Controls - instructions for use, analogs, reviews and release forms (20 mg and 40 mg tablets, injections for injections, Control) for the treatment of gastric and duodenal ulcers, GERD in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Controllers. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Control in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Controller in the presence of existing structural analogs.Use for the treatment of stomach and duodenal ulcers, GERD (gastroesophageal reflux disease) in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Controllers - Proton pump inhibitor (H-K-ATPase). It 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 Controls at a dose of 20 mg, the decrease in gastric juice secretion by 24% occurs 2.5-3.5 hours and 26% after 24.5-25.5 hours. After taking 1 time per day for 7 days, antisecretory activity rises to 56% by 2.5 -3.5 h and up to 50% after 24.5-25.5 h.

In duodenal ulcer associated with Helicobacter pylori (Helicobacter), a decrease in gastric secretion increases the sensitivity of microorganisms to antibiotics. Does not affect the motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of the application.

Compared to other inhibitors of the proton pump, the Controller has a great chemical stability at neutral pH and a lower interaction potential with the liver oxidase system dependent on cytochrome P450.Therefore, there was no clinically significant interaction between Controll preparation and many other drugs.

Composition

Pantoprazole sodium sesquihydrate + excipients.

Pharmacokinetics

Pharmacokinetics is the same as after a single, and after repeated use of the drug. Controller is quickly absorbed after ingestion. Cmax in blood plasma for oral administration is achieved after the first dose of 20 mg or 40 mg. Absolute bioavailability of Pantoprazole tablets is 77%. The simultaneous use of pantoprazole tablets with food does not affect AUC and Cmax. The binding of pantoprazole to plasma proteins is 98%. Metabolised in the liver. The main metabolite in the blood plasma and in urine is desmethylpentoprazole, conjugating with sulfate. The main way of excretion is through the kidneys (about 80%) in the form of metabolites of pantoprazole, in a small amount is excreted through the intestine. A slight increase in AUC and Cmax in the elderly is not clinically significant.

Indications

For tablets of 20 mg

• treatment of symptoms of gastroesophageal reflux disease of mild severity (such as heartburn, nausea, acidic eructation) in adults.

For tablets 40 mg

• peptic ulcer of the stomach and duodenum (in the phase of exacerbation), erosive gastritis (including those associated with taking non-steroidal anti-inflammatory drugs (NSAIDs));
• Zollinger-Ellison syndrome;
• eradication of Helicobacter pylori in combination with antibacterial agents.

Forms of release

Tablets, covered with enteric-coated shells of 20 mg and 40 mg (for markets outside of Russia is issued under the name Controllok Control).

Powder for the preparation of a solution for intravenous administration (injections in ampoules for injection).

Instructions for use and dosage

Pills

Controls are taken orally before meals, without chewing or grinding, with plenty of liquid.

Tablets 20 mg

For the treatment of symptoms of gastroesophageal reflux disease of mild severity (such as heartburn, nausea, acidic eructation) in adults prescribe Controls of 20 mg per day. To achieve positive dynamics in the removal of symptoms may require taking the drug for 2-3 days, but to completely eliminate the symptoms may require taking the drug for 7 days. If the condition worsens during the first 3 days of treatment, a specialist consultation is recommended.

The drug should be discontinued immediately after the symptoms disappear.If there is no positive dynamics during 2 weeks of continuous intake of the drug, the patient should consult a physician.

Tablets 40 mg

In the treatment of peptic ulcer of the stomach and duodenum, erosive gastritis (including those associated with the use of NSAIDs), the drug is prescribed in a dose of 40-80 mg per day.

The course of treatment is 2 weeks with exacerbation of duodenal ulcer and 4-8 weeks with peptic ulcer exacerbation. Anti-relapse treatment of peptic ulcer of the stomach and duodenum - 20 mg per day.

For the eradication of Helicobacter pylori the following combinations are recommended:

1. Controls of 20-40 mg twice a day + amoxicillin 1000 mg twice a day + clarithromycin 500 mg 2 times a day;
2. Controls 20-40 mg twice a day + metronidazole 500 mg 2 times a day + clarithromycin 500 mg 2 times a day;
3. Controls for 20-40 mg twice a day + amoxicillin 1000 mg twice a day + metronidazole 500 mg 2 times a day.

