Atropine Sulphate Injection Bp
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1. Trade Name of the Medicinal Product Atropine Sulphate Injection BP 1mg in 1ml
2. Qualitative and Quantitative Composition
Atropine Sulphate 0.10% w/v
3. Pharmaceutical Form
Solution for injection.
Clinical Particulars
4.1. Therap euti c Indi cati ons
1. Bradycardia after myocardial infarction or when caused by beta - adrenoceptor blocking
drugs.
2. To prevent excessive bronchial secretion during the use of general anaesthesia.
4.2. Posology and Method of Administration
Bradycardia
Adults and the elderly: 100 micrograms incremental doses by the-subcutaneous or
intravenous routes.
Children: Not recommended.
Pre - medication.
Adults and the elderly. By the intravenous route: 300 - 600 micrograms immediately
before induction of anaesthesia. By the intramuscular or subcutaneous route: 300 - 600 micrograms, 30 minutes before induction of anaesthesia.
Children:
Premature infants: Full term infants: 6 months - 1 year:
By the subcutaneous route 30 minutes before induction of anaesthesia.
Up to 60 micrograms.
Up to 100 micrograms.
Up to 200 micrograms.
By the intramuscular route 30 minutes before induction of anaesthesia.
For older children:
20 micrograms per kilogram body weight.
4.3. Contra-indications
Prostatic enlargement, use with caution to elderly men. Paralytic ileus and closed angle glaucoma.
4.4. Special Warnings and Precautions for Use
Use with caution in patients with fever, pyloric stenosis, ulcerative colitis, gastro - oesophageal reflex or cardiac insufficiency.
4.5. Interactions with Other Medicaments and Other Forms of Interaction
The effects of Atropine may be enhanced by the concomitant administration of drugs such as drugs with anticholinergics actions such as amantadine, some antihistamines, buterophenones, phenothiazines and tricyclic antidepressants.
The effects of Atropine may be opposed by metoclopramide.
4.6. Pregnancy and Lactation
There is no or inadequate evidence of safety of Atropine in human pregnancy, but the drug has been widely used for many years without apparent ill-consequence. If drug therapy is needed in pregnancy the use of this drug is acceptable.
Use during breast feeding is not recommended.
4.7. Effects on Ability to Drive and Use Machines
Atropine may impair vision and should be used with caution if the patient intends to drive or operate machinery.
4.8.
Undesirable Effects
Atropine may cause excitement, delirium, dilated pupils, rapid pulse, hot flushes, dry skin, dry mouth and thirst. These may be followed by arrhythmias, difficulty with micturition and constipation. Rarely, fever, confusional states and rashes may occur.
4.9. Overdose
Symptoms Signs of overdosage are those described in section 4.8.
Treatment Symptomatic and supportive treatment should be instituted. If the product has been introduced orally then gastric lavage should be included. In later stages respiratory depression may occur and artificial respiration may be needed. Circulatory failure may occur.
Pharmacological Properties
5.1. Pharmacodynamic Properties Atropine has central and peripheral actions.
Initially the central effects cause restlessness and excitement, but larger doses produce central depression with drowsiness, delirium and coma.
It diminishes the secretions of the salivary and sweat glands and of the bronchial and gastro - intestinal tracts. It increases the heart rate, produces vasodilation, dilates the pupils, paralyses the muscles of accommodation and increases intra - ocular pressure.
5.2. Pharmacokinetic Properties
Atropine is rapidly absorbed from mucous membranes, skin and the gastro -intestinal tract.
It is 50% plasma protein bound.
After 24 hours about 85% of a dose is excreted in the urine.
5.3. Preclinical Safety Data
None stated.
Pharmaceutical Particulars 6.1. List of Excipients
Sodium Chloride and Water for Injections. The pH may be adjusted using Sodium Hydroxide or Sulphuric Acid.
6.2. Incompatibilities
None known.
6.3 Shelf Life
36 months.
6.4. Special Precautions for Storage
None stated.
6.5. Nature and Contents of Container
1 ml in type 1 colourless neutral glass ampoules. Fusion sealed. Packed into carton of 10 ampoules.
6.6. Instruction for Use/Handling
None stated.
Administrative Data
7. Marketing Authorisation Holder
Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals Bampton Road,
Harold Hill,
Romford,
RM3 8UG
PL 01883/6172R
9. Date of First Authorisation/Renewal of Authorisation
First authorised 9 October 1989
Renewed 19 October 1994
10 DATE OF REVISION OF THE TEXT
20/04/2012