Controloc pills 40mg №14

Dosage form

Coated tablets

Composition

Enteric-coated tablets, oval, biconvex tablets, film-coated yellow, with a core from white to almost white; on one side of the pill in brown ink printed "P20", contain: Pantoprazole sodium sesquihydrate 2257 mg, corresponds to pantoprazole 40 mg.

Excipients: Sodium carbonate anhydrous, mannitol, Crospovidone, Povidone K90, Calcium stearate, Purified water.

Shell composition: Hypromelose-2910, Povidone C25, Titanium Dioxide (E 171), Yellow Iron Oxide (E172), Propylene Glycol, Eudragit L30D-55 (methacrylic acid and ethyl acrylate copolymer, Polysorbate 80, sodium lauryl sulfate), Triethyl citrate.

The composition of brown ink: Opacode S-1-26514 for labeling tablets: Shellac, Iron Oxide (E172) red CL77491, Iron Oxide (E172) black CL77499, Iron Oxide (E172) yellow CL77492, Soy Lecithin, Titanium Dioxide (E171) CL77891, Dimethicone 1510 (emulsion polydimethylsiloxane).

Packaging

In the package of 14 tablets.

Mechanism of action

Controloc - 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.

After ingestion of 20 mg of the drug, Controloc, the antisecretory effect occurs after 1 hour and reaches a maximum after 2-4 hours. With an 80 mg injection, the antisecretory effect of pantoprazole reaches a maximum for 1 hour and lasts 24 hours

In duodenal ulcer 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 to 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, Controloc does not interact with many other common drugs.

Indications and usage

- Peptic ulcer of the stomach and duodenum (in acute phase), erosive gastritis (including those associated with the intake of NSAIDs).
- Gastroesophageal reflux disease (GERD): treatment of erosive reflux esophagitis, symptomatic treatment of non-erosive reflux disease (NERD).
- Zollinger-Ellison syndrome.
- Eradication of Helicobacter pylori in combination with antibacterial agents.
- Treatment and prevention of stress ulcers, as well as their complications in the form of bleeding, perforation, penetration (for solution for intravenous administration).

Contraindications

- dyspepsia neurotic Genesis (for tablets, enteric-coated).
- Hypersensitivity to the drug.

With caution should use the drug for liver failure, pregnancy, during lactation.

There is no data on the clinical use of the drug Controloc in pediatric practice.

Pregnancy and Breastfeeding

Controloc should be used with caution during pregnancy and lactation.

Dosage and administration

Tablets Controloc should be taken inside: swallowing whole and squeezed fluid (you can not crush or dissolve). According to the indications that require taking the drug 1 time / day., The Control should be taken in the morning. Time of day and food intake do not affect the activity of the drug, but the recommended time for taking the drug contributes to better patient compliance with the treatment regimen.

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

Controlok 20 mg 2 times / day. + Amoxicillin 1000 mg 2 times / day. + Clarithromycin 500 mg 2 times / day.
Controlok 20 mg 2 times / day. + Metronidazole 500 mg 2 times / day. + clarithromycin 500 mg 2 times / day.
Controlok 20 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 the treatment of reflux esophagitis, Controloc is used in a dose of 20-40 mg / day. The course of treatment is 4-8 weeks. Anti-relapse treatment - 20 mg / day.

In the treatment of Zollinger-Ellison syndrome, Controloc is used 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 increasing levels of liver enzymes should discontinue use of the drug.

Elderly patients, as well as patients with impaired renal function should not exceed a dose of 40 mg / day. An exception is the use of combination antimicrobial therapy against Helicobacter pylori, when elderly patients should also use Controloc at a dose of 40 mg 2 times / day.

Introduce Controloc in / in should only be in cases where it is impossible to take the drug inside. The recommended dose is 40 mg / day.

With long-term treatment of Zolinger-Ellison syndrome and other pathological hypersecretory conditions, the recommended daily dose at the beginning of treatment is 80 mg IV. Later, the dose may be increased or decreased. When using the drug in a daily dose of more than 80 mg, the dose should be divided into 2 doses. Perhaps a temporary increase in the daily dose of up to 160 mg.

