Expiration date: 07/2025
Pharmacological action
Drotaverine is a myotropic antispasmodic. According to the chemical structure and pharmacological properties close to papaverine, but has a stronger and longer-lasting effect.
Reduces the flow of ionized calcium into smooth muscle cells by inhibiting phosphodiesterase and intracellular accumulation of camp.
Has a pronounced and long-term effect on the smooth muscles of internal organs and blood vessels.
Dilates blood vessels, causes a moderate decrease in blood pressure, increases the minute volume of the heart, has some antiarrhythmic effect.
It reduces the tone of the cerebral vessels and increases their blood filling.
Practically does not affect the autonomic nervous system and does not penetrate into the Central nervous system.
Drotaverine has no anticholinergic effect, so unlike cholinolytic antispasmodics can be used in patients with glaucoma.
Indications
- spasm of smooth muscles of internal organs (cardio-and pylorospasm),
- chronic gastroduodenitis,
- stomach and duodenal ulcer,
- gallstone disease (hepatic colic),
- chronic cholecystitis,
- postcholecystectomy syndrome,
- hypermotor biliary dyskinesia,
- spastic intestinal dyskinesia,
- intestinal colic due delay gas after surgery,
- colitis,
- proctitis,
- tenesmuses,
- flatulence,
- urolithiasis (renal colic),
- pyelitis,
- spasm of blood vessels of the brain, coronary and peripheral arteries, the need to reduce uterine contractions and relieve cervical spasm in childbirth,
- smooth muscle spasm during the instrumental interventions,
- dysmenorrhea,
- severe labor pains.
Drotaverine hydrochloride can also be used as an aid in hypertensive crises.
Contraindications
- hypersensitivity to the active substance (drotaverine hydrochloride) or to any of the auxiliary components;
- severe hepatic or renal failure,
- severe heart failure (low cardiac output syndrome),
- AV blockade II and III degree,
- cardiogenic shock,
- arterial hypotension,
- children under 12 years of age.
Use during pregnancy and breast-feeding
With caution, the drug is used during pregnancy and lactation (breastfeeding).
Special instruction
Intravenous and intra-arterial administration is carried out strictly under the supervision of a specialist, preferably in a hospital. When administered intravenously, the patient should be lying down due to the danger of collapse.
Influence on the ability to drive vehicles and other mechanisms that require increased concentration
During treatment should refrain from driving vehicles and activities potentially hazardous activities, require high concentration and psychomotor speed reactions.
Composition
1 tablet contains:
Active substance: drotaverine hydrochloride 40 mg.
Auxiliary substances: potato starch 30,71 mg, lactose monohydrate 57 mg, crospovidone (Polyplasdone XL-10) 2,923 mg, povidone (polyvinylpyrrolidone low molecular medical) 5,847 mg, 2.05 mg talc, magnesium stearate of 1.47 mg.
Dosage and administration
The drug is intended for intramuscular, subcutaneous, intravenous administration.
Adults and children over 12 years the average daily dose is 40-240 mg, divided into 1-3 intramuscular or subcutaneous administration of 2-4 ml of 2% solution.
In acute hepatic and / or hepatic colic, the drug is administered intravenously slowly in doses of 40-80 mg (2-4 ml of 2% solution).
With violations of peripheral blood circulation (obliterating endarteritis, Raynaud's disease), intra-arterial injection is allowed (slowly!).
To shorten the phase of cervical opening during physiological delivery at the beginning of the period of stretching drotaverine hydrochloride is administered intramuscularly at a dose of 40 mg once, with an unsatisfactory effect-again, once, for 2 hours.
Adults are administered orally 40-80 mg (1-2 tablets) 2-3 times a day.
Children under the age of 6 years appoint a single dose of 10-20 mg (1/4-1/2 tablet), from 6 to 12 years – 20 mg (1/2 tablet) 1-2 times a day.
