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Drotaverine hydrochloride solution for injection 20 mg/ml 2 ml ampoule No. 5

International nonproprietary name Drotaverine. Drotaverine. Synonyms Droverin, No-shpa Pharmacotherapeutic group Vasodilators. Myotropic antispasmodics. Composition: 1 ml of injection solution contains 20 mg of drotaverine hydrochloride. ATX code: A03AD02.

Pharmacological action Pharmacodynamics Myotropic antispasmodic. 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 ionized calcium into smooth muscle cells by inhibiting phosphodiesterase and intracellular accumulation of cAMP. It has a pronounced and long-lasting effect on the smooth muscles of internal organs and blood vessels. Dilates blood vessels, causes a moderate decrease in blood pressure, increases cardiac output, and has some antiarrhythmic effect. Reduces the tone of brain vessels and increases their blood supply. It has virtually no effect on the autonomic nervous system and does not penetrate the central nervous system. Drotaverine does not have an anticholinergic effect, therefore, unlike anticholinergic antispasmodics, it can be used in patients with glaucoma. Pharmacokinetics: 95-98% bound to plasma proteins. Evenly distributed in tissues, penetrates smooth muscle cells. Does not penetrate the BBB. Excreted mainly by the kidneys, to a lesser extent with bile. The half-life of the drug when administered intravenously is 2.4 hours.

Indications for use Spasm of smooth muscles of internal organs (cardio- and pylorospasm), chronic gastroduodenitis, gastric and duodenal ulcers, cholelithiasis (hepatic colic), chronic cholecystitis, postcholecystectomy syndrome, hypermotor dyskinesia of the biliary tract, spastic intestinal dyskinesia, intestinal colic due to retention gases after surgery, colitis, proctitis, tenesmus, flatulence, urolithiasis (renal colic), pyelitis, spasm of cerebral vessels, coronary and peripheral arteries, the need to weaken uterine contractions and relieve cervical spasm during childbirth, smooth muscle spasm during instrumental interventions, dysmenorrhea, severe labor pains. Drotaverine hydrochloride can also be used as an adjuvant for hypertensive crises.

Method of administration and dosage regimen The drug is intended for intramuscular, subcutaneous, intravenous administration. For adults and children over 12 years of age, the average daily dose is 40-240 mg, divided into 1-3 intramuscular or subcutaneous injections of 2-4 ml of a 2% solution. For acute hepatic and/or hepatic colic, the drug is administered intravenously slowly in doses of 40-80 mg (2-4 ml of 2% solution). In case of peripheral circulatory disorders (obliterating endarteritis, Raynaud's disease), intra-arterial administration is allowed (slowly!). To shorten the dilatation phase of the cervix during physiological labor, at the beginning of the distension period, drotaverine hydrochloride is administered intramuscularly in a dose of 40 mg once; if the effect is unsatisfactory, it is repeated once for 2 hours.

Special instructions Intravenous and intra-arterial administration is carried out strictly under the supervision of a specialist, preferably in a hospital setting. When administering the drug intravenously, the patient should be in a lying position due to the risk of collapse. After parenteral, especially intravenous administration, it is recommended to refrain from driving vehicles and working on complex machinery for 1 hour. The drug is used to a limited extent in patients with prostate adenoma (due to relaxation of the bladder detrusor, urinary retention may occur); Use with caution in cases of severe atherosclerosis of the coronary arteries and angle-closure glaucoma. The use of the drug during pregnancy is allowed only after carefully weighing the ratio of real benefits to the mother and potential risk to the fetus. Due to the lack of necessary clinical data, the use of the drug during lactation is not recommended. If necessary, breastfeeding should be stopped during treatment with the drug.

Side effects After parenteral (mainly intravenous) administration, a feeling of heat, dizziness, headache (rarely), insomnia may occur; Arrhythmias (rarely), hypotension, rapid heartbeat, sweating, nausea, constipation may occur. In some patients, especially in patients with hypersensitivity to bisulfites, allergic reactions are possible, usually the phenomenon of allergic dermatitis; very rarely, in patients with a history of asthma or allergic reactions, anaphylactic reactions and bronchospasm are possible.

Contraindications Hypersensitivity to the active substance (drotaverine hydrochloride) or to any of the auxiliary components; severe liver or kidney failure, severe heart failure (low cardiac output syndrome), AV block II and III degrees, cardiogenic shock, arterial hypotension, children under 12 years of age.

Interaction with other drugs Enhances the effect of other antispasmodics (including M-anticholinergics), hypotension caused by tricyclic antidepressants, quinidine, procainamide. Reduces the spasmogenic activity of morphine and the antiparkinsonian properties of levodopa (increased tremor and rigidity are observed). Phenobarbital increases the reliability of eliminating spasms.

Overdose Symptoms: collapse, atrioventricular block, cardiac arrest, paralysis of the respiratory center. Treatment: symptomatic therapy (there is no specific antidote).

Release form Solution for injection 20 mg/ml in 2 ml ampoules in blister packs No. 5, No. 10.

Drotaverine-Solopharm solution for intravenous, intramuscular administration 20 mg/ml, ampoule 2 ml 10 pcs.

