No-shpa tablets 40mg №24×1

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No-shpa tabl 40mg No. 24
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Convex tablets of yellow color, with a greenish or orange tint, on one side – marking “spa”. The main active ingredient Drotaverine Release form Tablets Dosage 40 mg Special instructions In case of low blood pressure, the use of the drug requires caution. The drug contains 52 mg of lactose. When taken according to the recommended dosage, each dose contains up to 156 mg of lactose. It can cause gastrointestinal complaints in individuals suffering from lactose intolerance. This form is unacceptable for patients suffering from lactose deficiency, galactosemia or impaired glucose / galactose absorption syndrome. Use in children strictly according to indications, since the use of drotaverine in this group of patients has not been sufficiently studied (see “Indications for use” and “Dosage and method of application”). Clinical studies on the use of the drug in children have not been conducted. Pharmacodynamics Mechanism of action Drotaverine is an isoquinoline derivative that exhibits an antispasmodic effect on smooth muscles by inhibiting the enzyme phosphodiesterase IV (PDE IV). Inhibition of the PDE IV enzyme leads to an increased concentration of cAMP, which inactivates the myosin kinase light chain and leads to smooth muscle relaxation. Drotaverine inhibits PDE IV in vitro without inhibiting the isoenzymes PDE III and PDE V. To reduce the contractility of smooth muscles, PDE IV is functionally very important, and its selective inhibitors can be useful in the treatment of hyperkinetic diseases and various symptoms caused by spastic conditions of the gastrointestinal tract. PDE III isoenzyme hydrolyzes cAMP in myocardial and vascular smooth muscle, and this explains the fact that drotaverine is an effective antispasmodic agent without serious cardiovascular side effects and strong cardiovascular therapeutic activity. 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 blood circulation in the tissues. 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 Drotaverine is rapidly and completely absorbed, both after oral administration and after intramuscular administration. Distribution Drotaverine is highly bound to plasma proteins, especially albumin (95-98%), alpha and beta globulins. The maximum plasma concentration is reached 45-60 minutes after ingestion. Biotransformation and excretion Drotaverine metabolizes in the liver, its half-life is 8-10 hours. After the first passage through the liver, 65% of the dose is in the circulation unchanged. For 72 hours, drotaverine is almost completely excreted from the body, more than 50% are excreted in the urine and about 30% in the feces. Drotaverine is excreted mainly as metabolites, the parent compound is not detected in the urine. 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. – 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 meteoristic forms of mucous colitis; – Tension type headaches (headaches of muscle tension, psychogenic, stress, chronic daily headache, transformed migraine); – in gynecology: with painful periods. Dosage and administrationAdults The usual daily dose is 120-240 mg, ie. 3-6 tablets per day, to be taken in 2-3 divided doses. Single dose for adults 40-80 mg (1-2 tablets). Children Clinical trials on the use of drotaverine in children have not been conducted. In cases when taking drotaverine in children is necessary: Children 6-12 years old: The recommended daily dose for children over the age of 6 years is 80 mg, i.e. 2 tablets per day to be taken in 2 divided doses. Single dose for children 6-12 years old – 40 mg (1 tablet). Children over 12 years of age: The recommended daily dose for children over 12 years of age is 160 mg, i.e. 4 tablets per day to be taken in 2-4 doses. A single dose for children over the age of 12 years is 40-80 mg, i.e. 1-2 tablets. Data on the use of the drug in children under 6 years of age are not available. Use during pregnancy and lactationAccording to retrospective clinical and animal studies, oral administration of drotaverine during pregnancy does not have a direct or indirect damaging effect on pregnancy, embryonic development, childbirth and postnatal development. However, when prescribing the drug during pregnancy, caution is necessary. Due to the lack of necessary clinical data, the use of the drug during breastfeeding is not recommended. Data on the effect of the drug on fertility are not available. Precautions In case of low blood pressure, the use of the drug requires caution. The drug contains 52 mg of lactose. When taken according to the recommended dosage, each dose contains up to 156 mg of lactose. It can cause gastrointestinal complaints in individuals suffering from lactose intolerance. This form is unacceptable for patients suffering from lactose deficiency, galactosemia or impaired glucose / galactose absorption syndrome. Use in children strictly according to indications, since the use of drotaverine in this group of patients has not been sufficiently studied (see “Indications for use” and “Dosage and method of application”). Clinical studies on the use of the drug in children have not been conducted. Interaction with other drugs Care must be taken when using the drug together with levodopa, since the anti-Parkinsonian effect of the latter is reduced and there is an increase in tremor or rigidity. Contraindications – hypersensitivity to the active substance or to any of the excipients of the drug; – severe liver or kidney failure; – severe heart failure. Composition One tablet contains: Active ingredient: drotaverine hydrochloride 40 mg. Excipients: magnesium stearate (E470), talc (E553), povidone (E1201), corn starch, lactose monohydrate. Overdose An overdose of drotaverine can cause cardiac arrhythmias and conduction disturbances, including complete blockade of the bundle branches and cardiac arrest, which can be fatal. In case of an overdose, the patient should be monitored and receive symptomatic and supportive treatment. Induction of vomiting and/or gastric lavage is recommended. Side effects During clinical trials, the following side effects were reported by researchers as associated with drotaverine and presented the following frequency of manifestations: very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100); rare (> 1/10000, < 1/1000; very rare (< 1/10000) and classified according to the following organ systems: - From the gastrointestinal tract: rarely: nausea, constipation - From the nervous system: rarely: headache , dizziness, insomnia - From the side of the cardiovascular system: rarely: palpitations, lowering blood pressure - Immune system disorders: rarely: an allergic reaction (angioneurotic edema, urticaria, rash itching) (see section "Contraindications"), B in case of side effects, it is necessary to stop taking the drug.Storage conditionsKeep out of the reach of children!Pills in PVC / aluminum blister packs: Store at a temperature not exceeding 25 ° C in a place protected from light. Tablets in a vial: Store at a temperature not exceeding 25 ° Buy No-shpa tablets 40mg No. 24x1 Price for No-shpa tablets 40mg No. 24x1