Drotaverine is an isoquinoline derivative with chemical structure and pharmacological properties similar to papaverine, but with stronger and longer action. Drotaverine has a powerful antispasmodic effect on smooth muscles by inhibiting the phosphodiesterase enzyme (PDE). Phosphodiesterase enzyme is required for hydrolysis of cAMP (cyclic adenosine-3′, 5′-monophosphate) to AMP (adenosine-5′-monophosphate).
Gastroduodenitis, Urolithiasis, Gallstone disease, Headache, Gall colic, Colic, Painful menstruation (algodysmenorrhea), Pain, Gastritis, Colitis
- Smooth muscle spasms in diseases of the biliary tract: Cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, inflammation of duodenal papilla.
- Smooth muscle spasms in diseases of the urinary tract: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder spasms.
- in spasms of the smooth muscles of the gastrointestinal tract: gastric and duodenal ulcer, gastritis, cardia and gatekeeper spasms, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome with flatulence;
- for tensor headaches (tension headaches); for algodysmenorrhea.
1 tablet contains:
- drotaverine hydrochloride – 80 mg;
- magnesium stearate,
- corn starch,
- lactose monohydrate.
How to take, the dosage
The drug is taken orally.
Use of the drug in case of arterial hypotension requires increased caution.
- High sensitivity to drotaverine and/or excipients in the drug.
- Deep hepatic or renal failure.
- Severe heart failure (decreased cardiac output).
- Breast-feeding period (see section “Pregnancy and lactation”).
- Children (no clinical studies have been conducted in children).
- Hereditary lactose intolerance, lactase deficiency, galactosemia, or glucose/galactose malabsorption syndrome (due to the presence of lactose in the drug). “
In case of arterial hypotension.
In pregnant women (see “Pregnancy and lactation”). Pregnancy and lactation
There is no evidence of teratogenic or embryotoxic effects or adverse effects on pregnancy based on limited retrospective data on the use of the drug in humans and data from animal studies when taking oral drotaverine. Despite this, caution should be exercised when using the drug in pregnant women and the drug should be prescribed only after careful weighing of the balance of benefits and risks to the mother and risks to the child.
There have been no studies on the excretion of drotaverine into maternal milk in animals. In the absence of such studies in animals and clinical data, it is not recommended to prescribe drotaverine during lactation.
The side effects listed below, which have been considered in clinical trials to be at least possibly associated with drotaverine, are given according to the following frequency gradations: very common ( 1/10), common (≥1/100, 1/10); rare (≥1/1000, 1/100); sometimes (≥1/10000, 1/1000); very rare (including individual reports) ( 1/10000); unknown frequency (the incidence cannot be determined from available data) and are grouped by organ system.
In case of overdose, patients should be under medical supervision and, if necessary, they should be treated with symptomatic and supportive treatment for basic body functions.
There are no data on overdose of the drug.
No-shpa, Drotaverine, Spasmonet, Drotaverine-Teva
|Conditions of storage|
Store at a temperature not exceeding 25 ° C.
Hinoin Pharmaceutical and Chemical Works, Hungary
Hinoin Pharmaceutical and Chemical Works
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