VADEMECUM. Syme Parma

Transcription

1 2018 VADEMECUM Syme Parma

2 CONTENTS DRUGS A ACNEDERM Tretinoin ACNERIN Erythromycine ADRENALIN Epinephrine ALLERGOSAN Chloropyramine AMBROXOL SOPHARMA Ambroxo AMIKACIN Amikacin AMIODARONE Amiodarone ANALGIN Metamizole sodium ANTIALLERSIN Promethazine ANTISTENOCARDIN Dipyridamole ATENOLOL SOPHARMA Atenolol B BELLERGAMIN Combined product BISACODYL Bisacodyl BROMHEXIN Bromhexine BRONCHOLYTIN Combined product BRONCHOLYTIN NEO Combined product BUSCOLYSIN Butylscopolamine C CALCIUM GLUCONICUM Calcium gluconate, Calcium laevulate CALCIUM PHOSPHO C Combined product CAPTOPRIL Captopril CARSIL Silymarin CHLOPHADON Combined product CHLOPHAZOLIN Clonidine CHLORPROMAZINE Chlorpromazine CINNARIZIN Cinnarizine CIPROFLOXACIN Ciprofloxacin CLENBUTEROL Clenbuterol D DEAVIT Combined product DEFLAMOL Combined product DERMOCORT Betamethasone DEXAMETHASONE SOPHARMA Dexamethasone DIAZEPAM SOPHARMA Diazepam DIMEX Combined product DUSOPHARM Naftidrofuryl E ETHAMBUTOL Ethambutol web: info@symepharma.com 2

3 F FELORAN Diclofenac FUROSEMID Furosemide FUROTALGIN Combined product G GLAUVENT Glaucine GLIBENCLAMID Glibenclamide GRIPOFEN Combined product H HALOPERIDOL Haloperidol HEXISEPT Chlorhexidine I INDOMETACIN SOPHARMA Indometacin INFLUDEX Combined product ISOCOR / VERAPAMIL K KALIUM CHLORATUM Potassium chloride KETOTIFEN SOPHARMA Ketotifen L LIDOCAIN Lidocainе LORATADIN Loratadine LYDOL Pethidinе M MESALAZIN Mesalazine METFORMIN / SOPHAMET Metformin METHYLPREDNISOLON SOPHARMA Methylprednisolonе N NANIPRUS Sodium nitroprusside NATRIUM BROMATUM Sodium bromidе NATRIUM CHLORATUM Sodium chloride NATRIUM CITRICUM Sodium citrate NIVALIN Galantaminе 129 P PARACETAMOL Paracetamol (Acetaminophen) PARACOFDAL Combined product PEFLAVIT C Combined product PENTOFYLLIN / PENTOXIPHARM Pentoxifylline PIRACETAM / PYRAMINOL Piracetam PIROXICAM Piroxicam PRAVASTATIN / PRAVAPRES Pravastatin PRAZOSIN Prazosin PROPRANOLOL Propranolol R RANITIDIN SOPHARMA/ RAZITAC Ranitidine REVULSAN Combined product web: info@symepharma.com 3

4 RHINOLEX Combined product RIMICID Isoniazid RYTMOCARD Propafenone S SALBUTAMOL Salbutamol SARIPHEZON Combined product SOFLUXEN Fluoxetine SOPHAFYLLIN Aminophyllinе SOPHANAX Alprazolam SOPHTENSIF Indapamide SOPRAL Omeprazole SPASMALGON Combined product STERILISED WATER FOR INJECTIONS T TABEX Cytisinе TAMOXIFEN Tamoxifen TEMPALGIN Combined product TILIDINE SOPHARMA Tilidine TRAMALGIN Tramadol TRIBESTAN V VASOPREN Enalapril VITAMIN A Retinol VITAMIN B1 Thiamine VITAMIN B2 Riboflavin VITAMIN B6 Pyridoxine VITAMIN B12 Cyanоcobalamin VITAMIN B COMPLEX Combined product VITAMIN C Ascorbic acid X XYLODREN Combined product XYLOPHARM Xylomethazoline TRIBESTAN plus TRIBESTAN VITA UNIFER MILD VASELINE BORIC VASELINE 3% FOOD ADDITIVES COSMETICS web: info@symepharma.com 4

5 INN: TRETINOIN Код АТХ: D10AD 1 ACNEDERM 1 g gel contains 0,25 mg tretinoin. 1 g cream contains 0,5 mg tretinoin. Gel superficial forms of acne vulgaris (I stage) where comedones predominate; cream more serious forms of acne vulgaris (II-III stage) where papules and pustules predominate. Gel and cream are applied once a day, in the evening before sleeping. The affected area is washed with water, the skin is dried and the gel/cream is carefully spread, excessive overlaying being avoided. Any effect of the treatment could be observed in 2-3 weeks, but for better results 6-12 weeks are required. When the beneficial effect is reached, a maintaining therapy of 2-4 applications per week will be sufficient for some patients. If severe erythema and itching appear, therapy should be discontinued or frequency of administration reduced till skin is recovered. Hypersensitivity to the product; acute inflammatory processes of the skin, acute eczema, acne rosacea, data of photoallergy, pregnancy. Do not administer to small children! Concomitant administration of Acnederm and local preparations, containing sulphur, resorcin and salicylic acid should be avoided. It is recommended Acnederm application to begin some time after discontinuation of the above products. Due to the risk of interaction with tretinoin, medical soaps and other washing preparations, skin disinfectants, soaps and cosmetic preparations with strong dehydrating effect as well as local preparations with high alcoholic content and astringent preparations should be used with caution. Acnederm is well tolerated if properly administrered. Upon therapy beginning, transitional skin reddening with a sense of burning and itching may appear in patients with sensitive skin. Acne aggravation may be manifested in the first weeks of the therapy. Very rarely: intensive reddening, edema, skin desquamation, as well as vesica and crust formation. In such cases, the frequency of administration should be reduced or Acnederm administration should be discontinued. Usually the skin recovers several days after therapy termination. In repeated treatment with Acnederm, temporary hyper- or hypopigmentation may be observed, In some patients, increased photosensitivity may be manifested. Sun or artificial UV-sources exposure during Acnederm therapy results in intensive skin reddening. Any contact of the preparation with eyes, lips and mucosa should be avoided. Tube of 30 g gel (0,025%). web: info@symepharma.com 5

