Active substanceBendazole + Metamizol sodium + Papaverine + PhenobarbitalBendazole + Metamizol sodium + Papaverine + Phenobarbital
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  • Dosage form: & nbsptabscesses
    Composition:

    For one tablet:

    Active substances:

    Metamizole sodium 250, 0 mg

    Phenobarbital 20.0 mg

    Dibazol (Bendazole) 20.0 mg

    Papaverine hydrochloride 20.0 mg

    Excipients:

    Potato starch - 47.0 mg

    Talc - 10.0 mg

    Calcium stearate - 3.0 mg

    Description:

    Ploskotsilindrichesky, round tablets white or white with a slightly yellowish shade of color, with a facet and a risk.

    Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic means + antispasmodics + barbiturate)
    ATX: & nbsp

    N.02.B.B.52   Metamizole sodium in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    Combined drug, has a vasodilating, analgesic, spasmolytic and sedative effect.

    Andipal as an antispasmodic agent is used for spasms of peripheral vessels and vessels of the brain.

    Reducing the overall peripheral resistance by acting on the arterioles. the drug lowers blood pressure, improves collateral circulation.

    Combination of myotropic type spasmolytics (benzazole and papaverine) with metamizole sodium increases the analgesic effect of the latter with headache, migraine. The presence of phenobarbital in the preparation promotes the manifestation of a sedative effect and the enhancement of the action of other components.

    Pharmacokinetics:

    Metamizol sodium: chorone and quickly absorbed into the gastrointestinal tract. In the intestinal wall it hydrolyzes with the formation of an active metabolite, unchanged metamizol sodium in the blood is absent (only after intravenous administration, its insignificant concentration is detected in the plasma). The association of the active metabolite with plasma proteins is 50-60%.Metabolized in the liver, excreted by the kidneys. In therapeutic doses penetrates into breast milk.

    Papaverine: absorption depends on the dosage form. Bioavailability on average - 54%. The connection with plasma proteins is 90%. Well distributed, penetrates through the histohematological barriers. Metabolised in the liver. The half-life (T1/2) - 0,5-2 hours (can extend up to 24 hours). It is excreted by the kidneys in the form of metabolites. Completely removed from the blood during hemodialysis.

    Phenobarbital: when taken orally phenobarbital completely, but relatively slowly absorbed. The maximum concentration in the blood is observed 1-2 hours after administration. About 50% binds to plasma proteins. The drug is evenly distributed in different organs and tissues; smaller concentrations of it are found in the brain tissues. The half-life in adults is 2-4 days. Isolated from the body slowly, which creates the prerequisites for cumulation. Metabolized by microsomal enzymes of the liver. It is excreted by the kidneys in the form of inactive metabolites 25-50% - unchanged.

    Indications:

    Pain syndrome (mild or moderate), associated with spasm of the peripheral arteries, smooth muscles of the gastrointestinal tract, cerebral vessels, with increased blood pressure.

    Contraindications:

    Hypersensitivity (including the derivatives of pyrazolone); oppression of bone marrow hematopoiesis; marked hepatic and / or renal insufficiency; deficiency of glucose-6-phosphate dehydrogenase; children under the age of 8; pregnancy, lactation; tachyarrhythmias, stable exertional angina III-IV functional class, unstable angina, spontaneous angina, collapse, decompensated chronic heart failure; angle-closure glaucoma; hyperplasia of the prostate; intestinal obstruction, megacolon; Respiratory diseases accompanied by obstructive syndrome; bronchial asthma, triggered by the use of acetylsalicylic acid, salicylates and other non-steroidal anti-inflammatory drugs; violation of atrioventricular conduction; coma; respiratory depression; elderly age; diseases accompanied by increased muscle tone, convulsive syndrome, porphyria (including in the anamnesis), myasthenia gravis; alcohol or drug addiction.

    Carefully:

    Arterial hypotension, peripheral blood disease, liver failure.

    Pregnancy and lactation:

    During pregnancy and during lactation, the drug is contraindicated.

