Papaverine hydrochloride tablets 40mg, No. 20

Smooth muscle spasm:

• abdominal organs (cholecystitis, pylorospasm, spastic colitis);

• renal colic, peripheral vessels (endarteritis);

• cerebral vessels; heart (angina pectoris - as part of complex therapy);

• bronchospasm.

Inside. Adults 40-60 mg 3-4 times a day. The highest single dose is 200 mg, the daily dose is 600 mg.

Children over 10 years old, 20 mg 3-4 times a day. Children under 10 years of age are advised to take pediatric forms of the drug.

Papaverine hydrochloride - 40 mg

Excipients : potato starch - 149.8 mg, stearic acid - 2.7 mg, sucrose (granulated sugar) - 157.5 mg.

- hypersensitivity to papaverine and other components of the drug;

- atrioventricular block;

- glaucoma;

- severe renal failure;

- sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;

- respiratory depression, coma;

- old age (risk of developing hyperthermia);

- children under 10 years of age (for this dosage form).

Carefully

- conditions after traumatic brain injury;

- violation of kidney function;

- insufficiency of adrenal function;

- hypothyroidism;

- prostatic hyperplasia;

- supraventricular tachycardia;

- shock conditions;

- pregnancy, lactation (see section 'Use during pregnancy and breastfeeding').

Trade name : Papaverine

International non-proprietary name or grouping name: Papaverine &

Chemical name - 1 - [(3,4-dimethoxyphenyl) methyl)] - 6,7-dimethoxyisoquinoline (as hydrochloride).

Dosage form: tablets

Composition for one tablet:

Papaverine hydrochloride - 40 mg

Excipients : potato starch - 149.8 mg, stearic acid - 2.7 mg, sucrose (granulated sugar) - 157.5 mg.

Description

Tablets are white, flat-cylindrical, chamfered and scored.

Pharmacotherapeutic group: antispasmodic agent.

ATX code: A03AD01

Pharmacological properties

Pharmacodynamics

Papaverine reduces smooth muscle tone, has a vasodilator and antispasmodic effect. It is an inhibitor of the enzyme phosphodiesterase and causes intracellular accumulation of cyclic 3.5 adenosine monophosphate, which leads to impaired contractility of smooth muscles of internal organs (gastrointestinal tract, respiratory and genitourinary systems) and blood vessels and their relaxation in spastic conditions. In large doses, it reduces the excitability of the heart muscle and slows down intracardiac conduction. The effect on the central nervous system is weak (in large doses it has a sedative effect).

Pharmacokinetics

Absorption is high. Bioavailability on average is 54%. Communication with plasma proteins - 90%. It is well distributed in tissues, penetrates the histohematogenous barriers. It is metabolized in the liver. The half-life is 0.5-2 hours. It is excreted by the kidneys in the form of metabolites. It is completely removed from the blood during hemodialysis.

Indications for use

Smooth muscle spasm:

• abdominal organs (cholecystitis, pylorospasm, spastic colitis);

• renal colic, peripheral vessels (endarteritis);

• cerebral vessels; heart (angina pectoris - as part of complex therapy);

• bronchospasm.

Contraindications

- hypersensitivity to papaverine and other components of the drug;

- atrioventricular block;

- glaucoma;

- severe renal failure;

- sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;

- respiratory depression, coma;

- old age (risk of developing hyperthermia);

- children under 10 years of age (for this dosage form).

Carefully

- conditions after traumatic brain injury;

- violation of kidney function;

- insufficiency of adrenal function;

- hypothyroidism;

- prostatic hyperplasia;

- supraventricular tachycardia;

- shock conditions;

- pregnancy, lactation (see section 'Use during pregnancy and breastfeeding').

Method of administration and dosage

Inside. Adults 40-60 mg 3-4 times a day. The highest single dose is 200 mg, the daily dose is 600 mg.

Children over 10 years old, 20 mg 3-4 times a day. Children under 10 years of age are advised to take pediatric forms of the drug.

Side effect

Allergic reactions, atrioventricular block, ventricular premature beats, decreased blood pressure, constipation, drowsiness, increased activity of 'hepatic' transaminases, eosinophilia.

Overdose

Symptoms: diplopia, weakness, decreased blood pressure, drowsiness.

Treatment: symptomatic (maintaining blood pressure).

Application during pregnancy and during breastfeeding

The safety of using the drug during pregnancy and during breastfeeding has not been established. During pregnancy and during breastfeeding, the use of the drug is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or child.

Interaction with other medicinal products

Papaverine reduces the antiparkinsonian effect of levodopa and the hypotensive effect of methyldopa.

In combination with barbiturates, the antispasmodic effect of papaverine is enhanced.

When used together with tricyclic antidepressants, procainamide, reserpine, quinidine, the hypotensive effect of papaverine may be enhanced.

Influence on the ability to drive vehicles and other mechanisms

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

special instructions

During the treatment period, ethanol intake should be excluded.

The vasodilating effect is reduced by smoking.

When prescribing Papaverine to patients with diabetes mellitus, it should be borne in mind that the tablet contains sucrose as auxiliary substances.

Release form

at production at OJSCPharmstandard-Tomskkhimfarm, Russia

40 mg tablets.

There are 10 tablets in a blister strip or 10 tablets in a blister-free contour packaging.

1 or 3 contour cell or non-cell packaging, together with instructions for use, are placed in a cardboard box.

Contoured non-cell packs, together with an equal number of instructions for use, are placed directly in the group pack.

100-1000 contoured non-cell packs, together with an equal number of instructions for use, are placed directly in a cardboard box ('For hospitals').

or during production at OJSCPharmstandard-Leksredstva, Russia

40 mg tablets.

There are 10 tablets in a blister strip or 10 tablets in a blister-free contour packaging.

1, 2 or 3 contour cell or 1 or 3 contour non-cell packaging together with instructions for use are placed in a cardboard box.

Contoured or non-cell packs, together with an equal number of instructions for use, are placed directly in the group pack.

100-1000 blister or non-blister packs, together with an equal number of instructions for use, are placed directly in a cardboard box ('For hospitals').

Storage conditions

At a temperature not higher than 25 ? C. Keep out of the reach of children.

Shelf life

5 years. Do not use later than the date indicated on the package.

Vacation conditions

Without recipe.

Name and address of manufacturer / organization accepting claims:

with production at JSCPharmstandard-Tomskhimfarm:

OJSC 'Pharmstandard-Tomskkhimfarm',

634009, Russia, Tomsk, Lenin Ave., 211, tel./fax: (3822) 40-28-56, www.pharmstd.ru

or

with production at JSCPharmstandard-Leksredstva:

Pharmstandard-Leksredstva OJSC,

305022, Russia, Kursk, st. 2nd Aggregatnaya, 1a / 18, tel./fax: (4712) 34-03-13, www.pharmstd.ru