Controlok tablets 20mg, No. 14

For tablets 20 mg

treatment of symptoms of gastroesophageal reflux disease of mild severity (such as heartburn, nausea, sour belching) in adults.

For 40 mg tablets

peptic ulcer of the stomach and duodenum (in the acute phase), erosive gastritis (including those associated with the use of NSAIDs); Zollinger-Ellison syndrome; eradication of Helicobacter pylori in combination with antibacterial agents.

ControlokЃ is taken orally before meals, without chewing or crushing, with a sufficient amount of liquid.

Tablets 20 mg

For the treatment of symptoms of gastroesophageal reflux disease of mild severity (such as heartburn, nausea, sour belching) in adults, ControlokЃ is prescribed at 20 mg / day. To achieve positive dynamics in eliminating symptoms, you may need to take the drug for 2-3 days, however, to completely eliminate the symptoms, you may need 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 discontinued as soon as symptoms disappear. If there is no positive dynamics within 2 weeks of continuous administration of the drug, the patient should consult a doctor. Tablets 40 mg

In the treatment of gastric ulcer and duodenal ulcer, erosive gastritis (including those associated with the use of NSAIDs), the drug is prescribed at a dose of 40-80 mg / day. The course of treatment is 2 weeks with exacerbation of duodenal ulcer and 4-8 weeks with exacerbation of gastric ulcer. Anti-relapse treatment of gastric ulcer and duodenal ulcer - 20 mg / day.

The following combinations are recommended for the eradication of Helicobacter pylori:

1. ControlocЃ 20-40 mg 2 times / day + amoxicillin 1000 mg 2 times / day + clarithromycin 500 mg 2 times / day;

2. ControlocЃ 20-40 mg 2 times / day + metronidazole 500 mg 2 times / day + clarithromycin 500 mg 2 times / day;

3. ControlokЃ 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. In Zollinger-Ellison syndrome, ControlocЃ is prescribed at a dose of 40-80 mg / day. In patients with severe hepatic dysfunction, the dose should be reduced to 40 mg every 2 days. In this case, it is necessary to monitor the biochemical parameters of the blood. With an increase in the level of liver enzymes, the drug should be discontinued. Elderly patients, as well as patients with impaired renal function, do not require dose adjustment, but the dose of 40 mg / day should not be exceeded. An exception is the use of combined antibiotic therapy against Helicobacter pylori, when elderly patients should also use ControlocЃ at a dose of 40 mg 2 times / day. You should not take ControlocЃ for prophylaxis.

pantoprazole

• dyspepsia of neurotic genesis;

• concomitant use with atazanavir;

• pregnancy;

• lactation period;

• age under 18;

• hypersensitivity to the components of the drug, as well as to soy.

pharmachologic effect

Proton pump inhibitor (H + -K + -ATP-ase). Blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. Antisecretory activity. After ingestion of the drug ControlocЃ at a dose of 20 mg, a decrease in gastric acid secretion by 24% occurs after 2.5-3.5 hours and by 26% after 24.5-25.5 hours. After taking 1 time / day for 7 days, the antisecretory activity increases to 56% after 2.5-3.5 hours and up to 50% after 24.5-25.5 hours. In case of duodenal ulcer associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of microorganisms to antibiotics. Does not affect gastrointestinal motility. Secretory activity is normalized 3-4 days after the end of the application.Compared to other proton pump inhibitors, ControlocЃ has a greater chemical stability at neutral pH and a lower potential for interaction with the liver oxidase system, which depends on cytochrome P450. Therefore, there was no clinically significant interaction between ControlocЃ and many other drugs.

Pharmacokinetics

The pharmacokinetics are the same after both single and multiple use of the drug. Absorption Pantoprazole is rapidly absorbed after oral administration. Cmax in blood plasma for oral administration is achieved after the first dose of 20 mg or 40 mg. On average, Cmax is 1.0-1.5 ?g / ml and is reached after 2-2.5 hours at a dose of 20 mg and 2.0-3.0 ?g / ml - after 2.5 hours at a dose of 40 mg. This indicator remains constant after repeated use of this drug. The absolute bioavailability of pantoprazole tablets is 77%. The simultaneous use of pantoprazole tablets with food does not affect the AUC and Cmax.

Distribution

The binding of pantoprazole to blood plasma proteins is 98%. Vd is 0.15 l / kg. Metabolism Metabolized in the liver. The main metabolite in blood plasma and urine is desmethylpantoprazole, conjugated with sulfate. Withdrawal T1 / 2 of the drug - 1 hour. Clearance - 0.1 l / h / kg. The main route of excretion 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 situations

When using pantoprazole in patients with limited renal function (including patients on hemodialysis), dose reduction is not required. As in healthy patients, the T1 / 2 of pantoprazole is short. Only a very small part of the drug is dialyzed. No cumulation occurs. 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. The AUC indicator increases 3-5 times (for a dose of 20 mg) and 5-7 times (for a dose of 40 mg). Cmax increases 1.3 times (for a dose of 20 mg) and 1.5 times (for a dose of 40 mg) in comparison with healthy patients. A slight increase in AUC and Cmax in the elderly is not clinically significant.