6 Tube of 30 g cream (0,05%). INN: ERYTHROMYCINE Код АТХ: D10AF 2 ACNERIN 10 ml cutaneous solution contain 0,3 g erythromycin base. For local treatment of various forms of acne vulgaris (acne papulo-pustulosa, acné comedonica) with excoriation or secondary impetigo. For external use, affected areas should be cleaned prior to application and then treated with the solution with the help of a cotton pad, 2 times daily. Existing comedones and pustules should be cleaned in advance. Therapy may continue up to 6-8 weeks. Hypersensitivity to any of product excipients; superficial or deep dermatomycosis. Acnerin should not be co-administered with resorcin, salicylic spirit, sulfur- containing products and tretinoins. Concomitant administration of preparations (cosmetic ones inclusive) with dehydrating effect should be avoided. It can be included in the complex therapy with keratolytic products and vitamins, but their concomitant application on the skin should be avoided. Acnerin is characterized with a good tolerance. In some cases it may cause skin reactions of hypersensitivity, manifested in reddening, itching and rash, sometimes desquamation. In such cases product administration should be discontinued. 100 ml (30 mg/ml) cutaneous solution in plastic bottles with dropper. INN: EPINEPHRINE Код АТХ: C01CA 24 ADRENALIN web: info@symepharma.com 6

7 One ampoule of 1 ml contains 1mg epinephrine (1 mg/ml). Used in anaphylactic shock; cardiac arrest; resistant ventricular fibrillation. Dosage should be defined according to disease severity. Adults: in case of anaphylactic shock, subcutaneously or intravenously, at doses of mg, maximally - up to 1 mg. In cardiac arrest it is used intravenously at a dose of mg every 3 to 5 minutes during resuscitation. Children: intravenously mg/kg body mass during resuscitation. Contraindicated in: pheochromocytoma, tachyarrhythmias and idiopathic hypertrophic subaortic stenosis. Adrenalin attenuates insulin activity. Saluretics and phenothiazines reduce Adrenalin activity, and thyroid hormones enhance it. Co-administration with imipramine group antidepressants and MAOinhibitors may induce hypertensive crises with rhythm disorders. The combination with beta-blockers may lead to bradycardia; with alpha-receptor blockers fall of arterial pressure; with cyclopropane, halothane, isoprenaline - there is a possibility of cardiac rhythm disorders. Palpitation; dizziness; tremor; pallor; sweating; difficult urination; nausea; vomiting; headache; ventricular arrhythmias; chest pain; hypertension, dyspnea; hyperglycemia and hypokalemia are possible. 10 or 100 ampoules of 1 ml (1 mg) solution for injection. INN: CHLOROPYRAMINE Код АТХ: R06AC 3 ALLERGOSAN One ampoule of 2 ml contains 20 mg chloropyramine hydrochloride (10 mg/ml). One coated tablet contains 25 mg chloropyramine hydrochloride. 1 g of ointment (1%) contains 10 mg chloropyramine hydrochloride. 1 g of cream (1%) contains 10 mg chloropyramine hydrochloride. web: info@symepharma.com 7

8 In the form of solution for injection, it is used in: acute allergic reactions related to urticaria treatment (due to foods, medicines, helminthes, etc.) and insect bite; in allergic reactions of general type (anaphylactic shock, serum disease, Quincke s edema), when the product is used as a part of the complex therapy. In the form of tablets: for treatment of allergic rhinitis, conjunctivities, hay fever, drug and food allergy, allergic reactions after insect bite. In the form of ointment or cream it is used for treatment of allergic skin reactions. Parenteral administration: in severe allergic reactions 1-2 ampoules intramuscularly or intravenously. Oral administration: adults - 25 mg (1 tabl.) 3-4 times daily (up to 150 mg, if necessary); children over 5 years: 1 tablet, 2-3 times daily. External application: affected area should be treated once or several times a day by applying a thin layer of ointment or cream. Solution for injection and tablets: adenoma of prostate; acute peptic ulcer; pyloricduodenal stenosis; glaucoma; pregnancy and lactation; hypersensitivity to the product. Ointment and cream should not be administered to patients with history data of hypersensitivity to the product. Allergosan should not be used parenterally or orally, concurrently with MAOinhibitors. Because of the anticholinergic activity of Allergosan, concomitant administration with cholinomimetics is not recommended as they may enhance adverse cholinomimetic effects. General anesthetics, analgesics and psycholeptics potentiate the sedative effect of Allergosan. Upon parenteral or oral administration Allergosan can induce: drowsiness, weak ness, vertigo, tiredness, dryness of mouth, constipation, and more rarely visión disorders and intraocular pressure elevation. Occasionally, external application may cause contact allergy and photosensitization. 10 or 100 ampoules of 2 ml (20 mg) solution for injection 20 coated tablets of 25 mg. Tube containing 18 g ointment (1%). Tube containing 18 g cream (1%). On doctor s prescription (ampoules and tablets). Without prescription (ointment and cream). web: info@symepharma.com 8

9 INN: AMBROXOL Код АТХ: R05CB 6 AMBROXOL SOPHARMA 5 ml syrup contain 15 mg amboxol hydrochloride. Secretolytic therapy in acute and chronic diseases of upper and lower respiratory tracts, accompanied by increased viscous secretion and impaired mucous conduction. Ambroxol syrup is administered orally during meals. In adults and children over 12 years, in acute disorders or as initial therapy in chronic disorders, therapy begins at a dose of 30 mg (10 ml syrup 2 teaspoonfuls), 3 times daily during the first 2-3 days and then the dose can be reduced by half 5 ml (1 teaspoonful) 3 times daily. In children from 6 to 12 years: 5 ml (1 teaspoonful) 2-3 times daily; from 2 to 6 years - 2,5 ml (1/2 teaspoonful) 3 times daily; from 1 to 2 years 2,5 ml (1/2 teaspoonful) 2 times daily; under 1 year not recommended. Administration of the product for over 5 days without physician s consultation is not recommended. Hypersensitivity to the product. Concomitant administration of Ambroxol and antibiotics (amoxicillin, cefuroxime, erythromycin, doxycyclin) leads to higher concentration of the antibiotic in the pulmonary tissue. Co-administration of Ambroxol and cough-suppressing preparations is not recommended. Clinically significant interactions of Ambroxol with other medicinal substances have not been reported. This medicinal product is usually well tolerated. It rarely causes dyspeptic disorders, allergic rashes, headache. There are insufficient data of its safety in pregnant and lactating women. Syrup in vials of 100 ml. Without prescription. web: info@symepharma.com 9

