The instruction for medical use of medicine Papazolum the Trade name Papazolum the International unlicensed name Is not present the Dosage form of the Tablet Structure One Tablet contains: active agents: Dibazolum of 0.030 g, papaverine hydrochloride of 0.030 g excipients: potato starch, calcium stearate, talc. The description of the Tablet of color, white or white with a grayish shade, ploskotsilindrichesky with a facet. Existence of hardly noticeable impregnations is allowed. Pharmacotherapeutic group Peripheral vazodilatator. Other peripheral vazodilatator. The ATX C04AX code the Pharmacological Pharmacokinetics Later properties of intake the papaverine and Dibazolum are quickly absorbed in digestive tract. The bioavailability of a papaverine is 29-57%, bioavailability of Dibazolum about 60%. Therapeutic effective concentration of drug in plasma correspond to the maintenance of a papaverine of 0.2-2.0 mkg/ml, Dibazolum of 0.5-2.0 mkg/ml. Linking with proteins of blood plasma makes for a papaverine 90%, for Dibazolum about 70%. Papazolum components easily pass through gistogematichesky barriers, including through gematoplatsentarny and hematoencephalic barriers. In tissue of a liver and fatty tissue the cumulation of a papaverine, Dibazolum is observed – practically does not kumulirut. The papaverine is exposed to biotransformation in a liver. The period of semi-elimination (T1/2) of a papaverine is 0.5-2.0 h. It is removed in the form of the phenolic metabolites conjugated with glucuronic acid with urine, insignificant quantities of a papaverine (less than 0.5%) are removed in not changed look. The biotransformations given relatively and eliminations of Dibazolum at the person are absent. The pharmacodynamics the Combined drug, has spasmolytic, hypotensive, arteriodilatiruyushchy effect. Bendazolum – antispasmodic of myotropic action, has hypotensive, vazodilatiruyushchy effect, stimulates function of a spinal cord, has the moderate immunostimulating activity. The papaverine – antispasmodic, has hypotensive effect. Inhibits FDE, causes accumulation in a cell of tsAMF and decrease in maintenance of Ca2+, reduces a tone and relaxes unstriated muscles of internals (a GIT, a respiratory and urinogenital system) and vessels. In high doses reduces excitability of a cardiac muscle and slows down intracardial conductivity. Action on central nervous system is significant poorly (in high doses renders sedation). Indications – spasms of peripheral arteries and vessels of a brain – moderate spasms of smooth muscles of internals (including a peptic ulcer of a stomach and a 12-perstny gut, the gatekeeper’s spasm, intestinal colic, cholecystitis, a spastic colitis). Route of administration and doses Inside. The adult on 1 tablet 2 – 3 times a day. Individual course of treatment, but no more than 8 – 14 days. Side effects – allergic reactions – nausea, vomiting, a constipation – the increased perspiration, inflows of heat – dizziness, a headache, weakness – drowsiness – atrioventricular block, disturbance of a warm rhythm (including ventricular arrhythmia) – decrease in contractility of a myocardium – increase in level of hepatic transaminases, an eosinophilia – dry cough – an ataxy – a hemorrhage from the place of an injection of the Contraindication – hypersensitivity to drug components – disturbance of atrioventricular conductivity – respiratory depression or coma – a convulsive syndrome or epileptic seizures in the anamnesis – a bronkhoobstruktivny syndrome – glaucoma – children’s age up to 18 years – arterial hypotension – age are more senior than 60 years – a liver and renal failure – insufficiency of function of adrenal glands – a craniocereberal injury – a prostate hyperplasia – a bronkhoobstruktivny syndrome – the raised tone of muscles – pregnancy and the period of a lactation Medicinal interactions At simultaneous use with spasmolysants, sedatives, diuretics, saluretics (Hydrochlorthiazidum, acetazoleamide, furosemide, Spironolactonum, etc.), tricyclic antidepressants, procaineamide, reserpine, quinidine, phentolamine, novokainamidy, a clonidine, strengthening of hypotensive effect is possible. At simultaneous use with cardiac glycosides (digoxin, strophanthin) weakens their action for the account decrease of the activity of cardiac glycoside. Barbiturates enhance spasmolytic effect of Papazolum. Weakens effect of antikholinesterazny drugs (Galantaminum, prozerin, fiziostigmin, etc.) on smooth muscles, reduces antiparkinsonichesky effect by a levodopa. At the combined use of Papazolum and nitrofurantoin the development of hepatitis is possible. At combined use with ascorbic acid strengthening of the immunostimulating effect of Papazolum is observed. At the smoking persons the metabolism of Papazolum is accelerated, and its pharmacological effects decrease. The adsorbents, milk, antiacid means (calcium carbonate, aluminum hydroxides, magnesium hydroxide, or aluminum phosphate) knitting and enveloping means reduce absorption of drug in digestive tract. The interval between their use and use of Papazolum has to make not less than 2 hours. Does not affect hypotensive effect of β-adrenoblockers, but prevents the increase in peripheric resistance of vessels mediated by β-adrenoblockers. Special instructions With care it is applied at: – an intestines hypoperistalsis – a disease of bronchial tubes – gastric bleeding – a hypothyroidism – adrenal insufficiency At pregnancy and a lactation the use of drug is not recommended. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms At use of drug should refrain from control of motor transport and work with difficult mechanisms. A form of release and packing On 10 tablets in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished or on 10 tablets in planimetric bezjyacheykovy packing from the packaging material combined on a paper basis. On 300, 500 planimetric bezjyacheykovy packs or blister strip packagings with iinstruktion on medical use in the state and Russian languages place in a box of cardboard bandbox. To Store storage conditions in the place protected from light at a temperature not above 25ºС. To store out of children’s reach! Not to apply a period of storage of 5 years after an expiration date Prescription status Without prescription JSC Irbit Chemical Pharmaceutical Plant Producer 623856, Russia, Sverdlovsk Region, Irbit, Karl Marx St., a 124-a the Owner of the registration certificate of JSC Irbit Chemical Pharmaceutical Plant, Russia the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers: SP Utegenova B. A. 050022, Kazakhstan, Almaty, Maulenov St., 123 and, quarter 7 Ph. / fax 8 (7172) 43-95-34 The name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine: SP Utegenova B. A. 050022, Kazakhstan, Almaty, Maulenov St., 123 and, quarter 7 Ph. / fax 8 (7172) 43-95-34
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