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  • Proxium 40 mg 32 tablets — Made in Spain — Free Delivery

Proxium 40 mg 32 tablets — Made in Spain — Free Delivery

(Proxium )
Proxium 40 mg 32 tablets — Made in Spain — Free Delivery
Proxium 40 mg 32 tablets — Made in Spain — Free Delivery
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Laboratorios Normon S.A Brand: Laboratorios Normon S.A
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Description Proxium 40 mg 32 tablets — Made in Spain — Free Delivery

Pharmacological properties

Pharmacodynamics. Mechanism of action. Pantoprazole is a substituted benzimidazole that inhibits the secretion of hydrochloric acid in the stomach by specifically blocking the proton pump of parietal cells.
Pantoprazole is transformed into an active form in an acidic medium in parietal cells, where it inhibits the H + -K + -ATPase enzyme, that is, it blocks the final stage of the production of hydrochloric acid in the stomach. Inhibition is dose-dependent and concerns both basal and stimulated acid secretion. In most patients, symptoms resolve within 2 weeks. The use of pantoprazole, as is the case with other proton pump inhibitors and H2-receptor inhibitors, reduces gastric acidity and thus increases gastrin secretion in proportion to the decrease in acidity. The increase in gastrin secretion is reversible. Since pantoprazole binds the enzyme distally to the cellular receptor, it can inhibit the secretion of hydrochloric acid independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same for oral and intravenous administration.
Fasting gastrin levels increase with pantoprazole. With short-term use, they in most cases do not exceed the upper limit of the norm. With long-term treatment, gastrin levels in most cases double. Their excessive increase occurs only in rare cases. As a consequence, in a small number of cases with long-term treatment, there is a slight to moderate increase in specific endocrine (ECL) cells in the stomach (similar to adenomatoid hyperplasia). However, studies to date have not shown the formation of cells that are precursors of neuroendocrine tumors (atypical hyperplasia) or neuroendocrine tumors of the stomach that have been found in animal studies in humans.
Based on the results of animal studies, it is impossible to exclude the effect of prolonged (more than one year) treatment with pantoprazole on the endocrine parameters of the thyroid gland.
Pharmacokinetics. Suction. Pantoprazole is rapidly absorbed, and Cmax in blood plasma is reached after a single dose of 40 mg. On average, 2.5 hours after taking Cmax in blood plasma at a level of about 2–3 μg / ml and remains at a constant level after repeated administration. Pharmacokinetic properties do not change after single or repeated administration. In the dose range of 10–80 mg, the pharmacokinetics of pantoprazole in blood plasma remains linear both when taken orally and when administered intravenously. It was found that the bioavailability of the tablets is about 77%. Simultaneous food intake does not affect the AUC or Cmax in blood plasma, and, accordingly, the bioavailability. With the simultaneous intake of food, only the variability of the latent period increases.
Distribution. The binding of pantoprazole to blood plasma proteins is about 98%. The volume of distribution is about 0.15 l / kg.
Metabolism. The substance is metabolized almost exclusively in the liver. The main metabolic pathway is demethylation by CYP 2C19 followed by sulfur conjugation; other metabolic pathways include oxidation by CYP 3A4.
Excretion. The final T½ is about 1 hour and the ground clearance is 0.1 l / h / kg. Several cases of delayed elimination have been noted. Due to the specific binding of pantoprazole to the proton pump of parietal cells, T½ does not correlate with a much longer duration of action (inhibition of acid secretion).
Most of the metabolites of pantoprazole are excreted in the urine (about 80%), the rest in the feces. The main metabolite in both blood plasma and urine is desmethylpantoprazole conjugated with sulfate. T½ of the main metabolite (about 1.5 hours) is slightly higher than that of pantoprazole.
Special patient groups. Slow metabolizers. In about 3% of individuals of the Caucasian race, a functional deficiency in the activity of the CYP 2C19 enzyme is noted; they are called slow metabolizers. In such individuals, the metabolism of pantoprazole is probably mainly catalyzed by the CYP 3A4 enzyme. After taking a single dose of 40 mg of pantoprazole, the mean area bounded by the plasma concentration-time pharmacokinetic curve was approximately 6 times greater in slow metabolizers than in individuals with functionally active CYP 2C19 enzyme (fast metabolizers). Cmax in blood plasma increased by about 60%. These results do not affect the dosage of pantoprazole.
Impaired renal function. There are no recommendations for dose reduction when prescribing pantoprazole to patients with impaired renal function (including patients on dialysis). As in healthy people, the T1 / 2 of pantoprazole is short. Only a very small amount of pantoprazole is dialyzed. Despite the fact that the main metabolite has a moderately long T1 / 2 (2–3 hours), excretion is still fast, so no cumulation occurs.
Liver dysfunction. Although in patients with liver cirrhosis (classes A and B on the Child-Pugh scale) T1 / 2 increases to 7-9 hours, and AUC - 5-7 times, Cmax in blood plasma increases only slightly - 1.5 times compared with healthy volunteers.
Elderly patients. A slight increase in AUC and Cmax in elderly volunteers compared to younger volunteers also has no clinical significance.
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 are comparable to those obtained from studies in adults.

