Controlok coated pills 40mg N28
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Active ingredients
Pantoprazole
Release form
Pills
Composition
Pantoprazole sodium sesquihydrate 45.1 mg, which corresponds to the content of pantoprazole 40 mg; Excipients: anhydrous sodium carbonate - 10.00 mg, mannitol - 42.70 mg, crospovidone - 50.00 mg, povidone K90 - 4.00 mg, calcium stearate - 3.20 mg, purified water - 9.00 mg.; Shell composition: hypromellose 2910 - 19 mg, Povidone C25 - 0.38 mg, titanium dioxide (E171) - 0.34 mg, iron dye yellow oxide (E172) - 0.03 mg, propylene glycol - 4.25 mg, Eudragit L 30D-55 * - 14.56 mg, triethyl citrate - 1.45 mg. * Eudragit dispersion composition L 30D-55: Eudragit L 30D-55 (Methacrylic acid and ethyl acrylate copolymer [1: 1]) - 14.13 mg, polysorbate 80 - 0.33 mg, sodium lauryl sulfate - 0.1 mg.; Opacode S-1-16530 brown ink composition for labeling on pills: shellac - 0.036 mg, iron dye red oxide (E172) - 0.009 mg, iron dye black oxide (E172) - 0.009 mg, iron dye yellow oxide (E172) - 0.0009 mg, ammonia solution concentrated 25% - 0.001 mg.
Pharmacological effect
Proton pump inhibitor (H + -K + -ATP-ase). Blocks the final stage of secretion of hydrochloric acid, reducing basal and stimulated secretion, regardless of the nature of the stimulus.; Antisecretory activity. After ingestion of the drug Controloc; at a dose of 20 mg, gastric juice secretion decreases by 24% after 2.5-3.5 hours and by 26% after 24.5-25.5 hours. After taking 1 time / day for 7 days, antisecretory activity increases to 56% after 2.5-3.5 hours and to 50% in 24.5-25.5 hrs; In duodenal ulcers associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of microorganisms to antibiotics. Does not affect the motility of the digestive tract. Secretory activity is normalized 3-4 days after the end of the application. Compared with other proton pump inhibitors Controloc; has greater chemical stability at neutral pH and less potential for interaction with the liver oxidase system, dependent on cytochrome P450. Therefore, no clinically significant interaction was observed between the drug Controloc; and many other drugs.
Pharmacokinetics
The pharmacokinetics are the same after a single dose, and after repeated use of the drug.; Absorption; Pantoprazole is rapidly absorbed after oral administration. Cmax in oral blood plasma is achieved already after the first dose of 20 mg or 40 mg. On average, Cmax is 1.0–1.5 mcg / ml and is achieved in 2–2.5 hours at a dose of 20 mg and 2.0–3.0 mcg / ml after 2.5 hours at a dose of 40 mg.This indicator remains constant after repeated use of this drug. Absolute bioavailability of pantoprazole pills - 77%. The simultaneous use of pantoprazole pills with food does not affect the AUC and Cmax.; Distribution; The binding of pantoprazole to plasma proteins is 98%. Vd is 0.15 l / kg.; Metabolism; Metabolized in the liver. The main metabolite in the blood plasma and urine is desmethylpanthoprazole conjugating with sulfate.; Elimination; T1 / 2 of the drug - 1 h. Clearance - 0.1 l / h / kg. The main route of elimination is through the kidneys (about 80%) in the form of pantoprazole metabolites, in a small amount is excreted through the intestines.; Pharmacokinetics in special clinical cases; When pantoprazole is used in patients with limited kidney function (including patients on hemodialysis a) dose reduction is not required. As in healthy patients, T1 / 2 pantoprazole is short. Only a very small portion of the drug is dialyzed. Cumulation does not occur. In patients with cirrhosis of the liver (classes A, B and C according to the Child-Pugh classification), the T1 / 2 value increases to 3-6 hours at a dose of 20 mg and up to 7-9 hours at a dose of 40 mg. AUC increases by 3-5 times (for a dose of 20 mg) and by 5-7 times (for a dose of 40 mg). Cmax increases by 1.3 times (for a dose of 20 mg) and 1.5 times (for a dose of 40 mg) by compared with healthy patients.; A slight increase in AUC and Cmax in the elderly is not clinically significant.
