Instruction for use: Nolpaza

Active substance Pantoprazole

ATX code A02BC02 Pantoprazole

Pharmacological group

Proton pump inhibitors

Nosological classification (ICD-10)

K21 Gastroesophageal reflux

Biliary reflux esophagitis, gastrocardiac syndrome, Gastroesophageal reflux disease, Gastro-oesophageal reflux disease, Non-erosive reflux disease, syndrome gastrocardiac, Remhelda syndrome, Erosive reflux esophagitis, Ulcerative reflux esophagitis

K21.0 Gastro-oesophageal reflux with oesophagitis

Reflux gastritis, Reflux esophagitis, Erosive and ulcerative esophagitis

K25 Gastric ulcer

Helicobacter pylori, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, Inflammation of the gastric mucosa, Inflammation of the gastrointestinal mucosa, Benign gastric ulcer, The disease of the stomach and duodenum, asotsiirovannoe with Helicobacter pylori, Aggravation gastroduodenita on the background of peptic ulcer, Exacerbation of peptic ulcer, The aggravation of gastric ulcer, The organic gastrointestinal disease, Peptic ulcer of the stomach and duodenum, Postoperative gastric ulcer, Recurrent ulcers, Symptomatic gastric ulcers, Chronic inflammatory disease of the upper gastrointestinal tract, associated with Helicobacter pylori, Helicobacter pylori eradication, Erosive and ulcerative lesions of the stomach, Erosive lesions of the stomach, The erosion of the gastric mucosa, Peptic ulcer disease, Stomach ulcer, Gastric lesion, Ulcerative lesions of the stomach, Symptomatic ulcers of the stomach and duodenum

K26 Duodenal Ulcer

Pain with duodenal ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, The disease of the stomach and duodenum, asotsiirovannoe with Helicobacter pylori, Exacerbation of peptic ulcer, The worsening of duodenal ulcer, Peptic ulcer of the stomach and duodenum, Relapse of duodenal ulcers, Symptomatic ulcers of the stomach and duodenum, Helicobacter pylori eradication, Erosive and ulcerative lesions of the duodenum, Erosive-ulcerative lesions of duodenal ulcers associated with Helicobacter pylori, Erosive lesions of the duodenum, Duodenal ulcer, Ulcerative lesions of the duodenum]

K27 Peptic ulcer, unspecified

Perforation of peptic ulcer, Drug-induced gastrointestinal ulcers, medication ulcers, Peptic ulcer of the digestive tract, Peptic ulcer with Helicobacter pylori, peptic ulcer, Damage of gastrointestinal mucosa caused by NSAID, Symptomatic ulcers digestive tract, stress ulcer, Stress gastric ulcer, Stress damage to the mucous membrane, stress ulcer, duodenal ulcer Stress, Stress ulcer, Stressful GI ulcers, Erosive-ulcerative lesions of the gastrointestinal tract, The erosion of the gastrointestinal tract, Erosion of the mucosa of the upper gastrointestinal tract, The erosion of the gastrointestinal mucosa, gastrointestinal ulcer, ulcer drug, peptic ulcer, postoperative ulcer, stress ulcer, Ulcerative lesions of the gastrointestinal tract, Acute stress ulcer gastrointestinal tract, Symptomatic gastrointestinal ulcers, Complications of peptic ulcers

K29.7 Unspecified gastritis

Gastritis with low acidityá Gastritisá Gastritis with a normal secretory functionáGastritisá Erosive gastritis

K31 Other diseases of the stomach and duodenum

Stress damage to the mucosa, Discomfort in the stomach

K31.8.2 * Hyperacidity of gastric juice

Pathological hypersecretion, Hyperacid indigestion, Hyperadic states, Increased secretion of gastric juice, Increased acid formation, Hyperacidosis,Hyper secretion of gastric juice, Increased acidity of gastric juice, High acidity

K86.8.3 * Zollinger-Ellison Syndrome

Adenoma of the pancreas ulzerogennosti, gastrinoma, Zollinger-Ellison Syndrome, gastrinoma

R12 Heartburn

R63.8 Other symptoms and signs involving food and fluid intake

Pain when swallowing, Appetite disturbance, Swallowing disorder, Hunger, Swallowing disorders

Y45 adverse reactions in therapeutic use of analgesic, antipyretic and anti-inflammatory agents

