Kontrolok tab n / an kish.rastv. 40mg 28 pc

$14.13

Kontrolok tab n / an kish.rastv. 40mg 28 pc

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Description

Composition
Active substance:
1 tablet contains: pantoprazole sodium sesquihydrate 45.10 mg, 40.00 mg pantoprazole corresponds.
Excipients:
Sodium carbonate anhydrous 10.00 mg; mannitol 42.70 mg; 50.00 mg crospovidone; Povidone K90 4.00 mg; calcium stearate 3.20 mg; Purified water 9.00 mg. sheath: hypromellose-2910 19.00 mg; Povidone K25 0.38 mg; Titanium dioxide E171 0.34 mg; dye E172 iron oxide yellow 0.03 mg; propylene glycol 4.25 mg; Eudragit L 30D-55 * 14.56 mg; triethyl citrate 1.45 mg. * Composition dispersion Eudragit L 30D-55: Eudragit L 30D-55 (a methacrylic acid-ethyl acrylate copolymer [1: 1]) 14.13 mg; Polysorbate 80 0.33 mg; Sodium lauryl sulfate 0.10 mg. brown ink Opacode S-1-16530 for marking the tablets: shellac (shellac) 0,036 mg; iron oxide red dye (E172) 0.009 mg; dye black iron oxide (E172) 0.009 mg; iron oxide yellow dye (E172) 0.0009 mg; Concentrated ammonia solution 25% 0,001 mg.
Description:
Oval biconvex tablets, film-coated yellow with a nucleus from white to almost white. On one side of the tablet is printed in brown ink: “P40”.
Product form:
Tablets coated with 40 mg enteric-coated. 14 tablets in blister Aluminum PVC / PVC Aluminum. 1 or 2 blisters together with instructions for use in a cardboard pack. 7 tablets in a blister, nested in collapsible cardboard cover. 1 or cardboard cover 4 together with instructions for use placed into cardboard pack.
Contraindications
Hypersensitivity to any component of the drug, and also to substituted benzimidazole; dyspepsia neurotic genesis; receiving HIV protease inhibitors such as atazanavir and nelfinavir, the absorption of which depends on the acidity (pH) of gastric juice; age of 18 years; pregnancy, breastfeeding.
Dosage
40 mg
Indications
Gastric ulcer and duodenal ulcer (in the acute phase), erosive gastritis (including those associated with the use of nonsteroidal anti-inflammatory drugs NSAIDs); Zollinger-Ellison syndrome; eradication of Helicobacter pylori in combination with antibacterial agents.
Interaction with other drugs
Not recommended simultaneous use of other proton pump inhibitors or H2 blockers histamine receptors without consulting a doctor. Simultaneous application Kontrolok® drug may reduce the absorption of drugs, bioavailability which is dependent on the pH of the gastric environment (e.g., ketoconazole, itraconazole, posaconazole, and other drugs such as erlotinib).
The combined use of pantoprazole and HIV protease inhibitors, absorption of which depends on the acidity (pH) of gastric juice, such as atazanavir, nelfinavir, greatly reduces their bioavailability. During studies of drug interactions have been identified clinically significant interactions when used Kontrolok® preparation in the following cases: in patients with diseases of the cardiovascular system, receiving cardiac glycosides (digoxin), blockers of slow calcium channels (nifedipine), beta-blockers ( metoprolol); patients with diseases of the gastrointestinal tract, taking antacids, antibiotics (amoxycillin, clarithromycin); in patients taking oral contraceptives containing levonorgestrel and ethinyl estradiol; in patients on nonsteroidal antiinflammatory drugs (diclofenac, naproxen, piroxicam); patients with diseases of the endocrine system, host glibenclamide, levothyroxine; in patients with anxiety, and sleep disorders, receiving diazepam; in patients with epilepsy receiving carbamazepine and phenytoin; in patients taking oral anticoagulants, such as warfarin and phenprocoumon, under the control of prothrombin time and INR is at the beginning and at the end of treatment and during the reception of irregular pantoprazole. Simultaneously, it should be noted that there are cases increasing INR and prothrombin time in patients treated with proton pump inhibitors, along with warfarin or phenprocoumon. The increase in INR and prothrombin time may lead to abnormal bleeding, life-threatening. In this regard, such patients should be monitored for timely detection of increase in INR and prothrombin time.
