SPAZMONET

Active material: Drotaverine
When ATH: A03AD02
CCF: Myotropic antispasmodic
ICD-10 codes (testimony): I73.0, I73.1, I73.9, K25, K26, K29, K31.3, K52, K59.0, K62.8, K80, K81.0, K81.1, K82.8, K91.5, N10, N11, N23, N94.4, N94.5, O20.0, O60, O62, R10.4, R51
When CSF: 01.14.05
Manufacturer: Krka-RUS OOO (Russia)

Pharmaceutical form, composition and packaging

◊ Pills from light yellow to greenish white to yellow with greenish tint, Valium, chamfered, scored on one side, allowed marbling.

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, Croscarmellose sodium, Colloidal anhydrous silica, talc, magnesium stearate.

10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.

Pharmacological action

Myotropic antispasmodic, in chemical structure and pharmacological properties similar to papaverine, but has a strong and long-acting. It reduces the flow of calcium ions into smooth muscle cells. It reduces the tone of smooth muscles of internal organs and intestinal peristalsis, dilates blood vessels. No effect on the autonomic nervous system, It does not penetrate the CNS. The direct effect on the smooth muscles can use it as an antispasmodic, when contraindicated drugs from the group of m-holinoblokatorov (zakrыtougolynaya glaucoma, prostatic hyperplasia).

Pharmacokinetics

Absorption

After oral administration, absorption is high. Bioavailability is 100%. FROM_max blood achieved through 2 no.

Distribution

Evenly distributed in the body, It penetrates into the smooth muscle cells. The binding to plasma proteins – 80-90%. Do not cross the BBB.

Metabolism and excretion

T_1/2 – 7-12 no. Drotaverine is extensively metabolised in the liver, Write mainly kidneys, less, the bile.

Testimony

Spasm and pain syndrome, spastic nature, arising in the following states:

- A spasm of smooth muscles of internal organs (počečnaâ how, želčnaâ how, kišečnaâ how);

- Biliary dyskinesia and gall bladder of hyperkinetic, holetsestit, postcholecystectomical syndrome, pyelitis;

- Spastic constipation, spasticheskiy colitis, proctitis, tenesmus;

- Pilorospazm, gastroduodenit, gastric ulcer and duodenal ulcer (exacerbation, in the complex therapy – for pain, spastic nature);

- Endartyeriit;

- A spasm of peripheral, coronary artery, as well as cerebral arterial spasm, accompanied by headaches;

- Algomenorrhea;

- To reduce the excitability of the uterus during pregnancy (threatening miscarriage, threatening preterm delivery), spasm of the cervix during labor, disclosure prolonged throat, afterpains.

For the prevention of spasm during some instrumental studies, holetsistografii.

Dosage regimen

Inside, drinking a small amount of liquid.

Children under 6 years appoint 10-20 mg 1-2 times / day, the maximum daily dose – 120 mg; children aged 6 to 12 years – 1/2tab. 2 times / day (20-40 mg), the maximum daily dose – 200 mg; adults and children over 12 years – by 1-2 tab. 3 times / day (120-240 mg).

Side effect

There are: nausea, dizziness, heartbeat, feeling the heat, increased perspiration, decrease in blood pressure, allergic skin reactions.

Contraindications

- Severe hepatic impairment;

- Severe renal insufficiency;

- Congestive heart failure;

— AV-blockade II and III degrees;

- Cardiogenic shock;

- Hypotension;

- Hypersensitivity to the drug.

The tablets contain lactose Spazmonet, therefore, patients with congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the drug.

FROM caution should be prescribed to children under the age of 6 years, with advanced atherosclerosis of the coronary arteries, angle-closure glaucoma, prostatic hyperplasia.

Pregnancy and lactation

The appointment of the drug during pregnancy and lactation is not contraindicated, but it should be used with caution, especially in the I trimester of pregnancy.

Cautions

In the treatment of gastric ulcer and duodenal ulcer drug is used in combination with other anti-ulcer agents.

Effects on ability to drive vehicles and management mechanisms

During the period of use of the drug should refrain from driving vehicles and Occupation potentially hazardous activities, requiring concentration and speed of psychomotor reactions.

Overdose

Symptoms: in large doses drotaverine violates AV-conduction, reduces the excitability of cardiac muscle, can cause heart failure and paralysis of the respiratory center.

Drug Interactions

In an application drotaverine can weaken the effect of levodopa antiparkinsonian.

It enhances the effect of papaverine, bendazol and other antispasmodics (incl. Mr. holinoblokatorov).

With simultaneous use of tricyclic antidepressants, quinidine and procainamide enhanced hypotensive effect.

Phenobarbital increases the severity of antispasmodic action drotaverine.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children, at a temperature no higher than 25 ° C. Shelf life – 2 year.