In the treatment and prevention of stress ulcers, as well as their complications (bleeding, perforation, penetration), Controllers are prescribed 80 mg / When using the drug in a daily dose of more than 80 mg, the dose should be divided into 2 doses.Perhaps a temporary increase in the daily dose of up to 160 mg Controloc.

Preparation of solution for injection: in a vial containing dry matter, add 10 ml of physiological sodium chloride solution. Mix the resulting pantoprazole solution with 100 ml of physiological sodium chloride solution or 5% glucose solution. The solution ready for administration must have a pH = 9. The introduction of the drug in / in should be done slowly - for 2-15 minutes. The prepared solution should be used within 3 hours from the moment of preparation.

Adverse reactions

When using Controloc in accordance with the indications and in the recommended doses, side effects are extremely rare.

Typical: abdominal pain, diarrhea, constipation, flatulence, headache.

Not typical: nausea, vomiting, dizziness, blurred vision (blurred vision), allergic reactions (including itching, skin rash).

Rare: dry mouth, arthralgia, depression, hallucinations, disorientation, and confusion (especially in predisposed patients), as well as an increase in these symptoms if they were previously observed in patients.

Very rare: leukopenia, thrombocytopenia, thrombophlebitis at the injection site (for solution for iv administration), peripheral edema, hepatocellular insufficiency leading to jaundice with / without hepatic insufficiency, Anaphylactic reactions (including anaphylactic shock), elevation of liver enzymes (transaminase),glutamyltranspeptidase), increased triglycerides, fever, myalgia, interstitial nephritis, urticaria, angioedema, Stevens-Johnson syndrome, erythema polymorphic, photosensitivity, Lyell's syndrome.

Special notes

I / V is recommended only if oral administration is not possible.

The use of pantoprazole is not indicated for the treatment of pulmonary gastrointestinal complaints, such as dyspepsia of neurogenic origin (for solution for iv administration).

Before and after treatment, in the presence of any of the alarming symptoms (including significant unintended weight loss, recurrent vomiting, dysphagia, anemia, melena) and in case of suspicion or the presence of a stomach ulcer, endoscopic control is recommended to rule out a malignant neoplasm, as treatment can mask the symptoms and delay the correct diagnosis.

If symptoms persist despite adequate treatment, further examination should be carried out.

You should not increase the daily dose of pantoprazole 40 mg in patients with impaired renal function, as well as in elderly patients (for solution for intravenous administration).

The simultaneous use of Controloc can reduce the absorption of drugs whose bioavailability depends on the pH of the stomach (including iron salts, Ketoconazole, atazanavir, ritonavir).

Controloc can be assigned without risk of drug interactions to patients with diseases of the cardiovascular system, receiving cardiac glycosides (digoxin), blockers of "slow" calcium channels (nifedipine),beta-blockers (metoprolol); patients with gastrointestinal diseases taking antacids, antibiotics (amoxicillin, clarithromycin); patients taking oral contraceptives; patients taking NSAIDs (diclofenac, phenazone, Naproxen, piroxicam); patients with endocrine diseases taking glibenclamide, levothyroxine; patients with anxiety and sleep disorders taking diazepam; epilepsy patients taking Carbamazepine and phenytoin; patients taking indirect anticoagulants, such as Warfarin and fenprokumon, patients undergoing transplantation, taking cyclosporine, tacrolimus.

The absence of drug interactions with theophylline, caffeine and ethanol was also noted.

To date, the effects of overdose as a result of the use of the drug Controloc have been noted. Doses up to 240 mg were administered iv for 2 min and were well tolerated. However, in the case of an overdose and only in the presence of clinical manifestations (possible increased side effects) symptomatic and supportive treatment is carried out. Pantoprazole is not excreted by hemodialysis.

Powder for preparing a solution for intravenous injection should be stored in a dark place at a temperature not exceeding 25 ° C.

2 years.