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.