Platiphyllin-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PLATYPHYLLIN-ZDOROVYE (PLATYPHYLLINE-ZDOROVYE)

Composition:

Active substance: platyphylline;

1 ml|of solution contains|contains| 2 mg of platyphylline hydrotartarate;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

Main physico-chemical properties: clear, colorless solution.

Pharmacotherapeutic group. Agents used in functional disorders of the gastrointestinal tract. Agents used in functional intestinal disorders. ATC code A03A X.

Pharmacological properties.

Pharmacodynamics. The mechanism of action of platyphylline is determined by blockade of M-cholinergic receptors, resulting in disruption of nerve impulse transmission from the endings of postganglionic cholinergic fibers to the cells of innervated effector organs; it also exerts a direct relaxing effect on smooth muscles. It additionally blocks N-cholinergic receptors in autonomic ganglia (to a significantly lesser extent).

The drug has an anticholinergic, dose-dependent effect: at lower doses, it inhibits secretion of salivary and bronchial glands, reduces sweating, affects accommodation of the eyes, causes pupillary dilation, and increases heart rate; at higher doses, it reduces contractile activity of the gastrointestinal tract (including bile ducts and gallbladder) and urinary tract, and suppresses gastric secretion.

Cholinoblocking action is more pronounced against a background of increased parasympathetic nervous system tone or under the influence of M-cholinomimetic agents.

By reducing the influence of the vagus nerve, platyphylline improves cardiac conduction, increases myocardial excitability, and enhances cardiac output. It causes dilation of small skin vessels. At high doses, it suppresses the vasomotor center and blocks sympathetic ganglia, resulting in vasodilation and decreased arterial pressure (primarily with intravenous administration). It induces relaxation of the smooth musculature of the uterus, urinary bladder, and urinary tract; exerting a spasmolytic effect, it relieves pain syndrome. It relaxes bronchial smooth muscle during spasm caused by increased vagal tone or cholinomimetics; increases respiratory volume, and suppresses bronchial gland secretion.

Its effect on peripheral cholinoreactive systems is close to that of atropine, but it is less toxic and better tolerated. Compared to atropine, it has a weaker effect on peripheral M-cholinergic receptors, causes less pronounced tachycardia (especially when used in high doses), and more weakly suppresses secretion of endocrine glands.

Pharmacokinetics. Platyphylline readily crosses histohematic barriers (including the blood-brain barrier), as well as cellular and synaptic membranes. When large doses are administered, it accumulates in tissues of the central nervous system at significant concentrations. It is metabolized in the liver. Eliminated by the kidneys and intestine.

When used correctly (appropriate doses and intervals between administrations), it does not accumulate.

Clinical characteristics.

Indications. As part of complex therapy: gastroduodenitis, functional dyspepsia, pylorospasm, cholecystitis, cholelithiasis, intestinal colic, renal colic, biliary colic. Bronchial asthma (for prevention of bronchospasm), bronchorrhea. Algomenorrhea. Cerebral arterial spasm. Angioneurosis.

Contraindications. Hypersensitivity to the components of the drug. Atrial fibrillation, tachycardia, chronic heart failure, ischemic heart disease, mitral stenosis, severe arterial hypertension. Acute bleeding. Thyrotoxicosis. Hyperthermic syndrome. Esophageal achalasia, pyloric stenosis, intestinal atony. Glaucoma. Hepatic and renal insufficiency. Myasthenia gravis. Urinary retention or predisposition to it. Brain injury.

Interaction with other medicinal products and other types of interactions. Enhances the sedative and hypnotic effects of phenobarbital, pentobarbital, magnesium sulfate, and ethaminal sodium; potentiates the effects of orally administered H2-histamine blockers, digoxin, and riboflavin (slows peristalsis and improves absorption); blocks the effects of proserine. Adrenomimetics and nitrates potentiate the increase in intraocular pressure.

Relieves bradycardia caused by verapamil; nausea, vomiting, and bradycardia caused by morphine.