Composition

Tablets, enteric coated 1 tab.

core

active substance:

pantoprazole sodium sesquihydrate 22.55 mg/ 45.1 mg

(corresponds to pantoprazole - 20 and 40 mg)

excipients: mannitol; crospovidone; sodium carbonate, anhydrous; sorbitol; calcium stearate

enteric coating: hypromellose; Povidone; titanium dioxide (E171); iron dye yellow oxide (E172); propylene glycol; methacrylic acid and ethyl acrylate copolymer (1: 1); 30% dispersion *; talc; macrogol 6000

* Polymer dispersion contains: 0.7% sodium lauryl sulfate and 2.3% polysorbate 80 as emulsifiers

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 - q.s. up to pH 11.3–11.7 **

** Corresponds to about 0.02 ml

Description of the dosage form

Enteric-coated tablets: oval, slightly biconvex, film-coated, light yellowish-brown in color.

Kind on a break: rough mass from white to light yellowish-brown color with a film cover of light yellowish-brown color.

Lyophilisate for preparation of solution for intravenous administration: from white to white with a slightly yellowish shade of color. Sintering is allowed.

pharmachologic effect

Pharmacological action - inhibiting proton pump.

Pharmacodynamics

For enteric-coated tablets

Inhibits the enzyme H + -K + -ATPase (proton pump) in the parietal cells of the stomach, thereby blocking the final stage of the synthesis of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion of hydrochloric acid, regardless of the nature of the stimulus. After a single dose of the drug is taken orally at a dose of 20 mg, pantoprazole acts within the first hour, the maximum effect is reached in 2–2.5 hours. It does not affect the motility of the gastrointestinal tract. After cessation of the drug, secretory activity is fully restored in 3-4 days.

During treatment with antisecretory drugs, the serum concentration of gastrin increases in response to a decrease in the secretion of hydrochloric acid. The level of chromogranin A (CgA) also increases due to a decrease in gastric acidity. Elevated CgA levels may interfere with the diagnosis of neuroendocrine tumors.

Published data suggest that the use of proton pump inhibitors (PPIs) should be discontinued in the range from 5 days to 2 weeks before determining the level of CgA. This allows you to use data on the level of CgA, which can be falsely increased during the treatment of PPI, and returns to the range of normal values after its cancellation.

For lyophilisate for preparing solution for intravenous administration

The proton pump inhibitor (H + / K + -ATPase) blocks the final phase of the secretion of hydrochloric acid, reducing the basal and stimulated secretion of acid, regardless of the nature of the stimulus.

Compared with other IPPs, pantoprazole has a higher chemical stability at neutral pH and a lower potential for interaction with the liver oxidase system, depending on cytochrome P450. Therefore, no clinically significant interaction between pantoprazole and other drugs was observed.

Pharmacokinetics

For enteric-coated tablets

Pantoprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma (1–1.5 µg / ml) is reached 2–2.5 hours after ingestion, while the value of Cmax remains constant during repeated administration. Bioavailability of the drug is 77%. Simultaneous food intake does not affect the AUC, Cmax and bioavailability; there is only a change in the onset of the drug.

Communication with plasma proteins is about 98%. Vd is approximately 0.15 L / kg, and clearance is 0.1 L / h / kg. Pantoprazole is almost completely metabolized in the liver. It is an inhibitor of the CYP2C19 enzyme system. T1 / 2 - 1 h. Due to the specific binding of pantoprazole to the proton pump of parietal cells, T1 / 2 does not correlate with the duration of the therapeutic effect. Removal of metabolites (80%) mainly through the kidneys; the rest is excreted in the bile. The main metabolite, determined in serum and urine, is desmethylpanthoprazole, which is conjugated with sulfate. T1 / 2 of desmethyl pantoprazole, the main metabolite is much more (approximately 1.5 hours) than the T1 / 2 of pantoprazole itself.

Chronic renal failure (including those on hemodialysis) does not require a dose change of the drug. T1 / 2 is short, as in healthy individuals. Very small amounts of pantoprazole can be dialyzed.

Liver cirrhosis (grades A and B according to Child-Pugh classification) when taking pantoprazole 20 mg / day T1 / 2 increases to 3–6 hours, AUC increases 3–5 times, and Cmax - 1.3 times compared with healthy by individuals.

