Nolpaza tablets 40mg, No. 14

For enteric-coated tablets.

gastroesophageal reflux disease (GERD), incl. erosive-ulcerative reflux esophagitis and symptoms associated with GERD: heartburn, sour regurgitation, pain when swallowing;

erosive and ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs;

peptic ulcer and duodenal ulcer, treatment and prevention;

eradication of Helicobacter pylori in combination with two antibiotics;

Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

For a lyophilisate for the preparation of a solution for intravenous administration.

peptic ulcer of the stomach and duodenum (in the acute stage), erosive gastritis (including those associated with the use of NSAIDs);

gastroesophageal reflux disease (GERD): erosive reflux esophagitis (treatment), symptomatic treatment of GERD (i.e. 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 (bleeding, perforation, penetration).

For enteric-coated tablets

Inside, the tablet should not be chewed or broken. Swallow the tablet whole with a small amount of liquid before meals, usually before breakfast. If taken twice, the second dose of the drug is recommended to be taken before dinner.

GERD, incl. erosive-ulcerative reflux esophagitis and associated symptoms: heartburn, sour regurgitation, pain when swallowing:

- mild: the recommended dose is 1 table. NolpazaЃ drug, 20 mg / day;

- moderate and severe: the recommended dose is 1-2 tablets. the drug NolpazaЃ 40 mg / day (40-80 mg / day). Symptom relief usually occurs within 2Ц4 weeks. The course of therapy is 4Ц8 weeks. For prophylaxis, as well as as maintenance long-term therapy, take 20 mg / day (1 tab. Of the drug NolpazaЃ, 20 mg), if necessary, the dose is increased to 40-80 mg / day. It is possible to take the drug on demand if symptoms occur.

Erosive and ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs: the recommended dosage is 1-2 tablets. the drug NolpazaЃ 40 mg (40-80 mg / day). The course of therapy is 4Ц8 weeks. For the prevention of erosive lesions against the background of prolonged use of NSAIDs - 20 mg each.

Peptic ulcer and duodenal ulcer (treatment and prevention) - appoint 40-80 mg / day. The course of treatment for exacerbation of duodenal ulcer is usually 2 weeks, gastric ulcer - 4-8 weeks. If necessary, the duration of therapy is increased.

Eradication of Helicobacter pylori (in combination with antibiotics): the recommended dose is 1 table. drug NolpazaЃ (40 mg) 2 times a day in combination with two antibiotics, usually the course of anti-Helicobacter pylori therapy is 7-14 days.

Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion: the recommended starting dose of long-term therapy with pantoprazole is 80 mg (2 tablets of NolpazaЃ, 40 mg each) per day, divided into 2 doses. In the future, the daily dose can be titrated depending on the initial level of gastric secretion. It is possible to temporarily increase the daily dose of pantoprazole to 160 mg in order to adequately control gastric secretion. The duration of therapy is selected individually.

Severe liver dysfunction: the dose of pantoprazole should not exceed 40 mg / day and it is recommended to regularly monitor the activity of liver enzymes, especially with long-term treatment with pantoprazole. With an increase in the activity of liver enzymes, it is recommended to cancel the drug.

Elderly persons and patients with kidney disease: the maximum daily dose of pantoprazole is 40 mg.

In elderly persons receiving Helicobacter pylori eradication therapy, the duration of therapy usually does not exceed 7 days.

For lyophilisate for preparation of solution for intravenous administration

IV, for 2-15 minutes.

The intravenous administration of the drug should be carried out by medical personnel. The intravenous use of the drug NolpazaЃ is recommended only if it is impossible to take it orally and for a period of no more than 7 days. If the patient has the possibility of oral administration, intravenous administration should be replaced by taking the drug NolpazaЃ, enteric-coated tablets.

Peptic ulcer and duodenal ulcer (in the acute stage), erosive gastritis (including those associated with taking NSAIDs) and GERD. The recommended daily dose is 40 mg (1 vial).

Zollinger-Ellison Syndrome. With long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory conditions, the recommended daily dose at the beginning of treatment is 80 mg of NolpazaЃ IV. In the future, the dose can be increased or decreased. In the case of using the drug NolpazaЃ in a daily dose of more than 80 mg, the dose should be divided and administered 2 times a day.

A temporary increase in the daily dose to 160 mg is possible, but no longer than necessary for adequate control of acidity.

If emergency control of acidity is required, an initial dose of 80 mg 2 times is sufficient to reduce acid release in the range of less than 10 mEq / h for 1 hour in most patients.

Treatment and prevention of stress ulcers and their complications (bleeding, perforation, penetration). The recommended daily dose is 80 mg. In the case of using the drug NolpazaЃ in a daily dose of over 80 mg, the dose should be divided and administered 2 times a day. A temporary increase in the daily dose to 160 mg is possible.

Renal dysfunction, elderly patients. No dose adjustment is required, but the daily dose of pantoprazole should not exceed 40 mg.

