Drotaverine (Tablets, Solution, Films) Instructions for Use

Instructions
Dosage forms

ATC Code

A03AD02 (Drotaverine)

Active Substance

Drotaverine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Myotropic antispasmodic

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders; papaverine and its derivatives

Pharmacological Action

A myotropic action antispasmodic. In its chemical structure and pharmacological properties, it is similar to papaverine, but surpasses it in efficacy and duration of action.

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

Pharmacokinetics

After oral administration, Drotaverine is rapidly absorbed from the gastrointestinal tract. After presystemic metabolism, 65% of the dose enters the systemic circulation. The C_max of drotaverine in blood plasma is reached within 45-60 minutes. Plasma protein binding is 95-98%. It is evenly distributed in tissues and penetrates smooth muscle cells. It does not cross the blood-brain barrier; Drotaverine and/or its metabolites may slightly cross the placental barrier. Drotaverine is almost completely metabolized in the liver. The T_1/2 of drotaverine is 8-10 hours. Within 72 hours, Drotaverine is almost completely eliminated from the body. About 50% is excreted by the kidneys and about 30% through the gastrointestinal tract. Drotaverine is mainly excreted as metabolites; the unchanged form of drotaverine is not detected in urine.

With parenteral administration, Drotaverine is rapidly absorbed. Bioavailability is 100%. Onset of action is within 2-4 minutes. C_max in blood plasma is reached within 30-40 minutes.

Indications

Spasms of smooth muscle in diseases of the biliary tract (cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis); spasms of smooth muscle of the urinary tract (nephrolithiasis, ureterolithiasis, pyelitis, cystitis, bladder spasms). As an auxiliary therapy for spasms of the smooth muscle of the gastrointestinal tract (gastric and duodenal ulcer, gastritis, cardia and pylorus spasms, enteritis, colitis, spastic colitis with constipation, irritable bowel syndrome with flatulence); for tension-type headaches; for dysmenorrhea; for performing some instrumental examinations, including cholecystography.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
G44.2	Tension-type headache
K25	Gastric ulcer
K26	Duodenal ulcer
K27	Peptic ulcer
K29	Gastritis and duodenitis
K31.3	Pylorospasm, not elsewhere classified
K52.8	Other specified noninfective gastroenteritis and colitis
K58	Irritable bowel syndrome
K59.0	Constipation
K62.8	Other specified diseases of anus and rectum (including proctitis)
K80	Cholelithiasis [cholelithiasis] (including biliary colic)
K81.0	Acute cholecystitis
K81.1	Chronic cholecystitis
K83.0	Cholangitis
K83.8	Other specified diseases of biliary tract
N10	Acute tubulointerstitial nephritis (acute pyelonephritis)
N11	Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N20	Calculus of kidney and ureter
N21	Calculus of lower urinary tract
N23	Unspecified renal colic
N94.4	Primary dysmenorrhea
N94.5	Secondary dysmenorrhea
R10.4	Other and unspecified abdominal pain (colic)
R14	Flatulence and related conditions (including abdominal bloating, belching)
R30.1	Vesical tenesmus

ICD-11 code	Indication
8A83	Other primary headache disorders
DA41.Y	Other specified disorders of gastroduodenal motility and secretion
DA42.Z	Gastritis, unspecified
DA51.Z	Duodenitis, unspecified
DA60.Z	Gastric ulcer, unspecified
DA61	Peptic ulcer of unspecified site
DA63.Z	Duodenal ulcer, unspecified
DA7Z	Diseases of stomach or duodenum, unspecified
DB32.1	Slow-transit constipation
DB70.Z	Infections of anal and rectal regions, unspecified
DB72.Z	Some specified diseases of the anal canal, unspecified
DC10.Z	Acquired structural (organic) changes of gallbladder or bile ducts, unspecified
DC11.Z	Cholelithiasis, unspecified
DC12.0Z	Acute cholecystitis, unspecified
DC12.1	Chronic cholecystitis
DC13	Cholangitis
DC14.Z	Diseases of the biliary tract, unspecified
DC1Z	Diseases of gallbladder and biliary tract, unspecified
DD91.0Z	Irritable bowel syndrome, unspecified
DD91.1	Functional constipation
DD93.1	Infantile colic
DE2Z	Diseases of the digestive system, unspecified
EG61	Infections of the anus or perianal skin
GA34.3	Dysmenorrhea
GB50	Acute tubulo-interstitial nephritis
GB51	Acute pyelonephritis
GB55.Z	Chronic tubulo-interstitial nephritis, unspecified
GB5Z	Renal tubulo-interstitial diseases, unspecified
GB70.Z	Calculus of upper urinary tract, unspecified
GB71.Z	Calculus of lower urinary tract, unspecified
MD81.4	Other and unspecified abdominal pain
ME08	Flatulence and related conditions
MF50.8	Vesical tenesmus
MF56	Renal colic

