Controlock, pills 20mg, 14pcs

Composition

Coated tablets.

1 tablet contains:

Active ingredients:

pantoprazole sodium sesquihydrate 22.57 mg (corresponds to 20 mg of pantoprazole);

pantoprazole sodium sesquihydrate 45.1 mg (corresponds to 40 mg of pantoprazole);

Auxiliary substances:

sodium carbonate anhydrous;

mannitol;

crospovidone;

povidone K 90;

calcium stearate;

purified water;

Shell:

hypromellose 2910; povidone K 25; titanium dioxide (E 171); iron oxide yellow (E 172); propylene glycol; eudragite L 30D-55 (methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate); triethyl citrate.

Description

Kontrolok is a proton pump inhibitor.

Indications

Peptic ulcer of the stomach and duodenum (in the acute phase), erosive gastritis (including those associated with taking 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, and penetration (for intravenous solution).

Contraindications

Hypersensitivity; dyspepsia of neurotic origin (tablets).

With caution: pregnancy, lactation, liver failure.

Side effects

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

Atypical: nausea/vomiting, dizziness, blurred vision; allergic reactions such as pruritus and skin rash.

Rare: dry mouth, arthralgia, depression, hallucinations, disorientation and confusion, especially in patients predisposed to this, as well as an increase in these symptoms if patients have previously experienced them.

Very rare: leukopenia, thrombocytopenia; thrombophlebitis at the injection site (powder for preparing a solution for intravenous use); peripheral edema; severe hepatocellular damage leading to jaundice with or without liver failure; anaphylactic reactions, including anaphylactic shock; increased liver enzymes (transaminases, glutamyltranspeptidase); increased triglycerides; increased body temperature; myalgia, interstitial nephritis; urticaria, angioedema; severe skin reactions such as Stevens-Johnson syndrome, erythema multiforme, photosensitivity, Lyell’s syndrome.

Interaction

Concomitant use of Kontrolok may reduce the absorption of drugs whose bioavailability depends on the pH of the gastric environment (for example, iron salts, ketoconazole).

Kontrolok®, unlike other proton pump inhibitors, can be prescribed without the risk of drug interaction: patients with cardiovascular diseases taking cardiac glycosides (digoxin), BCC(nifedipine), beta-blockers (metoprolol); patients with gastrointestinal diseases taking antacids, antibiotics (amoxicillin, clarithromycin); patients taking oral contraceptives; patients taking oral contraceptives. NSAIDs (diclofenac, phenazone, naproxen, piroxicam); patients with endocrine disorders 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 fenprocumone; transplant patients taking cyclosporine, tacrolimus.

There was also no drug interaction with theophylline, caffeine, and ethanol. Interaction with atazanavir and ritonavir (tablets) is possible.

How to take, course of use and dosage

Inside, wash down with liquid and swallow whole (tablets can not be crushed or dissolved). Peptic ulcer of the stomach and duodenum, erosive gastritis (including those associated with NSAIDs): 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 and duodenal ulcers-20 mg/day.

Eradication of Helicobacter pylori. The following combinations are recommended: Kontrolok® 20 mg 2 times a day + amoxicillin 1000 mg 2 times a day + clarithromycin 500 mg 2 times a day; Kontrolok® 20 mg 2 times a day + metronidazole 500 mg 2 times a day + clarithromycin 500 mg 2 times a day; Kontrolok® 20 mg 2 times a day + amoxicillin 1000 mg 2 times a day + metronidazole 500 mg 2 times a day. The course of treatment is 7-14 days. Reflux esophagitis: 20-40 mg/day. The course of treatment is 4-8 weeks.

Anti-relapse treatment — 20 mg/day. Zollinger-Ellison syndrome: 40-80 mg/day. In patients with severe hepatic impairment, the dose should be reduced to 40 mg once every 2 days. In this case, it is necessary to monitor the biochemical parameters of the blood. If the level of liver enzymes increases, the drug should be discontinued.

Elderly patients, as well as patients with impaired renal function, should not exceed the daily dose of 40 mg. An exception is the use of combined antimicrobial therapy against Helicobacter pylori, when elderly patients should also use the drug Controlok® 40 mg 2 times a day. For indications that require taking the drug 1 time a day, the drug Controlok® should be taken in the morning. It was found that neither the time of day nor food intake affects the activity of the drug, but the recommended time of taking Controlok® tablets contributes to better compliance of patients with the treatment regimen.

Overdose

To date, no overdose events have been observed as a result of the use of Controlok. Doses up to 240 mg were administered intravenously for 2 minutes and were well tolerated.

However, in case of overdose and only in the presence of clinical manifestations (possible increase in side effects), symptomatic and supportive treatment is carried out.

Pantoprazole is not eliminated by hemodialysis.

Special instructions

Before starting treatment with Kontrolok®, the presence of a malignant neoplasm should be excluded, since the drug can mask symptoms and delay the correct diagnosis.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Pantoprazole

Dosage form

Tablets