Controlock, 40 mg 28 pcs

Controlok is a proton pump inhibitor.

Proton pump inhibitor (H⁺-K⁺-ATPase). Blocks the final stage of hydrochloric acid secretion by reducing basal and stimulated secretion, regardless of the nature of the stimulus.

Antisecretory activity. After oral administration of 20 mg of Controlock^® antisecretory effect occurs in 1 hour and reaches a maximum in 2-4 hours. With intravenous administration of 80 mg the antisecretory effect reaches its maximum within 1 hour and lasts for 24 hours.

In duodenal ulcer associated with Helicobacter pylori, reduction of gastric secretion increases the sensitivity of microorganisms to antibiotics. It does not affect gastrointestinal motility. The secretory activity is normalized in 3-4 days after the end of administration.

Compared with other proton pump inhibitors, Controlock^® has greater chemical stability at neutral pH, and less potential for interaction with the cytochrome P450-dependent liver oxidase system. Therefore, Controlock does not interact with many other common drugs.

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, penetration (for solution for intravenous administration).

Pharmacological effect

Controloc is a proton pump inhibitor.

Proton pump inhibitor (H+-K+-ATPase). Blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus.

Antisecretory activity. After oral administration of 20 mg of the drug Controloc®, the antisecretory effect occurs within 1 hour and reaches a maximum after 2–4 hours. With intravenous administration of 80 mg, the antisecretory effect reaches a maximum within 1 hour and lasts 24 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 returns to normal 3–4 days after the end of administration.

Compared to other proton pump inhibitors, Controloc® has greater chemical stability at neutral pH, and a lower potential for interaction with the liver oxidase system, which is dependent on cytochrome P450. Therefore, Controloc does not interact with many other common drugs.

Special instructions

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

Active ingredient

Pantoprazole

Composition

1 tablet contains:

Active ingredients:

pantoprazole sodium sesquihydrate 45.1 mg (corresponding to 40 mg pantoprazole);

Excipients:

sodium carbonate anhydrous;

mannitol;

crospovidone;

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);

triethyl citrate.

Contraindications

Hypersensitivity; dyspepsia of neurotic origin (tablets).

With caution: pregnancy, lactation, liver failure.

Side Effects

Typical: pain in the upper abdomen, diarrhea, constipation, flatulence; headache.

Atypical: nausea/vomiting, dizziness, blurred vision (blurred vision); allergic reactions such as itching 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 they have previously been observed in patients.

Very rare: leukopenia, thrombocytopenia; thrombophlebitis at the injection site (powder for preparing a solution for intravenous 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’s syndrome.

Interaction

The simultaneous use of Controloc® may reduce the absorption of drugs whose bioavailability depends on the pH of the stomach (for example, iron salts, ketoconazole).

Controloc®, unlike other proton pump inhibitors, can be prescribed without the risk of drug interactions:

patients with cardiovascular diseases taking cardiac glycosides (digoxin), CCBs (nifedipine), β-blockers (metoprolol);
patients with gastrointestinal diseases taking antacids, antibiotics (amoxicillin, clarithromycin);
patients taking oral contraceptives;
patients taking NSAIDs (diclofenac, phenazone, naproxen, piroxicam);
patients with diseases of the endocrine system 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.

There was also no drug interaction with theophylline, caffeine and ethanol.

Possible interaction with atazanavir and ritonavir (tablets).

Overdose

To date, no overdose phenomena have been observed as a result of using the drug Controloc.

Doses up to 240 mg were administered intravenously over 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.

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

3 years.

Manufacturer

Takeda GmbH, Germany