INSTRUCTION
for medical application of preparation
Platyphyllin hydrotartrate 0,2% solution for injections in syrettes
(solutio platyphyllini hydrotartratis 0,2% pro injectionibus)
General characteristics:
platyphyllin - alkaloid of Senecio rhomboides, Senecio platyphyllus or Senecio planus. In medical practice it is used acid tartrate salt (hydrotartrate) of platyphyllin - Platyphyllini hydrotartratas (syn.: Platyphyllini hydrotartaricum);
international and chemical name: 3-ethyliden-6-hydroxi-5, 6-dimethylperhydro-1,8-dioxacyclododeca[2,3,4-gh] pyrrolysine-2,7-dion (in form of hydrotartrate);
basic physical-chemical properties: white crystalline powder of bitter taste, easily soluble in water (1:5 in hot water, 1:10 in cold water), weakly soluble in alcohol pH 0,2% solution - 3,6-4.0.;
composition: Platyphyllin hydrotartrate - 0,2 g, water for injections - 100 ml.
Production form. Solution for injections in 1 ml syrettes.
Pharmacological group. AO3 Spasmolytics, anticholinergics and agents stimulating peristalsis.
Pharmacological properties. Platyphyllin exerts cholinolytic effect. It blocks m-cholynoreceptors and makes them insensitive to acetylcholine. Platyphyllin exerts direct myotropic spasmolytic (papaverine-like) effect on smooth muscle organs: intestine, biliary tracts, bronchi, eyes. Direct oppressing effect to smooth muscle of vessels is expressed weakly. It exerts calming effect on central nervous system, especially on vasomotor center due to this vasodilatation and arterial pressure decreasing take place.
Pharmacokinetics. At subcutaneous injections Platyphyllin is well absorbed from subcutaneous fat. At injection of big doses it is accumulated in tissues of central nervous system in considerable concentrations. It is excreted by urinary and digestive systems.
Indications for application. Platyphyllin as a cholinolytic and spasmolytic agent is used mainly at spasms of smooth muscles of abdominal cavity organs (stomach, intestine, biliary tracts and gallbladder, ureters); at peptic ulcer of stomach and duodenum; at bronchial asthma; at heightened tonus and spasm of blood vessels (hypertensive disease, stenocardia, breach of cerebral circulation, angiotrophoneurosis); at colics (renal, hepatic, intestinal); as an agent for pupil dilatation.
Mode of application and dosage. Before applying open contour package. Without removing the cap from the needle-extension screw the needle on the syrette against the stop in order to pierce the body and provide free movement of the solution into the needle. Remove the cap from the needle holding the syrette on to the extension. Remove air by slightly pressing the syrette with fingers and without unclenching fingers inject the needle. Squeeze out the content of the syrette and remove the needle without unclenching fingers.
Platyphyllin hydrotartrate solution o,2% for injections is prescribed parenterally. For cupping acute ulcerous pain, renal, hepatic, intestinal colics, prolonged bronchial asthma attack, cerebral and peripheric angiospasms Platyphyllin is injected subcutaneously by 1-2 ml of 0,2% solution 1-2 times a day. As a spasmolytic agent subcutaneously Platyphyllin is prescribed by 1 ml of 0,2% solution every day within 1 month. The highest single dose for adults subcutaneously - 0,01 g (10 mg), daily dose - 0,03 g (30 mg). For children Platyphyllin is prescribed subcutaneously depending upon the age - from 0,0012 to 0,015 g for injections.
Side effect. Platyphyllin is tolerated well and at correct dosage it does not exert side effects.
Contraindications. Glaucoma, hepatic and renal insufficiency, paralytic intestinal obstruction or atony, ulcerative colitis, myasthenia.
Interaction with other medicines. At vessels spasms Platyphyllin could be combined with hypotensive and sedative agents. The preparation prolongs hypnotic action of phenobarbital, pentobarbital sodium, magnesium sulfate; it blocks effects of neostigmine. Platyphyllin increases effect of H2-histamioblockers, digoxin and riboflavin (slows peristalsis and improves absorption). Adrenomimetic substances (strengthen mydriasis) and nitrates potentiate increasing of intraocular pressure. At spasms of the brain vessels Platyphyllin could be also combined with with cordiamine and diaphyllin. It eliminates bradycardia, nausea, vomiting after morphine, bradycardia after verapamil application.
Peculiarities of application. Overdosage of the preparation is possible. Symptoms: xerostomia, palpitation, pupil dilatation with lack of reaction to light, breach of accommodation, tachycardia, decreasing of arterial pressure, dysuria, intestinal atony, dyspnea, convulsions, hyperthermia, skin reddening, stimulation of central nervous system with following oppression, breach of consciousness, hallucinations, convulsive syndrome, respiratory insufficiency, enteroparesis. Treatment: forced diuresis, injection of cholinesterase inhibitors (isostygmine, galantamine or neostigmine) which weaken enteroparesis and reduce tachycardia; at moderate excitement and unexpressed convulsions it is recommended to use magnesium sulfate, at critical cases - sodium hydroxybutyrate, oxygenotherapy, artificial pulmonary ventilation.
Conditions and period of storage. Store in dark place at the temperature maximum 25°C. Shelf life is indicated on the package.
Terms of distribution. Under prescription.
Package. 1 ml syrette. 1 syrette in contour cell free package. 5 or 10 contour packages in carton pack.
Manufactured by SC Concern Stirol
Address. Gorlovskoi Divizii Str., 10, 84610, Gorlovka, Donetsk region, Ukraine.
Adress in Internet: http://pharm.stirol.net
E-mail:support
