Summary of Product Characteristics Updated 02-Nov-2015 | Aguettant Ltd
Pre-anaesthetic medicationIntravenous administration immediately before surgery; if necessary an intramuscular administration 30-60 minutes before surgery is possible.
Adults:0.3 0.6 mg IV (3 6 ml)
Paediatric population:The usual dose in children is between 0.01-0.02 mg/kg body weight (maximum 0.6 mg per dose), dosage should be adjusted according to the patient's response and tolerance.In combination with neostigmine to limit its muscarinic effects:
Adults:0.6-1.2 mg IV (6 to 12 ml)
Paediatric population0.02 mg/kg IV
Treatment of hemodynamically compromising bradycardia, atrioventricular block, cardiopulmonary resuscitation:
Adults:- Sinus bradycardia: 0.5 mg IV (5ml), every 2-5 minutes until the desired heart rate is achieved.- AV block: 0.5 mg IV (5ml), every 3-5 minutes (maximum 3 mg)
Paediatric population0.02 mg/kg IV in a single dose (maximum dose 0.6 mg).
As an antidote to organophosphates (pesticides, nerve gases), to cholinesterase inhibitors and in muscarinic mushroom poisoning:Intravenous use.
Adults:0.5 - 2 mg atropine sulfate (5 - 20 ml), can be repeated after 5 minutes and subsequently every 10-15 minutes as required, until signs and symptoms disappear (this dose may be exceeded many times).
Paediatric population:0.02 mg atropine sulfate/kg body weight possibly repeated several times until signs and symptoms disappear.
Dose adjustmentsIn general, dosage should be adjusted according to patient's response and tolerance.Dosage to a total maximum dose of 3 mg in adults and 0.6 mg in children is usually increased until adverse effects become intolerable; then a slight reduction in dosage generally yields the maximum dosage tolerated by the patient.
Paediatric PopulationThis medicinal product is not appropriate to deliver a dose of less than 0.5 ml and should therefore not be used in neonates for which the body weight is inferior to 3 kg (see section 4.1).The dosage ranges for the paediatric weight groups as stated below are values for guidance. The usual dose in children is between 0.01-0.02 mg/kg body weight (maximum 0.6 mg per dose), dosage should be adjusted according to the patient's response and tolerance.
|Body weight (kg)||Dose of 0.01 mg/kg body weight Atropine sulfate 0.5 mg/5 ml Solution for Injection (ml)||Dose of 0.02 mg/kg body weight Atropine sulfate 0.5 mg/5 ml Solution for Injection (ml)|
|3 - 5||0.5 ml||0.5-1.0 ml|
|5-10||0.5-1.0 ml||1.0-2.0 ml|
|10 - 15||1.0-1.5 ml||2.0-3.0 ml|
|15 - 20||1.5-2.0 ml||3.0-4.0 ml|
|20 - 30||2.0-3.0 ml||4.0-6.0 ml|
|30 - 50||3.0-5.0 ml||6.0 ml|
Special populationsCaution is advised for patients with renal or hepatic impairment and in elderly (see section 4.4).
Method of administrationAtropine is administered by intravenous injection or intramuscular injection. Other pharmaceutical forms/strengths may be more appropriate in the cases where a dose above 0.5 mg is required.
Combinations to be taken into accountOther drugs with anticholinergic activity, such as tricyclic antidepressants, some H1-antihistamines, antiparkinsonian drugs, disopyramide, mequitazine, phenothiazines, neuroleptic drugs, atropinic antispasmodics, clozapine and quinidine, because of the risk of potentialisation of atropinic adverse effects (urinary retention, constipation, dry mouth).
PregnancyData on a limited number of exposed pregnancies indicate no adverse effects of atropine on pregnancy or on the health of the fetus/new-born child.Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).Studies of the pharmacokinetics of atropine in mother and fetus in late pregnancy indicated that atropine rapidly crosses the placental barrier. Intravenous administration of atropine during pregnancy or at term may cause tachycardia in the fetus and the mother. Atropine should not be used during pregnancy unless clearly necessary.