10 AMIKACIN INN: AMIKACIN Код АТХ: J01GB 6 One ampoule of 2 ml contains: 100 mg amikacin sulfate (50 mg/ml); 250 mg amikacin sulfate (125 mg/ml) or 500 mg amikacin sulfate (250 mg/ml). One ampoule of 4 ml contains: 1000 mg amikacin sulfate (250 mg/ml) In infections of: central nervous system; urogenital system; biliary and intestinal tract; skin and subcutaneous tissues; intraabdominal infections; pneumonia caused by gram-negative microorganisms; secondary infections due to burns; bacterial septicemia; infections of locomotor system and skin caused by Amikacin sensitive microorganisms. In adults and children with normal renal function, Amikacin is administered intramuscularly as an intravenous jet or by slow intravenous infusion at a dose of 5 mg/ kg body weight every 8 hours, or 7.5 mg/kg body weight every 12 hours for a period of 7 to 10 days. Before venous infusion, dissolve 500 mg Amikacin in 200 mg saline or other suitable solution. The infusion duration is minutes. Maximal daily dose should not exceed 15 mg/kg body weight, and the total dose for adults should not be more than 15 g. In newborn and premature infants, the initial single dose of Amikacin is 10 mg/kg body weight, after that the treatment continues at a dose of 7.5 mg/kg body weight every 12 hours for 7-10 days. Amikacin may be administered at single daily dose of 1 g intramuscularly or 15 mg/kg body weight intravenously. In patients with disturbed renal function, the dose should be reduced and Amikacin should be injected in longer intervals to avoid possible cumulation. In such cases, dosage should be determined according to creatinine clearance and creatinine serum level. Hypersensitivity to aminoglycoside antibiotics; pregnancy and lactation. Concomitant administration of Amikacin with myorelaxants potentiates their effects and cessation of breathing is possible. The combination of aminoglycoside antibiotics between themselves should be avoided because of the enhancement of their oto- and nephrotoxic effects. Co-administration of Amikacin with fast-acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with cephalosporins or polymixins increases the risk of nephrotoxicity. In prolonged treatment with Amikacin, most frequent are the nephrotoxic and ototoxic events. Ototoxic effects are vestibular toxic changes in the balance and cochlear toxic changes - affected hearing with a sense of pressure and noise in the ears and decreased perception of high frequency sounds. web: info@symepharma.com 10

11 Concomitant administration of Amikacin and other nephrotoxic drugs may lead to renal insufficiency. Relatively rare to occur are allergic reactions; nausea; vomiting; stomatitis; blood count changes; respiratory depression and muscle pareses. 10 or 100 ampoules of 2 ml (100 mg, 250 mg or 500 mg) solution for injection. 10 or 50 ampoules of 4 ml (1000 mg) solution for injection. INN: AMIODARONE Код АТХ: С01BD 1 AMIODARONE One tablet contains 200 mg amiodarone hydrochloride. For prophylaxis and treatment of life-threatening and/or refractory to other drugs supraventricular and ventricular arrhythmias, tachycardia of various etiology and electrogenesis, WPW syndrome and acute myocardial infarction inclusive. Amiodarone dosage depends on patient s idiosyncrasy. Therapy may begin with high, moderate or low initial dose to achieve saturation within 1-3 weeks, then individual maintenance dose should be administered for months or years with or without pause days. Initial dose: 600 to 1200 mg (3-6 tablets) for 24 hours, distributed in 3-4 intakes for days. Maintenance dose 200 to 400 mg (1-2 tablets) for 24 hours. Sinus bradycardia, atrioventricular block II and III degree, thyroid dysfunction, hypersensitivity to iodine and iodine products. Amiodarone is slowly eliminated from the body and for than reason it may interact with other drugs long time after its withdrawal. It should not be combined with preparations which may cause torsades de pointes: antiarrhythmic drugs (disopyramide, sotalol); bepridil, lidofazin, prenilamin, sparfloxacin, vincamin, astemizole, pentamidine. It enhances the effects of oral anticoagulants. When combined with beta-blockers and calcium antagonists, the risk of impaired automatism and conduction of the heart is increased. Concomitant administration with Diltiazem may increase the risk of bradycardia and atrioventricular block. Concurrent use with potassium-depleting diuretics and corticosteroids hides the risk of arrhythmia due to hypokalemia. web: info@symepharma.com 11

12 Co-administration of Amiodarone and phenytoin leads to a risk of phenytoin plasma level increase with overdosage manifestations. When used with general anesthetics, dangerous bradycardia may appear, resistant to Atropinum sulfuricum, as well as hypotension, problems in cardiac conduction and cardiac debit reduction. After prolonged treatment bradycardia (less than 55 strokes/min require suspending of therapy for some time), rarely conduction problems, atriosinusal block, atrioventricular block; headache, dizziness, disturbed coordination of movements, finger tremor, impaired gait; stomach discomfort, nausea, loss of appetite, constipation; increased transaminase levels in blood; diffuse interstitial pneumopathy, dyspnea during physical strain, pneumofibrosis; hypo- or hyperthyroidism. 30 tablets of 200 mg INN: METAMIZOLE SODIUM Код АТХ: N02BB 2 ANALGIN One ampoule of 2 ml contains 1 g metamizole sodium (0.5 g/ml). One ampoule of 5 ml contains 2.5 g metamizole sodium (0.5 g/ml). One tablet contains 0.5 g metamizole sodium. Analgin tablets are administered for the treatment of pains of various origin: toothache, headache, arthralgia, neuralgia, myalgia, milder visceral pains, dysmenorrhea, as an antipyretic in the complex therapy of inflammatory diseases of upper respiratory tract, infectious diseases. Analgin solution for injection is used in cases of acute and severe pain after surgical operations or traumas; pains due to tumors; renal and biliary colics and high temperature unaffected by other drugs. Solution for injection: administered intramuscularly. The single dose for all age groups is 8-16 mg/kg body weight according to the following scheme: kg body weight mg Analgin (1/2 ml); kg body weight mg Analgin (1 ml); kg body weight mg Analgin (1-1.5 ml); and over 63 kg body weight mg Analgin (1.5-2 ml). In persistent pain, the dose can be repeated in 6-8 hours. Maximal daily dose g Analgin. Tablets: dosage and duration of treatment must be determined according to the severity of the pain syndrome. The usual dose in adults is mg (1/2-1 tablet) 2 or 3 times daily. web: info@symepharma.com 12

