Kontrolok powder for solution in / veins. enter 40 mg vial 1 pc. (Pantoprazole)

Latin name

CONTROLOC

Pharmacological action

Control - inhibitory proton pump.

Inhibitor of the proton pump (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 oral administration of 20 mg of the drug Controlok®, the antisecretory effect occurs after 1 hour and reaches a maximum after 2–4 hours. With iv 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, decreased 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 dose.

Compared to other proton pump inhibitors, the Controlok® drug has greater chemical stability at neutral pH, and less potential for interaction with the liver oxidase system, which depends on cytochrome P450. Therefore, the drug Controlok 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 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 iv administration).

Contraindications

Hypersensitivity to dyspepsia of neurotic origin (tablets).

Precautions: pregnancy, lactation, liver failure.

Use during pregnancy and lactation

Control should be used with caution during pregnancy and lactation.

Composition

1 vial contains:

Active ingredient: pantoprazole sodium sesquihydrate - 45.1 mg (corresponding to pantoprazole sodium (anhydride) 42.3 mg and pantoprazole (free acid) 40 mg)

Excipients: disodium edetate - 1 mg sodium hydroxide - 0.24 mg.

Dosage and administration of

I / O administration of the drug Controlok® is recommended in cases where oral administration of the drug is not possible. The recommended dose is 40 mg / day.

With prolonged treatment of Zollinger-Ellison syndrome and other pathological hypersecretory conditions, the recommended daily dose at the beginning of treatment is 80 mg of the drug Controlok IV. After this, the dose can be increased or decreased. In the case of the use of the drug in a daily dose of more than 80 mg, the dose should be divided and administered twice a day. A temporary increase in the daily dose to 160 mg of the drug Controlok® is possible.

In the treatment and prevention of stress ulcers, as well as their complications (bleeding, perforation, penetration): Controlok® is prescribed at 80 mg / day. In the case of the use of the drug in a daily dose of more than 80 mg, the dose should be divided and administered twice a day. A temporary increase in the daily dose to 160 mg of the drug Controlok® is possible.

To prepare a ready-to-use solution for injection, 10 ml of physiological saline sodium chloride solution is added to a vial containing dry matter. This solution can be applied after mixing with 100 ml of physiological solution of sodium chloride, as well as with 5% glucose solution.

The solution for iv administration should have a pH of 9. The drug should be administered within 2-15 minutes.

The prepared solution should be used within 3 hours after preparation.

Drug Interaction

Concurrent administration of Kontrolok® may reduce the absorption of drugs whose bioavailability depends on the pH of the stomach (eg, iron salts, ketoconazole).

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

patients with cardiovascular diseases receiving cardiac glycosides (digoxin), BKK (nifedipine), -adrenoblockers (metoprolol) patients antacids, antibiotics (amoxicillin, clarithromycin)

to patients taking oral contraceptives

to patients receiving NSAIDs (diclofenac, phenazone, naproxen, piroxicam)

to patients with endocrine system diseases m glibenclamide, levothyroxine

to patients with anxiety and sleep disorders receiving diazepam

to patients with epilepsy receiving carbamazepine and phenytoin

to patients receiving indirect anticoagulants such as warfarin and fencupercontin patients

There was also a lack of drug interaction with theophylline, caffeine and ethanol.

Interaction with atazanavir and ritonavir (tablets) is possible.

overdose

To date, no overdose has been reported with the use of the drug. Doses up to 240 mg were administered in / over for 2 min and were well tolerated. However, in case of overdose and only in the presence of clinical manifestations (possible increase of side effects) is carried out symptomatic and supportive treatment. Pantoprazole is not excreted by hemodialysis.

Storage conditions

At a temperature not exceeding 25 ° C.

The Expiration of

is 3 years.

Deystvuyuschee substances

Pantoprazole

Dosage form

Dosage

infusion solution

Takeda GmbH, Japan



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