Indications

Adults and children over the age of 12:
reflux esophagitis.
Adults:
  • eradication of Helicobacter pylori in patients with H. pylori-associated gastric and duodenal ulcers in combination with appropriate antibiotics;
  • duodenal ulcer;
  • stomach ulcer;
Zollinger-Ellison syndrome and other hypersecretory pathological conditions.

Application

Proxy, gastro-resistant tablets, should be taken 1 hour before meals whole, without chewing or crushing, with water.
Recommended dosage. Adults and children over the age of 12. Reflux esophagitis treatment. The recommended dose is 1 tablet of Proxium 40 mg. In some cases, the dose can be doubled (2 tablets of the preparation Proxium 40 mg), especially if there is no effect from the use of other preparations for the treatment of reflux esophagitis. Reflux esophagitis usually takes 4 weeks to treat. If this is not enough, a cure can be expected within the next 4 weeks.
Adults. Eradication of H. 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 Proxium 40 mg 2 times a day + 1000 mg of amoxicillin 2 times a day + 500 mg of clarithromycin 2 times a day;
b) 1 tablet Proxium 40 mg 2 times a day + 400-500 mg of metronidazole (or 500 mg of tinidazole) 2 times a day + 250-500 mg of clarithromycin 2 times a day;
c) 1 tablet Proxium 40 mg 2 times a day + 1000 mg of amoxicillin 2 times a day + 400-500 mg of metronidazole (or 500 mg of tinidazole) 2 times a day.
When using combination therapy for the eradication of H. pylori, the second tablet of Proxium 40 mg 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, dosing 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, the preparation Proxium 40 mg is used for monotherapy in the following dose.
Stomach ulcer treatment. 1 tablet Proxium 40 mg. In some cases, the dose can be doubled (2 tablets of the preparation Proxium 40 mg), 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 Proxium 40 mg. In some cases, the dose can be doubled (2 tablets of the preparation Proxium 40 mg), 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 Proxium 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 Proxium 20 mg). You should not use the preparation Proxium 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 Proxium for the eradication of H. pylori in combination therapy in 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.

Contraindications

Hypersensitivity to the active substance, benzimidazole derivatives and preparation components.

Side effects

The occurrence of adverse reactions was observed in about 5% of patients. the most common adverse reactions are diarrhea and headache (about 1%).
In terms of frequency of occurrence, side 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 (triglycerides, cholesterol), 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 hepatic enzymes (transaminases, GGT); 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, rash, itching; rarely - urticaria, angioedema; unknown - Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, photosensitivity, subacute cutaneous lupus erythematosus (see SPECIAL INSTRUCTIONS).
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

Liver dysfunction. patients with severely impaired liver function should regularly monitor the level of liver enzymes, especially with long-term treatment. in case of an increase in the level of liver enzymes, treatment should be discontinued (see application).
Combined therapy. During combination therapy, the instructions for use of the respective medicinal products must be followed.
Malignant neoplasms of the stomach. A symptomatic response to pantoprazole may mask the symptoms of gastric malignancies and delay their diagnosis. In the presence of alarming symptoms (for example, in the case of a significant decrease in body weight, intermittent vomiting, dysphagia, vomiting with blood, anemia, melena), as well as if a stomach ulcer is suspected or present, the presence of a malignant process should be excluded, since pantoprazole treatment can mask symptoms and delay the establishment diagnosis.
If symptoms persist with adequate treatment, additional testing is necessary.
HIV protease inhibitors. The combined use of pantoprazole with HIV protease inhibitors (such as atazanavir), the absorption of which depends on gastric pH, is not recommended due to a significant decrease in their bioavailability (see INTERACTIONS).
Absorption of vitamin B12. In patients with Zollinger-Ellison syndrome and other hypersecretory pathological conditions requiring long-term treatment, pantoprazole, like all preparations that block the production of hydrochloric acid, can reduce the absorption of vitamin B12 (cyanocobalamin) due to the occurrence of hypo- and 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 with prolonged treatment or the presence of appropriate clinical symptoms.
Long-term treatment. With long-term treatment, especially for more than 1 year, patients should be under regular medical supervision.
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 Proxium 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 proton pump inhibitors such as pantoprazole for at least 3 months, and in most cases within a year. The following serious clinical manifestations of hypomagnesemia may occur and initially develop imperceptibly: fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia. With hypomagnesemia, in most cases, the patient's condition improved after replacement corrective therapy with magnesium preparations and discontinuation of proton pump inhibitors.
Patients requiring long-term therapy, or patients taking proton pump inhibitors concurrently with digoxin or preparations that can cause hypomagnesemia (such as diuretics), should have magnesium levels measured before starting 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. Observational studies indicate that the use of proton pump inhibitors can increase the overall risk of fracture 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.
Subacute cutaneous lupus erythematosus. The use of proton pump inhibitors is associated with very rare cases of subacute cutaneous lupus erythematosus. If a lesion occurs, especially in areas exposed to sunlight, and this is accompanied by arthralgia, the patient should immediately consult a doctor who will consider the need to discontinue Proxium. The occurrence of subacute cutaneous lupus erythematosus in patients during previous therapy with proton pump inhibitors may increase the risk of its development with the use of other proton pump inhibitors.
Use during pregnancy and lactation. Pregnancy. The available data on the use of the preparation Proxium in pregnant women (approximately 300-1000 reports of pregnancy results) indicate the absence of embryonic or fetal / neonatal toxicity of the preparation. Reproductive toxicity has been observed in animal studies. As a preventive measure, the use of Proxium in pregnant women should be avoided.
Lactation. Animal studies have shown the excretion of pantoprazole into breast milk. There are insufficient data on the excretion of pantoprazole into breast milk, but such excretion has been reported. Risk to newborns / babies cannot be ruled out. The decision to discontinue breastfeeding or to discontinue treatment with Proxium should be made in light of the benefits of breastfeeding for the baby and the benefits of treatment with Proxium for women.
Fertility Pantoprazole has not impaired fertility in animal studies.
Children. Proxium 40 mg is indicated for children over the age of 12 years for the treatment of reflux esophagitis. The preparation is not recommended for use in children under 12 years of age, as data on the safety and efficacy of the preparation for this age group are limited.
The ability to influence the reaction rate when driving vehicles or other mechanisms. Pantoprazole does not affect or has very little effect on the reaction rate when driving or using other mechanisms. It is necessary to take into account the possible development of adverse reactions such as dizziness and visual disturbances. In such cases, you should not drive vehicles or work with mechanisms.