    Pregnancy

    Data on the use of the combined preparation of Andipal during pregnancy are limited. Metamizol sodium, which is part of the drug, penetrates the placenta. According to the results of preclinical studies, the teratogenic effect of metamizole sodium was not detected. Although metamizol sodium weakly inhibits the synthesis of prostaglandins, premature (intrauterine) closure of the arterial duct, as well as perinatal complications caused by a violation of platelet aggregation in the mother or newborn can not be ruled out.

    Breast-feeding

    Metamizole sodium metamizole penetrates into breast milk, so when using the drug Andipal, and also within 48 hours after the last dose should be abandoned breastfeeding.

    Dosing and Administration:

    Tablets should be swallowed whole, with enough liquid. Initially, the lowest effective dose should be used.

    Adults and children over 8 years old take 1 tablet 2-3 times a day. The maximum daily dose is 3 tablets.

    The course of treatment depends on the nature and course of the disease, the effect achieved, the nature of complex pharmacotherapy. Duration of treatment should not exceed 3 days.

    Severe general condition and impaired creatinine clearance: patients with severe general condition and impaired creatinine clearance should reduce the dose, because they can be reduced excretion of metamizole sodium metabolites.

    Renal or hepatic impairment: since in patients with impaired renal or hepatic function the rate of drug withdrawal is reduced, multiple high doses should be avoided. In the short term, dose reduction is not required. Experience with prolonged use is absent.

    Side effects:

    The frequency of these side effects is indicated in accordance with the WHO classification: very often - more than 10%; often more than 1% and less than 10%; infrequently - more than 0, 1% and less than 1%; rarely - more than 0.01% and less than 0.1%; very rarely - less than 0, 01%, including individual cases: the frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

    For Andipal:

    To date, no side effects have been reported with this combination. The frequency of occurrence of the following possible side effects is unknown.

    From the central nervous system: drowsiness, decreased speed of psychomotor reactions.

    From the digestive system: nausea, constipation.

    From the side of the cardiovascular system: arterial hypotension.

    Allergic reactions:

    With prolonged use: leukopenia, agranulocytosis, impaired liver and kidney function.

    For Metamizol sodium:

    From the skin: infrequent - persistent drug rash; rarely - a rash (eg, maculopapular); very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis.

    From the urinary system: very rarely - acute renal dysfunction, which in very rare cases can lead to proteinuria, oligo- or anuria and acute renal failure, acute interstitial nephritis.

    On the part of the organs of hematopoiesis: rarely - leukopenia; very rarely - agranulocytosis, including cases with fatal outcome, thrombocytopenia; frequency unknown - aplastic anemia, pancytopenia, including fatal cases. *

    * These reactions may occur, even if earlier metamizol sodium did not cause complications. There are a number of signs of increased risk of agranulocytosis, if metamizol sodium apply more than one week. This reaction is dose-independent and may occur at any time during treatment. It is manifested by high fever, chills, sore throat, pain when swallowing, inflammation of the mucous membranes of the mouth, nose, throat, genital and anal area. However, with the use of antibiotics, these phenomena may be mild. There is a slight increase in lymph nodes and spleen, or it is completely absent. The sedimentation rate of erythrocytes is significantly increased, the content of granulocytes is sharply reduced or they are not determined. As a rule, but normal hemoglobin, erythrocyte and platelet counts are not always preserved. Tactics of treatment implies immediate withdrawal of the drug, that is, the drug should be canceled immediately, without waiting for the results of laboratory tests, if an unexpected deterioration in the general condition occurs, fever does not subside, or new or painful ulceration on the mucous membranes, especially in the mouth, nose or throat.If pancytopenia occurs, the drug should be immediately discontinued and the general blood test should be monitored before returning to normal.

    From the side of the cardiovascular system: infrequently - isolated decline arterial pressure (possibly pharmacologically conditioned and not accompanied by other manifestations of anaphylactic / anaphylactoid reactions). Reduction of blood pressure can be pronounced. With fever, a dose-dependent sharp drop in blood pressure is also possible without other signs of a hypersensitivity reaction.

