Drotaverine hydrochloride tablets 40mg №10×2

Name:
Drotaverine hydrochloride. Release form Tablets. Dosage 40 mg. Pack quantity: 20 pcs. Producer Borisov ZMP. MNNDrotaverin. FTHS antispasmodic.
Description:
Pills of yellow or yellow color with a greenish tint, flat-cylindrical, with a bevel. Composition Each tablet contains: active ingredient: drotaverine hydrochloride – 40 mg; excipients: lactose monohydrate, potato starch, talc, stearic acid. Pharmacotherapeutic group Synthetic antispasmodics. Papaverine derivatives. ATX code – A03AD02. Pharmacological properties Pharmacodynamics Drotaverine is an isoquinoline derivative that exhibits an antispasmodic effect on smooth muscles by inhibiting the enzyme phosphodiesterase IV (PDE IV). Inhibition of the enzyme phosphodiesterase IV leads to an increased concentration of cAMP, which inactivates the myosin kinase (MLCK) light chain, which in turn leads to smooth muscle relaxation. Drotaverine inhibits the enzyme phosphodiesterase (PDE) IV without inhibiting the isoenzymes PDE III and PDE V. PDE IV is functionally very important in reducing smooth muscle contractility and selective PDE IV inhibitors may be useful in the treatment of hyperkinetic diseases and various conditions associated with spastic conditions of the gastrointestinal tract. intestinal tract. The enzyme hydrolyzing cAMP in myocardial and vascular smooth muscle cells is mainly PDE III isoenzyme, which explains why drotaverine is an effective antispasmodic agent without cardiovascular side effects and a pronounced effect on the cardiovascular system. The drug is effective in spasms of smooth muscles caused by a violation of the nervous regulation and self-regulation of both nervous and muscular etiology. Regardless of the type of autonomic innervation, drotaverine acts on smooth muscles located in the gastrointestinal, biliary, urogenital and vascular systems. Due to its vasodilating effect, it improves tissue circulation. Its action is stronger than that of papaverine, and absorption is faster and more complete, it binds less to plasma proteins. The advantage of drotaverine is that it does not have a stimulating effect on the respiratory system, which was observed after parenteral administration of papaverine. Pharmacokinetics Absorption When administered orally, drotaverine hydrochloride is rapidly absorbed from the gastrointestinal tract, the half-absorption period is 12 minutes. Bioavailability – about 100%. Cmax in serum is reached in 45 – 60 minutes. Distribution Drotaverine hydrochloride does not penetrate the blood-brain barrier. Metabolism Drotaverine hydrochloride is biotransformed in the liver. Withdrawal After 72 hours, it is practically excreted from the body in the form of metabolites – 50% in the urine and 30% in the feces. Indications for use – spasms of smooth muscles associated with diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis; – spasms of smooth muscles of the urinary tract: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder tenesmus. As adjuvant therapy: – with spasms of smooth muscles of gastrointestinal origin: peptic ulcer of the stomach and duodenum, gastritis, spasms of the cardia and pylorus, enteritis, colitis, spastic colitis with constipation and flatulence; – tension headaches; – in obstetrics and gynecology: dysmenorrhea. Contraindications – hypersensitivity to the active substance or to any of the excipients of the drug; – severe liver and kidney failure; – severe heart failure (low cardiac output syndrome); – children’s age up to 6 years. Dosage and administration Inside, adults are prescribed 40-80 mg (1-2 tablets) 3 times a day; children aged 1-6 years are prescribed in a single dose of 10-20 mg (1/4 – 1/2 tablets), the maximum daily dose is 120 mg (3 tablets); at the age of 6 to 12 years – a single dose – 20 mg (1/2 tablet), the maximum daily dose – 200 mg (5 tablets). Multiplicity of appointment – 2 – 3 per day. Side effects When assessing the frequency of occurrence of various adverse reactions, the following gradations were used: very often -> 1/10, often – from 1/100 to <1/10, sometimes - from 1/1000 to <1/100, rarely - from 1/10000 up to <1/1000, very rarely - <1/10000. From the gastrointestinal tract: rarely - nausea, constipation; From the nervous system: rarely - headache, dizziness, insomnia; Since the cardiovascular system: rarely - palpitations, lowering blood pressure. From the immune system: rarely - allergic reactions (angioedema, urticaria, rash, itching). Special instructions The use of the drug for hypotension requires increased caution. Drotaverine tablets contain 53 mg of lactose. When taken according to the recommended dosage, each dose contains up to 159 mg of lactose. It can cause gastrointestinal disturbances in individuals suffering from lactose intolerance. This dosage form is not suitable for patients suffering from lactase deficiency, galactosemia or impaired glucose / galactose absorption syndrome. Application in persons with impaired renal and hepatic function Not recommended for persons with impaired renal and hepatic function Elderly patients Dose adjustment is not required Children Use in children strictly according to indications, since the use in this group of patients has not been studied enough. Pregnancy and lactation The use of drotaverine during pregnancy does not lead to teratogenic and embryotoxic effects. However, when prescribing the drug during pregnancy, caution is necessary. Due to the lack of necessary clinical data during lactation, it is not recommended to prescribe. Influence on the ability to drive vehicles and control mechanisms Patients should be informed that if dizziness occurs, they should avoid potentially dangerous activities, such as driving vehicles and potentially dangerous mechanisms. Interaction with other drugs With the simultaneous use of drotaverine may weaken the anti-Parkinsonian effect of levodopa. Overdose Symptoms: violation of the heart rhythm and conduction, including complete blockade of the legs of the bundle of His and cardiac arrest, which can be fatal. Treatment: The patient should be monitored and receive symptomatic and supportive treatment. Induction of vomiting and/or gastric lavage is recommended. Packing: 10 tablets in a blister pack made of PVC film and aluminum foil. 2 blister packs together with a leaflet in a pack of cardboard. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Shelf life 2 years. The medicinal product must not be used after the expiration date indicated on the package. Terms of dispensing from pharmaciesWithout a prescription. Buy Drotaverine hydrochloride tablets 40mg No. 10x2 The price of Drotaverine hydrochloride tablets 40mg No. 10x2