Lenoprel are on the heart, the smooth muscle of bronchi, skeletal muscle vasculature and the alimentary tract. Intravenous infusion of Lenoprel lowers peripheral vascular resistance and diastolic pressure fails. Cardiac output is raised because of the positive cardiac inotropic and chronotropic actions of Lenoprel. Renal blood flow is decreased in normotensive subjects but is markedly increased in patients in cardiogenic or septicemic shock. Lenoprel relaxes almost all varieties of smooth muscle when the tone is high, but this action is most pronounced on bronchial and gastrointestinal smooth muscle.

INDICATIONS:
1. The treatment of cardiac arrest.
2. As an adjunct in the treatment of cardiogenic shock after myocardial infarction or endotoxic shock.
3. The relief of bronchospasm.
CONTRA-INDICATIONS:
1. It should never be given simultaneously with adrenaline but may be used alternately.
2. Patients with pre-existing cardiac arrhythmias associated with tachycardia.
3. In digitalis intoxication and during anaesthesia with chloroform, cyclopropane, halothane, and other halogenated anaesthetics since it may provoke or worsen ventricular arrhythmias.
4. Hypersusceptible patients, including those with hyperthyroidism or cardiovascular disorders such as acute coronary disease or cardiac asthma.
WARNINGS:
Lenoprel should be administered cautiously and preferably under ECG-control.

DOSAGE AND DIRECTIONS FOR USE:
1. Cardiac arrest:
  Subcutaneous:
Initially, 1 mL (0,2 mg) undiluted solution, followed by 0,75 to 1 mL (0,15 to 0,2 mg)
  Intramuscular:
Initially, 1 mL (0,2 mg) undiluted solution, followed by 0,1 to 5 mL (0,02 to 1 mg)
  Intracardiac:
0,1 mL (0,02 mg) undiluted solution
  Direct intravenous injection:
1 mL (0,2 mg) solution should be diluted to 10 mL with sterile sodium chloride 0,9% or dextrose 5% in water. The usual initial dosage range of this 1:50 000 dilution is 1 to 3 mL (0,02 to 0,06 mg). Subsequent doses of 0,5 to 10 mL (0,01 to 0,2 mg) of this diluted solution are recommended.
  Intravenous infusion:
Add 10 mL of the 1:5 000 solution (2 mg) to 500 mL diluent. The usual rate is 0,125 to 2,5 mL (0,5 to 10 µg) per minute (the rate must be individualized according to the patient's needs). Higher doses up to 40 µg per minute may be necessary in the treatment of heartblock.
2. Shock:
Add 5 mL (1 mg) to 500 mL diluent to give a 1:500 000 solution. The usual rate of infusion is 0,25 to 2,5 mL (0,5 to 5 µg) per minute, but the rate must be individually adjusted.
3. Bronchospasm:
Dilute 1 mL (0,2 mg) to 10 mL with sterile dextrose 5% in water or sodium chloride 0,9%. Administer a dose of 0,5 to 1 mL (0,01 to 0,02 mg) by direct intravenous injection, repeat when necessary.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects may include any of the following: nervousness, nausea and vomiting, sweating, flushing of the skin, tremor, weakness, hypotension, with dizziness and fainting, headache, tachycardia, palpitations and precordial pain, cardiac arrhythmias. It should be used with caution in patients with diabetes mellitus or hypertension. Lenoprel exacerbates the adverse cardiovascular effects of tricyclic antidepressants, such as imipramine, and whenever possible concurrent administration should be avoided. The effects of Lenoprel may be enhanced by concomitant administration of aminophylline.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
For symptoms see above. Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear solution in clear ampoules.

PRESENTATION:
Boxes of 10 x 1 mL ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
W/5.1/261

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD
6 Gibaud Road
Port Elizabeth, 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1989 12-220/2-94
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