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets, Solution, Films

It is used orally, intramuscularly or intravenously. The dose, method, and regimen of application are determined individually, depending on the indications, clinical situation, and age.

When taken orally, adults are prescribed 40-80 mg 2-3 times/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 biliary) it is prescribed at a dose of 40-80 mg intravenously by slow bolus (injection duration approximately 30 seconds).

Adverse Reactions

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 with parenteral use rarely – reactions at the injection site.

Contraindications

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

For parenteral administration: AV block II-III degree; labor period.

With caution: in arterial hypotension; in children (insufficient clinical experience of use); during pregnancy. For parenteral use – in severe atherosclerosis of the coronary arteries, prostate adenoma, glaucoma.

Use in Pregnancy and Lactation

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 the lactation period (breastfeeding). If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use in Renal Impairment

Contraindicated in severe renal dysfunction.

Pediatric Use

Oral administration of drotaverine is contraindicated in children under 6 years of age.

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

Geriatric Use

Elderly patients should be prescribed with caution to avoid worsening of concomitant diseases.

Special Precautions

During intravenous administration of drotaverine, 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 ability to drive vehicles and machinery

During the 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 (for 1 hour after parenteral administration, especially intravenous).

Drug Interactions

With simultaneous use 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 is reduced.

With simultaneous use with levodopa, a decrease in the antiparkinsonian effect of levodopa is possible.

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

With simultaneous use with phenobarbital, the severity of the antispasmodic action of drotaverine increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Drotaverine [Alliancepharma, LLC (Russia)]
Tablets 40 mg: 10, 20, 25, 30, 50, 75, or 125 pcs.

Marketing Authorization Holder

Alliancepharma, LLC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 20, 25, 30, 50, 75, or 125 pcs.

Dosage Form, Packaging, and Composition

Tablets yellow with a greenish tint, round, flat-cylindrical in shape, with a bevel and a score line.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients : potato starch – 30.1 mg, lactose monohydrate (milk sugar) – 60.1 mg, povidone (polyvinylpyrrolidone) – 5.8 mg, talc – 2.6 mg, magnesium stearate – 1.4 mg.

10 pcs. – contour cell packs (1, 2, 3, 4, 5) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Drotaverine [Apteki 36,6, CJS (Russia)]
Tablets 40 mg: 20, 30, 50 or 100 pcs.

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Veropharm, JSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Drotaverine hydrochloride	40 mg

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Drotaverine [Armavir Biopharmaceutical Plant, FSE (Russia)]
Injection solution 20 mg/1 ml: amp. 5 or 10 pcs.

Marketing Authorization Holder

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Drotaverine

Injection solution 20 mg/1 ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution	1 ml
Drotaverine hydrochloride	20 mg

Ampoules (5) – contour cell packs (1) – cardboard packs.
Ampoules (5) – contour cell packs (2) – cardboard packs.

Drotaverine [Atoll LLC (Russia)]
Tablets 80 mg: 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 90, 100, 120, 125, 140, 150, 200, 250, 300, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Drotaverine

Tablets 80 mg: 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 90, 100, 120, 125, 140, 150, 200, 250, 300, or 500 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow with a greenish tint to yellow with a greenish tint with a score on one side and a bevel.