    Allergic reactions: rarely - anaphylactoid or anaphylactic reactions; ** very rarely - analgesic bronchial asthma. In patients with analgesic bronchial asthma, intolerance is usually manifested by attacks of bronchial asthma; frequency unknown - anaphylactic shock. **

    ** These reactions are especially characteristic for parenteral administration of metamizole sodium, can be severe and endanger life, in some cases, lead to death. These reactions can occur even if earlier metamizol sodium did not cause complications.These reactions may occur during administration or immediately after swallowing or develop several hours later. However, they predominantly occur within the first hour after application. In more mild cases, they are manifested by rashes on the skin and mucous membranes (for example, itching, burning, redness, blisters and swelling), shortness of breath and, more rarely, gastrointestinal disorders. In severe cases, these mild reactions can be transformed into generalized urticaria, severe angioedema (including the larynx), severe bronchospasm, cardiac arrhythmias, arterial hypotension (in some cases it is preceded by an increase in blood pressure), shock. In this regard, at the first signs of skin reactions the drug should be discarded.

    Other: frequency unknown - reported on staining of urine in red, which may be due to the presence of rubric acid in low concentrations (Metamizol sodium metabolite).

    For Phenobarbital:

    From the central nervous system: frequency unknown - asthenia, dizziness, general weakness, ataxia, nystagmus, paradoxical reaction (especially in elderly and weakened patients - arousal), hallucinations, depression, nightmarish dreams, syncope.

    From the digestive system: the frequency is unknown - vomiting, with prolonged use of a violation of liver function.

    On the part of the organs of hematopoiesis: frequency unknown - agranulocytosis, megaloblastic anemia, thrombocytopenia.

    Allergic reactions: frequency unknown - skin rash, hives, swelling of the eyelids, face and lips, shortness of breath, rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome).

    Other: frequency unknown - with prolonged use of drug dependence.

    For Bendazole:

    The listed effects are manifested when applied in large doses. When the dose is lowered or the drug is withdrawn, these side effects quickly disappear.

    From the central nervous system: frequency unknown - dizziness, headache.

    From the skin: frequency unknown - increased sweating.

    From the digestive system: frequency is unknown - nausea.

    For Papaverine hydrochloride:

    From the central nervous system: often - drowsiness.

    From the skin: often - skin rash (usually erythematous, urticaria), infrequently - itchy skin, rarely - excessive sweating.

    From the digestive system: often - nausea, constipation, infrequently - increased activity of "liver" transaminases.

    From the cardiovascular system: often - lowering blood pressure, infrequently - ventricular extrasystole.

    On the part of the organs of hematopoiesis: very rarely - eosinophilia.

    Overdose:

    For Andipal: symptoms of an overdose of the drug are due to the properties of the components included in it. In case of an overdose, there is severe drowsiness, dizziness, a collapsoid condition.

    Treatment: first aid - washing the stomach, taking activated charcoal. Symptomatic therapy aimed at maintaining vital functions. Treatment of intoxication, as well as the prevention of serious complications, require intensive medical supervision and treatment.

    For Metamizol sodium: symptoms of an overdose - Acute overdose is manifested by nausea, vomiting, abdominal pain, impaired renal function / acute renal insufficiency (for example, as a manifestation of interstitial nephritis) and, rarely, symptoms from the central nervous system (coma, convulsions) and a decrease in blood pressure leading to tachycardia and shock.With a high overdose, the excretion of rubric acid can stain the urine red.

    Treatment: a specific antidote is not known. In case of a recent overdose, in order to limit the intake of the drug, primary detoxification (for example, gastric lavage) or sorption therapy (for example, Activated carbon). The main metabolite (4N-methylaminoantipyrine) is removed during hemodialysis, haemofiltration, hemoperfusion and plasmafiltration. Treatment of an overdose, as well as the prevention of serious complications, may require general and special intensive medical supervision and treatment.

    For Phenobarbital: symptoms of an overdose - nystagmus, ataxia, headache, inhibition, lubricated speech, severe weakness, decrease or loss of reflexes, agitation, increase or decrease in body temperature, respiratory depression, dyspnea, lowering blood pressure, narrowing pupils (alternating with paralytic enlargement), oliguria, tachy- or bradycardia, cyanosis, confusion, cessation of brain electrical activity, pulmonary edema, coma, later - pneumonia, arrhythmias,heart failure; when taking 2-10 g - a lethal outcome; with chronic toxicity - irritability, weakened ability to critical evaluation, sleep disorders, confusion.