Breast-feedingSmall amounts of atropine may pass into human breast milk. Infants have an increased sensitivity to the anticholinergic effects of atropine. Atropine may inhibit the production of milk, particularly upon repeated use. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from treatment taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. If it is decided during treatment to continue breastfeeding, the child should be monitored for anticholinergic effects.
FertilityThere are no data on effects of this atropine sulfate on fertility in humans. Atropine sulfate reduced fertility in male rats, presumably as a consequence of an inhibitory effect on the transport of sperm and semen during the process of emission.
|Frequency||Very Common (≥1/10)||Common (≥1/100 to <1/10)||Uncommon (≥1/1,000 to <1/100)||Rare (≥1/10,000 to <1/1,000)||Very Rare (<1/10,000)||Not known (cannot be estimated from the available data)|
|System Organ Class|
|Immune system disorders||Allergic reactions||Anaphylaxis|
|Nervous system disorders||Excitement, incoordination, mental confusion, and/or hallucinations (especially with higher dosages), hyperthermia||Psychotic reactions||Seizure, drowsiness||Headache, restlessness, ataxia, insomnia|
|Eye disorders||Visual disturbances (mydriasis, inhibition of accommodation, blurred vision, photophobia)|
|Cardiac disorders||Tachycardia (arrhythmias, transient exacerbation of bradycardia)||Atrial arrhythmias, ventricular fibrillation, angina, hypertensive crisis|
|Respiratory, thoracic and mediastinal disorders||Reduced bronchial secretion|
|Gastrointestinal disorders||Dryness of the mouth (difficulty in swallowing and talking, thirst), parasympathetic inhibition of gastrointestinal tract (constipation and reflux), inhibition of gastric secretion, loss of taste, nausea, vomiting, bloated feeling|
|Skin and subcutaneous tissue disorders||Anhidrosis, urticaria, rash|
|Renal and urinary disorders||Inhibition of the parasympathetic control of the urinary bladder, urinary retention|
Paediatric populationInfants, children and children with spastic paralysis or brain damage may be more susceptible to antimuscarinic effects.
Special populationsAtropine may cause excitement, incoordination, confusion and/or hallucinations especially in the elderly. An epidemiological study similarly reported lower cognitive performance in elderly patients receiving antimuscarinics.Patients with Down syndrome may be more susceptible to antimuscarinic effects.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
United KingdomYellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
Treatment:Treatment should be supportive. An adequate airway should be maintained. Diazepam may be administered to control excitement and convulsions but the risk of CNS depression should be considered.
AbsorptionFollowing intravenous administration, the peak increase in heart rate occurs within 2 to 4 minutes. Peak plasma concentrations of atropine after intramuscular administration are reached within 30 minutes, although peak effects on the heart, sweating and salivation may occur 1 hour after intramuscular administration.
DistributionPlasma levels after intramuscular and intravenous injection are comparable at 1 hour. Atropine is distributed widely throughout the body and crosses the blood brain barrier and the placenta barrier.
BiotransformationAtropine is incompletely metabolised in the liver and is excreted in the urine as unchanged drug and metabolites. About 50% of the dose is excreted within 4 hours and 90% in 24 hours.
EliminationThe elimination half-life is about 2 to 5 hours. Up to 50% of the dose is protein bound.
Paediatric PopulationChildren, particularly those younger than two years, may be more susceptible to the actions of atropine. The elimination half-life is more than doubled in children less than two years compared to adults.
ElderlyThe elimination half-life of atropine is more than doubled in the elderly (>65 years old) compared to adults.
Instructions for use:
Be careful to strictly respect the protocol for the use of the syringe.The pre-filled syringe is for single patient only. Discard syringe after use. DO NOT REUSE.The content of un-opened and un-damaged blister is sterile, and must not be opened until used. The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from particles or precipitates should be used. The product should not be used if the tamper evident seal on syringe (plastic cover to the end cap) is broken.The external surface of syringe is sterile until blister is opened.1) Withdraw the pre-filled syringe from the sterile blister.
|2) Push on the plunger to free the bung.|
|3) Twist off the end cap to break the seal.|
|4) Check the syringe seal (plastic cover to the end cap and seal under end cap) has been completely removed. If not, replace the cap and twist again.|
|5) Expel the air by gently pushing the plunger.|
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