It is also noted the absence of clinically significant drug interactions with caffeine, ethanol, theophylline. There are reports of increasing blood levels of methotrexate in some patients by combining it in high doses (e.g., 300 mg) with proton pump inhibitors. Therefore, when using high doses of methotrexate, such as cancer or psoriasis, it may be necessary to consider whether the temporary cancellation of Pantoprazole.
Overdose
Hitherto overdose phenomena resulting Kontrolok® of the drug was observed. Doses up to 240 mg were administered intravenously for 2 minutes and well tolerated. In the case of overdose with clinical manifestations of toxicity being symptomatic and supportive therapy. Pantoprazole is output by hemodialysis.
pharmachologic effect
Pharmacological group:
Gastric glands secretion lowering agent – a proton pump inhibitor.
Pharmacodynamics:
The inhibitor of proton pump (H + K + ATPase). Blocks final step of acid secretion regardless of the nature of the stimulus. Pantoprazole is a substituted benzimidazole, which suppresses the secretion of hydrochloric acid in the stomach by specific blockade of the parietal cell proton pumps. Pantoprazole is transformed into its active form under acidic conditions in the parietal cells, where it inhibits the enzyme activity of H + K + ATPase, i.e. blocks the final phase of the formation of hydrochloric acid in the stomach. Suppression activity is dose-dependent and, as a result, reduced both basal and stimulated acid secretion. In the treatment of pantoprazole, as well as the use of other proton pump inhibitors and H2-receptor blockers, reduced acidity in the stomach and thereby increases the level of gastrin proportionally reduce acidity. Increasing the level of gastrin is reversible. Because pantoprazole enzyme binds distal to the cellular receptor, it can inhibit acid secretion irrespective of stimulation by other substances (acetylcholine, histamine, gastrin). Also increases the content of chromogranin A (CgA) in serum due to the reduction of acid secretion. Elevated levels of CgA may distort the results of diagnostic tests to detect neuroendocrine tumors.
Antisecretory activity.
After the first oral 20 mg Kontrolok® reduction of gastric acid secretion by 24% occurs within 2.5-3.5 hours and 26% after 24,5-25,5 hours. After oral administration of pantoprazole once a day for 7 days of its antisecretory activity measured after 2.5-3.5 hours after administration, increases to 56%, and after 24,5-25,5 hr – 50%. When duodenal ulcer associated with Helicobacter pylori, decrease gastric secretion increases the sensitivity of microorganisms to antibiotics. It does not affect the motility of the gastrointestinal tract. Secretory activity normalized in 3-4 days after admission. As compared with other proton pump inhibitors Kontrolok® has high chemical stability at neutral pH, and less potential interactions with liver oxidase system, which depends on cytochrome P450. Therefore, no clinically significant interaction between drug Kontrolok® and many other drugs.
