Drotaverine Reneval, tablets 40 mg 56 pcs

A myotropic antispasmodic, isoquinoline derivative. By chemical structure and pharmacological properties it is similar to papaverine, but has a stronger and longer action. It reduces influx of calcium ions into smooth muscle cells (inhibits phosphodiesterase, leads to accumulation of intracellular cyclic adenosine monophosphate).

Reduces smooth muscle tone of internal organs and intestinal peristalsis, dilates blood vessels. It does not influence vegetative nervous system. It does not influence central nervous system.

Presence of direct influence on smooth muscles allows to use it as an antispasmodic when drugs from m-cholinoblocker group are contraindicated (closed-angle glaucoma, prostatic hyperplasia).

Pharmacokinetics

When administered orally the absorption is high, period of semi-absorption – 12 min. Bioavailability – 100%. Evenly distributed in tissues, penetrates into smooth muscle cells. Maximal concentration in blood plasma is 2 hours. Plasma protein binding is 95-98%. It is mainly excreted by kidneys, to a lesser extent – with bile. Does not penetrate the blood-brain barrier.

Indications

Spasm of smooth muscles in diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, inflammation of the duodenal papilla.

Spasm of smooth muscles in diseases of the urinary tract: nephrourolithiasis, urethrolithiasis, pyelitis, cystitis, bladder spasm.

As an auxiliary therapy: for spasms of smooth muscles of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, spasm of the cardia and pylorus, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome with flatulence; tensor headache; algodismenorrhea, threatened miscarriage, threatened premature birth; spasm of the uterine pharynx during childbirth, prolonged opening of the pharynx, postpartum contractions.

When conducting some instrumental studies, incl. cholecystography.

Pharmacological effect

Myotropic antispasmodic, isoquinoline derivative. In terms of chemical structure and pharmacological properties, it is close to papaverine, but has a stronger and longer-lasting effect. Reduces the flow of calcium ions into smooth muscle cells (inhibits phosphodiesterase, leading to the accumulation of intracellular cyclic adenosine monophosphate).

Reduces the tone of smooth muscles of internal organs and intestinal motility, dilates blood vessels. Does not affect the autonomic nervous system, does not penetrate the central nervous system.

The presence of a direct effect on smooth muscles allows it to be used as an antispasmodic in cases where drugs from the group of m-anticholinergic blockers are contraindicated (angle-closure glaucoma, prostatic hyperplasia).

Pharmacokinetics

When taken orally, absorption is high, half-absorption period is 12 minutes. Bioavailability – 100%. It is evenly distributed throughout the tissues and penetrates smooth muscle cells. The maximum concentration in blood plasma is 2 hours. Communication with plasma proteins is 95-98%. It is mainly excreted by the kidneys, and to a lesser extent – ​​with bile. Does not penetrate the blood-brain barrier.

Special instructions

During the treatment period, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Drotaverine

Composition

Active substance:
Drotaverine hydrochloride – 0.04 g
Excipients:
lactose monohydrate (milk sugar) – 0.0700 g
potato starch – 0.0216 g
povidone K-30 – 0.0042 g
crospovidone – 0.0014 g
talc – 0.0014 g
magnesium stearate – 0.0014 g

Pregnancy

Controlled studies have not been conducted in pregnant women, but the potential benefit may justify the use of drotaverine for the mother, despite the possible risk to the fetus. Contraindicated during breastfeeding.

Contraindications

Hypersensitivity to the components of the drug, severe liver and kidney failure, lactation period, children under 3 years of age, galactose intolerance, lactase deficiency, glucose-galactose malabsorption.

With caution

Severe atherosclerosis of the coronary arteries, prostatic hyperplasia, closed-angle glaucoma, pregnancy.

Side Effects

Dizziness, headache, insomnia, palpitations, tachycardia, feeling of heat, increased sweating, nausea, constipation, decreased blood pressure, allergic skin reactions, angioedema, urticaria, rash, itching.

Interaction

When used concomitantly, it may weaken the antiparkinsonian effect of levodopa.
Enhances the effect of papaverine, bendazole and other antispasmodics (including M-anticholinergics), the decrease in blood pressure caused by tricyclic antidepressants, quinidine and procainamide.
Reduces the spasmogenic activity of morphine.
Phenobarbital increases the severity of the antispasmodic effect of drotaverine hydrochloride.

Overdose

Symptoms: exceeding doses disrupts atrioventricular conduction, reduces the excitability of the heart muscle, and can cause cardiac arrest and depression of the respiratory center.

Storage conditions

In a dry place at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

3 years.

Manufacturer

Update of PFC JSC, Russia