13 Maximal 24-hour dose is 3 g. In children over 15 years it is administered at a dose of 250 mg, 2-3 times daily. Analgin should not be administered longer than 3 days or in higher doses without consulting the attending physician. Hypersensitivity to metamizole and other pyrazolone derivatives; acute hepatic porphyria; inborn glucose-6-phosphate dehydrogenase deficiency; severe renal or hepatic diseases; hematologic diseases (aplastic anemia, leucopenia and agranulocytosis); first and last trimester of pregnancy. It should be avoided in lactating or pregnant women due to the lack of studies on its safety. Parenteral administration is contraindicated in children under 1 year. Analgin potentiates the analgesic and antipyretic action of non-steroid anti-inflammatory drugs. Analgin effects are potentiated by the tricyclic antidepressants; oral contraceptives; allopurinol; alcohol. Analgin decreases the activity of coumarin anticoagulants and plasma levels of cyclosporin. The enzyme inductors (barbiturates, glutethimide, phenylbutazone) reduce Analgin effects. Analgin potentiates the effects of CNS-inhibiting agents. Concomitant administration with chlorpromazine hides the risk of severe hypothermia. Analgin may be combined with buscolysin, Atropinum sulfuricum, codeine. Prolonged administration very rarely may cause reactions of agranulocytosis, leucopenia or thrombocytopenia, proteinuria, interstitial nephritis. In sensitive patients, rashes, urticaria, Quincke s edema, asthmatic attacks, and very rarely anaphylactic shock are possible. Red pigmentation of urine with acid ph is due to the metabolite rubazonic acid. 10 or 100 ampoules of 2 ml (1 g) solution for injection. 10 ampoules of 5 ml (2,5 g) solution for injection. 20 tablets of 0.5 g. 500 tablets of 0,5 g (50 blisters X 10 tablets). Ampoules on doctor s prescription. Tablets without prescription. INN: PROMETHAZINE Код АТХ: R06AD 2 АNTIALLERSIN One ampoule of 2 ml contains 50 mg (25 mg/ml) promethazine. web: info@symepharma.com 13

14 Symptomatic treatment of general-type allergic reactions anaphylactic shock (as adrenalin therapy supplement), serum disease, Quincke s edema, reactions of hypersensitivity to pharmaceuticals; insect bites; urticaria of various genesis; uncomplicated allergic reactions of general type where the administration of oral antiallergic drugs is impossible or contraindicated; travel sickness if intensive treatment is required; as a supplement in pre-operative and post-operative sedation in surgery and obstetrics; for stress sedation and relief as well as for provoking a light sleep when the patient wakes up easily. Administered parenterally deep muscularly or slowly intravenously. Promethazone i.v. is administered slowly at a speed not exceeding 25 mg/min and after a dilution of up to 10 times. Adults: in allergic conditions the dose is 25 mg and may be repeated in 2 hours; for sedation, it is administered in hospital and only to adults at a dose of mg; before and after surgical operations mg in combination with reduced doses of analgesics and atropine-containing medications. Maximum single dose is 50 mg, and maximum daily dose is 100 mg. Children 5 to 10 years of age: administered intramuscularly at the following single doses: morning mg/kg body weight and evening 0.5 mg/kg body weight, but not more than mg. Comatose conditions: glaucoma, prostatic hypertrophy, bladder obstruction; peptic ulcer and pyloroduodenal obstruction; bronchial asthma; concomitant administration with CNS depressants like alcohol, barbiturates, tranquilizers, due to the risk of sedation aggravation; within 14 days after MAO-inhibitors administration; hypersensitivity to promethazine; infants below 2 years of age due to the risk of sudden child death phenomenon or apnea during sleep; lactation. Promethazine potentiates the sedative effects of CNS inhibitors general anesthetics, analgesics, alcohol inclusive. Administered together with cholinolitics and tricyclic antidepressants, it enhances their anticholinergic effects. When combined with MAO-inhibitors, it may enhance their vasopressor effects. Sedative effect, dizziness, nervousness, tremor, sense of fatigue, reduced attention, impaired coordination, euphoria, insomnia, rarely - deep sleepiness, hallucinations, convulsions. When administered at higher doses, malignant neuroleptic síndrome may appear. Tachycardia, bradycardia, blood pressure elevation or drop, venous thromboses; moderate anesthesia of oral mucosa, nausea and vomiting, xerostomy; sometimes impaired accommodation, diplopia. Urine retention in rare cases; galactorrhea, porphyria and weight gain; possible are liver disorders with transaminase elevation; agranulocytosis, manifested as leucopenia; urticaria, dermatitis, bronchospasm, photosensitisation, angioneurotic edema. In rapid venous administration sharp arterial pressure drop and orthostatic collapse, and in muscular administration formation of painful infiltrates. In diabetics, blood sugar increase may be observed. It may cause excitation in children, related to its anticholinergic effect or the sudden child death phenomenon in early childhood. web: info@symepharma.com 14