Pharmacokinetics:
Pantoprazole is rapidly absorbed after oral administration. Maximum plasma concentration (Cmax) after oral administration is achieved after the first dose of 20 mg. On average, after about 2-2.5 hours after administration reached maximum serum concentration, about 1.0-1.5 g / mL and Cmax and remains constant after repeated use of the drug. Pharmacokinetics of pantoprazole after single and repeated application of the same. In the dose range 10-80 mg pantoprazole pharmacokinetics in blood plasma remains linear as in oral or by intravenous administration. The absolute bioavailability of pantoprazole tablets is about 77%. Joint meal no effect on area under the curve “concentration-time» (AUC), maximum concentration in serum and, accordingly, the bioavailability. When co-administered with food can vary the start time of the drug. Binding pantoprazole plasma proteins is 98%. The volume of distribution of 0.15 l / kg. It is metabolized primarily in the liver. The main pathway is via CYP2C19 demethylation followed sulfate conjugation. Other metabolic pathways include oxidation via CYP3A4. Terminal half-life of about 1 hour, and the clearance of about 0.1 l / h / kg. Because of the specific binding of pantoprazole with parietal cell proton pumps half-life does not correlate with the much longer duration of action (inhibition of acid secretion). The main excretion pathway – through the kidneys (approximately 80%) in the form of pantoprazole metabolites, the remainder is excreted in the feces. The main metabolite in plasma and urine desmetilpantoprazol is conjugated with sulphate. The half life of the major metabolite is about 1.5 hours, which is not much greater than the half-life of pantoprazole. In the application of pantoprazole in patients with limited kidney function (including patients on hemodialysis) dose reduction is required. As in healthy volunteers, the elimination half-life of pantoprazole is short. Dialyzed only a very small portion of the drug. Despite the moderately long half-life of the main metabolite (2-3 h), its removal is fast enough, and thus accumulation does not occur. In patients with liver cirrhosis (classes A and B according to the classification Child-Pugh) half-life period increased to 3-6 hours, AUC values ​​increased by 3-5 times, the maximum concentration in the serum rises slightly, only 1.5 times in comparison with that in healthy volunteers when using pantoprazole in the dosage of 20 mg. A slight increase in AUC and Cmax index in the elderly compared with the corresponding figures in is no more young people to be clinically significant.
Pregnancy and breast-feeding
Use during pregnancy
In the absence of data on the use of pantoprazole in pregnant women, as a precautionary measure, it is necessary to exclude the use of the drug during pregnancy Kontrolok®.
Breast-feeding
Pantoprazole and its metabolites have been found in breast milk. The effect of pantoprazole on newborns / infants is unknown. Kontrolok® should not be used during breastfeeding. If necessary, use during lactation should stop breastfeeding.
fertility
Data on the effects of the drug Kontrolok® on fertility in humans. Preclinical studies have shown no effect on male or female fertility.
Conditions of supply of pharmacies
Without a prescription.
side effects
When receiving Kontrolok® preparation according to the indications and recommended dosages unwanted reactions occur very rarely. The most common adverse reactions are diarrhea and headache – are observed in approximately 1% of patients.
Below shows the adverse drug reactions, depending on the frequency of their occurrence:
Very often> 1/10
Often> 1/100 and 1/1000, and 1/10000 and
Frequency not known (can not be estimated from the available data).
Violations by the blood and lymphatic system:
Seldom:
Agranulocytosis.
Very rarely:
Thrombocytopenia, leukopenia, pancytopenia.
Disorders of the nervous system:
Infrequently:
Headache, dizziness.
Seldom:
Taste disturbances.
Violations by the organs of vision:
Seldom:
Blurred vision (blurred).
Disorders of the gastrointestinal tract:
Often:
Polyps fundic gastric glands (benign).
Infrequently:
Diarrhea, nausea / vomiting, bloating and flatulence, constipation, dry mouth, discomfort and abdominal pain.
Violations of the kidneys and urinary tract:
Frequency unknown:
Interstitial nephritis.
Violations of the skin and subcutaneous tissue disorders:
Infrequently:
Rash / hives, itching, dermatitis.
Seldom:
Urticaria, angioedema.
Frequency unknown:
Malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity, subacute cutaneous lupus erythematosus.
Violations by musculoskeletal and connective tissue disorders:
Infrequently:
Fracture of the wrist, hip and spine.
Seldom:
Arthralgia, myalgia.
Violations by the metabolism:
Seldom:
Hyperlipidemia and the increased concentration of lipids (triglycerides, cholesterol), change in body weight.
Frequency unknown:
Hyponatremia, hypomagnesemia.
General disorders:
Infrequently:
Weakness, fatigue, and malaise.