Elderly patients. In elderly patients, a slight increase in AUC and Cmax is not clinically significant.

Indications

Common to two dosage forms

gastric ulcer and duodenal ulcer (in the acute stage), erosive gastritis (including those associated with the intake of NSAIDs).

For enteric-coated tablets

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

eradication of Helicobacter pylori in combination with two antibiotics;

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

For lyophilisate for preparing solution for intravenous administration

gastroesophageal reflux disease (GERD): erosive reflux esophagitis (treatment), symptomatic treatment of GERD (ie, 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).

Contraindications

Common to two dosage forms

simultaneous use with atazanavir;

pregnancy;

breastfeeding period;

children's age up to 18 years (efficiency and safety are not studied).

With care: liver failure.

For enteric-coated tablets

hypersensitivity to any of the components of the drug, as well as substituted benzimidazoles;

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

dyspepsia neurotic genesis.

With caution: risk factors for cyanocobalamin deficiency (vitamin B12), especially against the background of hypo- and achlorhydria.

For lyophilisate for preparing solution for intravenous administration

hypersensitivity to any of the components of the drug.

With care: use for elderly patients, simultaneous use with ritonavir.

pregnancy and lactation

For enteric-coated tablets

As a precautionary measure it is necessary to exclude the use of the drug Nolpaza during pregnancy.

Due to insufficient information on the use of the drug Nolpaza® in women during breastfeeding, the potential risk to newborns and infants who are breastfed cannot be excluded. In this regard, it is necessary to make a decision on the termination of breastfeeding or on the cancellation / suspension of treatment with Nolpaza®.

Data on the effect of the drug Nolpaza® on fertility in humans are not available. Preclinical studies have shown no effect on male or female fertility.

For lyophilisate for preparing solution for intravenous administration

The drug Nolpaza contraindicated during pregnancy and during breastfeeding.

Side effects

For enteric-coated tablets

Approximately 5% of patients can expect the development of undesirable drug reactions (NLR). The most common NLRs are diarrhea and headache, occurring in approximately 1% of patients. The following are the NLRs registered with pantoprazole, classified according to the frequency of occurrence as follows: very often (≥1 / 10); often (≥1 / 100 and <1/10); infrequently (≥1 / 1000 and <1/100); rarely (≥1 / 10,000 and <1/1000); very rarely (<1/10000); frequency unknown (cannot be estimated based on available data).

For NLR, detected with post-registration use of the drug, it is impossible to apply any category of frequency of occurrence, and therefore they are indicated as “frequency unknown”.

Within each group, the frequency of occurrence of NLR are presented in order of decreasing severity.

From the side of blood-forming organs: rarely - agranulocytosis; very rarely - leukopenia, thrombocytopenia, pancytopenia.

On the part of the immune system: rarely - increased sensitivity (including anaphylactic reactions, including anaphylactic shock).

On the part of metabolism and nutrition: rarely - hyperlipidemia and increased concentration of lipids (triglycerides, Xc) in the blood plasma, changes in body weight; frequency is unknown - hyponatremia, hypomagnesemia, hypocalcemia combined with hypomagnesemia, hypokalemia.

Mental Disorders: Infrequently - sleep disturbance; rarely, depression (including exacerbations of existing disorders); very rarely - disorientation (including exacerbations of existing disorders); frequency is unknown - hallucinations, confusion (especially in susceptible patients, as well as the possible worsening of symptoms, if present, before using the drug).

On the part of the nervous system: infrequently - headache, dizziness; rarely - dysgeusia (taste disturbance); frequency unknown - parasthesia.

On the part of the organ of vision: rarely - visual impairment / blurred vision.

On the part of the gastrointestinal tract: infrequently - diarrhea, nausea / vomiting, abdominal distension and flatulence, constipation, dryness of the oral mucosa, pain and discomfort in the abdomen.

On the part of the liver and biliary tract: infrequently - increased activity of liver enzymes (transaminases, GGT); rarely, increased bilirubin concentration; frequency is unknown - hepatocellular damage, jaundice, hepatocellular insufficiency.

From the skin and subcutaneous tissues: infrequently - skin rash / exanthema / rash, pruritus; rarely - urticaria, angioedema; frequency is unknown - Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, photosensitivity, subacute cutaneous lupus erythematosus (PKKV).