Side effect

When using the drug ControlokЃ in accordance with the indications and in the recommended doses, side reactions are extremely rare. Diarrhea and headache are most common (about 1%). 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 rare (<1/10 000, including isolated cases), the frequency is unknown (cannot be estimated from the available data). From the hematopoietic system: rarely - agranulocytosis; very rarely - thrombocytopenia, leukopenia, pancytopenia. From the nervous system: infrequently - headache, dizziness; rarely - dysgeusia. From the side of the organ of vision: rarely - visual impairment (fogging). From the gastrointestinal tract: infrequently - diarrhea, nausea / vomiting, bloating and flatulence, constipation, dry mouth,stomach ache. From the liver and biliary tract: infrequently - increased activity of hepatic enzymes (AST, GGT); rarely - an increase in the level of bilirubin; frequency unknown - hepatocellular damage, jaundice. From the urinary system: the frequency is unknown - interstitial nephritis. On the part of the skin and subcutaneous tissues: infrequently - exanthema / rash, itching; rarely - urticaria, angioedema; frequency unknown - malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity. From the musculoskeletal system: rarely - arthralgia, myalgia. From the side of metabolism: rarely - hyperlipidemia and increased concentration of lipids (triglycerides, cholesterols), changes in body weight; frequency unknown - hyponatremia, hypomagnesemia.From the immune system: rarely - hypersensitivity (including anaphylactic reactions and anaphylactic shock). From the side of the psyche: infrequently - sleep disturbance; rarely - depression (including exacerbation of existing disorders); very rarely - disorientation (including exacerbation of existing disorders); the frequency is unknown - hallucinations, confusion (especially in patients predisposed to this), as well as a possible exacerbation of symptoms if they exist before starting therapy. On the part of the genitals and mammary gland: rarely - gynecomastia. General disorders: infrequently - weakness, fatigue and malaise; rarely - an increase in body temperature, peripheral edema.rarely - depression (including exacerbation of existing disorders); very rarely - disorientation (including exacerbation of existing disorders); the frequency is unknown - hallucinations, confusion (especially in patients predisposed to this), as well as a possible exacerbation of symptoms if they exist before starting therapy. On the part of the genitals and mammary gland: rarely - gynecomastia. General disorders: infrequently - weakness, fatigue and malaise; rarely - an increase in body temperature, peripheral edema.rarely - depression (including exacerbation of existing disorders); very rarely - disorientation (including exacerbation of existing disorders); the frequency is unknown - hallucinations, confusion (especially in patients predisposed to this), as well as a possible exacerbation of symptoms if they exist before starting therapy. On the part of the genitals and mammary gland: rarely - gynecomastia. General disorders: infrequently - weakness, fatigue and malaise; rarely - increased body temperature, peripheral edema.rarely - gynecomastia. General disorders: infrequently - weakness, fatigue and malaise; rarely - an increase in body temperature, peripheral edema.rarely - gynecomastia. General disorders: infrequently - weakness, fatigue and malaise; rarely - increased body temperature, peripheral edema.

Application during pregnancy and lactation

ControlokЃ is contraindicated during pregnancy and lactation.

Application for violations of liver function

The drug should be used with caution in liver failure. In persons with severe hepatic impairment, the daily dose should be reduced to 20 mg of pantoprazole. In addition, in such patients, during therapy with ControlocЃ, it is necessary to control liver enzymes. In the event of an increase in their level, treatment should be interrupted.

Application for impaired renal function

Do not increase the daily dose of pantoprazole 40 mg in patients with impaired renal function, as well as in elderly patients.

Application in children

Contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

Elderly patients, dose adjustment is not required, but a dose of 40 mg / day should not be exceeded. An exception is the use of combined antibiotic therapy against Helicobacter pylori, when elderly patients should also use ControlocЃ at a dose of 20-40 mg 2 times / day.

special instructions

Before starting treatment with ControlocЃ, the possibility of a malignant neoplasm should be excluded, since the drug can mask symptoms and delay the correct diagnosis. Patients should consult a physician if they are to undergo an endoscopy or urea breath test. Patients should consult a physician in the following cases: unintentional weight loss, anemia, gastrointestinal bleeding, trouble swallowing, persistent vomiting or vomiting of blood. In these cases, taking the drug can partially alleviate the symptoms and delay the correct diagnosis; previous 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 illnesses that worsen overall health. Patients over 55 years of age who have new or recently changed symptoms should consult a physician. When taking drugs that reduce the acidity of gastric juice, the risk of infections caused by bacteria of the genus Salmonella spp., Campylobacter spp. Is slightly increased. or Clostridia difficile.

Influence on the ability to drive vehicles and use mechanisms

Patients should refrain from driving vehicles and other mechanisms that require increased attention, due to the likelihood of dizziness and visual impairment.

Overdose

Until now, overdose phenomena as a result of the use of the drug ControlokЃ have not been noted. Doses up to 240 mg were administered IV over 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.

Drug interactions

The simultaneous use of the drug ControlocЃ can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach environment (including iron salts, ketoconazole). ControlocЃ can be prescribed without the risk of drug interactions: patients with cardiovascular diseases taking cardiac glycosides (digoxin), slow calcium channel blockers (nifedipine), beta-blockers (metoprolol); patients with gastrointestinal diseases taking antacids, antibiotics (amoxicillin, clarithromycin); patients taking oral contraceptives containing levonorgestrel and ethinyl estradiol; 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 phenprocoumon (under the control of prothrombin time and INR at the beginning and at the end of treatment, as well as during irregular administration of pantoprazole); transplant patients taking cyclosporine, tacrolimus. There was no clinically significant drug interaction with caffeine, ethanol, theophylline.There was no clinically significant drug interaction with caffeine, ethanol, theophylline.There was no clinically significant drug interaction with caffeine, ethanol, theophylline.