Nolpaza 40mg 28 tablets — Made in Slovenia — Free Delivery
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Description Nolpaza 40mg 28 tablets — Made in Slovenia — Free Delivery
Pharmacological properties
Pharmacodynamics. Pantoprazole is a substituted benzimidazole that blocks the secretion of hydrochloric acid in the stomach by specifically affecting the proton pump of parietal cells.
Pantoprazole is transformed into an active form in the acidic environment of parietal cells, where it blocks the enzyme H + / K + ATPase, namely the final stage of hydrophilic secretion of hydrochloric acid in the stomach. Oppression is dose-dependent and affects basal and stimulated gastric secretion.
Treatment with pantoprazole, like other proton pump inhibitors and H2-receptor inhibitors, causes a decrease in gastric acidity and a proportional increase in gastrin secretion. The increase in gastrin levels is reversible. Since pantoprazole binds to enzymes that are distant from cellular receptors, it affects the secretion of hydrochloric acid regardless of stimulation by other substances (acetylcholine, histamine, gastrin). The effectiveness of the preparation is the same when administered orally or intravenously.
When using pantoprazole, the level of fasting gastrin increases. With short-term use, in most cases, it does not exceed the upper limit of the norm. With long-term treatment, the gastrin level in most cases doubles. Its excessive increase, however, occurs only in rare cases. As a result, in a small number of cases with long-term treatment, there is a weak or moderate increase in the number of enterochromaffin-like cells (ECL cells) of the stomach (adenomatoid hyperplasia). Nevertheless, according to the studies carried out at the moment, the formation of cells - precursors of neuroendocrine tumors of the stomach, which have been identified in animal experiments, has not been observed in humans. But with prolonged (more than 1 year) treatment, the effect of pantoprazole on the endocrine parameters of the thyroid gland cannot be excluded.
Pharmacokinetics. Pantoprazole is rapidly absorbed, Cmax in blood plasma is reached even after taking a single dose of 20 or 40 mg. On average, Cmax in blood plasma 1–1.5 μg / ml - for a dose of 20 mg and 2-3 μg / ml - for a dose of 40 mg is achieved within 2–2.5 hours after administration and remains constant also after repeated administration. The volume of distribution is about 0.15 l / kg of body weight, and the clearance is 0.1 l / h / kg. Food intake does not affect bioavailability (AUC or Cmax), but increases the instability of the delay time.
T½ is about 1 hour. In several cases, T½ increased. Due to the specific binding of pantoprazole to the proton pump of parietal cells, T½ is not associated with a longer duration of action.
Pharmacokinetics does not change after single or multiple doses. In the dose range of 10–80 mg, the kinetics of pantoprazole in blood plasma is linear both after oral and intravenous administration.
The binding of pantoprazole to blood plasma proteins is about 98%. The preparation is almost completely metabolized in the liver. The main route of excretion of about 80% of pantoprazole metabolites is through the kidneys, the rest is in the feces. The main metabolite in both blood plasma and urine is dismethylpantoprazole in combination with sulfate. T½ of the main metabolite (about 1.5 hours) is not much longer than pantoprazole.
Bioavailability. After oral administration, pantoprazole is completely absorbed. The absolute oral bioavailability is about 77%. Eating food does not affect the value of the AUC, Cmax in blood plasma and bioavailability; only the beginning of the action changes.
Characteristics of special groups of patients. For patients with impaired renal function (including those on hemodialysis), there is no need to reduce the dose. As in healthy people, the T½ of pantoprazole is short. Only a very small amount of pantoprazole can be dialyzed. Despite the fact that T½ of the main metabolite increases slightly (2-3 hours), it is rapidly excreted and does not accumulate.
In patients with liver cirrhosis (class A and B according to Child-Pugh classification), T½ increases to 7-9 hours and, accordingly, the AUC values increase 5-7 times, the Cmax of pantoprazole in blood plasma increases 1.5 times compared to with healthy people.
A slight increase in AUC and Cmax of pantoprazole in blood plasma in elderly volunteers compared to young volunteers is also not clinically significant.
Children. After a single dose of 20 or 40 mg of pantoprazole orally, AUC and Cmax in children aged 5-16 years were within the corresponding values in adults. After a single administration of pantoprazole at a dose of 0.8 or 1.6 mg / kg of body weight to children aged 2–16 years, there was no significant relationship between the clearance of pantoprazole and age or body weight. AUC and volume of distribution were consistent with those obtained from studies in adults.
