DROTAVERINE HYDROCHLORIDE(tablets 0.04 g)

Tabulettae Drotaverini hydrochloridi 0,04

International nonproprietary name (INN)

Drotaverine.

Pharmacotherapeutic group

Vasodilators. Myothropic spasmolytics.

Composition

1 tablet contains 40 mg of drotaverine hydrochloride.

Pharmacological effect

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%.

Indicationsforusage

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.

Administration and dosage

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.

Limitation for usage

Adenoma of prostate, apparent atherosclerosis of coronary arteries. Administerwithcareinpregnancy.

Adversereaction

Heat sensation, vertigo, arrhythmia, hypotensia, tachycardia, hyperhidrosis (often in parenteral introduction), allergic dermatitis.

Contraindications

Hypersensitivity, glaucoma.

Interaction with other drugs

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.

Overdose

АV block, cardiac arrest, paralysis of respiratory center.

Dosageform

Tablet 40 mg. 10 tablets in pack. 10 tabletsinblister. 2 blistersinpackage.