Drotaverinum Forte
Producer: CJSC FP OBOLENSKOYE Russia
Code of automatic telephone exchange: A03AD02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 80 mg of Drotaverinum of a hydrochloride.
Excipients: sugar milk (lactose), potato starch, talc, magnesium stearate, cellulose microcrystallic, sodium of a kroskarmelloz (primelloz).
Spasmolysant of myotropic action. Reduces a tone of unstriated muscles of internals, reduces their physical activity, has vazodilatiruyushchy effect.
Pharmacological properties:
Pharmacodynamics. Myotropic spasmolysant. On chemical structure and pharmacological properties drug is close to a papaverine, but possesses stronger and long action. Reduces receipt of calcium ions in smooth muscle cells (inhibits phosphodiesterase, leads to accumulation of intracellular cyclic adenosinemonophosphate). Reduces a tone of unstriated muscles of internals and a peristaltics of intestines, expands blood vessels.
Does not influence the autonomic nervous system. Existence of direct influence on smooth muscles allows to use as a spasmolysant in cases when medicines from group of m-holinoblokatorov are contraindicated (closed-angle glaucoma, a prostate hyperplasia).
Pharmacokinetics. At oral administration absorption - high, the semi-absorption period - 12 min. Bioavailability - 100%. It is evenly distributed in fabrics, gets into smooth muscle cells. Time of achievement of the maximum concentration of drug in a blood plasma (TCmax) - 2 h. Communication with proteins of plasma - 95-98%.
It is generally removed by kidneys, to a lesser extent - with bile. Does not get through a blood-brain barrier.
Indications to use:
Spasm of unstriated muscles of internals (dyskinesia of biliary tract and a gall bladder on hyperkinetic type, cholecystitis, a postcholecystectomy syndrome); pyelitis; spastic locks, spastic colitis, proctitis, tenesmus; the pylorospasm, gastroduodenit, a peptic ulcer of a stomach and duodenum (in an aggravation phase, as a part of complex therapy - for removal of a pain syndrome of spastic character). Spasm of peripheral, cerebral arteries. Algodismenorey.
Route of administration and doses:
Inside, to children 12 years – on 40 mg 3 times a day, the adult - on 40-80 mg 3 times a day are more senior. The maximum daily dose for adults - 240 mg.
Features of use:
At treatment of a peptic ulcer of a stomach and a 12-perstny gut Drotaverinum is applied in combination with other antiulcerous medicines.
During treatment it is necessary to abstain from driving of motor transport and occupations other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions (during 1 h after reception).
Side effects:
Dizziness, heartbeat, feeling of heat, the increased sweating, lowering of arterial pressure, allergic skin reactions.
Interaction with other medicines:
At simultaneous use Drotaverinum can weaken protivoparkinsonichesky effect of a levodopa.
Strengthens action of a papaverine, Bendazolum and other spasmolysants (including m-holinoblokatorov), strengthens the lowering of arterial pressure caused by tricyclic antidepressants, quinidine and procaineamide.
Reduces spazmogenny activity of morphine.
Phenobarbital increases expressiveness of spasmolytic action of Drotaverinum.
Contraindications:
Hypersensitivity, the expressed liver and renal failure; the lactation period, children's age up to 12 years. Intolerance of a galactose, deficit of lactase or glyukozo-galaktozny malabsorption.
With care: the expressed atherosclerosis of coronary arteries, closed-angle glaucoma, a prostate hyperplasia, arterial hypotension, pregnancy.
Overdose:
Symptoms: in high doses breaks atrioventricular conductivity, reduces excitability of a cardiac muscle, can cause a cardiac standstill and paralysis of a respiratory center.
Symptomatic treatment: absorbent carbon, intravenously sodium bicarbonate solution at lactoacidosis, intravenous administration of liquids for maintenance of intravascular volume, can be applied calcium at emergence of undesirable cardiovascular effects, a dopamine as a vazopressor.
When developing ventricular arrhythmias – treatment of arrhythmia; at bradycardia calcium solution, atropine, Isoproterenolum, or the driver of a cordial rhythm at inefficiency of other means can be applied.
Storage conditions:
To store in the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children! Period of validity: 3 years. Not to use after the period of validity specified on packaging.
Issue conditions:
Without recipe
Packaging:
Tablets of 80 mg. On 5, 10, 14 or 20 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 4, 5 or 6 blister strip packagings together with the application instruction place in a pack from a cardboard. On 10, 14 or 20 tablets place in bank polymeric with a cover or a glass jar with a cover. On banks paste labels from paper label. Banks together with the application instruction place in a pack from a cardboard.