Registration Certificate Holder

GROTEX (Russia)

Dosage form

Medicine - Drotaverine-SOLOpharm (Drotaverine-SOLOpharm)

Description

Solution for intravenous and intramuscular administration

from light yellow or greenish-yellowish to yellow greenish-yellow, transparent or slightly opalescent.

1 ml

drotaverine hydrochloride 20 mg

Excipients

: ethanol 95% - 67 mg, sodium disulfite - 1 mg, liquid water - up to 1 ml.

2 ml - glass ampoules (5) - contour cell packaging (1) - cardboard packs. 2 ml - glass ampoules (5) - contour cell packaging (2) - cardboard packs. 2 ml - glass ampoules (5) - contour cell packaging (10) - cardboard packs. 2 ml - glass ampoules (5) - contour cell packaging (20) - cardboard packs. 2 ml - glass ampoules (10) - contour cell packaging (1) - cardboard packs. 2 ml - glass ampoules (10) - contour cell packaging (5) - cardboard packs. 2 ml - glass ampoules (10) - contour cell packaging (10) - cardboard packs.

Indications

Spasms of smooth muscles in diseases of the biliary tract (cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis); spasms of smooth muscles of the urinary tract (nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder spasms). As an auxiliary therapy for spasms of smooth muscles of the gastrointestinal tract (peptic ulcer of the stomach and duodenum, gastritis, spasms of the cardia and pylorus, enteritis, colitis, spastic colitis with constipation, irritable bowel syndrome with flatulence); for tension headaches; with dysmenorrhea; when conducting some instrumental studies, incl. with cholecystography.

Contraindications for use

Hypersensitivity to drotaverine; severe renal failure, severe liver failure, severe heart failure (low cardiac output syndrome); lactation period (breastfeeding); children up to 6 years of age (for oral administration), children up to 18 years of age (for parenteral use).

For parenteral use: AV blockade II-III degree; period of childbirth.

Carefully:

with arterial hypotension; in children (lack of clinical experience); during pregnancy. When used parenterally - with severe atherosclerosis of the coronary arteries, prostate adenoma, glaucoma.

pharmachologic effect

Antispasmodic myotropic action. In terms of chemical structure and pharmacological properties, it is close to papaverine, but surpasses it in efficiency and duration of action.

Drotaverine is effective against smooth muscle spasms of both neurogenic and muscular origin. Regardless of the type of autonomic innervation, drotaverine relaxes the smooth muscles of the gastrointestinal tract, biliary tract, and genitourinary system. Due to its vasodilating effect, drotaverine improves blood supply to tissues.

Drug interactions

When used simultaneously with tricyclic antidepressants, quinidine, procainamide, the decrease in blood pressure caused by tricyclic antidepressants, quinidine and procainamide is enhanced.

With simultaneous use, the spasmogenic activity of morphine decreases.

When used simultaneously with levodopa, the antiparkinsonian effect of levodopa may be reduced.

With simultaneous use, the effect of papaverine, bendazole and other antispasmodics (including m-anticholinergics) is enhanced.

When used simultaneously with phenobarbital, the severity of the antispasmodic effect of drotaverine increases.

Dosage regimen

Apply orally, intramuscularly or intravenously. The dose, method and regimen of use are determined individually, depending on the indications, clinical situation and age.

When taken orally, adults are prescribed 40-80 mg 2-3 times a day. The maximum daily dose for adults is 240 mg. The dose for children is determined depending on age.

For parenteral use, the average daily dose is 40-240 mg, divided into 1-3 doses per day, intramuscularly. For acute colic (renal or cholelithiasis), a dose of 40-80 mg is prescribed intravenously in a slow stream (duration of administration is approximately 30 seconds).

Side effect

From the nervous system:

rarely - headache, dizziness, insomnia.

From the cardiovascular system:

rarely - palpitations, decreased blood pressure; with parenteral use - arrhythmia, tachycardia, collapse (with intravenous administration).

From the digestive system:

rarely - nausea, constipation.
Allergic reactions:
rarely - angioedema, urticaria, rash, itching; with parenteral use in some cases - anaphylactic shock.

Local reactions:

when used parenterally, rarely - reactions at the injection site.

special instructions

When administering drotaverine intravenously, the patient should be in a horizontal position due to the risk of collapse.

Use in pediatrics

Use drotaverine (for oral administration) with caution in children.
Parenteral use in children is contraindicated. Effect on the ability to drive vehicles and operate machinery
During the period of use of drotaverine, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions (within 1 hour after parenteral administration, especially intravenous).

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - Contraindicated.

Use during pregnancy is possible only in cases where the potential benefit to the mother outweighs the potential risk to the fetus.

Contraindicated for use during lactation (breastfeeding). If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Use for renal impairment

Restrictions for impaired renal function - With caution.

Use is contraindicated in cases of severe renal impairment.

Use for liver dysfunction

Restrictions for liver dysfunction - With caution. Use is contraindicated for severe liver dysfunction.

Use in elderly patients

Restrictions for elderly patients - With caution. Caution should be prescribed to elderly patients to avoid worsening the course of concomitant diseases.

Use in children

Restrictions for children - With caution.

Taking drotaverine orally is contraindicated in children under 6 years of age.
Parenteral use of drotaverine is contraindicated in children and adolescents under 18 years of age.