Seldom:
Fever, and peripheral edema.
Violations by the immune system:
Seldom:
Hypersensitivity (including anaphylactic reactions and anaphylactic shock).
Disorders of the liver and biliary tract:
Infrequently:
Elevated liver enzymes (transaminases, gamma glutamintransferazy).
Seldom:
Increased bilirubin level.
Frequency unknown:
Hepatocellular injury, jaundice, pechonochnokletochnaya failure.
Violations by the genitals and breast:
Seldom:
Gynecomastia.
Violations by the psyche:
Infrequently:
sleep disturbances.
Seldom:
Depression (including aggravation of existing disorders).
Very rarely:
Disorientation (including aggravation of existing disorders).
Frequency unknown:
Hallucination, confusion (especially in predisposed patients), as well as a possible worsening of symptoms when their existence prior to initiating therapy.
special instructions
Before starting treatment with Kontrolok® should exclude the possibility of cancer because the drug may mask the symptoms and delay the correct diagnosis. Patients should consult a doctor if they have to endoscopy or urea breath test.
Patients should consult with your doctor if you have the following cases: unintentional weight loss, anemia, gastrointestinal bleeding, swallowing disorder, persistent vomiting or vomiting with blood. In these cases, the drug could partially alleviate the symptoms and delay the correct diagnosis; previously undergone surgical intervention on the gastro-intestinal tract or stomach ulcer; continuous symptomatic treatment of dyspepsia and heartburn for 4 weeks or more; liver disease, including jaundice and hepatic failure; other serious diseases, worsening the general health.
Patients over the age of 55 years, if there are new or recently changed symptoms should consult a physician. Patients should not expect immediate elimination of the symptoms of malaise. Relief of symptoms is possible after about one day of receiving pantoprazole is also necessary to consider that to completely eliminate heartburn may need about 7 days. When you receive drugs that reduce gastric acidity, slightly increased risk of gastrointestinal infections caused by a bacterium genus Salmonella spp., Campylobacter spp. or C. difficile. In the treatment of proton pump inhibitors is very rarely observed the development of the subacute cutaneous lupus erythematosus (PKKV). If you experience skin lesions, especially in areas exposed to sunlight, as well as the presence of concomitant arthralgia, the patient should immediately seek medical help, and a doctor should assess the need to stop treatment with Kontrolok®. Occurrence PKKV after previous treatment of the proton pump inhibitor may increase the risk of PKKV in the treatment of other proton pump inhibitors.
In laboratory studies it is necessary to consider that high serum content CgA may distort the results of diagnostic tests to detect neuroendocrine tumors. In connection with this application Kontrolok® drug should be discontinued at least 5 days prior to the survey CgA content. If CgA gastrin content and did not return to normal values ​​after the first determination, the study should be repeated at 14 days after discontinuation of the proton pump inhibitor. The preparation is intended for short term use (up to 4 weeks). Chronic administration of the drug may experience additional risks, and the need to seek medical attention for the purpose of the drug followed by regular medical supervision. The following additional risks are considered significant with continued dosing.
Effects on absorption of Vitamin B12
Pantoprazole, like all proton pump inhibitors, can reduce the absorption of vitamin B12 (cyanocobalamin) by hypo- or achlorhydria. This should be considered in patients with reduced stocks in the body or factors reduce the risk of vitamin B12 absorption with long-term treatment or in the presence of appropriate clinical symptoms.
Effect on bone fractures
proton pump inhibitors, particularly at high doses and during long-term therapy (> 1 year), may slightly increase the risk of fracture of the hip, wrist and spine, especially in the elderly or in the presence of other known risk factors. Observations have shown that proton pump inhibitors can increase the overall risk of fracture by 10 – 40%. This increase may partly be due to other risk factors. Пациенты с риском развития остеопороза должны получать лечение в соответствии с действующими клиническими рекомендациями, и у них должно быть соответствующее поступление витамина D и кальция в организм.