On the part of the musculoskeletal system and connective tissue: infrequently - a fracture of the neck of the femur, bones of the wrist or spine; rarely - arthralgia, myalgia; frequency unknown - muscle spasm as a result of electrolyte imbalance.

On the part of the kidneys and urinary tract: the frequency is unknown - interstitial nephritis (with possible progression to renal failure).

On the part of the genitals and mammary gland: rarely - gynecomastia.

General disorders and disorders at the injection site: infrequently - asthenia, excessive fatigue and malaise; rarely - fever, peripheral edema.

For lyophilisate for preparing solution for intravenous administration

When using pantoprazole, a lyophilisate for preparing a solution for IV administration, in accordance with the indications and in recommended doses, side effects are extremely rare. The most frequent adverse reaction is thrombophlebitis at the injection site. Diarrhea and headache are observed in approximately 1% of patients.

Below are data on unwanted adverse reactions, depending on the frequency of their occurrence.

Classification of the incidence of side effects WHO: very often ≥1 / 10; often from ≥1 / 100 to <1/10; infrequently from ≥1 / 1000 to <1/100; rarely from ≥1 / 10,000 to <1/1000; very rarely <1/10000; frequency unknown - cannot be estimated based on available data.

From the side of blood and lymphatic system: rarely - agranulocytosis; very rarely - thrombocytopenia, leukopenia, pancytopenia.

On the part of the nervous system: infrequently - headache, dizziness; rarely - dysgeusia (taste disturbance).

On the part of the organ of vision: rarely - visual impairment (misting).

On the part of the gastrointestinal tract: infrequently - diarrhea, nausea / vomiting, bloating and flatulence, constipation, dryness of the oral mucosa, discomfort and pain in the abdomen.

On the part of the kidneys and urinary tract: the frequency is unknown - interstitial nephritis.

On the part of the skin and subcutaneous tissues: infrequently - exanthema / skin rash, pruritus; rarely - urticaria, angioedema; frequency is unknown - malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity.

From the musculoskeletal system and connective tissue: rarely - arthralgia, myalgia.

On the part of metabolism and nutrition: rarely - hyperlipidemia and increased concentration of lipids (triglycerides, cholesterols) in the blood plasma, changes in body weight; frequency is unknown - hyponatremia, hypomagnesemia.

General disorders and disorders at the injection site: often - thrombophlebitis at the injection site; infrequently - weakness, fatigue and malaise; rarely - fever, peripheral edema.

On the part of the immune system: rarely - increased sensitivity (including anaphylactic reactions, including anaphylactic shock).

On the part of the liver and biliary tract: infrequently - increased activity of liver enzymes - AST, GGT in the blood plasma; rarely, an increase in plasma bilirubin concentration; frequency is unknown - hepatocellular damage, jaundice.

On the part of the genitals and mammary gland: rarely - gynecomastia.

Mental Disorders: Infrequently - sleep disturbance; rarely, depression (including exacerbations of existing disorders); very rarely - disorientation (including exacerbations of existing disorders); the frequency is unknown - hallucinations, confusion (especially in patients predisposed to this), as well as exacerbation of the symptoms that existed before the start of therapy.

Interaction

For enteric-coated tablets

The simultaneous use of other IPP or H2-histamine receptor blockers is not recommended without consulting a doctor.

Effect of pantoprazole on the absorption of other drugs. Due to the deep and long-lasting suppression of gastric acid secretion, pantoprazole may decrease the absorption of drugs whose bioavailability depends on the pH of the stomach (for example, some azole antifungal drugs such as ketoconazole, itraconazole, posaconazole, and other drugs such as erlotinib).

Preparations for the treatment of HIV infection (atazanavir). The simultaneous use of atazanavir and other drugs for the treatment of HIV infection, the absorption of which depends on pH, with IPP can lead to a significant decrease in the bioavailability of these drugs for the treatment of HIV infection and affect the effectiveness of these drugs. The simultaneous use of IPP and atazanavir is not recommended.

In the event that the simultaneous use of HIV protease inhibitors and IPP is still necessary, it is recommended that careful clinical monitoring is recommended (for example, determination of viral load). The dose of pantoprazole should not exceed 20 mg per day. It may also be necessary to adjust the dose of the HIV protease inhibitor.