Interactions

Medicines, the absorption of which depends on the pH. as a result of complete and long-term inhibition of hydrochloric acid secretion, pantoprazole can affect the absorption of preparations for which the pH value of gastric juice is an important factor in their bioavailability (for example, some antifungal preparations such as ketoconazole, itraconazole, posaconazole or other preparations such as erlotinib)
HIV protease inhibitors. The combined use of pantoprazole with HIV protease inhibitors (such as atazanavir), the absorption of which depends on gastric pH, is not recommended, due to a significant decrease in their bioavailability (see SPECIAL INSTRUCTIONS).
In the case when the combined use of HIV protease inhibitors with proton pump inhibitors cannot be avoided, careful clinical monitoring (for example, viral load) is recommended. Do not exceed the daily dose of pantoprazole 20 mg. It may be necessary to adjust the dose of HIV protease inhibitors.
Indirect anticoagulants (phenprocoumon and warfarin). The combined use of pantoprazole with warfarin or fenprocoumon did not affect the pharmacokinetics of warfarin, fenprocoumon, or MNI. However, an increase in MNI and a prolongation of prothrombin time were reported in patients who used proton pump inhibitors and warfarin or phenprocoumon in combination. An increase in MNI and a lengthening of prothrombin time can lead to the development of pathological bleeding and even death. In the case of such a combined use, it is necessary to monitor the PIM and prothrombin time.
Methotrexate. The concomitant use of high doses of methotrexate (eg 300 mg) and proton pump inhibitors has been reported to increase blood levels of methotrexate in some patients. Patients taking high doses of methotrexate, such as those with cancer or psoriasis, are advised to temporarily discontinue pantoprazole treatment.
Other interactions. Pantoprazole is largely metabolized in the liver through the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by 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 and oral contraceptives containing levonorgestrel and ethinyl estradiol, have not revealed clinically significant interactions.
Interaction of pantoprazole with other preparations that are metabolized through the same enzyme system cannot be ruled out.
The results of a number of studies of possible interactions indicate that pantoprazole does not affect the metabolism of active substances that are metabolized by CYP 1A2 (eg caffeine, theophylline), CYP 2C9 (eg piroxicam, diclofenac, naproxen), CYP 2D6 (eg metoprolol), CYP 2E1 (e.g. ethanol), does not affect p-glycoprotein, which is associated with digoxin absorption.
There was no interaction with concomitantly prescribed antacids.
Studies have been conducted to study the interaction of pantoprazole with concomitantly prescribed certain antibiotics (clarithromycin, metronidazole, amoxicillin). There were no clinically significant interactions between these preparations.
Medicines that inhibit or induce CYP 2C19. Inhibitors of CYP 2C19, such as fluvoxamine, may increase the systemic effects of pantoprazole. The need to reduce the dose of the preparation should be considered for patients receiving long-term therapy with high doses of pantoprazole, and for patients with impaired liver function. Inducers of enzymes that affect CYP 2C19 and CYP 3A4, such as rifampicin and St. John's wort (Hypericum perforatum), can reduce plasma concentrations of proton pump inhibitors that are metabolized through these enzyme systems.

Overdose

Overdose symptoms are unknown. doses of up to 240 mg when administered intravenously for 2 minutes were well tolerated. because pantoprazole binds extensively to proteins, it is not a preparation that can be easily cleared by dialysis.
In case of an overdose with the appearance of clinical signs of intoxication, symptomatic and supportive therapy is used. There are no specific therapy recommendations.

Storage conditions

In original packaging.

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