The course of treatment is 7-14 days.

With Zollinger-Ellison syndrome, Controllers are prescribed in a dose of 40-80 mg per day.

In patients with severe impairment of liver function, the dose should be reduced to 40 mg once every 2 days. In this case it is necessary to control the biochemical parameters of the blood.With an increase in the level of liver enzymes should stop using the drug.

Older patients, as well as patients with impaired renal function, do not need to adjust the dose, but do not exceed 40 mg per day. An exception is the use of combined antibacterial therapy against Helicobacter pylori, when elderly patients should use Controll 40 mg twice daily.

Do not take Controls for prevention.

Vials or ampoules

Controls should be administered intravenously only in cases where it is not possible to take the drug inside. Duration of application - no more than 7 days. If there is a possibility of oral administration, intravenous administration should be replaced by ingestion of the tablet with enteric coating.

Peptic ulcer of the stomach and duodenum (in the phase of exacerbation), erosive gastritis (including those associated with taking NSAIDs), GERD: the recommended dose is 40 mg (1 bottle) per day.

Zollinger-Ellison syndrome: with the long-term treatment of Zolinger-Ellison syndrome and other pathological hypersecretory conditions, the recommended daily dose for IV administration at the beginning of treatment is 80 mg. After this, the dose may be increased or decreased.If the drug is used in a daily dose of more than 80 mg, the dose should be divided and administered 2 times a day. It is possible to temporarily increase the daily dose to 160 mg, but not longer than necessary for adequate acidity control. If an emergency acidity control is required, the initial dose of 80 mg twice a day is sufficient to reduce the acid release in the range of less than 10 mEq / h for 1 h in most patients.

Treatment and prevention of stress ulcers, as well as their complications (bleeding, perforation, penetration): the recommended dose is 80 mg per day. If the drug is used in a daily dose of more than 80 mg, the dose should be divided and administered 2 times a day. Perhaps a temporary increase in the daily dose to 160 mg.

In patients with severe impairment of liver function, the daily dose should not exceed 20 mg of pantoprazole (half a vial).

In elderly patients and patients with impaired renal function, dose adjustment is not required, but the recommended daily dose of pantoprazole 40 mg should not be exceeded.

Rules for the preparation and injection of injection solutions

To prepare a ready-to-use solution for injection, 10 ml of 0.9% sodium chloride solution is added to a vial containing a dry substance.The ready-made solution can be administered in an amount of 10 ml, it is also permissible to dilute it in 100 ml of a 0.9% solution of sodium chloride or in a 5% solution of glucose.

Do not use any other solvents!

The drug should be administered within 2-15 minutes.

The prepared solution is stable for 12 hours after preparation. However, it is recommended to use the solution immediately after preparation in order to avoid microbial contamination.

Side effect

• headache;
• dizziness;
• visual impairment (fogging);
• diarrhea, constipation;
• nausea, vomiting;
• bloating;
• flatulence;
• dry mouth;
• stomach ache;
• agranulocytosis, thrombocytopenia, leukopenia, pancytopenia;
• increased activity of hepatic enzymes (AST, GGT), increased levels of bilirubin;
• jaundice;
• interstitial nephritis;
• exanthema, rash;
• itching;
• hives;
• angioedema;
• malignant exudative erythema (Stevens-Johnson syndrome);
• exudative erythema multiforme;
• toxic epidermal necrolysis;
• photosensitivity;
• arthralgia;
• myalgia;
• hyperlipidemia and increased concentration of lipids (triglycerides, cholesterols);
• change in body weight;
• hyponatremia, hypomagnesemia;
• hypersensitivity (including anaphylactic reactions and anaphylactic shock);
• sleep disturbance;
• Depression (including exacerbations of existing disorders);
• disorientation (including exacerbations of existing disorders);
• hallucinations;
• confusion (especially in patients who are predisposed to this), as well as a possible exacerbation of symptoms when they exist before the start of therapy;
• gynecomastia;
• weakness;
• fatigue;
• malaise;
• increased body temperature;
• peripheral edema.