Indirect anticoagulants (fenprokumon or warfarin). Despite the fact that in clinical pharmacokinetic studies there was no interaction with the simultaneous use of pantoprazole with fenprocumone or warfarin, several separate cases of INO changes were recorded in the post-registration period. Therefore, it is recommended to monitor the MF / MNO at the beginning and at the end of therapy, as well as during the irregular use of pantoprazole.

Methotrexate. With the simultaneous use of high doses of methotrexate (for example, 300 mg) and PPI, the concentration of methotrexate in some patients increased. Patients (for example, with cancer or psoriasis) who are taking high doses of methotrexate are advised to temporarily discontinue pantoprazole treatment.

Other interactions. Pantoprazole is extensively metabolized in the liver with the participation of the cytochrome P450 enzyme system. The main metabolic pathway is demethylation under the action of the isoenzyme CYP2C19, other metabolic pathways include oxidation under the action of the isoenzyme CYP3A4.

Studies of drug interactions that are also metabolized by these routes, such as carbamazepine, diazepam, glibenclamide, nifedipine, and oral contraceptives containing levonorgestrel and ethinyl estradiol, have not revealed any clinically significant interactions.

The results of a number of studies of interactions showed that pantoprazole does not affect the metabolism of drugs that occur with the participation of CYP1A2 isoenzymes (such as caffeine, theophylline), CYP2C9 isoenzymes (such as piroxicam, diclofenac, naproxen), CYP2D6 isoenzymes (such as metoprolol), and isoenzymes of CYP2D6 (such as metoprolol). (such as ethanol), and does not affect the digoxin absorption associated with P-gp.

Inhibitors of CYP2C19 isoenzyme activity, such as fluvoxamine, can increase the systemic exposure of pantoprazole. Dose reduction may be necessary for patients receiving long-term treatment with high doses of pantoprazole or patients with liver failure.

Such inducers of the activity of CYP2C19 and CYP3A4 isoenzymes, such as rifampicin and St. John's wort (Hypericum perforatum), can reduce the concentration of PPIs metabolized by these enzyme systems in the blood plasma.

No drug interaction was observed with simultaneous use with antacids.

With simultaneous use of pantoprazole with antibiotics (clarithromycin, metronidazole, amoxicillin), there were no clinically significant drug interactions.

For lyophilisate for preparing solution for intravenous administration

The simultaneous use of atazanavir 300 mg / ritonavir 100 mg with omeprazole (40 mg once a day) or atazanavir 400 mg with lansoprazole (60 mg once) in healthy volunteers resulted in a significant decrease in the bioavailability of atazanavir. Atazanavir absorption depends on the pH of the gastrointestinal tract, so pantoprazole should not be used simultaneously with atazanavir.

Simultaneous use of the drug Nolpaza can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach (for example ketoconazole, intraconazole, posaconazole, and such as erlotinib).

The drug Nolpaza® can be used without the risk of negative drug interactions:

- in patients with cardiovascular diseases, taking cardiac glycosides (digoxin), BPC (nifedipine), beta-blockers (metoprolol);

- in patients with gastrointestinal diseases, taking antacids, antibacterial agents (amoxicillin, clarithromycin, metronidazole);

- in patients taking oral contraceptives containing levonorgestrel and ethinyl estradiol;

- in patients taking NSAIDs (diclofenac, naproxen, piroxicam);

- in patients with diseases of the endocrine system, taking glibenclamide;

- in patients with anxiety and sleep disorders taking diazepam;

- in patients with epilepsy, taking carbamazepine and phenytoin;

- in patients taking indirect anticoagulants (warfarin and fenprokumon) under the control of PV and INR at the beginning and at the end of therapy, as well as during the irregular use of pantoprazole;

Also noted the absence of clinically significant drug interactions with caffeine, ethanol, theophylline.

Dosage and administration

For enteric-coated tablets

Inside, the pill should not be chewed and broken. The tablet is swallowed whole, washed down with a small amount of liquid, before eating, usually before breakfast. When taking a second dose of the drug is recommended to take before dinner.

