- Approval Id
- 7d87ec3636b4702d
- Drug Name
- ATROPINE INJECTION BP 600 mcg/ml
- Product Name
- ATROPINE INJECTION BP 600 mcg/ml
- Approval Number
- SIN07360P
- Approval Date
- 1993-03-15
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- <p><strong>4.2 Dose and Method of Administration</strong></p>
<p>Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact.</p>
<p>Atropine Injection may be given by subcutaneous (SC), intramuscular (IM) or direct intravenous (IV) injection.</p>
<p>Atropine Injection should not be added to any IV infusion solutions for administration. Atropine Injection contains no microbial agent. It should be used in one patient on one occasion only and any residue discarded.</p>
<p><strong>Cardiopulmonary resuscitation</strong></p>
<p>The usual adult dose is 0.4 – 1 mg IV, which may be repeated at 5 minute intervals until the desired heart rate is achieved. The total dose should not exceed 2 mg.</p>
<p>The usual paediatric dose is 0.02 mg/kg (maximum single dose 0.5 mg) IV, which may be repeated at 5 minute intervals until the desired heart rate is achieved. The total dose should not exceed 1 mg.</p>
<p><strong>Premedication</strong></p>
<p>300 – 600 micrograms Atropine Injection may be given IM or SC 30 to 60 minutes prior to induction of anaesthesia, usually in conjunction with a narcotic. Alternatively 300 – 600 micrograms IV may be given immediately before induction of anaesthesia.</p>
<p>Suitable premedication doses to be given SC 30 to 60 minutes prior to surgery in infants and children are:</p>
<ul>
<li><p>infants < 3 kg: 100 micrograms</p></li>
<li><p>7 to 9 kg: 200 micrograms</p></li>
<li><p>12 to 16 kg: 300 micrograms</p></li>
<li><p>20 to 27 kg: 400 micrograms</p></li>
<li><p>32 kg: 500 micrograms</p></li>
<li><p>41 kg: 600 micrograms.</p></li>
</ul>
<p><strong>Reversal of competitive neuromuscular block</strong></p>
<p>May be given by slow IV injection in conjunction with an anticholinesterase agent (e.g. neostigmine, physostigmine). Six hundred micrograms (600 micrograms – 1.2 mg atropine for each 0.5 – 2.5 mg neostigmine methylsulfate in adults and 0.02 mg/kg atropine for each 0.04 mg/kg neostigmine methylsulfate in children.</p>
<p><strong>Organophosphate poisoning</strong></p>
<p>1 – 2 mg atropine may be given IV. Additional 2 mg doses may be administered IM or IV every 5 to 60 minutes until muscarinic signs and symptoms subside; and repeated if these reappear. For severe cases 2 – 6 mg may be administered IV, with subsequent additional doses of 2 – 6 mg being administered IM or IV every 5 to 60 minutes until muscarinic signs and symptoms subside.</p>
<p>Doses up to 50 mg may be required within the first 24 hours. With severe cases atropine therapy should be withdrawn gradually to avoid sudden recurrence of symptoms (e.g. pulmonary oedema). A cholinesterase reactivator (e.g. pralidoxime) is administered concomitantly.</p>
<p>The dose for children is 0.05 mg/kg IM or IV, repeated at 10 to 30 minute intervals until muscarinic signs and symptoms subside. This is to be repeated if these reappear.</p>
- Route Of Administration
- INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 Therapeutic Indications</strong></p>
<ul>
<li><p>Preanaesthetic medication to reduce salivary secretions and bronchial secretions</p></li>
<li><p>to prevent cholinergic cardiac effects such as cardiac arrhythmias, hypotension and bradycardia</p></li>
<li><p>management of patients with acute myocardial infarction and sinus bradycardia who have associated hypotension and increased ventricular irritability</p></li>
<li><p>concurrent administration with anticholinesterase agents (e.g. neostigmine, physostigmine) to block the adverse muscarinic effects of these agents following surgery to terminate curarisation</p></li>
<li><p>for poisoning by organophosphate pesticides, atropine may be used concomitantly with a cholinesterase reactivator such as pralidoxime to reverse muscarinic effects.</p></li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li><p>Known hypersensitivity to atropine or other anticholinergic agents</p></li>
<li><p>severe ulcerative colitis</p></li>
<li><p>toxic megacolon complicating ulcerative colitis</p></li>
<li><p>gastrointestinal obstruction, e.g. pyloroduodenal stenosis, achalasia, cardiospasm, paralytic ileus, intestinal atony</p></li>
<li><p>closed-angle glaucoma</p></li>
<li><p>obstructive uropathy, e.g. bladder neck obstruction caused by prostatic hypertrophy</p></li>
<li><p>myasthenia gravis</p></li>
<li><p>tachycardia secondary to cardiac insufficiency or thyrotoxicosis</p></li>
<li><p>acute haemorrhage with unstable cardiovascular status</p></li>
<li><p>febrile patients or patients exposed to elevated ambient temperature, due to the risk of provoking hyperpyrexia and heat prostration</p></li>
<li><p>prostatic enlargement</p></li>
<li><p>pregnancy induced hypertension.</p></li>
</ul>
- Atc Code
- A03BA01
- Atc Item Name
- atropine
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