	1 tab.
Drotaverine hydrochloride	80 mg

Excipients : lactose monohydrate (milk sugar) – 33.2 mg, microcrystalline cellulose – 40 mg, corn starch – 20 mg, croscarmellose sodium – 8 mg, povidone K25 – 7 mg, magnesium stearate – 1.8 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (3) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
50 pcs. – contour cell packs (1) – cardboard packs.
50 pcs. – contour cell packs (2) – cardboard packs.
50 pcs. – contour cell packs (3) – cardboard packs.
50 pcs. – contour cell packs (4) – cardboard packs.
50 pcs. – contour cell packs (5) – cardboard packs.
50 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Drotaverine [Atoll LLC (Russia)]
Tablets 40 mg: 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 90, 100, 120, 125, 140, 150, 200, 250, 300, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 90, 100, 120, 125, 140, 150, 200, 250, 300, or 500 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow with a greenish tint to yellow with a greenish tint, with a score on one side and a bevel.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients: lactose monohydrate (milk sugar) – 16.6 mg, microcrystalline cellulose – 20 mg, corn starch – 10 mg, croscarmellose sodium – 4 mg, povidone K25 – 3.5 mg, magnesium stearate – 0.9 mg.

Drotaverine [Atoll LLC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/ml: 2 ml amp. 5, 10, 50, or 100 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Drotaverine

Solution for intravenous and intramuscular administration 20 mg/ml: 2 ml amp. 5, 10, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration from greenish-yellow to intense yellow with a greenish tint, transparent.

	1 ml
Drotaverine hydrochloride	20 mg

Excipients: sodium disulfite – 1 mg, ethanol 96% – 66 mg, water for injection – up to 1 ml.

2 ml – ampoules made of colorless type I glass (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules made of colorless type I glass (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules made of colorless type I glass (5) – contour cell packs (10) – cardboard packs.
2 ml – ampoules made of colorless type I glass (5) – contour cell packs (20) – cardboard packs.

Drotaverine [Biomed named after I.I.Mechnikov, PJSC (Russia)]
Solution for injection 40 mg/2 ml: amp. 5, 10 or 20 pcs.

Marketing Authorization Holder

Biomed named after I.I.Mechnikov, PJSC (Russia)

Dosage Form

Drotaverine

Solution for injection 40 mg/2 ml: amp. 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for injection	1 ml	1 amp.
Drotaverine hydrochloride	20 mg	40 mg

2 ml – dark glass ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – dark glass ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – dark glass ampoules (5) – contour cell packs (4) – cardboard packs.

Drotaverine [Biosintez, PJSC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/ml: 2 ml amp. 5, 10, or 15 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Drotaverine

Solution for intravenous and intramuscular administration 20 mg/ml: 2 ml amp. 5, 10, or 15 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration from greenish-yellow to intense yellow with a greenish tint, transparent.

	1 ml
Drotaverine hydrochloride	20 mg

Excipients: sodium disulfite – 1 mg, ethanol 96% – 66 mg, water for injection – up to 1 ml.

Drotaverine [Biosintez, PJSC (Russia)]
Tablets 40 mg: 10 or 20 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Drotaverine hydrochloride	40 mg

10 pcs. – contour cell packs.
10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.

Drotaverine [Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)]
Tablets 40 mg: 20 pcs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Drotaverine

Tablets 40 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets yellow or yellow with a greenish tint, round, flat-cylindrical, with a bevel.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients: lactose monohydrate, talc, stearic acid, potato starch.

10 pcs. – contour cell packs (2) – cardboard packs.

Drotaverine [Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)]
Solution for intravenous and intramuscular administration 20 mg/1 ml: 2 ml amp. 10 pcs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Drotaverine

Solution for intravenous and intramuscular administration 20 mg/1 ml: 2 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, from light yellow or light yellow with a greenish tint to yellow to yellow with a greenish tint, with a characteristic odor of acetic acid.

	1 ml
Drotaverine hydrochloride	20 mg

Excipients: sodium disulfite (sodium metabisulfite), sodium acetate trihydrate, glacial acetic acid, ethanol (ethyl alcohol) 96.3%, water for injection.

2 ml – glass ampoules (10) – cardboard packs with an insert.
2 ml – glass ampoules (10) – cardboard boxes with an insert.

Drotaverine [Bright Way, LLC (Russia)]
Solution for intravenous and intramuscular administration 20 mg/1 ml: 2 ml or 4 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Bright Way, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Dosage Form

Drotaverine

Solution for intravenous and intramuscular administration 20 mg/1 ml: 2 ml or 4 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent greenish-yellow liquid.

	1 ml
Drotaverine hydrochloride	20 mg

Excipients: sodium disulfite (sodium metabisulfite), ethanol (ethyl alcohol) 95%, water for injection.