15 10 or 100 ampoules of 2 ml (25 mg/ml) solution for injection INN: DIPYRIDAMOLE Код АТХ: B01AC 7 ANTISTENOCARDIN One coated tablet contains 25 mg dipyridamole. Prophylaxis of thromboembolic complications in: patients with ischemic heart disease as a sole antithrombocytic medication or in combination with aspirin in the same group of patients, but only in case of special clinical considerations; cerebrovascular disease (for reducing the risk of cerebral insult, alone or in combination with aspirin); cardiac surgery (aortocoronary bypass) in combination with aspirin. Recommended therapeutic dose as a prophylactic antiaggregation agent in ischemic heart disease, after myocardial infarction and cerebrovascular disease is mg, 3 times a day. In combined administration with 325 mg aspirin, dipyridamole dose may be reduced to mg, 3 times a day. This therapy should be applied uninterruptedly for 7 months to 1 year and more. Tablets should be taken 1 hour before or 2 hours after meal with some liquid. For prevention of thromboembolic complications after valve prosthesing, it is administered at a dose of 3-4 tablets, 4 times daily, in combination with an anticoagulant. For prevention of thrombosis in aortocoronary bypass operation, the medicine is administered at a dose of 100 mg, 4 times daily, for 2 days before surgery; then 100 mg, 1 hour after surgery; 75 mg, combined with 325 mg aspirin, 7 hours after surgery; after that - 75 mg, 3 times a day, combined with 325 mg aspirin. Antistenocardin (without aspirin) is administered 7 days after surgery for prophylaxis of thromboembolic complications. Hypersensitivity to the product; patients with proved severe generalized coronary sclerosis and myocardial infarction in acute stage. Xanthine derivatives (novphylline) may reduce the effect of Antistenocardin. Concomitant treatment with heparin increases the risk of hemorrhages. Antistenocardin elevates maximal serum concentration and toxicity of aspirin. web: info@symepharma.com 15

16 Antistenocardin potentiates the effect of nitrates; increases doxorubicine and vinblastine cell concentration; potentiates the effects of adenosine; enhances metotrexate toxicity; potentiates the hypotensive effects of calcium antagonists. Observed have been nausea and vomiting; dizziness; headache. In most cases these reactions fade in long-term treatment. In high doses hypotension and ECG-changes. Possible are hypersensitivity reactions with itching and rashes. 60 coated tablets of 25 mg coated tablets of 25 mg. (40 blisters X 30 tabl.) Combined product Код АТХ: N05CM 0 BELLERGAMIN One coated tablet contains: 0.1 mg Belladonna alkaloids; 0.30 mg ergotamine tartrate; 20 mg phenobarbital. Neurosis; climacteric symptom complex; neuro-vegetative dystonia; Meniere s syndrome; migraine; neurodermitis and pruritus; kinetosis; bradycardia, incl. In digitalis intoxication. The recommended dose is 1 tablet, 3-4 times daily. If any satisfactory therapeutic effects are lacking, the daily dose may be increased to 6 tablets daily. Hypersensitivity to the product; arterial hypertension; angina (unstable and Prinzmetal); myocardial infarction; tachyarrhythmia atrioventricular spastic disorders; pregnancy and lactation; liver porphyria and other severe liver and renal diseases; narrow-angle glaucoma; severe hypertrophy of prostate; sepsis; children under 14 years; thyrotoxicosis. Phenothiazine preparations, antiparkinsonians and tricyclic antidepressants potentiate the effects of Atropinum sulfuricum. Ergotamine toxicity is increased with the simultaneous administration of macrolide antibiotics and non-selective betablockers. Phenobarbitalum natricum decreases the activity of dicumarol and increases toxicity of phenytoin and halothane. Alcohol and narcotic analgesics enhance the sedative effect of Phenobarbitalum natricum. web: info@symepharma.com 16

17 Mouth dryness; sense of fatigue; drowsiness; visual disturbances (mydriasis and cycloplegia); glaucoma attack at higher doses; reduced gastrointestinal motility and constipation; gastrointestinal discomfort (nausea, vomiting, colics); tachycardia; urine retention; localized edema of limbs and face; arterial pressure rise; stenocardia; peripheral vasospasm; hypersensitivity manifestations; agranulocytosis; thrombocytopenia; exfoliative dermatitis (due to the presence of Phenobalbitalum natricum); dizziness and irritability. With regard to drivers and machine operators, precise assessment of the benefit/ risk ratio is required for each patient. 20 coated tablets. INN: BISACODYL Код АТХ: A06AB 2 BISACODYL One suppository (for children) contains 5 mg bisacodyl. One suppository (for adults) contains 10 mg bisacodyl. One gastro-resistant tablet contains 5 mg bisacodyl. Short-term treatment of functional constipation; conditions requiring easier defecation; for mastering post-operative constipation; for cleaning the rectum before diagnostic and surgical procedures. Adults and children over 12 years: Constipation: 5-10 mg daily (1-2 tabl. or 1 suppository for adults). Diagnostic procedures: mg daily (2-4 tabl. or 1-2 suppositories for adults). Children from 6 to 12 years: 5 mg daily (1 tabl. or 1 suppository for children). Tablets are swallowed whole, 1 hour before or 2 hours after meal. They should not be taken with milk or antiacids. Suppositories are applied rectally, usually in the evening before sleep. Hypersensitivity to the product; ileus; acute inflammations of abdominal organs; gastrointestinal and uterine hemorrhages; acute enterocolitis; dehydration; rectal bleeding (fissure, laceration, hemorrhoids); Crohn s disease. To pregnant and lactating women, it is administered only on doctor s prescription. web: info@symepharma.com 17

18 Concomitant administration of Bisacodyl and oral anticoagulants may lead to reduction of absorption time, which imposes correction of anticoagulants dose. Bisacodyl is a contact laxative preparation and its activity is reduced by local anesthetics and narcotics. Co-administration of Bisacodyl tablets and antiacid drugs or H2-blockers may lead to manifestations of gastroduodenal irritation. Cholinomimetic agents (acetilcholine, Pilocarpinum hydrochloricum, etc.), as well as adrenolytic agents (yohimbine, vasolat), stimulate cholinergic innervation of bowels and create conditions for potentiation of product activity. On the contrary, adrenomimetic and cholinolytic preparations create conditions for reduction of its effect. Bisacodyl may increase the risk of potassium loss if co-administered with thiazide or loop diuretics, and glucocorticoids. Nausea, abdominal discomfort and meteorism; colic-like abdominal pains; anal and rectal inflammation; proctitis. In long-term treatment the preparation may cause diarrhea, fluid and electrolyte loss, as well as development of tolerance to the product. 6 suppositories of 5 mg. 6 suppositories of 10 mg. 30 gastro-resistant tablets of 5 mg Bisacodyl Sopharma. Without prescription. INN: BROMHEXINE Код АТХ: R05CB 2 BROMHEXIN One ampoule of 2 ml contains 4 mg bromhexine hydrochloride (2 mg/ml). One tablet contains 4 mg or 8 mg bromhexine hydrochloride. 5 ml syrup contain 4 mg bromhexine hydrochloride. Bromhexin solution for injection, is indicated for the treatment of more severe cases of difficult discharge of bronchial secretion, as well as before and after surgery for prevention of postoperative complications. Bromhexin syrup and tablets are indicated as mucolytic preparation in all forms of acute and chronic bronchitis; COPD; pneumonia; bronchiectasis, and other chronic inflammations of lungs and bronchi; pneumoconiosis. Tablets: Adults and children over 12 years 8-16 mg, 3 times daily. web: info@symepharma.com 18