Liver dysfunction. In patients with severely impaired liver function, the daily dose of pantoprazole should not exceed 20 mg (1/2 vial).

Preparation of a solution for intravenous administration. To prepare a ready-to-use solution for intravenous administration, 10 ml of 0.9% sodium chloride solution is injected into a vial containing a lyophilisate. The finished solution can be introduced in a volume of 10 ml or diluted in 100 ml of 0.9% sodium chloride solution or 5% glucose solution. Do not use other solvents.

The prepared solution is stable for 12 hours after preparation. However, it is recommended to use the solution immediately after preparation to avoid microbial contamination.

Enteric-coated tablets

1 tab.

core

active substance: pantoprazole sodium sesquihydrate 22.55 mg 45.1 mg (corresponds to pantoprazole - 20 and 40 mg)

excipients: mannitol - 5.95 / 11.9 mg, crospovidone - 32.5 / 65 mg; sodium carbonate, anhydrous - 5/10 mg; sorbitol - 18/36 mg; calcium stearate - 1/2 mg

enteric shell: hypromellose - 8.13 / 6.26 mg; povidone - 0.2 / 0.4 mg; titanium dioxide (E171) - 0.15 / 0.3 mg; iron dye yellow oxide (E172) - 0.02 / 0.04 mg; propylene glycol - 2/4 mg; methacrylic acid and ethyl acrylate copolymer (1: 1); 30% dispersion (dispersion Eudragit L30D, in addition to methacrylic acid and ethyl acrylate copolymer and water, contains sodium lauryl sulfate (0.7%, calculated on dry matter in dispersion) and polysorbate 80 (2.3%, calculated on dry matter in dispersion) - 10/16 mg; talc - 3.7 / 6 mg; macrogol 6000 - 1 / 1.6 mg

Lyophilisate for preparation of solution for intravenous administration

1 fl.

active substance: pantoprazole sodium sesquihydrate 45.1 mg (in terms of pantoprazole - 40 mg)

excipients: mannitol 140 - mg, sodium citrate dihydrate - 5 mg, sodium hydroxide 1 N solution - qs to pH 11.3-11.7 (corresponds to ї0.02 ml)

For enteric-coated tablets.

hypersensitivity to pantoprazole or other components of the drug;

the drug contains sorbitol, therefore it is not recommended for persons with rare hereditary fructose intolerance;

dyspepsia of neurotic genesis;

children under 18 years of age (efficacy and safety have not been studied).

With care: pregnancy, lactation, liver failure, risk factors for cyanocobalamin (vitamin B12) deficiency, especially against the background of hypo- and achlorhydria.

For a lyophilisate for the preparation of a solution for intravenous administration.

hypersensitivity to any component of the drug;

simultaneous use with atazanavir;

pregnancy;

breastfeeding period;

children under 18 years of age.

With caution: liver failure, use in elderly patients, concomitant use with ritonavir.

pharmachologic effect

Inhibitor of H + -K + -ATPase. Blocks the final stage of hydrochloric acid secretion, reduces the level of basal and stimulated (regardless of the type of irritant) secretion of hydrochloric acid in the stomach. In case of duodenal ulcer disease associated with Helicobacter pylori, such a decrease in gastric secretion increases the sensitivity of the microorganism to antibiotics. Pantoprazole has its own antimicrobial activity against Helicobacter pylori.

Side effect

From the digestive system: diarrhea; rarely - nausea, pain in the upper abdomen, flatulence. From the side of the central nervous system: headache; rarely - weakness, dizziness; in isolated cases - the initial manifestations of depressive conditions, visual impairment. Dermatological reactions: rarely - rash, itching. Others: weakness, dizziness; in isolated cases - edema, increased body temperature.

Application during pregnancy and lactation

If it is necessary to use pantoprazole during pregnancy, it is necessary to assess the intended benefit to the mother and the potential risk to the fetus. If necessary, use during lactation should decide on the termination of breastfeeding. In experimental studies, it was found that pantoprazole is excreted in breast milk.

Application for violations of liver function

When used in patients with impaired liver function, the activity of hepatic enzymes in blood plasma should be regularly monitored and pantoprazole should be canceled when it rises.

special instructions

Before starting therapy, the possibility of a malignant neoplasm in the stomach and esophagus should be excluded, since the use of pantoprazole reduces the severity of symptoms and may delay the establishment of the correct diagnosis. The diagnosis of reflux esophagitis requires mandatory endoscopic confirmation. When used in patients with impaired liver function, the activity of hepatic enzymes in blood plasma should be regularly monitored and pantoprazole should be canceled when it rises. Drug interactions

With the simultaneous use of pantoprazole can change the absorption of drugs, the absorption of which depends on the pH of the gastric contents (ketoconazole). Due to the fact that pantoprazole is metabolized in the liver by the cytochrome P450 enzyme system, the possibility of drug interaction with drugs metabolized by the same enzyme system cannot be excluded.