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

- mild: recommended dose - 1 table. Nolpaza® drug at 20 mg / day;

- moderate and severe: the recommended dose is 1-2 tablets. Nolpaza® 40 mg / day (40–80 mg / day). Relief of symptoms usually occurs within 2-4 weeks. The course of therapy is 4-8 weeks. For prophylaxis, as well as supporting long-term therapy, they take 20 mg / day (1 tab. Of Nolpaza® 20 mg), if necessary, increase the dose to 40–80 mg / day. It is possible to take the drug on demand, if symptoms occur.

Peptic ulcer of the stomach and duodenum, erosive gastritis (including those associated with taking NSAIDs): 40–80 mg / day. The course of treatment for 2 weeks - with exacerbation of duodenal ulcer, if this time is not enough, then healing can usually be achieved within the next 2 weeks of therapy. The course of treatment is 4–8 weeks - with acute gastric ulcer and erosive gastritis. Anti-relapse treatment of gastric ulcer and duodenal ulcer - 20 mg / day.

Eradication of Helicobacter pylori (in combination with antibiotics): the recommended dose is 1 table. Nolpaza® (40 mg) 2 times a day in combination with two antibiotics, usually a course of anti-helicobacter 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 / day (2 tablets of Nolpaza® 40 mg each) divided into 2 doses. In the future, the daily dose can be titrated depending on the initial level of gastric secretion. Perhaps a temporary increase in the daily dose of pantoprazole to 160 mg in order to adequately control gastric secretion. The duration of therapy is selected individually.

Severe abnormal liver function: the dose of pantoprazole should not exceed 40 mg / day and it is recommended to regularly monitor the activity of hepatic enzymes, especially with prolonged treatment with pantoprazole. With increasing activity of liver enzymes, it is recommended to cancel the drug.

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

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

For lyophilisate for preparing solution for intravenous administration

In / in, for 2-15 minutes

In / in the introduction of the drug should be carried out by medical personnel. In / in the use of the drug Nolpaza® is recommended only when it is impossible to ingest and for a period of not more than 7 days. If a patient has the possibility of oral administration, intravenous infusion should be replaced by the use of Nolpaza®, an enteric-coated tablet.

Peptic ulcer of the stomach and duodenum (in the acute stage), erosive gastritis (including associated with the intake of NSAIDs) and GERD. The recommended daily dose is 40 mg (1 fl.).

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 Nolpaza® IV. In the future, the dose may be increased or decreased. In the case of the use of the drug Nolpaza 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 of up to 160 mg is possible, but not longer than is necessary for adequate control of acidity.

If necessary, emergency control of acidity, the initial dose of 80 mg 2 times is sufficient to reduce acid emissions in the range of less than 10 mEq / h for 1 h 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 the use of the drug Nolpaza in a daily dose of more than 80 mg, the dose should be divided and administered 2 times a day. Perhaps a temporary increase in the daily dose of up to 160 mg.

Renal impairment, elderly patients. Dose adjustment is not 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 fl.).

Preparation of solution for on / in the introduction. To prepare a ready-to-use solution for iv administration, 10 ml of 0.9% sodium chloride solution is injected into the vial containing the lyophilisate. The finished solution can be introduced in a volume of 10 ml or diluted in 100 ml of a 0.9% solution of sodium chloride 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.

Overdose

There were no cases of overdose as a result of using Nolpaza®. Doses of pantoprazole up to 240 mg were administered IV in 2 minutes and were well tolerated.

Treatment: in case of overdose, and only with the appearance of clinical manifestations, symptomatic and supportive therapy is carried out. Hemodialysis is ineffective.

special instructions

The general for two dosage forms

Simultaneous use with atazanavir. Simultaneous use of atazanavir with PPI is not recommended. If the use of atazanavir with PPI is necessary, careful clinical monitoring should be carried out (for example, measuring viral load) in combination with increasing the dose of atazanavir to 400 mg using 100 mg of ritonavir. Do not exceed the daily dose of pantoprazole 20 mg (see "Interaction").

Gastrointestinal infections caused by bacteria. Pantoprazole, like other IPPs, can increase the number of bacteria that are usually present in the upper GI tract. Treatment of PPI may slightly increase the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile.

Hypomagnesemia. Cases of severe hypomagnesemia have been reported in patients treated with PPI, such as pantoprazole, for at least 3 months and in most cases within a year. Severe manifestations of hypomagnesemia, such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia, may start unnoticed and may be missed. In most cases, the patient's condition improves after substitution therapy with magnesium and discontinuation of treatment with IPP.