Indications
Nolpaza 20 mg tablets
Adults and children over the age of 12
Symptomatic treatment of gastroesophageal reflux disease;
long-term treatment and prevention of recurrence of reflux esophagitis.
Adults:
prevention of gastric and duodenal ulcers caused by the use of NSAIDs in risk group patients who must use NSAIDs for a long time.
Nolpaza 40 mg tablets
Adults and children over 12 years old:
reflux esophagitis.
Adults:
eradication of Helicobacter pylori (H. pylori) in patients with H. pylori-associated gastric and duodenal ulcer in combination with appropriate antibiotics;
duodenal ulcer;
stomach ulcer;
Zollinger-Ellison syndrome and other hypersecretory pathological conditions.
Nolpaza, injections:
reflux esophagitis;
ulcers of the stomach and duodenum;
Zollinger-Ellison syndrome and pathological conditions of hypersecretion.
Nolpaza control: treatment of GERD and its symptoms (such as heartburn, regurgitation) in adults.
Application
Nolpaza 20 mg tablets
Symptomatic treatment of GERD. The recommended dose for adults and children over the age of 12 is 1 tablet of Nolpaza 20 mg / day. Symptoms usually disappear after 2–4 weeks of treatment. For the treatment of associated esophagitis, as a rule, it takes 4 weeks. If this period is not enough, treatment is continued for the next 4 weeks. After the symptoms disappear, their relapses can be controlled by using 20 mg / day, depending on the need.
Long-term treatment and prevention of recurrence of reflux esophagitis. The recommended dose is 1 tablet of Nolpaza 20 mg / day. With an expected exacerbation, it is possible to increase the dose to 40 mg / day, in which case it is recommended to use Nolpaz 40 mg tablets. After the relapse is eliminated, the dose can again be reduced to 20 mg of pantoprazole per day.
Prevention of gastric and duodenal ulcers caused by taking non-selective NSAIDs in patients at risk who need NSAIDs for a long time. The recommended dose is 1 tablet of Nolpaza 20 mg / day. In patients with severe hepatic impairment, the daily dose should not exceed 20 mg of pantoprazole. There is no need to reduce the dose in elderly patients and patients with impaired renal function.
Nolpaza 40 mg tablets. The tablets should be taken 1 hour before meals whole, without chewing or crushing, with water.
Adults and children over the age of 12
Reflux esophagitis treatment. The recommended dose of Nolpaza 40 mg for adults is 1 tablet per day. In some cases, the dose may be increased to 2 tablets per day, especially if there is no effect from the use of other preparations for the treatment of reflux esophagitis. Typically a 4-week course of treatment is needed. If this is not enough, then you should continue taking the preparation for the next 4 weeks.
Adults
Eradication of Helicobacter pylori in combination with two antibiotics. In patients with gastric and duodenal ulcers and who test positive for H. pylori, it is necessary to achieve eradication of the microorganism using combination therapy. Consideration should be given to local data on bacterial resistance and national recommendations for the use and administration of appropriate antibacterial agents. Depending on the sensitivity, the following therapeutic combinations can be prescribed for the eradication of H. pylori in adults:
(a) 1 tablet of Nolpaza 40 mg 2 times a day
+ 1000 mg amoxicillin 2 times a day
+ 500 mg clarithromycin 2 times a day;
(b) 1 tablet of Nolpaza 40 mg 2 times a day
+ 400-500 mg metronidazole (500 mg tinidazole) 2 times a day
+ 500 mg clarithromycin 2 times a day;
(c) 1 tablet of Nolpaza 40 mg 2 times a day
+ 1000 mg amoxicillin 2 times a day
+ 400-500 mg of metronidazole (500 mg of tinidazole) 2 times a day.
When using combination therapy for the eradication of H. pylori, the second 40 mg Nolpaza tablet should be taken in the evening 1 hour before meals. The duration of treatment is 7 days and can be extended for another 7 days with a total duration of treatment of no more than 2 weeks. If further treatment with pantoprazole is indicated to ensure ulcer healing, dosage recommendations for gastric and duodenal ulcers should be considered. If combination therapy is not indicated, for example, in patients with a negative result for H. pylori, for monotherapy, Nolpaza 40 mg is used in the doses indicated below.
Stomach ulcer treatment. 1 tablet Nolpaz 40 mg / day In some cases, the dose can be doubled (2 tablets of the preparation Nolpaza 40 mg / day), especially if there is no effect from the use of other preparations.
Stomach ulcers usually take 4 weeks to treat. If this is not enough, ulcer healing can be expected within the next 4 weeks.
