Acefylline
(Injection)

Composition:
Each 5 ml ampoule contains:
Acefylline piperazine ................................. 500 mg.

Properties:
Acephylline piperazine is a theophylline derivative with a direct bronchodilator action. It has the advantages over theophylline in being far less toxic and producing minimal gastric irritation.

Indications:
Asthma, emphysema, acute and chronic bronchitis associated with bronchospasm
Chronic inflammatory lung diseases.
Inhalation of irritants.

Use in pregnancy:
Safety is not established.

Drug interactions:
Xanthenes derivatives may:
  • Produce excessive C.N.S. Stimulation when given with ephedrine or other sympathomimetic specially in children (In the very young) convulsions may occur.
  • Enhance the toxicity of digitalis glycosides
  • The bronchodilator action of xanthenes may be antagonized by beta adrenergic blockers and reduced by smoking
  • Tachycardia may occur when xanthenes are given with reserpine or sympathomimetic
  • Increased serum levels and effects of xanthenes derivatives may occur with erythromycin.lincomycin, clindamycin and allopurinol.

Precautions:
The dose should not be exceeded in children especially neonates
Use with caution in cases of:
compromised cardiac or circulatory function, hyperthyroidism, prostate hypertrophy, peptic ulcer, glaucoma, diabetes mellitus, severe hypertension and in nursing mothers.

Contraindications:
  • Hypersensitivity to xanthenes
  • Severe renal or hepatic impairment
  • Gastritis and active peptic ulcer
  • Rapid cardiac arrhythmias and acute coronary heart disease when myocardial stimulation.
  • Might be harmful.
Dosage & route of administration & duration:
The optimum therapeutic serum concentration is considered to range from 10 to 20 mcg/ml
To avoid adverse effects the rate of infusion administration should not exceed 20 mg / min
For I.M & slow I.V injection of 200 mg over at least 15 min.
For IV infusion a loading dose of 4 mg/kg may be given over 20 to 30 min followed by a suggested maintenance dose of 0.5 mg /kg / hour reduced after 12 hours to 0.4 mg/kg/hour.

Suggested Doses for children:
4mg/Kg by slow IV injection over at least 15 min or by infusion with a loading dose of 4 mg/kg followed by maintenance doses of:
  • Children from 6 months to 6 years
    0.8 to 1 mg/kg/hour, reduced after the first 12 hours to 0.6 mg/kg/hour.
  • Children over 6 years
    0.75 mg/kg/hour, reduced after the first 12 hours to 0.5 mg/kg/hour.
Adverse effects:
  • Gastrointestinal disturbance: epigastria pain, nausea, vomiting and diarrhea.
  • C.N.S. stimulation: irritability (Specially in children), nervousness, insomnia & headache.
  • Palpitations, tachycardia and extra systole.
  • Tachypnea.
  • Transient urinary frequency.

Storage:
Keep at temp. not exceeding 30°C.
Keep medicine out of reach of children.

Presentation: Box of 100 ampoules.