Controlock, 20 mg 14 pcs

Peptic ulcer disease 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.

The treatment and prevention of stress ulcers, as well as their complications in the form of bleeding, perforation, penetration (for solution for IV administration).

Active ingredient

Composition

coated tablets.

1 tablet contains:

Active substances:

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

p>pantoprazole sodium sesquihydrate45.1 mg (corresponding to 40 mg of pantoprazole);

Excipients:

Sodium carbonate anhydrous;

Mannitol;

Crospovidone;

/p>

povidone K90;

calcium stearate;

purified water;

Shell:

Hypromellose 2910; povidone K25; titanium dioxide (E171); iron oxide yellow (E172); propylene glycol; Eudragit L 30D-55 (methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate); triethylcitrate.

How to take, the dosage

Inhaled with liquid and swallowed whole (tablets should not be crushed or dissolved). Gastric and duodenal ulcer, erosive gastritis (including those associated with taking NSAIDs): 40-80 mg/day. The course of treatment is 2 weeks in case of duodenal ulcer exacerbation and 4-8 weeks – in case of gastric ulcer exacerbation. Antiretroviral treatment of gastric and duodenal ulcer – 20 mg/day.

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

Antiretroviral treatment – 20 mg/day. Zollinger-Ellison syndrome: 40-80 mg/day. In patients with significant liver dysfunction the dose should be reduced to 40 mg once every 2 days. In this case it is necessary to monitor blood biochemical parameters. In case of liver enzymes level increase the drug should be discontinued.

Elderly patients and patients with impaired renal function should not exceed the daily dose of 40 mg. The exception is the use of combined antimicrobial therapy against Helicobacter pylori, when also elderly patients should use the drug Controlox® 40 mg 2 times daily. For indications that require taking the drug once daily, Controlock® should be taken in the morning. Neither the time of day nor food intake has been found to affect the activity of the drug, but the recommended timing of Controlloct® tablets promotes better patient compliance.

Interaction

The concomitant use of Controlock® may reduce absorption of drugs whose bioavailability depends on the pH of the stomach (e.g., iron salts, ketoconazole).

Controlok®, unlike other proton pump inhibitors, can be prescribed without the risk of drug interaction: patients with cardiac diseases, taking cardiac glycosides (digoxin), BCC(nifedipine), β-adrenoblockers (metoprolol); patients with GI diseases, taking antacids, antibiotics (amoxicillin, clarithromycin); patients taking oral contraceptives; patients taking 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 phenprocoumon; transplant patients taking cyclosporine, tacrolimus.

The absence of drug interaction with theophylline, caffeine and ethanol has also been noted. Possible interaction with atazanavir and ritonavir (tablets).

Special Instructions

Before starting treatment with Controlock® , you should rule out the presence of a malignancy because the drug can mask symptoms and delay a correct diagnosis.

Contraindications

Hypersensitivity; dyspepsia of neurotic genesis (tablets).

With caution: pregnancy, lactation, liver failure.

Side effects

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

Atypical: nausea/vomiting, dizziness, visual disturbances (blurred vision); allergic reactions such as itching and skin rash.

Rare: dry mouth, arthralgia, depression, hallucinations, disorientation and confusion, especially in patients who are predisposed to it, and an increase in these symptoms if patients have previously had them.

Very rare: Leukopenia, thrombocytopenia; thrombophlebitis at the injection site (powder for preparation of solution for IV administration); peripheral edema; severe hepatocellular damage leading to jaundice with or without liver failure; anaphylactic reactions, including anaphylactic shock; increased liver enzymes (transaminases, glutamyl transpeptidase); increased triglycerides; increased body temperature; myalgia, interstitial nephritis; urticaria, angioedema; severe skin reactions such as Stevens-Johnson syndrome, erythema multiforme, photosensitivity, Lyell syndrome.

Overdose

To date, no overdose has been observed with Controlock. Doses up to 240 mg have been administered by IV within 2 minutes and have been 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 provided.

Pantoprazole is not excreted by hemodialysis.

Similarities