Read the package insert carefully before use. Keep out of reach of children. This medicinal product is prescription drug.

1. Pharmaceutical form: Injection solution, transparent, colorless solution.

2. Ingredients:

Active ingredient: Atropin sulphat……………….. 0,25 mg

Expicients: Acid hydroclorid, and distilled water for injection q.s.f …..1 ml

3. Indications:

• Treatment of acute and chronic diarrhea caused by instestinal motility disorder, abdominal pain caused by gastritis and duodenitis and other disorders with smooth muscle spasm, i.e, spasmodic pain in bile duct, and urinary tract ( Renal colic)
• Treatment of bronchospasm
• Treatment of poison caused by herbticide ( organice phosphate, carbamat), neurotoxin, Amanita muscaria fungi
• Premedication
• Treatment of bradycardia, hypotension in emergency cardiopulmonary resuscitation, after myocardial infarction due to nitroglycerin, digitalis poisoning or poison caused by halothan, propofol, suxamethonium.
• Extrapyramidal symptoms, drug-induced Parkinson’s syndrome

4. Administration and dosage:

Adults: Instramuscular, intravenous or subcutaneous injection: 0,4 – 0,6mg ( from 0,3 – 1,2 mg)

Children: 0,01mg/kg or 0,3mg/m2, normallty not exceeding 0,4 mg. If needed, the administration can be repeated with the interval between 4 to 6 hours.

Surgery

Premedication

• Adults: 0, 4 mg ( from 0,2 – 1mg), administered by instramuscular or subcutaneous injection 30 to 60 minutes prior to anesthesia
• Children: body weight of 3 kg: 0,1mg, 7 – 9kg: 0,2mg, 12 – 16kg: 0,3mg

Block side effects of musarin of anti-Cholinesterase drugs ( neostigmin)

• Adults: Atropine is admistered by intravenous injection, dose of 0.6 – 1.2mg for each 0.5 – 2.5mg neostigmin (atropine administered simultaneously but injected individually or a few minutes before anti-Cholinesterase)
• Infants and kids: 0.02mg / kg atropine admistered simultaneously with 0.04mg neostigmin

Cardiopulmonary resuscitation

• Adults who are given treatment of bradycardia in emergency cardiopulmonary resuscitation: 0.5 mg,  intravenous administration, repeated every 3-5 minutes until reaching desired heart rate or total dose of 3 mg. Treatment of asystole, slow electrical activitation without pulses, administered in intravenous injection 1mg, can be repeated every 3-5 minutes if needed, up to a total dose of 3mg.
• Children: 0.02 mg / kg given intravenously or in bone marrow, minimum dose of 0.1 mg and maximum dose of 0.5 mg in children and 1 mg in teenagers. The dose may be repeated once in 5 minutes with a total maximum dose of 1mg in children and 2mg in teens. Higher doses may be needed in special cases such as organophosphorus poisoning or neurotoxin.

Treatment of poisoning caused by organic phosphate, carbamat, neurotoxin

• Adults: The first dose is 1-2mg or more, given intramuscularly or intravenously every 5-60 minutes until muscarin symptoms are resolved. In severe cases, a dose of 50mg may be required in the first 24 hours. When high doses of atropine is used, the dose must be gradually reduced to avoid sudden relapse of the symptoms (such as pulmonary edema). The total dose of atropine used in carbamate poisoning is usually less. The dose of atropine needed depends greatly on the severity of the poisoning.
• Children: Usual intramuscular or intravenous dose: 0.03 – 0.05mg / kg 10 to 30 minutes apart until muscarin symptoms is resolved. Reapply if the symptoms recur.

5. Contraindications

• Prostate hypertrophy (urinary retention), intestinal paralysis or pyloric stenosis, myasthenia gravis (but can be used to reduce muscarinic effects of anti-Cholinesterase drugs), angle-closure or narrow-angle glaucoma (increased intraocular pressure and may promote glaucoma appearance), tachycardia, symptoms of thyroid poisoning.
• Children: when ambient temperature is high or the patients are having severe fever

6. Special warnings and precautions for use

• Children and the elderly (may  be more susceptible to side effects of the drug)
• Childen with Down syndrome
• People with diarrhea.
• Fever, muscle weakness.
• People with heart failure, cardiac surgery.
• People with acute myocardial infarction who have high blood pressure.
• People with liver and kidney failure.

