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Active substance: dotaverine hydrochloride
АТС: АО3А D02
How supplied Tablets 0.04 g No.10, No.30.
International nonproprietaryand chemicalnames:drotaverinе;
main physicochemical properties:round, plain tablets of light-yellow, light yellow with greenish shade, yellow or yellow with greenish shade colour with beveled edge. The surface of tablets can be marble.
composition: 1 tabletcontains drotaverinе hydrochloride 0.04 g (40 mg) calculated as 100% substance;
excipients:potato starch, GranuLac-70 (lactose monohydrate), medicinal low molecular polyvinylpyrrolidone, calcium stearate.
Pharmacotherapeutic group.Synthetic antispasmodic and anticholinergic agents.
АТС Code А03А D02.
Pharmacodynamics. Myotropic spasmolytic. Its chemical structure and pharmacological properties are close to those of papaverine, but the effect is stronger and more durable. It decreases the influx of active calcium into smooth muscles due to inhibiting of phosphodiesterase and intracellular increase of cAMP level. The preparation decreases the tone of smooth muscles in visceral organs, reduces intestinal peristalsis, dilatates blood vessels. It does not have an impact on vegetative nervous system, does not cross blood-brain barrier. The preparation increases minute blood volume.
Pharmacokinetics.Rapidly and completely is absorbed in gastro-intestinal tract. Following oral administration bioavailability of drotaverine is close to 100%, elimination half-life is 12 minutes. Drotaverine is uniformly distributed in tissues, penetrates smooth muscles. The preparation is excreted in the urine.
Indications for use. Spasm of smooth muscles in visceral organs (cardio- and pyloric spasm), chronic gastroduodenitis, gastric and duodenal ulcers, cholelithiasis, nephrolithiasis (colics), chronic cholecystitis, postcholecystectomy syndrome, hypermotor biliary dyskinesia, spasmodic intestinal dyskinesia, intestinal colic associated with postoperative flatulence, colitis, proctitis, tenesmus, flatulence, pyelitis, headache associated with cerebral vasospasm, spasms of the coronary and peripheral arteries (obliterating endarteritis, Raynaud's disease), to weaken uterine contractions when needed and to relieve cervical spasm in labor, spasm of smooth muscles during instrumentation.
Posology and Method of Administration. Drotaverine is intended for oral use.
Adultsare prescribed 1 - 2 tablets 2 - 3 times daily. The duration of treatment depends on the nature of the disease and should be determined by a physician.
Since no reliable information on the use of the medication in children is available, Drotaverine should only be used on prescription and under a physician's supervision, having weighed the potential risks and benefits.
Childrenof 1 to 6 years of age are prescribed 1/2 tablet 1 - 2 times daily; children of 6 to 12 years of age - 1 tablet 2 - 3 times daily; over 12 years of age- 1-2 tablets 2 - 3 times daily. When used in children, a tablet should be crushed and taken with a small volume of water.
Undesirable effect. Drotaverine is usually well tolerated. Occasionally arrhythmia, arterial hypotension, palpitations, allergic dermatitis, constipation, sweating, flushing may occur.
Contraindications.Hypersensitivity to drotaverine; significant hepatic, renal, and cardiac insuffiency, II - III degree atrioventricular block, cardiogenic shock, arterial hypotension, children under 1 year of age..
Overdose. In case of overdose atrioventricular block, cardiac arrest, paralysis of respiratory center may occur. The treatment is symptomatic.
Special warnings and precautions for use.The preparation should be used with caution in pregnant, in patients with marked coronary atherosclerosis.
Drotaverine may be used as a part of combined treatment in management of hypertonic crisis.
Drotaverine as well as papaverin has no anticholinergic effect, and therefore, unlike cholinolytic antispasmodic, may be administered in patients with glaucoma. Coincidently, the preparation should be administered with caution in patients with prostatic hypertrophy (prostate adenoma) since due to detrusor muscle relaxation urine retention may occur.
Interaction with other medicaments.Intensifies the effect of other spasmolytics (including M-cholinoblockers), increases hypotension caused by tricyclic antidepressants, quinidine, and novocainamid. Concurrent use of phenobarbital has additive beneficial effect on spasm. The preparation reduces spasmogenic morphine activity, antiparkinsonian levodopa activity.
Shelf-life and conditions for storage.Store in protected from the light place at the temperature
15 - 25 °С.Shelf-life 3 years.
Keep out of reach of children.
Dispensing category Non-prescription medicine.
Nature and content of container. Tablets 0.04 g№10 in blister, 1 or3 blisters in pack.
Location. Ukraine, 01032, Kyiv, Saksaganskogo str,139.
Phone(044) 490 7522.