Spasmol - instructions for use, dose, side effects, contraindications

lactose (milk sugar) - 66.0 mg, potato starch - 30.0 mg, povidone (low molecular weight polyvinylpyrrolidone) 3.0 mg, calcium stearate 0.5 mg, stearic acid 0.5 mg.

Description:Tablets of yellow or greenish-yellow color, flat-cylindrical shape.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.D.02 Drotaverine

Pharmacodynamics:

Myotropic antispasmodic.

Farmakodinamika: Reduces the flow of calcium ions into smooth muscle cells (inhibits phosphodiesterase, leads to the accumulation of intracellular cAMP). Reduces the tone of the smooth muscles of internal organs and intestinal motility, dilates the blood vessels.

The presence of direct influence on the smooth muscles allows the use of drotaverin as an antispasmodic in cases,when drugs from the group of M-holinoblokatorov (closed angle glaucoma, prostatic hypertrophy) are contraindicated. Does not affect the autonomic nervous system.

Pharmacokinetics:

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

Indications:

Prevention and treatment of functional conditions and pain syndrome associated with spasm of smooth muscles of internal organs: chronic gastroduodenitis, chronic cholecystitis, cholelithiasis, renal stone disease, postcholecystectomy syndrome, peptic ulcer and duodenal ulcer, cardio and pilorospasm, spastic colitis, algodismenorea.

Spasm of peripheral arterial vessels, vessels of the brain.

When carrying out instrumental research.

Contraindications:

Hypersensitivity to the components of the drug.Pronounced hepatic, renal, heart failure; atrioventricular block II-III degree, cardiogenic shock, arterial hypotension. Children under 6 years. Breastfeeding period (lack of clinical data). Lactose intolerance, lactase deficiency, glucose / galactose malabsorption syndrome (due to the presence of lactose in the formulation).

Carefully:Patients with severe atherosclerosis of the coronary arteries; hyperplasia of the prostate; glaucoma; during pregnancy.

Pregnancy and lactation:

As shown by reproductive studies in animals and retrospective data on the clinical use of drotaverine, the use of drotaverine during pregnancy had neither teratogenic nor embryotoxic effects. Despite this, when using the drug during pregnancy, the potential benefit to the mother and the possible risk to the fetus should be correlated. In connection with the lack of the necessary clinical data during the period of breast-feeding is not recommended.

Dosing and Administration:

Inside. Adults appoint 40-80 mg (1-2 tablets) 2-3 times a day. The maximum dose is 240 mg.Children aged 6 to 12 years are prescribed a single dose of 20 mg.

Multiplicity of reception 1-2 times a day. Duration of admission is determined by the doctor depending on the disease.

Side effects:

Dizziness, headache, insomnia, palpitation, lowering blood pressure; sensation of heat, sweating, nausea, constipation; allergic reactions.

Overdose:

In large doses violates atrioventricular conduction, reduces the excitability of the heart muscle, can cause heart failure and respiratory center paralysis.

Interaction:

Strengthens the action of papaverine, bendazole and other antispasmodics (including M-holinoblokatorov).

With simultaneous application drotaverine weakens the antiparkinic effect of levodopa.

Increases the reduction in blood pressure caused by tricyclic antidepressants, quinidine and procainamide.

Reduces the spasmogenic activity of morphine.

Phenobarbital increases the severity of spasmolytic action of drotaverine.

Effect on the ability to drive transp. cf. and fur:

If there are any side effects, the issue of driving and working with machinery requires individual consideration.

In case of dizziness after taking the drug, you should avoid engaging in potentially dangerous activities, such as driving and working with machinery.

Form release / dosage:

Tablets of 40 mg.

Packaging:

For 10, 20 or 50 tablets in a planar cell package.

For 30, 50 or 100 tablets in a polymer tube with a lid-compensator for medicines.

1, 2, 3 or 5 contour mesh packages or 1 tube with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years. The drug should not be used after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N001132 / 01

Date of registration:17.03.2008 / 16.06.2014

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp16.06.2016

Illustrated instructions

Instructions

Spazmol® (Spasmol®)