7. Pregnancy and lactation

7.1. Pregnancy

Atropine crosses the placenta after intravenous injection and the maximum concentration in the blood of umbilical cord is reached after 5 minutes and has the strongest effect on the fetal heart after 25 minutes. However, there is no known toxic risk to embryos and fetuses. Atropin should be used with great cautions in the last months of pregnancy because of possible adverse effects on the fetus.

7.2. Lactation

Infants are very sensitive to anti- acetylcholin drugs, so the use of this drug should be avoided during breastfeeding.

8. Effects on ability to drive and use machines

Do not use this drug while driving, operating machinery

9. Interactions and incompatilities with other drugs

9.1. Interactions

• .Atropin and alcohol: consumption of alcohol and atropine at the same will reduce the attention span that may cause dangers while driving vehicles and machines.
• Atropine and other anti-acetyl cholinergic drugs: the anticholinergic effects will be much stronger, both peripheral and central. The consequences can be very dangerous.
• Atropine and some antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants: if atropine is used concurrently with the abovementioned drugs, the effect of atropine will increase.
• Atropine may reduce the absorption of other drugs because it decreases gastric motility

9.2. Incompatabilities

Physical incompatibility will occur if  parenteral atropine sulfate is mixed with norepinephrine bitartrate, metaraminol bitartrate and sodium bicarbonate. Mixing atropine sulphate with sodium methohexital solution will bring precipitation in 15 minutes.

10. Adverse effects

Common: ADR > 1/100

• Body: dry mouth, difficulty in swallowing, and pronouncing, thirst, fever, decreased bronchial secretions.
• Eyes: dilated pupils, loss of eye adaptation, fear of light.
• Cardiovascular: transient bradycardia followed by tachycardia, palpitations and arrhythmia.
• Central nerve system: confusion, paranoia, irritability.

Rare: 1/1000 < ADR < 1/100

• Body: Allergic reactions, red and dry skin, vomiting.
• Urology: difficulty urinating.
• Gastrointestinal: decreased tone and motility of the gastrointestinal tract, leading to constipation.
• Central nerve system: staggering, lightheadedness.

Inform doctors of undesirable effects while using this drug

11. Overdosage and treatment:

11.1. Overdose:

The appearance of the symptoms such as mydriasis, tachycardia, tachypnea, high fever, irritated central nervous system (jitteriness, confusion, euphoria, psychotic reactions and psychological, paranoid, delirious, sometimes convulsive indicates that the patients got poisoned. In severe poisoning, over-stimulated central nervous system can lead to inhibition, coma, circulatory failure, respiratory failure, and death.

11.2. Treatment:

Supportive measures are needed.  diazepam can be used for treatment of overstimulated and convulsive. Do not use phenothiazine because it will increase the effect of anticholinergics.

12. Pharmadynamic properties

• Pharmatheraopeutic group: Anticholinergic drugs (sympathomimetic inhibitors). Antidote
• ATC code: A03BA01

Atropine is an anti-muscarin alcaloid, a tertiary amine compound that has both central and peripheral contempt effects. Inhibitors compete with acetylcholine in the muscarin receptors of organs that are governed by the sympathetic system (cholinergic fibrotic fiber) and inhibit the effect of acetylcholine on smooth muscle without cholinergic nerves. Atropine first stimulates then inhibits the effect of the central nervous system and has antispasmodic effect on smooth muscles and reduces the secretion of salivary and bronchial glands.

Atropine inhibits the vagus nerve so the heart beats fast. Because of its effect on heart rate, atropine is used to treat bradycardia and systolic beats due to many causes including cardiac – respiratory resuscitation. Due to its anti-muscarin effect, atropine is used as an anesthetic, antispasmodic smooth muscle spasm, antispasmodic antispasmodic, treatment of fungal poisoning and organic phosphorus pesticides.

13. Pharmakinetic properties

Atropine is rapidly absorbed by intramuscular injection. It achieves its peak in 30 minutes after intramuscular injection. The drug crosses rapidly from the blood and is distributed throughout the body. The drug crosses the blood-brain barrier, and  the placenta and has traces in breast milk. The half-life of the drug shows 2 distinct phases, the first phase is about 2 hours, the next phase is about 12.5 hours or longer. In kids, children and elderly, the half-life of the drug lasts longer. As a metabolized atropine in the liver, the drug is excreted by the kidneys in the form of 50% and in the form of metabolism.

14. Packaging

Vial of 1ml, box of 20 vials, 50 vials, 100 vials enclosed with a package insert

15. Storage condition, shelf life, specification

Storage condition: Store in a dry place, avoid direct light. Do not store above 30⁰C

Shelf life: 36 months from the date of manufacturing

Specification: Vietnamese pharmacopeia