19 Children from 6 to 12 years: - 4 mg, 3 times daily; from 2 to 6 years the use of Bronhexin syrup is more suitable. Syrup: Adults and children over 12 years - 10 ml, 3 times daily. Children, 2-6 years ml, 3 times daily; 6-12 years - 5 ml, 3 times daily. In milder cases therapy duration is usually several days, whereas in chronic pulmonary infections, several weeks of treatment is indicated. Tablets should be taken with sufficient quantity of water. In more severe cases, the solution for injection is administered intramuscularly or intravenously in adults (slowly for 3 minutes) at a dose of 4 mg 1-3 times daily. The product may be administered also as an intravenous infusion together with glucosa, levulose or Ringer s solution. Hypersensitivity to the product; pregnancy and lactation. Bromhexin should not be used together with cough-suppressing medications, both along the central and peripheral mechanisms (codeine, codterpin, diolan, glauvent, antitussin). In such cases there is danger of accumulation of large amounts of bronchial secretion in the bronchi. Concurrent use with antibiotics leads to better penetration of the latter in the pulmonary tissue and significant elevation of antibiotic concentration in the bronchial secretion. Bromhexin may be co-administered with the inhalation forms of the same product, bronchodilators, cardiovascular products. Allergy reactions - skin rash, rhinitis. The preparation may provoke gastrointestinal disorders (nausea, vomiting, stomach pains, diarrhea) and sweating, which are transient. 10 or 100 ampoules of 2 ml (4 mg) solution for injection 20 tablets of 4 mg. 20 tablets of 8 mg. Vial of 125 ml syrup. On doctor s pr Combined product Код АТХ: R05FA 2 BRONCHOLYTIN 5 g syrup contain: 5.75 mg glaucine hydrobromide; 4.60 mg ephedrine hydrochloride. web: info@symepharma.com 19

20 Combined treatment of diseases affecting respiratory system, accompanied by cough and catarrhal changes of various intensity: acute catarrhal inflammations of the upper respiratory tract, acute and chronic bronchitis and tracheobronchitis; bronchial asthma; pneumonia; bronchiectasis; whooping cough. In adults: 2 scoops (10 ml), 3-4 times daily. In children from 3 to 10 years: 1 scoop (5 ml), 3 times daily In children over 10 years: 2 scoops (10 g), 3 times daily. Due to Ephedrinun hydrochloricum content, the product is contraindicated in stenocardia; severe organic diseases of the heart; thyrotoxicosis; hypertension; pheochromocytoma; glaucoma; prostate hypertrophy with urine retention. Broncholytin is contraindicated in patients with hypersensitivity to the product. Broncholytin is not suitable for patients with inborn intolerance to fructose, glucose/ galactose syndrome of malabsorption or sucrose-isomaltose deficiency. Broncholytin may be used together with antibiotics, chemotherapeutics, antipyretics, and vitamins. Concomitant administration with digitalis glycosides or general anesthetics may provoke cardiac arrhythmia. Similar effects may be observed in interaction with ergotamine, methylergometrine or oxytocin. MAO-inhibitors potentiate the pressure effect of Ephedrinum hydrochloricum (there is a risk of hypertensive reactions). Reserpine reduces the pressure effect of Ephedrinum hydrochloricum. The interaction of Ephedrinum hydrochloricum with other sympathomimetics may enhance their effects. Due to Ephedrinum hydrochloricum content in the syrup, minutes after administration mild and transient adverse reactions may appear as tremor, palpitations, mild agitation, and sweating; somnolence in children. Possible are reactions of hypersensitivity (urticaria, dermatitis, bronchospasm), due to parahydroxybenzoates content in the product. In patients with prostatic hypertrophy, urine retention may be observed. In patients with cardiovascular system diseases, rhythm and conductivity disturbances and arterial hypertension are possible. Vial containing 125 g syrup. Without prescription.escription. web: info@symepharma.com 20

21 Combined product Код АТХ: R05FA 2 BRONCHOLYTIN NEO 5 ml syrup contain: 6 mg glaucine hydrochloride; 5 mg pseudoephedrine hydrochloride. For treatment of cough in acute and chronic bronchitis, tracheobronchites, bronchial asthma and whooping cough. Syrup: Adults and children over 10 years - 15 ml, 3-4 times daily. Children, 4-10 years - 5 ml, 3 times daily. Hypersensitivity to the product. Due to the content of pseudoephedrine, the product should not be administered to: patients with high blood pressure, severe organic diseases of the heart with manifestations of decompensation, stenocardia, atherosclerosis; insomnia; thyrotoxicosis; phreochromocytoma; narrow-angle glaucoma; prostatic adenoma with urine retention; therapy with MAO-inhibitors; children under 4 years. It should be administered with caution in diabetes, liver diseases, alcoholism, epilepsy, pregnant women, children. Broncholytin Neo syrup is unsuitable for persons with inborn intolerance to fructose, glucose/galactose syndrome of malabsorption or sucrose-isomaltose deficiency. Concomitant administration of Broncholytin Neo with the product guanetidine, the effect of guanetidine is antagonized. MAO-inhibitors and beta-adrenergic blockers may potentiate the effect of pseudoephedrine. Adverse interactions may be expected in co-administration with the following drugs: ammonium chloride, amphetamine; bicarbonates, citrates or other acetate products; cocaine; Bromocriptine; caffeine; furazolidine; preparations for cold or difficult respiration; antidepressants; drugs for migraine; theophylline; procarbazine; antihypertensives; preparations for weight loss. Rarely, mild and transient tremor and palpitation may appear minutes after product administration. Due to the content of parahydroxybenzoates in Broncholytin Neo composition, possible are reactions of hypersensitivity (urticaria, dermatitis, bronchospasm). In patients with prostatic hypertrophy, urine retention may be observed. In patients with cardiovascular system diseases, rhythm and conductivity disturbances and arterial hypertension are possible. Vial containing 110 ml syrup. Without prescription. web: info@symepharma.com 21

