Project Description
Drotaverine hydrochloride
tablets 0.04 g – Tabulettae Drotaverini hydrochloridi 0,04
international nonproprietary name
Drotaverine
Ref
BP-0045
Pharmacotherapeutic group
Vasodilators. Myothropic spasmolytics.
Composition of the preparation
1 tablet contains 40 mg of drotaverine hydrochloride.
Pharmacological action
Pharmacodynamics
Drotaverine hydrochloride is of spasmolytic, myothropic, vasodilation, hepotensive action.
It decreases ionized active calcium supply to smooth muscle cells due to inhibition of phosphoesterase and intracellular accumulation of adenosine monophosphate. It is of apparent and prolonged action on smooth muscles of inner organs and vessels, it decreases moderately arterial pressure, increases minute volume of heart, is of some antiarrhythmic action. It decreases tone of cerebral vessels and increases their bloof-filling. Practically it does not influence vegetative nervous system and does not penetrate to CNS.
Pharmacokinetics
Rapid and total absorption by gastrointestinal tract. Bioavailability isabout 100%. Half-absorptionis 12 min. Smooth distribution in tissues of plain muscle cells. Drotaverine is bound with plasma proteins to 95-98%.
Indications
Spasm of smooth muscles of inner organs (cardio- and pylorospasm), chronic gastroduodenitis, stomach and duodenum ulcer, cholelithiasis (biliary colic), chronic cholecystitis, post cholecystectomy syndrome, hypermotoric biliary track dyskinesia, spasmodic intestines dyskinesia, intestines colic caused by gas retard after intervention, colitis, proctitis, tenesmus, meteorism, urolithiasis (renal colic), pyelitis, spasm of brain vessels, of coronary and peripheral arteries, necessary abatement uterus traction in parturition and reversal of spasm of neck of uterus in parturition, spasm of smooth muscles in instrumental intervention.
special indication
Not established
special warning
Not established
Dosage and method of administration
The drug is administered for interior use. 1-2 tablets (0.04—0.08 g) 2—3 time a day. In children under 6 0.01—0.02 g 1—2 times a day, in children of 6—12 years old — 0.02 g 1—2 times a day. In children after 12 the adult dose.
overdosage
АV block, cardiac arrest, paralysis of respiratory center.
safety measures
Not established
Side effects
Heat sensation, vertigo, arrhythmia, hypotensia, tachycardia, hyperhidrosis (often in parenteral introduction), allergic dermatitis.
Contraindications
Hypersensitivity, glaucoma.
Interactions with other medicinal preparations
Enhances the affect of other spasmolytics (cholinergic antagonist inclusive), hypotensia caused by tricyclic antidepressants, by quinidine, by procainamide hydrochloride. The secure spasm elimination is enhanced by phenobarbital. It inhibits spasmogenic action of morphine, antiparkinsonian activity of levodopa.
The form of release
Tablet 40 mg. 10 tablets in pack. 10 tabletsinblister. 2 blistersinpackage.