Drotaverine – Drotaverin tablets 40 mg Renewal 28 pcs

Description

Latin name

Drotaverine

Release form

Tablets.

Packing

14 pcs. – blister packs (2) – packs of cardboard.

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Indications

Spasm of smooth muscles in diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, inflammation of the papilla of the duodenum.

Spasm of smooth muscle in diseases of the urinary tract: nephrourolithiasis, urethrolithiasis, pyelitis, cystitis, spasm of the bladder. As an adjunct therapy: for spasms of smooth muscles of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, spasm of the cardia and pylorus, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome with flatulence, tensor headache, algodismenorea, threatening miscarriage, threatening preterm birth, spasm of the uterus during childbirth, prolonged opening of the pharynx, postpartum contractions.

When conducting some instrumental studies, including cholecystography.

Contraindications

Hypersensitivity, cardiogenic shock, arterial hypotension, angle-closure glaucoma, prostate adenoma, severe liver and kidney failure, lactation, children under 3 years of age.

Caution. Severe atherosclerosis of the coronary arteries.

Use during pregnancy and lactation

Drotaverinum does not have teratogenic and embryotoxic effects.

However, the use of the drug is recommended only after careful weighing of the ratio of the expected benefits and possible risks.

Due to the lack of necessary clinical data, drotaverine is not recommended for use during lactation (breastfeeding).

Composition

1 tablet contains:

CORE:

Active ingredient: pancreatin (porcine) (with enzyme activity: lipases 20,000 Units. Pharm., amylases 12,000 Units. Heb. Pharm. and drotease 900 Units. Pharm.) 269.12 mg – 279, 44 mg (15% excess of pancreatin is caused by technical losses during production. 10% excess of pancreatin is used to compensate for decay during the storage period.)

Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, anhydrous, magnesium stearate .

Shell: hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E171), talc, simethicone emulsion, vanilla flavor 54286 C, bergamot flavor 54253 T, macrogol 6000, carmelose sodium, polysulfate 80 contains:

Active ingredient:

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 polyvinyl pyrrolidone) 5.847 mg,

talc 2.05 mg,

magnesium stearate 1.47 mg.

Dosage and administration of

Adults, 40 “80 mg orally (1-2 tablets) 2-3 times a day.

For children, orally at the age of 3-6 years – 40-120 mg in 2-3 doses, the maximum daily dose is 120 mg 6-18 years old – 80-200 mg in 2-5 doses, the maximum daily dose is 240 mg.

Side effects

Dizziness, headache, insomnia, palpitations, tachycardia, fever, excessive sweating, nausea, constipation, low blood pressure, allergic skin reactions, angioedema, urticaria, rash, itching.

Drug Interaction

When used with drotaverine, the anti-parkinsonian effect of levodopa may be weakened. Increases the effect of papaverine, bendazole and other antispasmodics (including m-cholin blockers), reducing blood pressure caused by tricyclic antidepressants, quinidine and procainamide.

Phenobarbital increases the severity of spasmolytic action of drotaverine. Reduces the spasmogenic activity of morphine.

Overdose

Symptoms: Excessive dosage disrupts atrioventricular conduction, reduces cardiac muscle excitability, may cause cardiac arrest and respiratory center depression.

Treatment: the patient should be closely monitored by a physician and receive symptomatic and supportive treatment. It is recommended to induce vomiting and / or wash the stomach.

Storage conditions

Store the product in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Expiration

3 years.

Deystvuyuschee substances

Drotaverine

dosage form

dosage form

tablets

Upgrading PFC, Russia