Smooth muscle contraction states associated with biliary diseases: cholelithiasis, cholecystitis, and smooth muscle of the urinary tract: kidney stones, pelvic inflammatory disease, cystitis, painful urge to urinate. Supportive in smooth muscle contractions of the gastrointestinal tract: in peptic ulcer of the stomach and duodenum, in spastic states of cardia and gastric pylorus, irritable bowel syndrome, spastic constipation and flatulence, and in contractile states within the genital tract: dysmenorrhea, severe pains, miscarriage threatening.
Composition:
1 tabl contains 40 mg of drotaverine hydrochloride.
Action:
A papaverine derivative with a strong spasmolytic activity, which is the result of the inhibitory action on the enzyme phosphodiesterase IV. It has a diastolic effect on the smooth muscles, with nervous and muscular contraction, and dilates the vessels, resulting in increased blood flow through the tissues. The effect of drotaverine does not depend on the type of innervation and the location of smooth muscle. Rapidly absorbed from the gastrointestinal tract, bioavailability is 25.5-91%. The maximum concentration is observed after 45-60 min. It binds with proteins in 80-95%. Drotaverine is metabolised in the liver, T0,5 is 8-10 hours. It is excreted in the form of metabolites in the urine (about 50%) and in the faeces (about 30%).
Contraindications:
Hypersensitivity to Drotaverin or other components of the preparation. Severe hepatic, renal or cardiac failure. Porphyria. Atrioventricular conduction disorders (total atrioventricular block).
Precautions:
Caution should be exercised in patients with hypertension.
Pregnancy and lactation:
The preparation can be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus. Drotaverin crosses the placenta. The use of the preparation during breastfeeding is not recommended.
Side effects:
Rare: palpitations; hypotension; pain and dizziness, insomnia; nausea, constipation. Not known: acute attacks of porphyria; vomiting, loss of appetite.
Dosage:
Orally. Adults: daily dose 40-240 mg (1-6 tabl.) In 1-3 divided doses. Elderly patients with renal or hepatic impairment are advised to use individual dose adjustments. After 1 day of treatment, the symptoms should go away.
(C)