    Treatment: there is no specific antidote. Gastric lavage, reception of activated charcoal, conduct of detoxification therapy, symptomatic treatment, maintenance of vital body functions.

    For Bendazol: there is no information on overdose cases. The most likely adverse event may be a marked decrease in blood pressure.

    Treatment: at the expressed decrease in arterial pressure to give to the patient a position "lying" with the raised lower extremities, to spend symptomatic therapy.

    For Papaverine hydrochloride: symptoms of an overdose - Diplopia (double vision), weakness, lowering blood pressure.

    Treatment: symptomatic (maintenance of arterial pressure).

    Interaction:

    Pharmacodynamic: combination with nitrates (including nitroglycerine, isosorbide dinitrate), blockers of slow calcium channels (including propranolol, metoprolol, oxprenolol, talinolol), ganglioblocators (including azamethonium bromide), diuretics (including dipyridamole, aminophylline) enhances the hypotensive effect of Andinal.

    Joint application of alpha-adrenomimetics direct (including epinephrine, norepinephrine) and indirect (ephedrine) type of action, H-cholinomimetics (including nicotine, acetylcholine), analeptics (including camphor, sulphocamphocaine [procaine + sulfocamphoric acid], nikethamide, bemegrid, lobelia, cytisine), tonic (including ginseng root, eleutherococcus spiny rhizomes and roots extract, rhodiola extract) and Andipal reduces the hypotensive effect of the latter.

    Pharmacokinetic: combination of adsorbents (Activated carbon), astringent and enveloping agents reduces the absorption of the drug in the gastrointestinal tract.

    Bendazole prevents beta-blockers caused by an increase in total peripheral vascular resistance.

    Fentolamine increases hypotensive effect benzazole.

    Papaverine reduces antiparkinsonian effect levodopa and hypotensive effect of methyldopa.

    In combination with barbiturates The spasmolytic effect of papaverine is enhanced.

    When combined with tricyclic antidepressants, procainamide, reserpine, quinidine it is possible to intensify the hypotensive effect of papaverine.

    In combination with alprostadil increased risk of priapism.

    Phenobarbital reduces antibacterial activity antibiotics and sulfonamides, antifungal action griseofulvin.

    Reduces efficiency indirect anticoagulants, glucocorticosteroids, doxycycline, estrogens and other drugs metabolized in the liver along the oxidation pathway (accelerates their destruction).

    Sleeping effect is reduced with simultaneous admission atropine, belladonna extract, dextrose, thiamine, nicotinic acid, analeptics and psychostimulating drugs.

    When combined with reserpine reduces anticonvulsant action, under the influence of amitriptyline, nialamide, diazepam, chlordiazepoxide - is amplified.

    Acetazolamide, alkalinizing urine, reduces the reabsorption of phenobarbital in the kidneys and weakens its effect.

    Metamizol sodium

    With cyclosporine: metamizole sodium can cause a decrease in plasma concentrations of cyclosporine, so when they are used simultaneously, monitor the concentration of cyclosporine.

    With chlorpromazine: with the simultaneous use of metamizole sodium and chlorpromazine may develop severe hypothermia.

    With methotrexate: the simultaneous use of metamizole sodium and methotrexate or other myelotoxic agents may increase the hematotoxicity of the latter, especially in elderly patients. Therefore, this combination should be avoided.

    With other non-narcotic analgesics: simultaneous The use of sodium metamizole with other non-narcotic analgesics can lead to a mutual enhancement of toxic effects.

    With tricyclic antidepressants, oral contraceptives, allopurinol: tricyclic antidepressants, oral contraceptives, Allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

    With barbiturates, phenylbutazone and other inducers of microsomal liver enzymes: barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium.

    With sedatives and tranquilizers: sedatives and tranquilizers increase the analgesic effect of metamizole sodium.

    With drugs that have a high association with plasma proteins (oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin): metamizol sodium, displacing from the connection with plasma proteins, oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their activity.