Treatment of duodenal ulcers. 1 tablet Nolpaz 40 mg / day In some cases, the dose can be doubled (2 tablets of Nolpaza® 40 mg / day), especially if there is no effect from the use of other preparations.
Duodenal ulcers usually take 2 weeks to treat. If this is not enough, ulcer healing can be expected within the next 2 weeks.
Treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions. For long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory conditions, the initial daily dose is 80 mg (2 tablets of Nolpaza 40 mg). If necessary, then the dose can be titrated, increasing or decreasing, depending on the indicators of gastric acidity. A dose exceeding 80 mg / day must be divided into 2 doses. A temporary increase in the dose over 160 mg of pantoprazole is possible, but the duration of use should be limited only by the period necessary for adequate control of acidity.
The duration of treatment for Zollinger-Ellison syndrome and other pathological conditions is not limited and depends on the clinical need.
Patients with impaired liver function. Patients with severely impaired liver function should not exceed a daily dose of 20 mg (1 tablet of Nolpaz 20 mg). You should not use the preparation Nolpaza for the eradication of H. pylori in combination therapy in patients with moderate to severe hepatic impairment, since there is currently no data on the efficacy and safety of such use for this category of patients.
Patients with impaired renal function. No dose adjustment is required for patients with impaired renal function. You should not use the preparation Nolpaza for the eradication of H. pylori in combination therapy of patients with impaired renal function, since there is currently no data on the efficacy and safety of such use for this category of patients.
Elderly patients do not require dose adjustment.
Nolpaza, injection. The preparation is used in adults as directed and under the direct supervision of a physician.
IV use of the preparation is recommended only if oral administration is impossible. There is data on the duration of IV treatment up to 7 days. Therefore, if it is clinically feasible, the transition from intravenous administration of Nolpase® to oral administration is carried out.
Reflux esophagitis, duodenal ulcer, stomach ulcer. The recommended dose is 40 mg of pantoprazole (1 bottle) per day intravenously.
Treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions. For long-term treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions, the recommended dose of Nolpaz is 80 mg / day. If necessary, the dose can be titrated, increasing or decreasing, depending on the rate of acid secretion in the stomach. Doses exceeding 80 mg / day must be divided into 2 administrations. A temporary increase in the dose of pantoprazole more than 160 mg is possible, but the duration of use should be limited only by the period that is necessary for adequate control of acid secretion.
If a rapid decrease in acidity is required, an initial dose of 80 mg 2 times a day is sufficient for most patients to achieve the desired level (10 mEq / h) within 1 hour.
Preparation for use. The powder is dissolved in 10 ml of 0.9% sodium chloride solution, added to the bottle. The solution can be administered directly or after mixing with 100 ml of 0.9% sodium chloride solution or 5% glucose solution in plastic or glass bottles.
After dilution, the chemical and physical stability of the preparation is maintained for 12 hours at a temperature of 25 ° C. From a microbiological point of view, the diluted preparation must be used immediately.
Nolpazu must not be prepared or mixed with solvents other than those indicated above.
The introduction of the preparation must be carried out within 2-15 minutes.
The bottle is for single use only. Before use, it is necessary to visually check the vials with the preparation (in particular, for discoloration, the presence of sediment).
The diluted solution should have a transparent yellowish color.
Liver failure. Patients with severely impaired liver function should not exceed a daily dose of 20 mg (½ bottle of the preparation Nolpaza, lyophilisate for the preparation of injection solution, 40 mg).
Renal failure Patients with impaired renal function do not require dose adjustment.
Elderly patients do not require dose adjustment.
Nolpaza control
Dosing. The recommended dose is 20 mg pantoprazole (1 tablet) once a day.
To relieve symptoms, it may be necessary to take the tablets for 2–3 days. After the symptoms disappear, the treatment should be discontinued. The duration of treatment should not exceed 4 weeks without additional medical examination (after consulting a doctor).
If a decrease in the severity of symptoms is not noted after 2 weeks of continuous treatment, the patient should consult a doctor.
Characteristics of special groups of patients. Elderly patients or patients with impaired renal or hepatic function do not require dose adjustment.
Method of administration. Enteric-coated tablets, Nolpaza Control 20 mg should be swallowed whole, without chewing or breaking, with a small amount of liquid before meals.
Contraindications
Hypersensitivity to pantoprazole, benzimidazole derivatives or any other substance that is part of the preparation. pantoprazole, like other proton pump inhibitors, is contraindicated for use with atazanavir.
Side effects
The occurrence of adverse reactions is noted in about 5% of patients. the most common adverse reactions are diarrhea and headache (about 1%).