2 ml – ampoules with a break ring or a notch and a point (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules with a break ring or a notch and a point (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules with a break ring or a notch and a point (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules with a break ring or a notch and a point (5) – contour cell packs (2) – cardboard packs.

Drotaverine [Bright Way, LLC (Russia)]
Tablets 40 mg: 10, 12, 14, 20, 24, 28, 30, 36, 40, 42, 48, 50, 56, 60, 70, 72, 80, 84, 90, 96, 98, 100, 108, 112, 120, 126, 140, 144, 150, 160, 168, 180, 192, 200, 210, 216, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Marketing Authorization Holder

Bright Way, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 12, 14, 20, 24, 28, 30, 36, 40, 42, 48, 50, 56, 60, 70, 72, 80, 84, 90, 96, 98, 100, 108, 112, 120, 126, 140, 144, 150, 160, 168, 180, 192, 200, 210, 216, 240, 250, 270, 300, 350, 400, 450, or 500 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow with a greenish tint to yellow with a greenish tint, round, flat-cylindrical, with a bevel; the presence of “marbling” is allowed.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients: povidone K17 (low molecular weight medical polyvinylpyrrolidone 12600±2700, plasdone K-17), lactose monohydrate (milk sugar), calcium stearate, potato starch, talc.

10 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
12 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
14 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
20 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
24 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
30 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
50 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
24 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
150 pcs. – jars (1) – cardboard packs.
200 pcs. – jars (1) – cardboard packs.
250 pcs. – jars (1) – cardboard packs.
300 pcs. – jars (1) – cardboard packs.

Drotaverine [Vifitech, CJSC (Russia)]
Injection solution 40 mg/2 ml: amp. 5, 10, or 25 pcs.

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Dosage Form

Drotaverine

Injection solution 40 mg/2 ml: amp. 5, 10, or 25 pcs.

Dosage Form, Packaging, and Composition

Solution for injection	1 ml	1 amp.
Drotaverine hydrochloride	20 mg	40 mg

2 ml – dark glass ampoules (5) – contour plastic packs (1) – cardboard packs.
2 ml – dark glass ampoules (5) – contour plastic packs (2) – cardboard packs.
2 ml – dark glass ampoules (5) – contour plastic packs (5) – cardboard packs.
2 ml – dark glass ampoules (10) – cardboard packs.

Drotaverine [Dalkhimpharm, JSC (Russia)]
Injection solution 40 mg/2 ml: amp. 5 or 10 pcs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Drotaverine

Injection solution 40 mg/2 ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection	1 ml	1 amp.
Drotaverine hydrochloride	20 mg	40 mg

2 ml – dark glass ampoules (5) – contour plastic packs (1) – cardboard packs.
2 ml – dark glass ampoules (5) – contour plastic packs (2) – cardboard packs.
2 ml – dark glass ampoules (10) – cardboard packs.

Drotaverine [Europharm, CJS (Russia)]
Tablets 40 mg: 10, 20, 30, 40, 50, 60, 80, or 100 pcs.

Marketing Authorization Holder

Europharm, CJS (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 20, 30, 40, 50, 60, 80, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Drotaverine hydrochloride	40 mg

Drotaverine [Irbit Chemical Pharmaceutical Plant, JSC (Russia)]
Tablets 40 mg: 20 or 50 pcs.

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets yellow with a greenish tint, round, flat-cylindrical in shape, with a double-sided bevel.

	1 tab.
Drotaverine hydrochloride (calculated as 100% substance)	40 mg

Excipients: lactose monohydrate – 51.2 mg, potato starch – 44 mg, povidone K17 – 2.5 mg, magnesium stearate – 0.8 mg, stearic acid – 0.6 mg, citric acid monohydrate – 0.9 mg.

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Drotaverine [Deko Company, LLC (Russia)]
Injection solution 40 mg/2 ml: amp. 10 pcs.

Marketing Authorization Holder

Deko Company, LLC (Russia)

Dosage Form

Drotaverine

Injection solution 40 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution	1 ml	1 amp.
Drotaverine hydrochloride	20 mg	40 mg

2 ml – dark glass ampoules (5) – blister packs (2) – cardboard packs.

Drotaverine [Lekpharm, SOOO (Republic of Belarus)]
Tablets 40 mg: 20, 40, or 60 pcs.