Indications
For pills of 20 mg; - treatment of symptoms of gastroesophageal reflux disease of mild severity (such as heartburn, nausea, sour regurgitation) in adults; For pills of 40 mg; - gastric ulcer and duodenal ulcer (in acute phase), erosive gastritis (in including those associated with taking NSAIDs); - Zollinger-Ellison syndrome; - eradication of Helicobacter pylori in combination with antibacterial agents.
Contraindications
- dyspepsia neurotic genesis; - combined use with atazanavir; - pregnancy; - lactation period; - age up to 18 years; - Hypersensitivity to the components of the drug, as well as to soy.
Use during pregnancy and lactation
Kontrolok; contraindicated in pregnancy and lactation.
Dosage and administration
Kontrolok; taken orally before eating, not chewing or crushing, drinking enough liquid.; 20 mg pills; For the treatment of symptoms of gastroesophageal reflux disease of mild severity (such as heartburn, nausea, sour belching) in adults, Controlrok is prescribed; at 20 mg / day.To achieve positive dynamics in the elimination of symptoms, it may be necessary to take the drug for 2-3 days, but to completely eliminate the symptoms, it may be necessary to take the drug for 7 days. If the condition worsens during the first 3 days of treatment, it is recommended to consult a specialist.; The drug should be stopped immediately after the symptoms disappear. If within 2 weeks of continuous use of the drug there is no positive dynamics, the patient should consult a doctor.; 40 mg pills; In the treatment of gastric ulcer and duodenal ulcer, erosive gastritis (including those associated with the use of NSAIDs), the drug is prescribed in a dose of 40 -80 mg / day; The course of treatment is 2 weeks with an exacerbation of duodenal ulcer and 4-8 weeks with an exacerbation of gastric ulcer. Anti-relapse treatment of gastric ulcer and duodenal ulcer - 20 mg / day; For the eradication of Helicobacter pylori, the following combinations are recommended: 1. Controlo; 20-40 mg 2 times / day + amoxicillin 1000 mg 2 times / day + clarithromycin 500 mg 2 times / day; 2. Control; 20-40 mg 2 times / day + metronidazole 500 mg 2 times / day + clarithromycin 500 mg 2 times / day; 3. Control; 20-40 mg 2 times / day + amoxicillin 1000 mg 2 times / day + metronidazole 500 mg 2 times / day; The course of treatment is 7-14 days. With the Zollinger-Ellison syndrome Controloc; prescribed in a dose of 40-80 mg / day. In patients with severely impaired liver function, the dose should be reduced to 40 mg 1 time in 2 days. In this case, it is necessary to monitor blood biochemical parameters. With an increase in liver enzymes, the use of the drug should be discontinued.; Elderly patients, as well as patients with impaired renal function, dose adjustment is not required, but the dose of 40 mg / day should not be exceeded. An exception is the use of combination antibiotic therapy against Helicobacter pylori, when older patients should also use Krolok; at a dose of 40 mg 2 times / day; Do not take Controlok; in order to prevent.
