Atropine sulphate. 1mg.ml. 1ml. 10amp
Atropine sulphate. 1mg./ml. 1ml. 10amp
What is Atropine Sulphate and what it is used
This product contains the active substance atropine, which is an alkaloid isolated from the plant Belladonna or Nightshade (Atropa Belladonna). It relaxes smooth muscles of the bronchi , gastrointestinal tract, biliary and urinary tract accelerates heart rate, suppresses bronchial , salivary and sweat glands.
Sopharma atropine injection is used in :
disturbance in conduction and cardiac arrest with reduced blood pressure in patients with acute myocardial infarction;
cardio- pulmonary resuscitation to treat slow heart rate , low blood pressure , impaired blood flow to the organs or irregular heartbeat ;
preparation for surgery to reduce the formation of mucus in the airways ;
during anesthesia to prevent reflex bradycardia ( slow heart rate ) ;
as an antidote ( antidote ) in acute poisoning with anticholinesterase agents , in the treatment of poisoning with organophosphorus insecticides, carbamates, mushrooms , overdose with medicinal products parasimpatikomimetichno action ;
in treatment of acute spastic conditions of the gastrointestinal tract, the urinary and biliary ducts.
2 . What you should know before using Atropine Sopharma
Do not use Atropine Sopharma :
if you are allergic to the active substance, other anticholinergics or any of the other ingredients of this medicine (listed in Section 6) ;
if you have glaucoma ( increased eye pressure) ;
if you have a urinary disorders - urinary retention, an enlarged prostate ;
if you are breastfeeding .
Warnings and Precautions
Atropine is used with caution in patients with hypertrophy (enlargement ) of the prostate, kidney and liver failure , heart failure, arrhythmias , coronary heart disease ( angina pectoris ) , narrowed mitral valve , hypertension ( high blood pressure), hyperthyroidism (increased thyroid gland ) , chronic bronchitis , autonomic neuropathy, hiatusova hernia with reflux oesophagitis ( regurgitation of gastric contents into the esophagus ) , paralytic ileus ( bowel obstruction ) , intestinal atony , toxic megacolon (extension of the wall of the large intestine) ;
Atropine may cause a rise in body temperature , and should therefore be used with caution in patients with fever, especially in children ;
Children and the elderly (over 65 years) have increased sensitivity to atropine .
Other medicines and Atropine Sopharma
Tell your doctor or pharmacist if you are using or have recently used it is possible to use other drugs.
Inform physician if taking drugs for treating Parkinson's disease , depression, psychoses ( chlorpromazine, thioridazine , and others. ) , Allergies ( antihistaminic H1 -blockers ) , cardiac arrhythmias ( quinidine and procainamide ) , drugs for treating diseases of the peripheral nervous system ( galanthamine , pilocarpine , neostigmine and others. ) MAO inhibitors (antidepressants ) , cisapride, digoxin.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine .
Sopharma atropine administered to a pregnant under strict medical supervision. If you are breastfeeding and it is imperative undergoing treatment with this medicine, you should stop breastfeeding while continuing treatment .
Driving and using machines
Sopharma atropine can cause visual impairment and therefore you should not drive while on treatment.
3 . How to use Atropine Sopharma
Always use this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
Atropine Sofarma injection may be given subcutaneously , intramuscularly or intravenously.
Dose and route of administration are determined by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines, Sopharma Atropine may cause side effects, although not everybody gets them.
Adverse reactions to atropine Sopharma transient and dose-dependent. You may feel : dry mouth and accompanied by this thirst and difficulty swallowing, visual disturbances (extension of the pupils , paralysis of accommodation, photophobia, increased intraocular pressure and the risk of an attack of glaucoma) , increased viscosity of bronchial secretions , transient bradycardia tachycardia and arrhythmia, high blood pressure in a hypertensive crisis , constipation, urinary retention, particularly in prostate enlargement , irritability and mental confusion in elderly patients , seizures . At high doses can cause weakness , headache, drowsiness , confusion, insomnia , nausea, vomiting, flushing and dryness of skin rashes on the face and upper body hyperthermia ( fever ), inflammation of the salivary glands after prolonged use. Possible occurrence of hypersensitivity. Adverse effects are reversible and disappear after dose adjustment .
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store Atropine Sopharma
In original packaging , protected from light place , at temperatures below 25 ° C. Do not freeze !
Keep out of reach of children.
Do not use Atropine Sopharma after the expiry date stated on the pack . The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines which you no longer use. These measures will help to protect the environment.
6 . Package Contents and more information
What does Atropine Sopharma
The active substance is atropine sulphate 1 mg per ampoule of 1 ml.
Other ingredients are: hydrochloric acid, 1 mol / l, water for injections.
Atropine Sopharma looks like and contents of pack
Clear, colorless liquid in colorless glass ampoules with a capacity of 1 ml, marked the opening at the top - colored dot or ring; 10 ampoules in PVC foil , 1 or 10 blisters in a carton with leaflet.
The following information is intended for healthcare professionals only :
Method of administration : subcutaneous , intramuscular or intravenous .
Adults and children over 12 years and elderly
Bradyarrhythmias - in 0,3 - 0,6 mg intramuscularly or intravenously over 4-6 hours until a maximum of 2 mg.
Cardiac resuscitation - at 0,5 mg atropine intravenously every 5 minutes until the desired heart rate . At asystole is administered intravenously at a dose of 3 mg once.
In premedication - in 0,3 - 0,6 mg intramuscularly or subcutaneously 30-60 minutes prior to anesthesia or immediately prior to surgery.
Acute intoxication with anticholinesterase agents , phosphorus compounds - 1 mg intramuscularly or intravenously over 5-10 minutes to obtain a suspension of mydriasis and perspiration and saliva . The maximum dose for the first 24 hours must not exceed 100 mg.
Children under 12 years
Atropine was administered subcutaneously , intramuscularly or intravenously in a dose of 0,01 mg / kg body weight.
Cardiac resuscitation - at 0,01 - 0,02 mg / kg intravenously every 5 minutes. Maximum dose of 0,1 mg.
In premedication was administered intramuscularly or subcutaneously 30-60 minutes prior to anesthesia or immediately prior to surgery at doses :
children over 3 kg - 0,1 mg;
7-9 kg - 0,2 mg;
12-16 kg- 0, 3 mg;
over 20 kg - dosage for adults.
Poisoning by organophosphorus compounds atropine may be administered , if necessary, every 10 minutes at the doses of 0,02 mg / kg intravenously or intramuscularly to give mydriasis and eliminate perspiration and saliva .
Symptoms: Overdose can occur at high doses. Elderly patients and children are more sensitive to the effects of atropine . Initial symptoms of overdose are: unpleasant dry mouth and throat , difficulty in swallowing and speech , mydriasis , palpitations , erythema , fever, tachycardia , tremor, gait disturbance ( atropine drunkenness ) , visual disturbance . Higher doses may result in a hyperactivity with hallucinations, clonic convulsions, coma .
Treatment: As a specific antidote physostigmine slowly injected intravenously or intramuscularly at a dose of 1 to 4 mg (0,5 to 1 mg, in children) to reduce dry mouth , slowing of the heart and reducing the extension of the pupil . For removal of psychomotor agitation using morphine , phenobarbital, chloral hydrate .