Contraindications

• dyspepsia of neurotic genesis;
• joint application with atazanavir;
• pregnancy;
• lactation period;
• age to 18 years;
• hypersensitivity to the components of the drug, as well as to soy.

Application in pregnancy and lactation

Controls are contraindicated in pregnancy and lactation.

Use in children

Contraindicated in children and adolescents under the age of 18 years.

Application in elderly patients

To elderly patients, dose adjustment is not required, but it should not be exceeded by a dose of 40 mg per day. An exception is the use of combined antibacterial therapy against Helicobacter pylori, when elderly patients should use Controll in a dose of 20-40 mg twice a day.

special instructions

Before beginning treatment with the drug Controls should exclude the possibility of malignant neoplasm, as the drug can mask the symptoms and delay the correct diagnosis.

Patients should consult a physician if they are to carry out endoscopy or a urea breath test.

Patients should consult a physician in the following cases:

• Inadvertent weight loss, anemia, gastrointestinal bleeding, swallowing disorder, persistent vomiting or vomiting with blood. In these cases, taking the drug can partially alleviate the symptoms and delay the correct diagnosis;
• previously suffered surgical intervention on the gastrointestinal tract or stomach ulcer;
• continuous symptomatic treatment of dyspepsia and heartburn for 4 weeks or more;
• liver disease, incl. jaundice and liver failure;
• Other serious diseases that worsen the general state of health.

Patients over the age of 55 years, with new or newly 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 of gastrointestinal Salmonella spp., Campylobacter spp., Increases slightly. or Clostridia difficile.

Impact on the ability to drive vehicles and manage mechanisms

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

Drug Interactions

Simultaneous use of the drug Controls can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach (including iron salts, ketoconazole).

Controllers can be prescribed without the risk of drug interactions:

• patients with diseases of the cardiovascular system, taking cardiac glycosides (digoxin), slow calcium channel blockers (nifedipine), beta-blockers (metoprolol);
• patients with gastrointestinal diseases who take antacids, antibiotics (amoxicillin, clarithromycin);
• patients taking oral contraceptives containing levonorgestrel and ethinylestradiol;
• patients taking NSAIDs (diclofenac, phenazone, naproxen, piroxicam);
• patients with diseases of the endocrine system, taking glibenclamide, levothyroxine;
• patients with anxiety and sleep disorders receiving diazepam;
• patients with epilepsy taking carbamazepine and phenytoin;
• patients taking indirect anticoagulants, such as warfarin and fenprocumone (under the control of prothrombin time and INR at the beginning and at the end of treatment, as well as during the irregular intake of pantoprazole);
• patients who underwent transplantation, taking cyclosporine, tacrolimus.

There was a lack of clinically significant drug interaction with caffeine, ethanol (alcohol), theophylline.

Analogues of the drug Controls

Structural analogs for the active substance:

• Zipantola;
• Controls Control;
• Crosatide;
• Nolpaz;
• Pantaz;
• Pantoprazole Canon;
• Panum;
• Pepazol;
• Пиженума сановель;
• Puloreph;
• Sunpras;
• Ulter.

Analogues for the pharmacological group (proton pump inhibitors):

• Acrylase;
• Beret;
• Gastrozole;
• Dexylant;
• Demeprazole;
• Zhelezolic;
• A zerocide;
• Zipantola;
• Zolispan;
• Zolser;
• Zulbeks;
• Chrismel;
• Lanzabel;
• Lanzap;
• Lansoprazole;
• Lansofed;
• Lancid;
• Losek;
• Loenzar sanovel;
• Nexium;
• Nophdyuks;
• Omal;
• Omez;
• Omez Insta;
• Omesol;
• Omeprazole;
• Omepros;
• Omeface;
• Omizak;
• OmiPix;
• Omitox;
• Ontime;
• Ortanol;
• Ozid;
• Parries;
• Pepticum;
• Pleom 20;
• Pomez;
• Puloreph;
• Rabelock;
• Rabeprazole;
• Razo;
• Romesque;
• Ulzol;
• Ulcozol;
• Ultop;
• Hirabesol;
• Helicid;
• Helol;
• Cisagast;
• Esomeprazole;
• Emanera;
• Epicurus.

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