Description
Release form
Tablets
Packing
28 pcs.
Pharmacological action
Control – proton pump inhibitor.
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.
Special instructions
Before starting treatment with the drug Controlok ®, the presence of malignant neoplasms should be excluded, since the drug can mask the symptoms and delay the correct diagnosis.
Composition
1 tablet contains:
Active ingredients:
pantoprazole sodium sesquihydrate 45.1 mg (corresponding to 40 mg pantoprazole)
Excipients:
sodium carbonate anhydrous mannitol crospovidone povidol K90 calcium
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.
Dosage and administration
Inside, washed down with liquid and swallowed whole (tablets cannot 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 peptic ulcer of the stomach and duodenum – 20 mg / day.
Eradication of Helicobacter pylori. The following combinations are recommended:
Control ® 20 mg 2 times a day + amoxicillin 1000 mg 2 times a day + clarithromycin 500 mg 2 times a day
Control ® 20 mg 2 times a day + metronidazole 500 mg 2 times a day day + clarithromycin 500 mg 2 times a day
Control ® 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 control the biochemical parameters of the blood. With an increase in the level of liver enzymes, the use of the drug should be discontinued.
Older patients, as well as patients with impaired renal function, should not exceed a daily dose of 40 mg. An exception is the use of combination antimicrobial therapy against Helicobacter pylori, when elderly patients should use the drug Controlok 40 mg 2 times a day.
According to indications requiring taking the drug once a day, the drug Controlok ® should be taken in the morning. It s found that neither the time of day, food intake does not affect the activity of the drug, but the recommended time for taking Controlok ® tablets helps patients to better adhere to the treatment regimen.
Side effects
Typical: pain in the upper abdomen, diarrhea, constipation, flatulence headache.
Atypical: nausea / vomiting, dizziness, blurred vision (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 observed them.
Very rare: leukopenia, thrombocytopenia thrombophlebitis at the injection site (powder for solution for iv) peripheral edema severe hepatocellular damage, anaphylactic reactions leading to jaundice with or without liver failure, including anaphylactic shock, increased liver enzymes (transaminases, glutamyl transpeptidases), increased triglycerides, increased body temperature, myalgia, interstitial nephritis, urticaria, angioedema severe skin reactions such as Stevens Johnson’s sensitivity, light sensitivity, Johnson’s sensitivity Lyell’s syndrome.
Drug Interactions
Concomitant use of the drug Controlok ® may decrease the absorption of drugs whose bioavailability depends on the pH of the stomach (for example, iron salts, ketoconazole).
Controlok ®, unlike other proton pump inhibitors, it can be prescribed without the risk of drug interaction:
for patients with CVD diseases taking cardiac glycosides (digoxin), BKK (nifedipine), β-adrenergic blockers (metoprolol)
for patients with gastrointestinal tract diseases, taking antacids, antibiotics (amoxicillin, clarithromycin)
to patients taking oral contraceptives
to patients taking NSAIDs (diclofenac, phenazone, naproxen, piroxicam)
to patients with endocrine diseases 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
patients transplanted, taking cyclosporine, tacrolimus.
There was also a lack of drug interaction with theophylline, caffeine and ethanol.
Possible interaction with atazanavir and ritonavir (tablets).
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.
Shelf life
3 years.
Active ingredient
Pantoprazole
Terms and conditions
prescription
dosage form
tablets
Possible Product Names
Controls tablets coated solution solution 40 mg 28 pcs.
Takeda GmbH, Japan