22 INN: BUTYLSCOPOLAMINE Код АТХ: A03BB 1 BUSCOLYSIN One ampoule of 1 ml contains 20 mg butylscopolamine (20 mg/ml). One coated tablet contains 10 mg butylscopolamine. In gastrointestinal diseases - stomach and duodenal ulcer; esophageal and cardiac spasms; pylor spasm; vomiting; biliary colic; biliary dyskinesia; cholecystitis. Diseases of the urogenital system - renal colic; urinary bladder tenesmus; spasm in urolithiasis. In obstetrics and gynecology - spastic dysmenorrhoea; as a supplementary drug in incipient and incomplete abortion; spasms of the delivery pathways during parturition; manual extraction of placenta. Solution for injection: in acute spastic pains in adults mg intramuscularly or intravenously, 2-4 times daily. Intravenously the preparation may be applied as a drop infusion diluted in some parenteral solution used in practice. Maximal dose in adults is 100 mg/24 h. In children over 6 years Buscolysin is administered intramuscularly or intravenously at a dose of 5-10 mg, 2-4 times daily. Tablets: The recommended daily dose for adults and children over 12 years is 1-2 tablets, 3-4 times daily. In children over 6 years - 1 tablet, 3 times daily. Hypersensitivity to any of product excipients; myasthenia gravis. M-cholinolytic action of Buscolysin is antagonised by M-cholinomimetics as Pylocarpinum hydrochloricum and anti-cholinesterase agents - galantamine, fisostigmine, pyridostigmin, due to the functional antagonism. Butylscopolamine enhances anti-cholinergic effects of amantadine, quinidine, tri- and tetra-cyclic antidepressants, neuroleptics, antihistamines and antiparkinsonians. Due to gastrointestinal motor function depression, Buscolysin enhances absorption and serum concentration of Digoxin (by about 1/3), and may lead to its relative overdosage. Co-administration of Buscolysin and ketoconazole or metoclopramide may result in a reduction of their therapeutic efficacy. Buscolysin depresses the secretory function of endocrine glands (mouth dryness and dry and red skin); accommodation disorders - mydriasis and cycloplegia. It may provoke glaucoma attack due to intraocular pressure rise; anxiety and hallucinations in case of overdosage in children and elderly patients; tachycardia or tachyarrhythmia, as well as hypersensitivity manifestations - rash, urticaria; in elderly male patients with prostatic hypertrophy - miction disorders and urine retention. web: info@symepharma.com 22

23 10 or 100 ampoules of 1 ml (20 mg) solution for injection 20 or 800 coated tablets of 10 mg. CALCIUM GLUCONICUM INN: CALCIUM GLUCONATE, CALCIUM LAEVULATE Код АТХ: A12AA 3 One ampoule of 10 ml contains: 760 mg Calcium gluconate (76 mg/ml); 164 mg Calcium laevulate (16.4 mg/ml), equivalent to 894 mg calcium ions. For treatment of acute hypocalcemia; hyperkalemia; hypermagnesemia; electrolyte disbalance; cardiac arrest. In adult patients it is administered slowly intravenously at a dose of ml and the dose may be repeated, if necessary. In children the dosage is 2-5 ml intravenously. Intravenous injection should be made slowly - 5 ml for 3-5 minutes, and the patient should be in supine position. The preparation should not be administered to patients with primary or secondary hypercalcemia; hypercalciuria; renal stones with calcium content; sarcoidosis; renal failure; intoxication with digitalis products. Calcium salts reduce tetracycline absorption. Concomitant administration with cardiac glycosides increases the risk of arrhythmias. Usually, adverse reactions appear with calcium overdosage. They are in the form of mouth dryness, metal taste, thirst, loss of appetite, constipation, fatigue and weakness, anxiety, depression, headache. Fast parenteral administration may cause nausea, vomiting, diarrhea, bradycardia, hypotension and rarely collapse. 5 ampoules of 10 ml solution for injection. 50 ampoules of 10 ml solution for injection. web: info@symepharma.com 23

24 Combined product Код АТХ: A12AX CALCIUM PHOSPHO C One filmtablet contains: 150 mg Calcium hydrogenphosphate dihydrate; 70 mg Calcium lactate; 50 mg Calcium glycerophosphate; 20 mg ascorbic acid. Diseases accompanied by calcium-phosphoric balance disorders - hypocalcemia of various origin, osteomalacia, allergy diathesis, convalescence following severe disease; fractures etc. In elderly patients with osteoporosis, for normalization of calcium-phosphoric exchange. Physiological conditions of higher calcium demands - pregnancy, lactation, accelerated body growth, etc. For prophylaxis of bone structure changes in patients with diabetes, thyrotoxicosis and prolonged corticosteroid therapy. In adults tablets, 3-4 times daily. In children over 6 years - 1 tablet, 2-4 times daily. Dosage and therapy duration are determined by the attending physician, depending on the severity of the disease. If necessary, the preparation may be used in longterm treatment courses or in intervals of several months. Accelerated blood clotting, thrombophlebitis, predisposition to thrombosis; hypercalcemia; atherosclerosis; chronic renal failure; severe liver disorders; prosthetic cardiac valves; glucoso-6- phosphate dehydrogenase deficiency; nephrolithiasis and hyperoxaluria; thalassemia. Calcium enhances the effect of digitalis glycosides and sensitivity to them; reduces the effectiveness of some local anesthetics. Concomitant administration of calcium preparations and tetracycline antibiotics reduces the resorption rate of the later in the gastrointestinal tract, because of the formation of non-resorbable complexes with calcium. Co-administration with barbiturates reduces the rate of excretion of the later, elevates their plasma levels and enhances their pharmacological and toxic activity. Most frequent adverse reactions are gastrointestinal manifestations - nausea, vomiting, gastrointestinal discomfort in predisposed patients. web: info@symepharma.com 24

