Active substanceAtropineAtropine
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  • Atropine sulfate
    solution for injections 
  • Dosage form: & nbspinjection
    Composition:

    Composition for 1 ml.

    Active substance: atropine sulfate (in terms of anhydrous substance) 1.0 mg;

    Excipients: hydrochloric acid solution 1M - to a pH of 3.0-4.5, water for injection - up to 1.0 ml.

    Description:

    Colorless or slightly colored transparent liquid.

    Pharmacotherapeutic group:M-holinoblokator
    ATX: & nbsp

    A.03.B.A   Alkaloids belladonna, tertiary amines

    A.03.B.A.01   Atropine

    Pharmacodynamics:

    The blocker of m-holinoretseptorov, is a natural tertiary amine. It is believed that atropine to the same extent binds to M1-, M2- and M3-subtypes of muscarinic receptors. Affects both central and na peripheral m-holinoretseptory. Reduces the secretion of salivary, gastric, bronchial, sweat glands. Reduces the tone of smooth muscles internal organs (including bronchi, organs of the digestive system, urethra, bladder), reduces the motility of the gastrointestinal tract (GIT). Virtually does not affect the secretion of bile and pancreas.In average therapeutic doses atropine has a moderate stimulating effect on the central nervous system (CNS) and a delayed, but prolonged sedation. The central anticholinergic action explains the ability of atropine to eliminate tremor in Parkinson's disease. In toxic doses atropine causes excitement, agitation, hallucinations, coma. Atropine reduces the tone of the vagus nerve, which leads to an increase in the heart rate (with a slight change in blood pressure (BP)), increasing conduction in the bundle.

    In therapeutic doses atropine does not have a significant effect on peripheral vessels, but with an overdose there is vasodilation.
    Pharmacokinetics:

    After systemic administration, it is widely distributed in the body. Penetrates through the blood-brain barrier. Significant concentration in the central nervous system is reached within 0.5-1 h. Binding to plasma proteins is moderate. Half-life (Ti/2) is 2 hours. It is excreted in urine; about 60% - in unmodified form, the rest - in the form of products of hydrolysis and conjugation.

    Indications:

    - Spasm of smooth muscles of the digestive tract; gastric ulcer disease (exacerbation) and duodenum (exacerbation), acute pancreatitis, hypersalivation (parkinsonism, poisoning by heavy metal salts, in dental interventions), renal colic, hepatic colic, bronchospasm, laryngospasm (prevention);

    - premedication before surgical operations;

    - atrioventricular block, bradycardia; poisoning with m-cholinomimetics and anticholinesterase substances (reversible and irreversible action).

    Contraindications:

    Hypersensitivity, angle-closure glaucoma (mydriatic effect, which leads to an increase in intraocular pressure, may trigger an acute attack), tachyarrhythmia, severe chronic heart failure, coronary artery disease, mitral stenosis, reflux esophagitis, hiatal hernia, pyloric stenosis, hepatic and / or renal failure, bowel atony, obstructive bowel disease, paralytic ileus, toxic megacolon, ulcerative colitis, dry mouth, myasthenia gravis, for urge or predisposition to it, diseases accompanied by obstruction of the urinary tract (incl.neck of the bladder due to prostatic hypertrophy), pregnancy toxicity, Down's disease, cerebral palsy, lactation.

    If you have one of the listed diseases (conditions), before taking the drug always consult a doctor.

    Carefully:

    Hyperthermia, open-angle glaucoma, chronic heart failure, arterial hypertension, chronic lung diseases, acute blood loss, hyperthyroidism, age over 40 years, pregnancy.

    Pregnancy and lactation:

    Atropine penetrates the placental barrier. Adequate and strictly controlled clinical studies of the safety of atropine during pregnancy have not been conducted.

    With intravenous administration during pregnancy or shortly before birth, it is possible to develop tachycardia in the fetus.

    The drug should be used during pregnancy only in cases where the potential benefit justifies the potential risk to the fetus.

    Atropine is found in breast milk in trace concentrations.

    If you need to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    For relief of acute pain in gastric ulcer and duodenal ulcer and pancreatitis, with renal and hepatic colic the drug is administered subcutaneously or intramuscularly at 0.25-1 mg (0.25-1 ml solution).

    To eliminate bradycardia - intravenously for 0.5-1 mg, if necessary, after 5 minutes, the administration can be repeated.

    For the purpose of premedication, intramuscularly 0.4-0.6 mg 45-60 minutes before anesthesia.

    Children the drug is administered in a dose of 0.01 mg / kg.

    When poisoning with m-cholinostimulants and anticholinesterase agents, 1,4 ml is administered intravenously, preferably in combination with cholinesterase reactivators.

    Side effects:

    From the digestive system: dry mouth, constipation, intestinal atony.

    From the side of the central nervous system: headache, dizziness.

    From the cardiovascular system: sinus tachycardia, aggravation of myocardial ischemia due to excessive tachycardia, ventricular tachycardia and ventricular fibrillation.

    From the urinary system: difficulty urinating, atony of the bladder.

    From the sense organs: photophobia, mydriasis, paralysis of accommodation, impaired tactile perception, increased intraocular pressure.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    Symptoms: Dryness of the mucous membrane of the oral cavity and nasopharynx, violation of swallowing and speech, dry skin, hyperthermia, mydriasis (increased severity of side effects); motor and speech excitation, memory impairment, hallucinations, psychosis.

    Treatment: Anticholinesterase and sedatives.

    Interaction:

    When used simultaneously with anticholinergics and anticholinergic agents, anticholinergic action is enhanced.

    With simultaneous application with atropine, it is possible to slow the absorption of zopiclone, mexiletine, reduce the absorption of nitrofurantoin and its excretion by the kidneys. Probably strengthening the therapeutic and side effects of nitrofurantoin.

    With simultaneous use with phenylephrine, an increase in blood pressure is possible. Under the influence of guanethidine, a decrease in the hypoxecretory effect of atropine is possible. Nitrates increase the likelihood of increased intraocular pressure.

    Procainamide enhances the anticholinergic effect of atropine.

    Atropine reduces the concentration of levodopa in the blood plasma.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, it is necessary to refrain from driving vehicles and practicing other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for injection, 1 mg / ml.

    Packaging:

    For 2 ml in glass syringes of neutral glass with the Luer Lock lock, with a hard cap and accessories. 1 syringe per circuit cell packaging from a film of polyvinylchloride or polyethylene terephthalate. On 1 contour acheikova packing together with a needle injecting and the instruction on application in a pack from cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    The drug should not be used after the expiry date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004414
    Date of registration:15.08.2017
    Expiration Date:15.08.2022
    The owner of the registration certificate:FARMZASCHITA NPC, FSUE FARMZASCHITA NPC, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.09.2017
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