Side effects
When using the drug Controloc; In accordance with the indications and in the recommended doses, adverse reactions are extremely rare. Most often (about 1%) diarrhea and headache are observed. Determination of the frequency of adverse reactions: very often (> 1/10),often (> 1/100 and <1/10), infrequently (> 1/1000 and <1/100), rarely (> 1/10 000 and <1/1000), very rarely (<1/10 000, including individual cases), the frequency is unknown (it is impossible to estimate on the basis of available data) .; From the hematopoietic system: rarely - agranulocytosis; very rarely - thrombocytopenia, leukopenia, pancytopenia. From the nervous system: infrequently - headache, dizziness; rarely - dysgeusia. On the part of the organ of vision: rarely - blurred vision (misting) .; On the part of the gastrointestinal tract: rarely - diarrhea, nausea / vomiting, abdominal distension and flatulence, constipation, dry mouth, abdominal pain.; and biliary tract: infrequently - increased activity of liver enzymes (AST, GGT); rarely, increased bilirubin levels; frequency unknown - hepatocellular damage, jaundice.; From the urinary system: frequency unknown - interstitial nephritis. From the skin and subcutaneous tissues: infrequently - exanthema / rash, itching; rarely - urticaria, angioedema; unknown frequency - erythema malignant exudative (Stevens-Johnson syndrome), erythema multiforme exudative, toxic epidermal necrolysis, photosensitivity.; From the musculoskeletal system: rarely - arthralgia, myalgia; From the metabolic side: rarely - hyperlipidemia and elevated lipid concentration (triglycerides, cholesterols), change in body weight; frequency is unknown - hyponatremia, hypomagnesemia; From the immune system: rarely - hypersensitivity (including anaphylactic reactions and anaphylactic shock); From the psyche: rarely - sleep disturbance; rarely, depression (including exacerbations of existing disorders); very rarely - disorientation (including exacerbations of existing disorders); the frequency is unknown - hallucinations, confusion (especially in predisposed patients), and the possible exacerbation of symptoms if they exist before the start of therapy.; From the genital organs and the mammary gland: rarely - gynecomastia.; General disorders: infrequently - weakness, fatigue and malaise; rarely - fever, peripheral edema.
Overdose
To date, the effects of overdose as a result of the use of the drug Controloc; it was not noted. Doses up to 240 mg were administered intravenously for 2 minutes and were well tolerated. Treatment: in case of overdose and only in the presence of clinical manifestations, symptomatic and supportive therapy is carried out. Pantoprazole is not excreted by hemodialysis.
Interaction with other drugs
The simultaneous use of the drug Controloc; can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach (including iron salts, ketoconazole); Controloc; can be prescribed without the risk of drug interaction: - patients with cardiovascular diseases receiving cardiac glycosides (digoxin), slow calcium channel blockers (nifedipine), beta-adrenoblockers (metoprolol); - patients with gastrointestinal diseases, taking antacids, antibiotics (amoxicillin, clarithromycin); - patients taking oral contraceptives containing levonorgestrel and ethinyl estradiol; - to patients taking NSAIDs (diclofenac, phenazone, naproxen, piroxicam); - patients with endocrine system diseases, taking glibenclamide, levothyroxine; - patients with anxiety and sleep disorders taking diazepam; - patients with epilepsy taking carbamazepine and phenytoin; - patients taking indirect anticoagulants, such as warfarin and fenprokumon (under the control of prothrombin time and INR at the beginning and at the end of treatment, as well as during the irregular administration of pantoprazole); - patients undergoing transplantation, taking cyclosporine, tacrolimus. There was a lack of clinically significant drug interactions with caffeine, ethanol, theophylline.
special instructions
Before starting treatment with Controloc; the possibility of a malignant neoplasm should be excluded, since the drug can mask the symptoms and delay the correct diagnosis.; Patients should consult a doctor if they are to undergo endoscopy or a urea breath test.; Patients should consult a doctor in the following cases: - unintended weight loss, anemia , gastrointestinal bleeding, swallowing disorder, persistent vomiting or vomiting of blood. In these cases, taking the drug may partially alleviate the symptoms and delay the correct diagnosis; - previously undergone surgery on the gastrointestinal tract or stomach ulcer; - continuous symptomatic treatment of dyspepsia and heartburn for 4 weeks or more; - liver diseases, incl. jaundice and liver failure; - other serious diseases that worsen the overall health.; Patients over the age of 55 years,if you have new or recently changed symptoms, you should consult with your doctor. When you take drugs that reduce the acidity of gastric juice, the risk of infections caused by bacteria of the gastrointestinal genus Salmonella spp., Campylobacter spp. or Сlostridia difficile.; Influence on ability to drive motor transport and control mechanisms; Patients should refrain from driving and other mechanisms that require increased attention, because of the likelihood of dizziness and visual impairment.