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Logo EUPHYLLIN RETARD® (Tablets)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

EUPHYLLIN RETARD® (Tablets)

COMPOSITION
One Euphyllin Retard
® filmcoated tablet contains: 250 mg anhydrous theophylline

PHARMACOLOGICAL CLASSIFICATION
A.10.2 Bronchodilator.

PHARMACOLOGICAL ACTION
Euphyllin Retard
® is a delayed release formulation of anhydrous theophylline and has a bronchodilator action.

INDICATIONS
Reversible airways obstruction in chronic obstructive bronchitis, emphysema and bronchial asthma.

CONTRA-INDICATIONS
Hypersensitivity to theophylline or other xanthine derivates. Acute myocardial infarction.
Safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE
Euphyllin Retard
® tablets are scored and can be halved for individual dosage titration. Breaking the tablet does not affect the retard-mechanism because the tablet contains a large number of micro-pellets each of which is individually retard-coated.
Unless prescribed otherwise by the physician, Euphyllin Retard
® is dosed as follows:
Adults: Generally, one tablet taken twice a day (every 10-12 hours) after meals, preferably with some water. Depending upon the effect achieved and in severe cases one tablet can be administered 3 times a day (at intervals of 8 hours, or half tablets can be added to the dosage. As a general guideline the average daily dosage can be given as 10-14 mg/kg body mass/day.
Therapeutic serum levels of theophylline are considered to be between 10 and 20 ug/mL; higher levels may produce toxic effects. There is wide interpatient variation in the dosage needed to achieve and maintain therapeutic serum levels. Because of these wide variations and the relatively narrow range between therapeutic and toxic serum levels, dosage must be individualized, and serum level monitoring is recommended particularly when prolonged use is planned.
Dosage should be calculated on the basis of lean (ideal) body weight since theophylline does not distribute into fatty tissue.
Giving theophylline with food may prevent stomach irritation, although absorption may be slower, it is still complete.

Measurement of serum theophylline concentrations:
The pharmacokinetics of theophylline in an individual patient can only be determined by means of a blood level profile because of the individual biotransformation variation.
For the purposes of these measurements, serum should be obtained at the time of peak drug absorption. An average peak concentration of Euphyllin Retard
® is attained approximately 2 to 5 hours after ingestion of the tablet.

DOSAGE ADJUSTMENT IS BASED ON SERUM THEOPHYLLINE MEASUREMENTS AND WHEN THESE INSTRUCTIONS HAVE NOT BEEN FOLLOWED, THERE MAY BE A RISK OF TOXICITY TO THE PATIENT.

Adolescents: older than 14 years (body mass of approxiately 45 kg or more) may be given half a tablet twice daily.

Babies, infants and children: up to the age of 14 years should not be given Euphyllin Retard
®.

Any additional treatment should only be taken in accordance with the instructions of a physician.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects relate to a great extent, to plasma concentrations and are seen frequently with theophylline concentrations exceeding 20 mg/L.
The most common side-effects include insomnia, headache, nausea, vomiting, diarrhoea, diuresis, tremor, malaise, excitation, anorexia, dizziness, gastralgia, tachycardia and palpitations, reduced exercising ability, excessive sweating, metallic taste in the mouth, gastro-intestinal bleeding, visual disorders, confusion and anxiety.
If side-effects appear, plasma levels of theophylline should be monitored.
Euphyllin Retard
® should be administered with caution and the dosage must be reduced in the elderly and in patients with cardiac failure and impaired hepatic function.
Use with caution in the following conditions: hyperfunction of the thyroid (hyperthyroidism), epilepsy, recent myocardial infarction and tachycardia.
Care should be taken in patients with a history of peptic ulceration.

Interactions
Concurrent use of cimetidine, antibiotics of the macrolid type (e.g. erythromycin), lincomycin, allopurinol, furosemide and oral contraceptives may enhance the effect of Euphyllin Retard
®. While barbiturates, phenytoin, carbamazepine and sulphinpyrazone may weaken it.
Theophylline weakens the effect of lithium carbonate. Additional medication with beta-sympathomimetics, other theophylline-containing preparations and ephedrine may produce untoward effects or potentiate existing ones.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Severe overdosage or idiosyncracy may lead to maniacal behaviour, repeated vomiting with extreme thirst, delirium, hypotension, hyperthermia and convulsions.
Treatment is symptomatic. Gastric lavage may be used. Fluid and electrolyte balance should be maintained with intravenous fluids and sedatives and oxygen given if necessary.

IDENTIFICATION
Light blue, convex, oblong, scored, filmcoated tablets.

PRESENTATION
Packs of 60 and 500 tablets.

STORAGE INSTRUCTIONS
Store in a dry place below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
K/10.2/311.

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Byk Madaus (Pty) Ltd.
Reg. No. 82/11215/07
2nd Road (cnr. 16th Road)
Randjespark, Midrand 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
26 October 1993.

                        ER PI         06/97/01
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