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

Logo PETERPHYLLIN INJECTION I.V.
PETERPHYLLIN INJECTION I.M.

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PETERPHYLLIN INJECTION I.V.
PETERPHYLLIN INJECTION I.M.

COMPOSITION:
Contains
Aminophylline (Dihydrate)
Intravenous injection: 250 mg in 10 mL
Intramuscular injection: 500 mg in 2 mL

PHARMACOLOGICAL CLASSIFICATION:
A.10.2. (Bronchodilator)

PHARMACOLOGICAL ACTION:
Peterphyllin (Aminophylline) relaxes smooth muscle and relieves bronchial spasm. Aminophylline is more soluble than pure theophylline.

INDICATIONS:
Relief of bronchospasm associated with asthma, bronchitis and emphysema.

CONTRA-INDICATIONS:
Hypersensitivity to Peterphyllin (Aminophylline).

WARNINGS:
There is evidence that Peterphyllin (Aminophylline) acts synergistically with ephedrine and this must be taken into account if the two drugs are prescribed together. Some children may be unusually sensitive to Peterphyllin (Aminophylline). Safe use of Peterphyllin (Aminophylline) in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Intravenous –Adults 250-500 mg.
Children 6-12 years: 50-100 mg.
The solution should be warmed to body temperature and must be injected slowly.
Intramuscular –Adults, 500 mg.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects commonly encountered with theophylline and its derivatives are gastro-intestinal irritation and stimulation of the central nervous system. Peterphyllin (Aminophylline) may cause nausea, vomiting, gastro-intestinal bleeding, visual disorders, insomnia, headache, anxiety, confusion, restlessness, hyperventilation, vertigo, and palpitations.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may lead to maniacal behaviour, repeated vomiting with extreme thirst, delirium, hyperthermia, 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. Fluid and electrolyte balance should be maintained with intravenous fluids and oxygen given as necessary. Convulsions should be controlled by the intravenous administration of diazepam 5 or 10 mg or, if necessary, thiopentone sodium.

IDENTIFICATION:
Clear colourless to pale yellow solutions in ampoules.

PRESENTATION:
Intravenous –10 mL ampoules, 10's or 100's.
Intramuscular –2 mL ampoules, 10's or 100's.

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

REFERENCE NUMBER:
I.V.: G628 (Act 101/1965)
I.M.: G629 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (Pty) Limited
6 Gibaud Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1990 12-319/3-93
  KOHLER C&P P.E.

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