International generic name

Atropine

Drug form and composition

Solution for injection. One ampoule of 1 ml contains 1 mg Atropine sulfate (1 mg/ml).

Indications

Cholelithiasis and nephrolithiasis manifesting with spastic pain; ulcer disease; pylor constriction; cholecystitis; bronchial asthma; acute intoxications with cholinergic agents and digitalis glycosides.

Dosage and administration

Solution for injection - subcutaneous, intramuscular and intravenous application. Dosage for adults is 0.25-1 mg, 1-3 times daily. Maximal single dose is 1 mg, whereas the maximal dose is 3 mg per 24 hours. When Atropine is used as a counter-position in intoxication with phosphoorganic compounds, the daily dose may be enhanced - 1 mg of the medicine is injected in intervals of 15 minutes intramuscularly or intravenously. In children the preparation is injected subcutaneously or intravenously in dose 0.01 mg per kg body weight, each 4-6 hours, if necessary.

Contraindications

Glaucoma; urinary bladder and intestinal atonia; prostate gland hypertrophy; pylor stenosis; tachyarrhythmia and heart failure; reflux-esophagitis; active pulmonary tuberculosis. Pregnancy in the prenatal period and lactation - the preparation passes through the placenta and is excreted in the mother milk, which may lead to intoxication of the fetus and the infant.

Special warnings and precautions

Atropine should be used with caution in patients with renal and hepatic insufficiency; hyperthyroidism; cardiac rhythm disorders; and coronary artery disease. During the treatment the patient should not drive and operate machinery.

Drug interactions

Amantadine, chinidine, three- and fourcyclet antidepressants, and neuroleptics all potentiate the anticholinergic action of Atropine. Atropine antagonizes the M-cholinomymetic effect of nivalin, pilocarpine, and neostigmine. In concomitant application of Atropine and H1- blockers, disopyramide, and antiparkinsonic medicines a sedative effect may appear.

Adverse reactions

Due to absorption and systemic action of Atropine following adverse reactions may appear: xerostomia; mydriasis; cycloplegia, intraocular pressure elevation and risk of glaucoma attack in patients with glaucoma; urine retention, particularly in patients with prostate gland hypertrophy; atonic constipation; irritability and confusion in elder patients. Mouth drying and palpitations may appear.

Pharmacological mechanisms

Atropine is an antagonist of the M-choline receptors. It abolishes the parasympathetic influence on the target organs as well as the M-cholinomymetic action of the anticholinesterase agents. Blocking M-cholinoreceptors, Atropine disturbs the neural impulse conduction from postganglionergic cholinergic nerves to effector organs, including exogene and endogene secreting glands, the heart; smooth muscles of the gastrointestinal tract, billiary and urinary pathways. Atropine dilates the pupil and paralyses the accommodation. Atropine is a caunter-poison in intoxication with all agents, acting by M-choline receptor influence, as it penetrates in CNS and eliminates central effects of toxins.

Supplied

10 ampoules of 1 ml (1 mg). 100 ampoules of 1 ml (1 mg).

Expiry

5 years.