    With thymazole: Thymazole increases the risk of developing leukopenia.

    With codeine, H blockers2-gistaminovyh receptors and propranolol: codeine, blockers H2-gistaminovyh receptors and propranolol enhance the effects of metamizole sodium.

    With acetylsalicylic acid (ASA): with the simultaneous use of metamizole sodium can reduce the effect of ASA on the aggregation of platelets. Therefore, this combination should be used with caution in the treatment of patients taking ASA as an antiplatelet agent.

    With bupropion: metamizole sodium can reduce the concentration of bupropion in the blood, which should be taken into account when they are used simultaneously.

    With other medicinal products: It is well known that pyrazolone derivatives can interact with indirect anticoagulants, captopril, lithium and triamterene, and also affect the effectiveness of antihypertensive agents and diuretics. The drug interaction of metamizole sodium with these drugs has not yet been studied.

    In view of the increased risk of anaphylactic / anaphylactoid reactions during treatment with metamizole sodium, radiocontrast agents, colloidal blood substitutes and penicillin should not be used.

    Special instructions:

    If there is no effect within 3 days, stop taking the drug and consult a doctor.

    Patients who have anaphylactic or other immuno-mediated reactions (eg, agranulocytosis) in response to metamizole sodium use are also at risk of developing them in response to other pyrazolones and pyrazolidones.

    Pancytopenia, agranulocytosis

    With the development of pancytopenia and agranulocytosis, the drug should be immediately discontinued and the general blood test should be monitored until the parameters return to normal. All patients should be advised to seek medical help immediately if there are signs and symptoms reminiscent of blood disorders (for example, general weakness, infections, persistent fever, the appearance of bruising, bleeding, pallor) during treatment.

    Anaphylactic / anaphylactoid reactions

    An increased risk of hypersensitivity reactions metamizol sodium stipulate the following states:

    - analgesic bronchial asthma or intolerance to analgesics (type of urticaria-angioneurotic edema);

    - bronchial asthma, especially accompanied by rhinosinusitis and polyposis of the nose;

    - chronic urticaria;

    - intolerance to dyes (eg tartrazine), preservatives (eg benzoates);

    - alcohol intolerance.

    Severe skin reactions

    Stevens-Johnson syndrome (SDS) and toxic epidermal necrolysis (TEN). When there are signs of SS or TENS (such as a progressive skin rash,often accompanied by blistering or ulceration of the mucous membrane) treatment with metamizole sodium should be stopped immediately and never restarted.

    Careful monitoring of skin reactions, especially at the beginning of treatment.

    Isolated hypotensive reactions

    These reactions can be dose-dependent. The risk of such reactions is increased with: previous arterial hypotension, decreased circulating blood volume or dehydration, unstable hemodynamics, or acute circulatory disturbance (eg, in patients with myocardial infarction or trauma), in patients with high fever.

    In such patients, detailed diagnostics should be carried out and careful monitoring should be performed.

    In patients who have a reduction in blood pressure should be avoided at all costs, metamizol sodium It can only be used with careful monitoring of hemodynamic parameters.

    Abdominal pain

    It is inadmissible to use the drug to relieve acute pain in the abdomen (until finding out their cause).

    Impaired renal or hepatic function

    In patients with impaired renal or hepatic function metamizol sodium is allowed only with a rigorous assessment of the benefits and risks, observing all necessary precautions.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Pills.

    Packaging:

    For 10 tablets in a contour non-cellular package of paper with a polymer coating.

    For 10 tablets in a contour mesh box made of polyvinyl chloride film and foil of aluminum printed lacquered.

    1, 2, 3 or 5 contour mesh or contour non-jawed packages together with the instruction for use are placed in a cardboard box.

    200, 400, 500, 600, 1000 contour non-jawed packages with an equal number of instructions for use are placed in a cardboard box (For hospitals).

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003892
    Date of registration:07.10.2016
    Expiration Date:07.10.2021
    The owner of the registration certificate:UZOLE-SIBERIAN CHEMICAL PLANT, OJSC UZOLE-SIBERIAN CHEMICAL PLANT, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.09.2017
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