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5 X 1 ml X 1 mg
Pre-anesthetic medication: Adults: The recommended dose is 0.3-0.6 mg by intravenous injection immediately before the anesthesia induction or by intramuscular injection 30-60 minutes before the induction.
Children: The recommended dose is 0.02 mg/kg (maximum dose 0.6 mg).
Treatment of sinus bradycardia: The recommended dose is between 0.3 and
1.0 mg intravenously.
Antidote in poisoning by organophosphorus: Adults: The recommended dose is 2 mg (intramuscularly or intravenously, taking into account the severity of the poisoning) every 5-10 minutes, until the skin becomes red and dry, the pupils dilate and tachycardia appears.
Children: The recommended dose is 0.02 mg/kg.
Preanesthetic medication to decrease excessive salivation and secretions of the respiratory tract. Treatment of sinus bradycardia, particularly if complicated by hypotension.
Antidote in poisoning by organophosphorus.
Hypersensitivity to the active ingredient or to any of the excipients. Angle- losure glaucoma, esophageal reflux, pyloric stenosis, gastrointestinal obstruction, ulcerative colitis, prostatic hypertrophy, paralytic ileus, intestinal atony.
The solution should be clear, colorless and free of visible particles.
The ampoule is for a single, uninterrupted administration and any unused residual solution should be discarded. Precautions must be taken in geriatric patients for whom you may need a dose adjustment for a possible occurrence of adverse events related to the cardiovascular system and the central nervous system.
Use with caution in patients with ileostomy or colostomy; the occurrence of diarrhea may indicate an incomplete intestinal obstruction.
Use with caution in cases of myasthenia gravis, hyperthyroidism, coronary artery disease, acute myocardial ischemia, tachycardia, tachyarrhythmia, prostatic hypertrophy and other obstructive uropathies.
Important information about some of the excipients: The solution Atropine Sulphate S.A.L.F 1mg/ml contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic or lifethreatening symptoms or severe asthmatic episodes in susceptible patients.
Below are the side effects of atropine organized according to the MedDRA system organ classification. There are insufficient data to determine the frequency of the single effects listed.
Endocrine disorders: Change in the levels of the growth hormone.
Metabolism and nutrition disorders: Porphyria, hyperthermia, hypothermia.
Nervous system disorders: Sedation, disorientation, dizziness, impaired short-term memory, psychosis.
Eye disorders: Diplopia, disturbances in accommodation, mydriasis, changes in intraocular pressure.
Cardiac disorders: Angina, arrhythmias, transient bradycardia (followed by tachycardia, palpitations and arrhythmias), atrioventricular block, hypertension,
Respiratory, thoracic and mediastinal disorders: Reduction of bronchial secretions.
Gastrointestinal disorders: Esophageal regurgitation.
Skin subcutaneous tissue: Redness and dryness of the skin. In the case of intramuscular administration, a reduction in the activity of the sweat glands can be observed.
General disorders and administration site conditions: Hypersensitivity reactions – Anaphylactic reactions.
Derivatives of Belladonna: increase of the anticholinergic activity.
Halothane: attenuation of the depressor effect on the heart rate.
Procainamide: increased vagal effects at atrioventricular level.
Methacholine: inhibition of the bronchoconstriction induced by methacholine inhalation.
Pregnancy and Lactation
Animal studies are insufficient to determine possible effects related to the use of the drug during pregnancy or lactation. The potential risk for humans is not known. Use with caution and only when necessary.
Symptoms: In case of an overdose of the drug, you may have the intensification of the side effects described. In particular, dryness of mucous membranes, dilated pupils, tachycardia, fever and skin rash are possible; neurological symptoms such as confusion, hallucinations, etc., that can persist for 48 hours or more, can also be observed. In some cases respiratory depression, coma, circulatory collapse and death can be observed.
Treatment: At the first signs, in the case of respiratory depression, it is recommended to administer oxygen and, in the case of a persistence of seizures, if the circulatory conditions permit it, proceed with an intravenous administration of short-acting barbiturates (e.g. thiopental) or benzodiazepines (e.g. diazepam). Since atropine is excreted through the kidneys, an intravenous administration of fluids is recommended. In cases of delirium and coma, the administration of physostigmine by a slow intravenous infusion at a dose range of 1 to 4 mg (0.5 to 1 mg in children) is recommended.
Incompatibility: The drug must not be mixed with alkali.
Shelf life: 3 years in unopened package. The product should be used immediately after opening, any unused residual solution should be discarded.
Storage: Store in the original package to protect the drug from light. Store below 25°C.