M-cholinoblockers, amantadine, haloperidol (in patients with schizophrenia, a possible reduction in antipsychotic effect), phenothiazines, monoamine oxidase inhibitors, tricyclic antidepressants, benzactizine, quinidine sulfate, isoniazid, certain antihistamine drugs, disopyramide, procainamide increase the risk of developing anticholinergic adverse effects. Do not use simultaneously with anticholinesterase drugs.

Morphine enhances the suppressive effect on the cardiovascular system; MAO inhibitors enhance the positive chronotropic and bathmotropic effects; cardiac glycosides enhance the positive bathmotropic effect; quinidine and procainamide enhance the cholinoblocking effect.

In pain associated with smooth muscle spasm, the drug's action is enhanced by analgesics, sedatives, tranquilizers; in vascular spasms – by antihypertensive and sedative agents.

Special precautions for use

Use with caution in patients with prostatic hyperplasia or urinary tract obstruction, Down's syndrome, cerebral palsy in children; in patients with reflux esophagitis or hiatal hernia associated with reflux esophagitis; in ulcerative colitis, megacolon; in patients over 40 years of age due to possible manifestation of undiagnosed glaucoma; in autonomic neuropathy; in elderly or debilitated patients; in chronic pulmonary diseases associated with low production of thick, difficult-to-expectorate sputum, or in reverse obstruction. Prolonged use in patients with xerostomia may lead to further reduction of salivary secretion.

Use during pregnancy or breastfeeding. The drug should be used with caution and only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction rate when driving or operating machinery. During treatment, patients should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Method of Administration and Dosage

Administer subcutaneously.

For adults and children aged 15 years and older, to relieve spasmodic pain, prolonged attacks of bronchial asthma, and cerebral or peripheral angiospasm, administer 1–2 mL 1–2 times daily.

For course treatment, administer subcutaneously 1–2 mL 1–2 times daily for 10–15–20 days.

The single and daily doses, as well as frequency of administration, are determined individually by a physician depending on indications and patient's age. Maximum single dose – 10 mg; maximum daily dose – 30 mg.

Children. The drug may be used in children aged 15 years and older.

Overdose. Symptoms: Paralytic intestinal obstruction, acute urinary retention (in patients with benign prostatic hyperplasia), accommodation paralysis, increased intraocular pressure; dryness of mucous membranes of the mouth, nose, and throat; difficulty swallowing, mydriasis (up to complete disappearance of iris visibility), tremor, seizures, hyperthermia, central nervous system excitation followed by its depression, respiratory and vasomotor center depression.

Treatment: Forced diuresis, administration of cholinesterase inhibitors (physostigmine, galantamine, or neostigmine) to relieve intestinal paresis and reduce tachycardia. In cases of moderate excitation and mild seizures – administration of magnesium sulfate; in severe cases – administration of sodium oxybutyrate, oxygen therapy, and artificial ventilation of the lungs. In life-threatening tachycardia – use of quinidine sulfate or propranolol.

Adverse reactions.

Gastrointestinal disorders: dry mouth, sensation of thirst, taste disturbances, dysphagia, decreased intestinal motility up to atony, reduced tone of bile ducts and gallbladder.

Renal and urinary disorders: difficulty and retention of urination.

Cardiovascular disorders: tachycardia, arrhythmia (including extrasystoles), facial flushing, hot flushes, decreased blood pressure.

Nervous system disorders: headache, dizziness, dysarthria, central nervous system stimulation, insomnia, anxiety, amnestic syndrome.

Eye disorders: mydriasis, photophobia, accommodation paralysis, increased intraocular pressure.

Respiratory system disorders: decreased secretory activity and bronchial tone, leading to formation of viscous sputum that is difficult to expel.

Skin and subcutaneous tissue disorders: skin rashes, urticaria, exfoliative dermatitis, decreased

Immune system disorders: anaphylactic reactions (including anaphylactic shock).

Shelf life. 5 years.

Storage conditions. Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility. Do not mix with other medicinal products.

Packaging. Injection solution 2 mg/mL, 1 mL in ampoules No. 10 in a box; No. 5×2, No. 10 in blister pack in a box.

Prescription category. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVTYA".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.