Marketing Authorization Holder

Lekpharm, SOOO (Republic of Belarus)

Dosage Form

Drotaverine

Tablets 40 mg: 20, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Drotaverine hydrochloride	40 mg

10 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (3) – cardboard packs.

Drotaverine [Moscow Endocrine Plant FSUE (Russia)]
Tablets 40 mg: 10, 20, or 50 pcs.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 20, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets yellow with a greenish tint, round, flat-cylindrical in shape, with a bevel.

	1 tab.
Drotaverine hydrochloride (calculated as 100% substance)	40 mg

Excipients: lactose monohydrate – 56 mg, potato starch – 33.8 mg, povidone K-17 – 3.2 mg, crospovidone type B – 4.2 mg, magnesium stearate – 1.4 mg, talc – 1.4 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Drotaverine [Mosfarm LLC (Russia)]
Injection solution 20 mg/ml: 2 ml amp. 5, 10, or 20 pcs.

Marketing Authorization Holder

Mosfarm LLC (Russia)

Dosage Form

Drotaverine

Injection solution 20 mg/ml: 2 ml amp. 5, 10, or 20 pcs.

Dosage Form, Packaging, and Composition

Injection solution: a clear greenish-yellow liquid.

	1 ml
Drotaverine hydrochloride	20 mg

Excipients: sodium metabisulfite – 1 mg, ethyl alcohol 95% – 67 mg, water for injection up to 1 ml.

2 ml – ampoules (5) – blister pack (1) – cardboard packs.
2 ml – ampoules (5) – blister pack (2) – cardboard packs.
2 ml – ampoules (10) – blister pack (1) – cardboard packs.
2 ml – ampoules (10) – blister pack (2) – cardboard packs.

Drotaverine [N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)]
Tablets 40 mg: 20 pcs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow to yellow, flat-cylindrical, with a bevel; a greenish tint and inclusions from white with a yellowish tint to yellow or yellow with a greenish tint are allowed.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients: potato starch 30.71 mg, lactose monohydrate 57 mg, crospovidone (Polyplasdone XL-10) 2.923 mg, povidone (low molecular weight medical polyvinylpyrrolidone) 5.847 mg, talc 2.05 mg, magnesium stearate 1.47 mg.

10 pcs. – blister packs (2) – cardboard packs.

Drotaverine [Novosibkhimpharm, JSC (Russia)]
Solution for injection 40 mg/2 ml: amp. 5, 10 or 20 pcs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Drotaverine

Solution for injection 40 mg/2 ml: amp. 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for injection	1 ml	1 amp.
Drotaverine hydrochloride	20 mg	40 mg

2 ml – dark glass ampoules (5) – plastic contour packs (1) – cardboard packs.
2 ml – dark glass ampoules (5) – plastic contour packs (2) – cardboard packs.
2 ml – dark glass ampoules (10) – cardboard packs.
2 ml – dark glass ampoules (10) – plastic contour packs (2) – cardboard packs.

Drotaverine [Novosibkhimpharm, JSC (Russia)]
Tablets 40 mg: 10, 20, or 50 pcs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Manufactured By

Valenta Pharm, JSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 20, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow with a greenish tint to yellow with a greenish tint, round, flat-cylindrical, with a bevel.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients: lactose monohydrate, potato starch, crospovidone, talc, calcium stearate.

10 pcs. – blister packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Drotaverine [Pharmazashchita SPC, FSUE FMBA of Russia (Russia)]
Solution for intravenous and intramuscular administration 20 mg/1 ml: 2 ml syringes

Marketing Authorization Holder

Pharmazashchita SPC, FSUE FMBA of Russia (Russia)

Dosage Form

Drotaverine

Solution for intravenous and intramuscular administration 20 mg/1 ml: 2 ml syringes

Dosage Form, Packaging, and Composition

Solution for IV and IM administration in the form of a clear greenish-yellow liquid.

	1 ml	1 syringe
Drotaverine (as hydrochloride)	20 mg	40 mg

Excipients: sodium disulfite (sodium metabisulfite) – 1 mg, ethanol 95% – 0.08 ml, water for injection – up to 1 ml.

2 ml – glass syringes (1) – blister packs (1) with an injection needle – cardboard packs.