In terms of frequency of occurrence, undesirable effects are classified into the following categories: 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 (1/10 000), unknown (frequency not determined from available data).
From the side of the blood and lymphatic system: rarely - agranulocytosis; very rarely - leukopenia, thrombocytopenia, pancytopenia.
From the immune system: rarely - hypersensitivity reactions (including anaphylactic reactions, anaphylactic shock)
Metabolism and metabolic disorders: rarely - hyperlipidemia and increased lipid levels (TG, CS), changes in body weight; unknown - hyponatremia, hypomagnesemia (see SPECIAL INSTRUCTIONS), hypocalcemia1, hypokalemia.
Mental disorders: infrequently - sleep disorders; rarely - depression (including exacerbations); very rarely - disorientation (including exacerbations); unknown - hallucination, confusion (especially in patients with a tendency to these disorders, as well as exacerbation of these symptoms if they have a history).
From the nervous system: infrequently - headache, dizziness; rarely - taste disturbances; unknown - paresthesia.
From the side of the organ of vision: rarely - visual impairment / blurred vision.
From the digestive tract: infrequently - diarrhea, nausea, vomiting, bloating, constipation, dry mouth, abdominal pain and discomfort.
On the part of the hepatobiliary system: infrequently - an increase in the level of liver enzymes (transaminases, γ-glutamyl transferase); rarely - an increase in the level of bilirubin; unknown - damage to hepatocytes, jaundice, hepatocellular insufficiency.
On the part of the skin and subcutaneous tissues: infrequently - skin rash, exanthema, itching; rarely - urticaria, angioedema; unknown - Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, photosensitivity.
From the musculoskeletal system and connective tissue: infrequently - fractures of the hip, wrist, spine (see. SPECIAL INSTRUCTIONS); rarely - arthralgia, myalgia; unknown - muscle spasm 2.
From the kidneys and urinary system: unknown - interstitial nephritis (with the possible development of renal failure).
From the reproductive system and mammary glands: rarely - gynecomastia.
General disorders: infrequently - asthenia, fatigue, malaise; rarely - an increase in body temperature, peripheral edema.
1 Hypocalcemia simultaneously with hypomagnesemia.
2 Muscle spasm as a result of electrolyte imbalance.
Special instructions
Patients with impaired liver function. in case of severe violations of liver function during treatment, especially with prolonged use, regular monitoring of the level of liver enzymes is necessary. in case of an increase in the level of liver enzymes, treatment should be discontinued.
Concomitant use of atazanavir. Concomitant use of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with proton pump inhibitors is unavoidable, close clinical monitoring (eg, measurement of viral load) should be performed in conjunction with increasing the dose of atazanavir to 400 mg with 100 mg ritonavir. The dose of pantoprazole 20 mg / day should not be exceeded.
Influence on the adsorption of vitamin B12. In patients with Zollinger-Ellison syndrome and other hypersecretory conditions requiring long-term treatment, pantoprazole, like other preparations that block the secretion of gastric juice, can reduce the absorption of vitamin B12 (cyanocobalamin) due to the occurrence of hypo- or achlorhydria. This should be taken into account in patients with reduced body weight or the presence of risk factors for reduced absorption of vitamin B12 (cyanocobalamin), especially with prolonged treatment or the presence of appropriate clinical symptoms.
Long-term treatment. If the duration of treatment is more than 1 year, the patient should be under constant supervision.
In the presence of alarming symptoms. Malignant diseases of the esophagus or stomach should be excluded before treatment, since pantoprazole treatment can mask the symptoms of malignant disease and thus prevent the establishment of a correct diagnosis.
Hypomagnesemia. Cases of severe hypomagnesemia have been reported in patients treated with proton pump inhibitors such as pantoprazole for at least 3 months, and in most cases within 1 year. The following serious clinical manifestations of hypomagnesemia may occur and initially develop imperceptibly: fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia. In the case of hypomagnesemia, in most cases, the patient's condition improved after replacement corrective therapy with magnesium preparations and discontinuation of proton pump inhibitors.
Patients who require long-term therapy, or patients who take proton pump inhibitors concurrently with digoxin or preparations that can cause hypomagnesemia (such as diuretics), should have their magnesium levels measured before starting treatment with proton pump inhibitors and periodically during treatment.
Bone fractures. Long-term treatment (more than 1 year) with high doses of proton pump inhibitors may slightly increase the risk of fractures of the hip, wrist and spine, mainly in the elderly or in the presence of other risk factors. Controlled studies indicate that the use of proton pump inhibitors can increase the overall risk of fractures by 10–40%. Some of these may be due to other risk factors. Patients at risk of developing osteoporosis should receive treatment according to current clinical guidelines and consume adequate amounts of vitamin D and calcium.