25 30 filmtablets. Without prescription. INN: CAPTOPRIL Код АТХ: C09AA 1 CAPTOPRIL One tablet contains 25 mg or 12,5 mg captopril. Mild, moderate and severe essential hypertension (even in cases which are not sufficiently influenced by other antihypertensive drugs); renovascular hypertension (as a monotherapy or in combination with other medications in inoperable patients); chronic congestive heart failure. Usual dose in arterial hypertension is 12.5 mg to 25 mg, 2-3 times daily. If blood pressure reduction is insufficient, the dose may be increased up to 50 mg, 2-3 times daily. In renovascular and renal hypertension the dose is 12.5 mg, 3 times daily. In renal failure daily dose depends on the creatine clearance and dosage intervals are extended. In heart failure the initial dose is 6.25 mg or 12.5 mg, 3 times daily and the dose is gradually increased. Initial Captopril dose should be consistent with any diuretic therapy in progress. In children Captopril should be used with particular caution and after precise assessment. The recommended dose is 1-2 mg/ kg body weight. Tablets should be taken 1 hour before meal. Hypersensitivity to Captopril or to other ACE inhibitors; in patients with neutropenia and thrombopenia; Quincke s edema; pregnancy and lactation. Captopril may enhance the hypoglycemic effect of insulin and oral antidiabetics. Concomitant administration with potassium-sparing diuretics increases the risk of hyperkalemia. Higher risk of leucopenia exists in concurrent use with immunosupressive agents. The orthostatic hypotension is more frequent in co-administration of Captopril with neuroleptics. Captopril elevates Digoxin serum levels and reduces the effect of calcium antagonists. Non-steroid antiinflammatory drugs reduce its antihypertensive effect. Hypotensive effect of Captopril is enhanced in concomitant treatment with vasodilators, diuretics and beta-adrenoblockers. web: info@symepharma.com 25

26 Gastrointestinal disorders (mild and transient); taste disorders; rashes; headache; dizziness; paresthesias; orthostatic hypotension, tachycardia, stenocardia, angioedema. In high doses, proteinuria, neutropenia, leucopenia, plasma level elevation of potassium, creatinine and urea may appear. Dry irritable cough may appaer as adverse reasctin which fade away after product withdraw. 40 tablets Captopril of 25 mg. 60 tablets Captopril of 12,5 mg. INN: SILYMARIN Код АТХ: A05BA 3 CARSIL One coated tablet contains 35 mg Silymarin. One capsule contains 100 mg Silymarin. Toxic liver disorders; supplementary treatment in patients with chronic liver inflammation disorders or cirrhosis. Usual dose is mg (1-2 tablets), 3 times daily or 1 capsule, 2-3 times daily. The treatment of the severe liver intoxications begins at a dose of mg, 3 times daily and continues at a dose of 140 mg, 2 times daily. If necessary and according to attending physician s assessment, MDD may be increased up to 800 mg. The therapeutic course usually lasts 3 mounts. In children the daily dose is 5 mg/kg body weight, divided in 2-3 intakes. Hypersensitivity to the product. No data are available of any clinically significant interactions. In some cases mild laxative and diuretic effects may be observed. Very rarely, in predisposed patients, exacerbation of existing vestibular disorders may appear, which fade away after product withdrawal. web: info@symepharma.com 26

27 80 coated tablets of 35 mg. 30 capsules of 100 mg. Coated tablets without prescription. Capsules - on doctor s prescription. INN: MECLOFENOXATE Код АТХ: N06BX 1 CENTROPHENOXIN One ampoule of 10 ml contains 250 mg meclofenoxate hydrochloride (powder for solution for injection). One ampoule of 10 ml contains 10 ml sterilized water for injections (solvent). Comatose conditions; cranio-cerebral trauma; after cerebral insult; encephalopathy; psychic disorders (in combination with psychotropic agents); mental and psychomotor delay in children; brain-affecting intoxication; alcohol psychoses; neuritis and polyneuritis. Administered intravenously, subcutaneously and intramuscularly, most frequently at a single dose of 250 mg (1 ampoule). The ampoule content is diluted just before injection. Depending on patient s condition, the dose may reach 1-2 g/24h. Therapy duration depends on the severity of the disease and should be determined by the attending physician. Hypersensitivity to the product; CNS infectious disorders; epilepsy; neuroses with tension and phobia; renal and hepatal insufficiency. Centrophenoxin is used as a basic therapy in mental disorders. In such cases it is combined with psychotropic agents (antipsychotics, anxiolytics, and antidepressants). In clincial practice Centrophenoxin is successfully combined with antiepileptics and antiparkinsonians. In intoxication with alcohol and CNS-depressing agents, Centrophenoxin exerts a detoxifying effect. Concomitant administration with psychoanaleptics enhances CNS excitation processes. In isolated cases and in predisposed patients, particularly in elderly persons, Centrophenoxin may provoke excitation, aggression, insomnia, and headache. In patients with paranoid and hallucination symptoms, the preparation may aggravate their condition. In some cases skin allergy and gastrointestinal disorders may appear. web: info@symepharma.com 27

28 10 ml (250 mg) powder for solution for injection and 10 ml solvent, both in 5 ampoules each. Combined product Код АТХ: C02LC 1 CHLOPHADON One tablet contains: 0.15 mg clonidine hydrochloride; 20 mg chlorthalidone. Arterial hypertension. Tablets should be taken during meal. The usual initial dose is 1/2-1 tablet daily. If necessary, the dose may be gradually increased by 1/2-1 tablet 2-3 times daily. Dosage and therapy duration are determined by the attending physician, lowest therapeutic doses being used to avoid adverse effects. Hypersensitivity to the product; sick sinus syndrome; AV-block II or III degree; peripheral circulation disorders; severe renal failure; hepatal comma; cerebrovascular diseases; recent myocardial infarction or coronary insufficiency; depression; hypokalemia. Tricyclic antidepressants reduce Chlophadon efficiency. Concomitant administration with cardiac glycosides may cause bradycardia and AV - block. Chlophadon reduces the hypoglycemic effect of antidiabetics, which requires correction of their dose. Non- steroid antiinflammatory drugs reduce diuretic and antihypertensive activity of Chlophadon. Concomitant administration of glycocorticoids and carbenoxolone enhances the hypokalemic effect of Chlophadon. Fatigue; headache; orthostatic hypotension; depletion phenomenon in case of abrupt interruption of treatment; AV-conduction disorders; bradycardia; tremor; allergy rashes; photosensitization; nausea; vomiting. In long-term treatment: gynecomasty; hypokalemia; tubular necrosis and interstitial nephritis; elevation of cholesterol and triglycerides serum levels. 50 tablets. web: info@symepharma.com 28