Drotaverine [Obnovlenie Pfc, JSC (Russia)]
Tablets 40 mg: 10, 14, 20, 28, 50, 56, or 200 pcs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 14, 20, 28, 50, 56, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets yellow with a greenish tint, flat-cylindrical, with a bevel.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients: lactose monohydrate 70 mg, potato starch 21.6 mg, povidone K-30 4.2 mg, crospovidone 1.4 mg, talc 1.4 mg, magnesium stearate 1.4 mg.

10 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (20) – cardboard packs.
10 pcs. – blister packs (PVC/paper) (1) – cardboard packs.
10 pcs. – blister packs (PVC/paper) (2) – cardboard packs.
10 pcs. – blister packs (PVC/paper) (5) – cardboard packs.
10 pcs. – blister packs (PVC/paper) (20) – cardboard packs.

Drotaverine [Organika, JSC (Russia)]
Tablets 40 mg: 20 or 50 pcs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Drotaverine hydrochloride	40 mg

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Drotaverine [Promomed Rus LLC (Russia)]
Solution for injection 20 mg/ml: 2 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Dosage Form

Drotaverine

Solution for injection 20 mg/ml: 2 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection	1 ml	1 amp.
Drotaverine hydrochloride	20 mg	40 mg

2 ml – dark glass ampoules (5) – blister packs (1) – cardboard packs.
2 ml – dark glass ampoules (5) – blister packs (2) – cardboard packs.
2 ml – dark glass ampoules (10) – cardboard packs.

Drotaverine [Rozpharm CJSC (Russia)]
Tablets 40 mg: 10, 20, 30, or 50 pcs.

Marketing Authorization Holder

Rozpharm CJSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Drotaverine hydrochloride	40 mg

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Drotaverine [Sintez PJSC (Russia)]
Tablets 40 mg: 10, 20, 30, 40, 50, or 100 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets yellow with a greenish tint, flat-cylindrical.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients: milk sugar (lactose), potato starch, polyvinylpyrrolidone (povidone), calcium stearate, talc.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (5) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Drotaverine [Tatkhimpharmpreparaty, JSC (Russia)]
Tablets 40 mg: 10, 20, or 50 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 10, 20, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow with a greenish tint to yellow with a greenish tint, round, flat-cylindrical, with a bevel and a score; marbling is allowed.

	1 tab.
Drotaverine hydrochloride	40 mg

Excipients: lactose monohydrate – 62.9 mg, potato starch – 28 mg, povidone K-25 (medium molecular weight polyvinylpyrrolidone) – 4.2 mg, talc – 2.1 mg, crospovidone (Kollidon CL-M) – 1.4 mg, magnesium stearate – 1.4 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
25 pcs. – blister packs (2) – cardboard packs.

Drotaverine [Pharmproekt, JSC (Russia)]
Tablets 40 mg: 20 or 100 pcs.

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Form

Drotaverine

Tablets 40 mg: 20 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Drotaverine hydrochloride	40 mg

10 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
100 pcs. – blister packs (1) – cardboard packs.

Drotaverine [Endocrine Technologies, LLC (Russia)]
Buccal films 10 mg: sachet 20 pcs.; containers 5, 15 or 25 pcs.

Marketing Authorization Holder

Endocrine Technologies, LLC (Russia)

Manufactured By

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Drotaverine

Buccal films 10 mg: sachet 20 pcs.; containers 5, 15 or 25 pcs.

Dosage Form, Packaging, and Composition

Buccal films translucent, rectangular in shape, from light yellow to yellow with a brownish tint, with a characteristic odor.

	1 film
Drotaverine hydrochloride	10 mg

Excipients: hydroxypropylbetadex – 30 mg, hypromellose E15 – 60 mg, sucralose – 4.5 mg, aspartame – 4.5 mg, tartaric acid – 2 mg, levomenthol – 5 mg, mint flavor – 10 mg, orange flavor – 4 mg.

1 pc. – sachets made of combined material (20) – cardboard packs.
1 pc. – polypropylene containers (5) – sachets made of combined material (1) with a zip-lock closure – cardboard packs.
1 pc. – polypropylene containers (5) – sachets made of combined material (3) with a zip-lock closure – cardboard packs.
1 pc. – polypropylene containers (5) – sachets made of combined material (5) with a zip-lock closure – cardboard packs.

Medixlife (Author)

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