Гипомагниемия:
У пациентов, принимающих ингибиторы протонного насова (ИПН), в том числе пантопразол, в течение как минимум трех месяцев, и, в большинстве случаев, в течение года наблюдалась тяжелая гипомагниемия. При этом возможно развитие серьезных проявлений гипомагниемии, таких как утомляемость, тетания, бред, судороги, головокружение и желудочковая аритмия, они могут начинаться незаметно и быть пропущены. У большинства пациентов с подобными нарушениями гипомагниемия была скорректирована после заместительной терапии магнием и прекращения приёма ИПН. У пациентов, которым предстоит длительное лечение, или пациентам, принимающим ИПН совместно с дигоксином или другими препаратами, которые могут вызвать гипомагниемию (например, диуретики), следует провести исследование содержания магния в сыворотке крови перед началом лечения ИПН и периодически осуществлять его контроль во время лечения
Влияние на способность управления транспортными средствами/механизмами.
Следует воздержаться от управления транспортными средствами и другими механизмами, требующими повышенного внимания, из-за вероятности головокружений и нарушения зрения.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Контролок® принимают внутрь, до еды, не разжевывая и не измельчая, запивая достаточным количеством жидкости
Язвенная болезнь желудка и двенадцатиперстной кишки, эрозивный гастрит (в том числе, связанные с приемом нестероидных противовоспалительных препаратов НПВП).
По 40-80 мг в сутки. Курс лечения – 2 недели при обострении язвенной болезни двенадцатиперстной кишки, если этого времени недостаточно, то заживление обычно может быть достигнуто в течение последующих 2-х недель терапии. Курс лечения 4-8 недель при обострении язвенной болезни желудка и эрозивном гастрите.
Эрадикация Helicobacter pylori.
Рекомендованы следующие комбинации: 1. Контролок® по 40 мг 2 раза в сутки + амоксициллин по 1000 мг 2 раза в сутки + кларитромицин по 500 мг 2 раза в сутки 2. Контролок® по 40 мг 2 раза в сутки + метронидазол по 500 мг 2 раза в сутки + кларитромицин по 500 мг 2 раза в сутки 3. Контролок® по 40 мг 2 раза в сутки + амоксициллин по 1000 мг 2 раза в сутки + метронидазол по 500 мг 2 раза в сутки.
Курс лечения – 7-14 дней.
Zollinger-Ellison syndrome.
Для длительного лечения синдрома Золлингера-Эллисона и других патологических гиперсекреторных состояний, лечение следует начинать с суточной дозы 80 мг (2 таблетки Контролок® по 40 мг). Затем, при необходимости, дозу можно повышать или уменьшать, в зависимости от показателей кислотности желудочного сока. Дозы выше 80 мг в день следует разделять и применять два раза в день. Возможно временное повышение дозы пантопразола выше 160 мг, но оно не должно продолжаться дольше, чем это требуется для достижения контроля кислотности. Продолжительность лечения при синдроме Золлингера-Эллисона и при других патологических гиперсекреторных состояниях не ограничена, и сроки терапии могут определяться в зависимости от клинической необходимости.
У пациентов с выраженными нарушениями функции печени суточная доза пантопразола не должна превышать 20 мг в сутки (1 таблетка пантопразола 20 мг). В связи с этим, применение пантопразола в дозировке 40 мг у данной группы пациентов не рекомендуется. Следует регулярно контролировать уровень печеночных ферментов во время лечения пантопразолом, особенно при длительном применении препарата. В случае повышения уровня печеночных ферментов лечение следует прекратить.
Не требуется коррекции дозы у пожилых пациентов и пациентов с почечной недостаточностью.
В связи с отсутствием данных о применении препарата Контролок® в составе комбинированной антимикробной терапии в отношении Helicobacter pylori у пациентов с нарушением функции почек, а также у пациентов со средней и тяжелой степенью печеночной недостаточности, препарат применять не следует.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TAKEDA

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