Smooth muscle contraction states associated with biliary diseases: cholelithiasis, gall bladder inflammation, perituberal inflammation, cholangitis, Vater's papilla inflammation. Contractions of the smooth muscle of the urinary tract: kidney stones, urolithiasis, pelvic inflammation, cystitis, painful urinary urgency. Supportive in smooth muscle contractions of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, intestinal inflammation, colitis, contractile states of the cardia and gastric pylorus, irritable bowel syndrome, spastic constipation and flatulence, pancreatitis; in gynecological diseases: dysmenorrhea; in addition, a dose of 80 mg in tension headaches.
Composition:
1 tabl contains 40 mg of drotaverine hydrochloride (tablets contain lactose). 1 tabl powl. Comfort contains 40 mg of drotaverine hydrochloride (excl. Tables include lactose and tartrazine). 1 tabl forte contains 80 mg of drotaverine hydrochloride (tablets contain lactose). 1 tabl powl. Max contains 80 mg of drotaverine hydrochloride (excl. Tables include lactose and quinoline yellow).
Action:
An isoquinoline derivative with a strong spasmolytic activity on smooth muscle. The mechanism of action is based on the inhibition of phosphodiesterase IV (PDE IV), resulting in increased cAMP concentration, inactivation of myosin light chain kinase and smooth muscle relaxation. Drotaverine is used to treat smooth muscle spasms of both neurogenic and muscular origin. Regardless of the type of autonomic innervation drotavinin acts on smooth muscle found in the gastrointestinal tract, bile ducts, urogenital system and circulatory system. Due to the vasodilating effect, drotaverine increases blood flow in the tissues. After oral administration, drotaverine is rapidly and completely absorbed from the gastrointestinal tract, reaching a maximum concentration in the blood after 45-60 min. It binds to plasma proteins in 95-98%. It is metabolized in the liver. T0,5 is 8-10 h. It is excreted mainly in the form of metabolites in the urine (approximately 50%) and to a lesser extent in the faeces (approximately 30%).
Contraindications:
Hypersensitivity to the components of the preparation. Severe hepatic, renal failure, circulatory insufficiency. Atrio-ventricular block IIst. and IIIst. The 40 mg medication (table and comfort table) should not be used in children under 6 years of age. The drug at a dose of 80 mg (table forte and table space Max) do not use in children under 12 years.
Precautions:
Caution in patients with hypotension. Use with caution in children, due to the lack of studies on the effects of drotaverine in this group of patients. Due to its lactose content, the preparation should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. Due to the content of tartrazine (Comfort surface table) or choline yellow (Table of contents of Max), the drug may cause allergic reactions.
Pregnancy and lactation:
It can only be used during pregnancy if the benefit outweighs the risk factors. Drotaverin crosses the placenta. Do not use the preparation during labor, due to the increased risk of postpartum haemorrhage. It is not recommended to use the product during breastfeeding.
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