Consumer medicine information

WHAT IS IN THIS LEAFLET?

This leaflet contains information about Atropine Sulfate Injection MINIJET. Please read it carefully and keep it for future reference. The information in this leaflet is only a summary and is not intended to replace advice from your doctor.

Please consult your doctor or pharmacist if you have any comments or questions.

WHAT IS ATROPINE?

Atropine stops the effect of a chemical which we have in our bodies which slows the heartbeat, makes us produce saliva in our mouths and helps us to digest our food. The poison in mushrooms contains a similar chemical. Atropine therefore can increase the heartbeat, slow the digestive processes and act as an antidote to mushroom poisoning.

WHEN IS ATROPINE USED?

Atropine is used in emergency situations where the heart is beating too slowly. It can also be used to prevent such emergencies. Atropine is also very effective for treating people who become ill as a result of eating poisonous mushrooms.

Atropine is occasionally used before a general anaesthetic to dry up saliva and fluid in the lungs.

As atropine is only used in medical emergencies, the injection may be given by paramedical personnel such as ambulance or nursing staff.

WHO SHOULD NOT HAVE ATROPINE INJECTIONs?

As atropine is often used in medical emergencies it should rarely be withheld from anyone who needs it.

Apart from this situation, atropine should NOT be used if you:

• are allergic to it
• have had a previous severe reaction to it
• have trouble passing urine
• have certain heart conditions
• have high pressure in the eye (glaucoma)
• have heartburn
• have certain stomach problems such as pyloric stenosis
• have certain bowel problems such as severe ulcerative colitis or bowel obstruction
• have myasthenia gravis.

BEFORE YOU HAVE AN ATROPINE INJECTION

If you are conscious, you should tell your doctor if you:

• have ever had an allergic reaction to atropine
• have any trouble passing your water
• have any heart complaints
• have ulcerative colitis or obstructive disease of the gastrointestinal tract
• have pyloric stenosis
• have high pressure in your eyes (glaucoma)
• have indigestion
• are taking any medicines and what they are, especially if they are for depression, Parkinson's syndrome, allergy, bowel disorders or heart problems
• are pregnant
• are breast feeding
• have a fever
• have high blood pressure
• are suffering from any other illness.

SIDE EFFECTS OF ATROPINE

As with any medicine, some side effects may occur.

With atropine they are usually mild but severe effects can be caused by larger doses (see OVERDOSE).

Common mild side effects include: dry mouth, constipation, thirst, blurred vision, palpitations, difficulty in passing urine, dizziness, headache, nervousness, nausea.

Always tell your doctor if you have any unpleasant effects after receiving an Atropine Sulfate Injection MINIJET.

THE DOSE OF ATROPINE

The dose of atropine injection is not always the same. Some conditions need a small dose whilst others need a larger amount.

Adults: the usual dose is 0.4 to 0.6 mg which can be repeated if necessary. Larger doses are often needed for mushroom poisoning.

Children: the dose is usually 0.01 mg per kg of bodyweight, but can be increased in certain circumstances.

OVERDOSE

An overdose of atropine will give all the effects listed under SIDE EFFECTS OF ATROPINE but they will be more severe. They include: very dry mouth, difficulty in swallowing, fever, rash, nausea and vomiting, palpitations, high blood pressure, tremor, confusion, drowsiness - leading to coma and possibly death.

There is a product which can be used to reverse the effects of atropine.

WHAT DOES Atropine Sulfate Injection MINIJET CONTAIN?

Atropine Sulfate Injection MINIJET contains atropine at a concentration of 0.1 mg in each mL of injection solution.

Each Atropine Sulfate Injection MINIJET also contains: sodium chloride, sodium citrate, citric acid and water.

HOW TO STORE Atropine Sulfate Injection MINIJET

Atropine Sulfate Injection MINIJET should be protected from light and stored below 25°C. They should not be used after the expiry date on the package.

WHERE CAN I GET MORE INFORMATION?

You can get more information from your doctor or pharmacist.

Sponsor

UCB Pharma
A division of UCB Australia Pty Ltd
Level 1, 1155 Malvern Road
Malvern Vic 3144, Australia

Atropine Sulfate Injection MINIJET
- AUST R 48529

Date of Preparation

March 2012

MINIJET® is a registered trademark of International Medications Systems, Limited.

Published by MIMS June 2012

Name of the medicine

Atropine sulfate.

Excipients

Description

Chemical name: (1R,3r,5S,8r)-tropan- 3-yl-(±)-tropate sulfate monohydrate. Molecular formula: (C₁₇H₂₃NO₃)₂H₂SO₄.H₂O. CAS: 5908-99-6. Atropine is an odourless, bitter tasting, crystalline powder and an alkaloid which is widely distributed in nature, especially in the deadly nightshade plant, Atropa belladonna.