Gastrointestinal infections caused by bacteria. Pantoprazole, like other proton pump inhibitors, can increase the number of bacteria that are commonly found in the upper GI tract. Treatment with the preparation may slightly increase the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.
Information on excipients. The preparation Nolpaza contains sorbitol. Patients with rare hereditary diseases of fructose intolerance should not use the preparation.
Application during pregnancy or lactation. The experience of using the preparation during pregnancy is limited. In studies of reproductive function in animals, slight embryotoxicity was noted at doses of 5 mg / kg of body weight. The potential risk to humans is unknown. The preparation is used during pregnancy only if absolutely necessary.
Data were obtained on the excretion of pantoprazole in breast milk. The decision to use the preparation during breastfeeding should be made after a careful assessment of the benefits / risks.
Children. The experience of using the preparation in children is limited, therefore, pantoprazole is not recommended for use in patients of this age category.
The ability to influence the reaction rate when driving or operating other mechanisms. In the event of adverse reactions such as dizziness and blurred vision, you should refrain from driving and working with potentially dangerous machinery.
Interactions
The effect of pantoprazole on the absorption of other preparations. pantoprazole can reduce the absorption of preparations whose bioavailability depends on the ph of gastric juice, such as certain azoles, antifungal preparations such as ketoconazole, itraconazole, posaconazole, and other preparations such as erlotinib.
HIV preparations (atazanavir). The combination of atazanavir and other preparations for the treatment of HIV, the adsorption of which depends on pH, with proton pump inhibitors can lead to a significant decrease in the bioavailability of the latter and affect their effectiveness. Therefore, concomitant administration of proton pump inhibitors with atazanavir is not recommended.
Coumarin anticoagulants (warfarin or phenprocoumon). Despite the lack of interaction with simultaneous use with phenprocoumon or warfarin, during clinical trials, isolated cases of changes in the international normalized ratio (INR) in the post-marketing period were recorded. Thus, patients using coumarin anticoagulants (for example, phenprocoumon or warfarin) of the series are recommended to monitor the prothrombin time or INR after the start, end or with irregular administration of pantoprazole.
Methotrexate. It has been reported that the simultaneous use of high doses of methotrexate (eg 300 mg) and proton pump inhibitors increases the level of methotrexate in the blood in some patients. Patients taking high doses of methotrexate, such as those with cancer or psoriasis, are advised to temporarily discontinue pantoprazole treatment.
Exploration of other interactions. Pantoprazole is extensively metabolized in the liver by the cytochrome P450 system. The main metabolic pathway is demethylation by CYP 2C19 and other metabolic pathways, including oxidation by the CYP 3A4 enzyme.
Studies with preparations that are also metabolized by these pathways, such as carbamazepine, diazepam, glibenclamide, nifedipine, phenprocoumon and oral contraceptives containing levonorgestrel and ethinyl estradiol, have not revealed clinically significant interactions.
Interaction studies indicate that pantoprazole does not affect the metabolism of active substances metabolized by CYP 1A2 (such as caffeine and theophylline), CYP 2C9 (eg piroxicam, diclofenac, naproxen), CYP 2D6 (eg metoprolol), CYP 2E1 (eg ethanol) and does not affect p-glycoprotein, which ensures the absorption of digoxin.
There was no interaction with concomitantly prescribed antacids.
Special studies of the interaction of pantoprazole with certain antibiotics (clarithromycin, metronidazole, amoxicillin) have been carried out, with the simultaneous use of clinically significant interactions between these preparations have not been revealed.
Incompatibility. The preparation Nolpaza, injections, should not be mixed with other preparations, except for those indicated in the APPLICATION section (Route of administration).
Overdose
There are no reports of overdose. intravenous doses of up to 240 mg were administered for more than 2 minutes, the tolerance was good. pantoprazole binds extensively to proteins and is not completely eliminated by dialysis.
In case of overdose with clinical manifestations of intoxication, symptomatic and supportive treatment is recommended.
Storage conditions
Nolpaza, tablets, and nolpaza control: at a temperature not exceeding 30 ° C in the original packaging to protect against moisture. nolpaza, lyophilisate for injection solution: in its original packaging to protect from light at a temperature not exceeding 25 ° c. after dilution, chemical and physical stability is maintained for 12 hours at a temperature of 25 ° c. from a microbiological point of view, the preparation should be taken immediately.
Tags: Nolpaza
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