Patients requiring long-term therapy or taking IPP in combination with digoxin or drugs that may cause hypomagnesemia (for example, diuretics) should determine the magnesium content in blood plasma before starting treatment with IPP and periodically during treatment.

Fractures of the bones. Long-term treatment (more than 1 year) with high doses of PPI may slightly increase the risk of fractures of the hip, wrist and spine, mainly in the elderly or with other risk factors. Observational studies suggest that STIs may increase the overall risk of fractures by 10–40%. Some of them may be due to other risk factors. Patients at risk for osteoporosis should receive treatment in accordance with the current clinical guidelines and consume sufficient amounts of vitamin D and calcium.

Pkkv The use of an IPP can, in very rare cases, cause PKKV. In the event of lesions on the skin, especially in areas exposed to sun exposure, accompanied by arthralgia, the patient should immediately seek medical help. The physician should consider withdrawing Nolpaza®. PKKK due to previous therapy with IPP may increase the risk of developing PKKV with subsequent therapy with other IPPs.

For enteric-coated tablets

Liver failure. In patients with severely impaired liver function, it is necessary to regularly monitor the activity of liver enzymes during pantoprazole treatment, especially with prolonged use of the drug. With an increase in liver enzyme activity, therapy should be discontinued.

Combination therapy. In the case of combination therapy, it is necessary to read the instructions for medical use for the drugs used in the combination.

Effect on the absorption of vitamin B12. In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, pantoprazole, like all drugs that block acid secretion, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with a reduced supply of vitamin B12 in the body or with risk factors for the absorption of vitamin B12 during prolonged therapy or the presence of relevant clinical symptoms.

Long-term therapy. With prolonged therapy, especially for more than 1 year, patients should be under the regular supervision of a physician.

For lyophilisate for preparing solution for intravenous administration

Liver failure. In patients with severely impaired liver function, it is necessary to regularly monitor the level of liver enzymes. At increase in activity of liver enzymes it is necessary to stop use of the drug Nolpaza® (see. "Route of administration and doses").

Influence on ability to drive vehicles, mechanisms (for both dosage forms). You should refrain from driving and other mechanisms that require increased attention, because may develop dizziness and visual disturbances.

Release form

Enteric-coated tablets, 20 mg and 40 mg. At 14 tab. in the blister of the combined material OPA / aluminum / PVC and aluminum foil. 1, 2, 4 bl. placed in a cardboard box.

Lyophilisate for preparation of solution for intravenous administration, 40 mg. On 40 mg of pantoprazol in a vial, with a capacity of 15 ml, from colorless glass (type I), sealed with a color stopper made of chlorobutyl rubber, with a running-in aluminum cap, closed with a colored plastic lid of the first opening control. 1 fl. placed in a cardboard box. On 1 pallet (on 5 fl.) Or 2 pallets (on 5 fl.), Or 4 pallets (on 5 fl.) Place in a pack cardboard. The pallet is made of transparent PVC film.

Comment

Own prospective, controlled, stratified, multicenter, clinical study (34 centers in Russia, Poland, Slovenia.): "Efficacy and safety of Pantoprazole in patients in treating and alleviating the symptoms of gastroesophageal reflux disease (GERD) - PAN-STAR" 1

Nolpaza 40 mg 1 time / day for 4–8 weeks, with subsequent control after 1 month.

Parameters evaluated:

1. Evaluation of the effectiveness of healing of erosions in GERD.

2. Assessment of symptom relief.

3. Assessment of changes in the quality of life.

The results of the study:

1. Effective healing of erosion (endoscopic remission of GERD by 28 days in 91.1%, by day 56 - 100%).

2. Persistent relief of GERD symptoms (non-return 1 month after the end of therapy).

3. High commitment (at the 2nd visit - compliance with 93%, at the 3rd visit - 96%).

4. Safe therapy (95% of patients noted excellent tolerability of therapy).

5. Significant stable improvement in the quality of life.

Pharmacy sales terms

On prescription.

Storage conditions

At temperatures not higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life

tablets, enteric coated 20 mg - 5 years.

tablets, enteric coated 40 mg - 5 years.

lyophilisate for preparation of solution for intravenous administration of 40 mg - 3 years.

Do not use after the expiration date printed on the package.