Pharmacology

Atropine is an antimuscarinic agent which competitively antagonizes acetylcholine at postganglionic nerve endings, thus affecting receptors of the exocrine glands, smooth muscle, cardiac muscle and the central nervous system.
Peripheral effects include tachycardia, decreased production of saliva, sweat and bronchial, nasal, lachrymal and gastric secretions, decreased intestinal motility and inhibition of micturition.
Atropine increases sinus rate and sinoatrial and A-V conduction by blocking vagal tone. The heart rate is usually increased but is sometimes preceded by an initial bradycardia.
Atropine inhibits secretions throughout the respiratory tract and relaxes bronchial smooth muscle, producing bronchodilatation.
Peak plasma concentrations of atropine after intramuscular administration are reached within 30 minutes. The elimination half-life varies between 2 and 5 hours. Plasma levels after intramuscular and intravenous injection are comparable after one hour. Atropine is distributed widely throughout the body and crosses the blood brain barrier and placenta. Up to 50% of the dose is protein bound.
Peak effects on the heart occur within 4 minutes of intravenous and about 1 hour after intramuscular administration. Atropine is metabolised in the liver by oxidation and conjugation to give inactive metabolites. About 50% of the dose is excreted within 4 hours and 90% in 24 hours in the urine, about 30 to 50% as unchanged drug.

Indications

Cardiac.

Anaesthesia.

Anticholinesterase poisoning.

Contraindications

Atropine is contraindicated in patients with known hypersensitivity to the drug, those with prostatic hypertrophy, bladder neck obstruction, pyloric obstruction, reflux oesophagitis, unstable cardiac rhythm, narrow angle glaucoma and myasthenia gravis (unless used to treat the adverse effects of an anticholinesterase agent).
Severe ulcerative colitis or toxic megacolon complicating ulcerative colitis, obstructive disease of the GI tract (e.g. pyloroduodenal stenosis, achalasia) cardiospasm, paralytic ileus or intestinal atony (especially in geriatric or debilitated patients) should be included.

Precautions

Antimuscarinic agents should be used with caution in the elderly and in children since these patients may be more susceptible to adverse events. Atropine should also be used with caution in patients with hyperthyroidism, hepatic or renal disease or hypertension. Use with caution in febrile patients or when ambient temperature is high since antimuscarinics may cause an increase in temperature. Antimuscarinics block vagal inhibition of the S-A nodal pacemaker and should thus be used with caution in patients with tachyarrhythmias, congestive cardiac failure or coronary heart disease.
Atropine should be used with extreme caution in patients with mild to moderate ulcerative colitis.
Parenterally administered atropine should be used cautiously in patients with chronic pulmonary disease, since a reduction in bronchial secretions may lead to the formation of bronchial plugs. Antimuscarinics should be used with extreme caution in patients with autonomic neuropathy.
Antimuscarinics decrease gastric motility, relax the lower oesophageal sphincter and may delay gastric emptying; they should therefore be used with caution in patients with gastric ulcer, oesophageal reflux, pyloric stenosis, diarrhoea or gastrointestinal infection.
Systemic administration of conventional doses of atropine may precipitate acute glaucoma in susceptible individuals. Tachycardia may result from vagal inhibition and induce angina pectoris in patients with coronary heart disease.
Infants, patients with Down's syndrome and children with spastic paralysis or brain damage may be hypersensitive to atropine's effect.
As atropine may affect eyesight and cause drowsiness, patients should not be allowed to drive cars or operate machinery.
The atropine is in a single use Minijet prefilled syringe. Once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit.

Use in pregnancy.

Use in lactation.

Interactions

The effects of atropine may be enhanced by the concomitant administration of other drugs with anticholinergic activity such as tricyclic antidepressants, antispasmodics, antiparkinsonian drugs, some antihistamines, phenothiazines, disopyramide and quinidine. By delaying gastric emptying, atropine may alter the absorption of other drugs.

Adverse Effects

Adverse events are dose related and usually reversible when therapy is discontinued. In relatively small doses, atropine reduces salivary, bronchial and sweat secretions; dryness of the mouth and anhidrosis may develop, these effects being intensified as dosage is increased. Reduced bronchial secretion may cause dehydration of residual secretion and consequent formation of thick bronchial plugs that are difficult to eject from the respiratory tract.
Larger doses dilate the pupil and inhibit accommodation of the eye; they also block vagal impulses with consequent increase in heart rate with possible atrial arrhythmias, atrioventricular dissociation, multiple ventricular ectopics and angina; parasympathetic control of the urinary bladder and gastrointestinal tract is inhibited, causing urinary retention and constipation. Further increase in dosage inhibits gastric secretion. Anaphylaxis, urticaria and rash, occasionally progressing to exfoliation, may develop in some patients. Other effects include increased ocular tension, loss of taste, headache, nervousness, drowsiness, weakness, dizziness, flushing, insomnia, nausea, vomiting and bloated feeling. Mental confusion and/or excitement may occur, especially in the elderly.

Dosage and Administration

Adults.

Anaesthetic premedication.

To control muscarinic side effects of neostigmine.

Anticholinesterase poisoning.

Children.

Cardiac.

Anaesthetic premedication.

Anticholinesterase poisoning.

Overdosage

Symptoms and signs.

Treatment.

Presentation

Injection (sterile solution), 0.1 mg/mL, 10 mL: 1's (Minijet: single use prefilled syringe).

Storage

Store below 25°C. Protect from light.

Poison Schedule

S4.