Atropine
Producer: Federal State Unitary Enterprise Moscow Endocrine Plant Russia
Code of automatic telephone exchange: A03BA01
Release form: Liquid dosage forms. Drops are eye.
General characteristics. Structure:
Active ingredient: 10 mg of Atropini sulfas in terms of dry matter in 1 ml of solution.
Excipients: sodium chloride, sodium disulphite (sodium metabisulphite), water for injections.
Pharmacological properties:
Pharmacodynamics. The alkaloid which is contained in plants of family of a nightshade family, a m-holinoretseptorov blocker to the same extent communicates with m1, sq.m, and m3 - subtypes of muskarinovy receptors. Influences both on central, and peripheral m-holinoretseptory. Works also (though is much weaker) on - N-holinoretseptory. Expands a pupil, complicates outflow of intraocular liquid, increases intraocular pressure, causes accommodation paralysis.
The pupil expanded with atropine is practically not narrowed at instillation of cholinomimetics. The maximum mydriasis comes in 30-40 min. after instillation, disappears in 7-10 days.
Pharmacokinetics. It is well soaked up through a conjunctiva.
Indications to use:
For a mydriasis and achievement of paralysis of accommodation: definition of a true refraction of an eye, eyeground research; creation, functional rest at inflammatory diseases of an eye (including at an iritis, an iridocyclitis, a choroiditis, a keratitis), at injuries of an eye, an embolism and a spasm of the central artery of a retina.
Route of administration and doses:
Locally. Dig in on 1-2 drops 1% of solution in an eye, frequency rate of use - to 3 times with an interval of 5-6 h. Medicine apply on 1-2 drops 1% of solution in the form of instillations in a conjunctival sac of an eye. Frequency rate of use to 3 times with an interval of 5-6 hours.
Features of use:
Pregnancy and lactation. Atropine gets through a placental barrier. It is found in breast milk in trace concentration. Adequate and strictly controlled clinical trials of safety of use of atropine at pregnancy were not conducted. Use of medicine at pregnancy and feeding is allowed by a breast if the expected advantage for mother exceeds potential risk for a fruit and the child.
Before use of medicine it is necessary to remove soft contact lenses.
During instillation of drops in a conjunctival sac for reduction of risk of development of system side effect easy pressing by a finger on area of a projection of dacryocysts at an internal corner of an eye within 1-2 min. after an instillation for an exception of absorption of drug mucous a nose and strengthening of side effect is recommended.
At instillation of solution in an eye it is necessary to press the lower lacrimal opening in order to avoid hit of solution in a nasopharynx.
Intensively pigmented iris is steadier against dilatation, for achievement of effect happens it is necessary to increase concentration or frequency of introductions therefore it is necessary to be afraid of overdose of midriatik.
The mydriasis can provoke a bad attack of glaucoma at patients with glaucoma, 60 years and the people with a hypermetropia predisposed to glaucoma because they have a superficial anterior chamber are more senior than persons.
At use by persons 65 years are more senior, there is a probability of increase in eye pressure.
Drug is limited to use at the increased body temperature (perhaps further increase owing to suppression of activity of sweat glands), to children with injury of a brain, cerebral palsy, to patients with a Down syndrome (reaction to m-holinoblokatory increases) and albinism.
Influence on ability to manage vehicles and mechanisms. It is necessary to warn patients that driving of the car during at least 2 h after the research is forbidden!
During use it is necessary to abstain from driving of motor transport and occupations, potentially dangerous types of activity demanding the increased concentration of attention, speed of psychomotor reactions and good sight.
Side effects:
Local: passing pricking and increase in intraocular pressure; at prolonged use - a dermahemia a century, a hyperemia and a chemosis, a century and an eyeglobe, photophobia; contact dermatitis; toxic system reactions to atropine at children of younger age and very elderly (instillation of 1 drop of 1% of solution of Atropini sulfas to children not only causes a mydriasis and a tsikloplegiya, but can also lead to a hyperthermia, dryness in a mouth).
System: dryness in a mouth, tachycardia, an intestines atony, a lock, an ischuria, a xerostomia, a bladder atony, a headache, dizziness, disturbance of tactile perception.
If any of the effects specified in the instruction collateral are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor!
Interaction with other medicines:
Antimyasthenic means, potassium chloride - strengthening of toxic effects of these drugs in connection with possible delay of a passage through digestive tract.
Effect of atropine is strengthened by sympathomimetics, m-holinoblokatory, and the means possessing m-holinoblokiruyushchimi properties, weaken m cholinomimetics. Probability of development of system side reactions tricyclic antidepressants, fenotiazina, амантадин raise, quinidine, antihistaminic and other medicines with m-holinoblokiruyushchimi properties.
Procaineamide strengthens m-holinoblokiruyushchee effect of atropine.
At simultaneous use with Phenylephrinum increase in arterial pressure is possible. Under the influence of a guanetidin reduction of hyposecretory effect of atropine is possible. Nitrates increase probability of increase in intraocular pressure. Atropine reduces concentration of a levodopa in a blood plasma.
Contraindications:
Hypersensitivity to drug components, closed-angle glaucoma (including suspicion on it), a keratoconus. Front and back synechias; children's age up to 7 years.
With care. Arrhythmias, chronic heart failure, coronary heart disease, a mitral stenosis, a reflux esophagitis, a liver and/or renal failure, the expressed ischuria at a prostate hyperplasia, an intestines atony, obstructive diseases of intestines, paralytic Ilheus, toxic megacolon, ulcer colitis, hernia of an esophageal opening of a diaphragm, a hyperthermia, arterial hypertension, a hyperthyroidism, age are more senior than 40 years (danger of display of not diagnosed glaucoma), a myasthenia.
Overdose:
At use of atropine it is necessary to observe, care in a dosage and to consider a possibility of the increased individual sensitivity of patients. The overdose can cause dryness in a mouth, expansion of pupils, accommodation disturbance, tachycardia, dizziness. However there are no exact data concerning overdose of atropine at its topical administration.
Storage conditions:
In the place protected from light at a temperature not above 25 °C. To store in the places unavailable to children. A period of validity - 3 years. Not to apply after the period of validity specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Drops eye 1%. Packaging: 1 bottle in a set with a sterile cover dropper and the application instruction of drug is placed in a pack from a cardboard. 5 bottles in a blister strip packaging. 1 blister strip packaging complete with 5 sterile covers droppers and the application instruction of drug is placed in a pack from a cardboard. 30 blister strip packagings in a set with sterile covers - droppers (by quantity of bottles) and 15 application instructions, drug place in a box from a cardboard or in a box from corrugated fibreboard (for hospitals).