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

Logo Q-MED THEOPHYLLIN Injection I.V.
Q-MED THEOPHYLLIN Injection I.M.

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

Q-MED THEOPHYLLIN Injection I.V.
Q-MED THEOPHYLLIN Injection I.M.

COMPOSITION:
Intravenous injection: Each 10 mL contains 250 mg
aminophylline.
Intramuscular injection: Each 2 mL contains 500 mg aminophylline and 2% v/v benzyl alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A 10.2 (Bronchodilator).

PHARMACOLOGICAL ACTION:
Aminophylline relaxes smooth muscle and relieves bronchial spasm.

INDICATIONS:
Relief of bronchospasm associated with asthma, bronchitis and emphysema and acute respiratory infections.
Q-Med Theophyllin ampoules are primarily for use in emergency situations.

CONTRA-INDICATIONS:
Hypersensitivity to aminophylline, or other xanthine preparations. Theophylline crosses the placenta and also enters breastmilk. Safety in pregnancy and lactation has not been established.
Porphyria.

WARNINGS:
Aminophylline acts synergistically with sympathomimetics ie. ephedrine, and this must be taken into account if the two agents are prescribed together. Intravenous injections must be administered slowly to prevent central nervous system, and cardiovascular side effects.

DOSAGE AND DIRECTIONS FOR USE:
Intravenous:
In patients who have not been taking aminophylline or theophylline, aminophylline is given in a loading dose of 5 to 6 mg per kg body-weight by slow intravenous injection, usually over 20 to 30 minutes. In patients who have been receiving aminophylline or theophylline, ideally the serum-theophylline concentration should be measured before administering a loading dose. The loading dose can then be determined on the basis that aminophylline 600 µg per kg lean body-weight can be expected to increase the serum-theophylline concentration by approximately 1 µg per mL, and a serum concentration of 10 to 20 µg per mL is required.
In an emergency where the serum-theophylline concentration is not available, a loading dose of 2,5 to 3,0 mg per kg may be given. The rate of intravenous administration of aminophylline should not exceed 25 mg per minute.
Intravenous infusion maintenance doses:
Children - aged 6 months to 9 years: 1,0 mg per kg body weight hourly.
Children - aged 10 to 16 years: 800 µg per kg hourly;
Adults - Adults smoking: 800 µg per kg per hour;
Non-smoking adults: 500 µg per kg per hour;
Older patients or patients with cor pulmonale: 300 µg per kg per hour;
Patients with congestive heart failure: 100 to 200 µg per kg per hour.
Serum-theophylline concentration measurement is recommended, and maintenance doses should be reduced if serum concentrations exceed 20 µg per mL or the patient experiences toxicity. Plasma concentration of theophylline greater than 20 µg per mL are considered to be toxic.
Intramuscular:
Adults 250 to 500 mg.
Intramuscular administration is only recommended when vascular access is not possible.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Theophylline can precipitate sinus tachycardia and supraventricular and ventricular premature contractions at therapeutic serum theophylline concentrations.
Hypokalaemia has also been reported in patients with plasma-theophylline concentrations within the therapeutic range. Hypophosphataemia and hyponatraemia can also occur at therapeutic plasma-theophylline concentrations. It is recommended that plasma-potassium is monitored during intravenous theophylline therapy particularly if other agents predisposing to hypokalaemia are also administered. Metabolic disturbances such as hyperglycaemia, hypophosphataemia, hypercalcaemia, metabolic acidosis, and respiratory alkalosis occur.
Hypersensitivity reactions have been reported following oral or intravenous administration of aminophylline. Reactions include erythematous rash with pruritus, erythroderma, and exfoliative dermatitis.
It was recommended that plasma-glucose concentrations be monitored in preterm infants receiving theophylline.
Theophylline or aminophylline should also be given with caution to patients with congestive heart failure, hepatic dysfunction or chronic alcoholism, acute febrile illness, severe hypoxia, pulmonale, chronic lung disease, and to neonates and the elderly, since in all of these circumstances theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.
The bronchodilator and toxic effects of theophylline or aminophylline and sympathomimetics or other xanthines are additive. Concomitant use of other xanthine medications should be avoided.
Theophylline clearance may be reduced by interaction with other drugs including cimetidine, disulfiram, macrolide antibiotics and quinolones, oral contraceptives, thiabendazole, and viloxazine necessitating dosage reduction. Phenytoin and some other anticonvulsants, rifampicin, and cigarette smoking may increase theophylline clearance, necessitating an increase in dose or dosing frequency.

KNOWN SYMPTOMS OF OVERDOSAGE ITS TREATMENT:
Overdosage may lead to maniacal behaviour, diuresis and repeated vomiting with extreme thirst, tremor, delirium, hyperthermia, tachycardia and convulsions. Hypotension may follow intravenous injection, particularly if the injection is too rapid, and sudden deaths have been reported. Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear colourless to faintly yellow solution in ampoules.

PRESENTATION:
Intravenous - 10 mL ampoules packed in 10's.
Intramuscular - 2 mL ampoules packed in 10's.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
Keep all medicine out of reach of children.

REGISTRATION NUMBERS:
Q-MED Theophyllin Injection I.V. : 29/10.2/0632
Q-MED Theophyllin Injection I.M. : 29/10.2/0633

NAME AND BUSINESS ADDRESS OF APPLICANT:
Quatromed Limited
10 Lindley Street
BETHLEHEM
9700

DATE OF PUBLICATION:
October 1995                PTH 0081/11-95

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