COMPOSITION: Atropine Sulphate 0,5 mg in 1 mL and 1,0 mg in 1 mL.
PHARMACOLOGICAL CLASSIFICATION: A 5.4 Cholinolytics
PHARMACOLOGICAL ACTION: Atropine Sulphate is a parasympatholytic agent with central and peripheral actions.
INDICATIONS: Atropine Sulphate by injection is used in many conditions for its parasympatholytic effects.
CONTRA-INDICATIONS: Atropine should not be given to patients with closed-angle glaucoma or a narrow angle between the iris and the cornea. Caution must be observed in administering atropine to patients with prostatic enlargement, coronary insufficiency or cardiac failure. Tachycardia may result from vagal inhibition and induce angina of effort in patients with coronary heart disease. Atropine is also contra-indicated in patients with paralytic ileus.
DOSAGE AND DIRECTIONS FOR USE: 0,25 to 2,0 mg in single or divided doses. Maximum by injection in 24 hours is 3 mg.
SIDE EFFECTS AND SPECIAL PRECAUTIONS: Side effects include dryness of the mouth, thirst, dilation of the pupils with loss of accommodation and photophobia, flushing and dryness of the skin, tachycardia, a desire to urinate with the inability to do so, as well as reduction in the tone and motility of the gastro-intestinal tract, leading to constipation, occasionally vomiting, giddiness and staggering may occur. Hypersensitivity to atropine is not uncommon and occurs as conjunctivitis or a skin rash.
The effects of atropine may be enhanced by the concomitant administration of other drugs with parasympatholytic properties, such as some antihistamines, phenothiazines and tricyclic antidepressants.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Toxic doses of atropine cause tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement and hallucinations passing into delirium. In severe intoxication, depression of the central nervous system may occur with circulatory failure and respiratory depression. Treatment of toxic effects is symptomatic and supportive. In severe cases physostigmine should be administered by slow intravenous injection of 1 to 4 mg. Since physostigmine is rapidly destroyed the patient may again lapse into coma within one or two hours and repeated doses of physostigmine may be needed.
IDENTIFICATION: A clear, colourless solution in 1 mL colourless ampoules.
PRESENTATION: Containers of 10 ampoules.
STORAGE INSTRUCTIONS: Store below 25°C.
Protect from light.
Keep out of reach of children.
REGISTRATION NUMBER/APPLICATION NUMBER:
Intramed Atropine Sulphate Injection 0,5 mg/1 mL:
Intramed Atropine Sulphate Injection 1,0 mg/1 mL:
C 1005 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF APPLICANT: Intramed (Pty) Ltd.
6 Gibaud Road