No-shpa forte tablets 80mg №24×1

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No-shpa forte tabl 80mg №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 formYellow tablets with a greenish or orange tint, oblong, biconvex, engraved “NOSPA” on one side and a break line on the other. Dosage 80 mg Special instructions When using the drug in patients with arterial hypotension, increased caution is required. Each No-shpa® forte tablet contains 104 mg of lactose. When taken according to the recommended dosing regimen, up to 156 mg of lactose (1.5 tablets of No-shpa® forte) may be supplied with each dose, which may cause gastrointestinal disturbances in patients suffering from lactose intolerance. This form of the drug is not suitable for patients with lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome. Influence on the ability to drive vehicles and control mechanisms When taken orally in therapeutic doses, drotaverine does not affect the ability to drive vehicles and perform work that requires increased concentration. If any adverse reactions occur, the issue of driving vehicles and working with mechanisms requires individual consideration. In the event of dizziness after taking the drug, the patient should avoid engaging in potentially hazardous activities, such as driving vehicles and working with mechanisms. 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 vino without inhibiting the isoenzymes PDE III and PDE V. To reduce the contractility of smooth muscles, PDE IV is functionally very important, selective PDE IV 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. 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, unlike parenteral administration of papaverine, it does not have a stimulating effect on the respiratory system. Pharmacokinetics Absorption Drotaverine is rapidly and completely absorbed, both after oral administration and after intramuscular administration. The maximum plasma concentration is reached 45-60 minutes after ingestion. Distribution Drotaverine is highly bound to plasma proteins, especially albumin (95-98%), alpha and beta globulins. Biotransformation and excretion Drotaverine is metabolized 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% is 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 flatulence; • Tension-type headaches; • in gynecology: dysmenorrhea. Dosage and administration The drug is intended for oral administration. Always take your medicine exactly as directed in the package insert or as directed by your healthcare professional. Adults The recommended daily dose is 120-240 mg divided into 2-3 doses. If necessary, No-Shpa 40 mg tablets can be used to obtain a single dose. Children Clinical trials on the use of drotaverine in children have not been conducted. In cases when taking drotaverine in children is necessary: Children over 12 years old: The maximum daily dose is 160 mg, it can be taken in 1 dose, or divided into 2 doses. 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 during breastfeeding, it is not recommended to prescribe. Data on the effect of the drug on fertility are not available. Precautions Use the drug with caution in case of arterial hypotension, during pregnancy. Interaction with other drugs Phosphodiesterase inhibitors, like papaverine, reduce the antiparkinsonian effect of levodopa. 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 and rigidity. Contraindications • hypersensitivity to the active substance or to any of the excipients of the drug; • severe liver or kidney failure; • severe heart failure (low cardiac output); Composition Drotaverine hydrochloride 80 mg. Excipients: magnesium stearate, talc, povidone, 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 overdose, the patient should be monitored and receive symptomatic and supportive treatment. Induction of vomiting and/or gastric lavage is recommended. Side effects The following side effects, which in clinical studies were regarded as at least possibly associated with drotaverine, are given in accordance with the following frequency of occurrence: very often (? 1/10), often (? 1/100, <1/10 ); rarely (? 1/1000, < 1/100); sometimes (? 1/10 000, < 1/1000); very rarely, including individual messages (< 1/10,000); the frequency is unknown (the frequency of occurrence cannot be determined from the available data). From the nervous system: sometimes - headache, dizziness, insomnia. From the side of the cardiovascular system: sometimes - palpitations, lowering blood pressure. From the digestive system: sometimes - nausea, constipation. Allergic reactions: rarely - itching, rash, urticaria, angioedema. Storage conditionsKeep out of the reach of children! Store at a temperature not exceeding 25 ° C in a place protected from light. Buy No-shpa forte tablets 80mg No. 24x1 Price for No-shpa forte tablets 80mg No. 24x1