Pantogas 40 DHG medicine for reflux esophagitis (2 blisters x 10 tablets)

Pharmacological group treatment: Proton pump inhibitors.

Mechanism of action

Pantoprazol is an alternative of benzimidazol that has the effect of inhibiting the excretion of the stomach hydrochloride acid by inhibiting the proton pump of the stomach cells.

pantoprazol is converted into an active form in the acidic environment in the cells into the stomach to cause an inhibition of h, k -atpase enzyme, the final stage of producing hydrochloride acid in the stomach.

Dosage dependence and simultaneous impact on both the basic excretion and increase in the production of hydrochloride acid. In most patients, symptoms are completely lost within 2 weeks. As well as other lower -in -pumping and low -inhibited pump inhibitors, treatment with pantoprazol can reduce stomach acid, thus increasing the level of gastrin that is reversible. Because Pantoprazol binds the enzyme in a receptor location in the face cell, can cause separate inhibition to excrete hydrochloride acid by stimulating other substances (such as acetylcholin, histamine, gastrin). This impact is the same even when oral or intravenous treatment.

Gastrin values ​​when hungry increases according to pantoprazol. When in short -term use, in most cases these values ​​do not exceed the upper limit of normal levels. During long -term treatment, Gastrin concentration doubled in most cases. However, excessive increase only occurs in individual cases. The results have been observed slightly to the average of the number of specific endocrine cells (ECL) in the stomach in a few cases during the long -term treatment (simply glandular hyperplasia).

However, according to studies have been conducted so far, the formation of carcinoid predecessors (non -typical increase) or stomach carcinoid has been noticeable in animal tests that have not been observed on humans.

It is not possible to completely exclude the effects of long -term treatment with pantoprazol for more than one year on the endocrine parameters of the thyroid according to the results in animal studies.

Dynamic pharmacokinetics

absorption

Pantoprazol is quickly absorbed and achieved the highest concentration in plasma even after taking a single dose of 40 mg. On average, after use about 2.5 hours, the highest concentration in the serum is about 2-3 mcg/ml and these values ​​remain unchanged after use many times. Pharmacokinetics do not change after the only dose or repeat. Within 10 - 80 mg, pharmacokinetics of pantoprazol in linear plasma after oral use and intravenous injection.

The absolute bioavailability of the tablet is recorded about 77%. Used with food does not affect AUC, the highest concentration in the serum and thus does not affect bioavailability. Only the variation of late time will increase due to simultaneous use.

distribution

Pantoprazol ratio combined with serum protein is about 98%. The distribution volume is about 0.15 v/kg.

transformation

The drug is metabolized almost completely through the liver. The main metabolic line is methyl by CYP2C19 and then combined with sulphate, other metabolic lines include oxidation by CYP3A4.

Elimination

The final waste time is about 1 hour and the clearance is about 0.1 v/hour/kg. In some cases, the phenomenon of slow excretion is. Due to the selective cohesion of Pantoprazol into proton pumps in the walls, half -life elimination of the drug is not correlated with the ability to extend the impact of the drug (acid excretion inhibitor).

The metabolites of pantoprazol excreted mainly through the kidneys (about 80%), the rest is deducted through feces. The main metabolic form in the serum and urine is Desmethylpantoprazol, the substance will match with sulphat. The sale time of the main metabolic form (about 1.5 hours) is not longer than the selling time of pantoprazol.

Properties in patients/groups of special patients

Poor metabolic people

about 3% of European population lacks CYP2C19 function enzyme and is called poor metabolic. In these people, the metabolism of Pantoprazol can mainly be catalyzed by CYP3A4. After taking a single dose of 40 mg pantoprazol, the area under the plasma concentration curve over time is about 6 times higher than that of people with inferior metabolic people compared to those with CYP2C19 function enzymes (normal metabolic people). Peak concentration in plasma increased by about 60%. These findings have no effect on the dose of pantoprazol.

Patients with renal failure

It is not recommended to reduce the dose in patients with renal function (including patients who have to climb blood). As well as on healthy people, the sale time of short pantoprazol. Only a very small amount of pantoprazol is separated. Although the main metabolic form of Pantoprazol has relatively slow selling time (2-3 hours), the excretory process still takes place quickly and does not see the accumulation phenomenon.

Patients with liver failure

However, in patients with cirrhosis (type A and type B according to the Child classification system), the value of the selling time increases from 7 to 9 hours and the value of the area under the curve increases according to the coefficient of 5 - 7, the maximum concentration in the serum also increases slightly with a factor 1.5 when compared to healthy people.

Older people

There is a slight increase in the value of the area under the curve and the maximum concentration on the older volunteer when compared to the younger control but not clinically related.

Children

After using only 20 mg or 40 mg pantoprazol doses for children from 5 to 16 years old, AUC and CMAX are within the corresponding value in adults. After a single dose intravenous injection 0.8 mg or 1.6 mg/ kg pantoprazol for children from 2 to 16 years old, there is no significant related between the clearance of pantoprazol and age or weight. AUC and integral distribution in accordance with the data in adults.

To ensure the healing of ulcers, pantoprazol can be extended, but it is necessary to consider recommended doses for duodenal ulcers and stomach ulcers.

If there is no coordination treatment as in the case of Helicobacter pylori test, the application of Pantogas 40 therapy is as follows:

Treatment of stomach ulcers

1 pantogas 40 daily. In particular, the dosage may be used (increasing to 2 pantogas 40/ day) especially when not responding to other treatment. Treatment of stomach ulcer is usually 4 weeks.

If not enough, the results are usually achieved after another 4 weeks of treatment.

Treatment of duodenal ulcer

1 pantogas 40 daily. In particular, the dosage may be used (increasing to 2 pantogas 40/ day) especially when there is no response to other treatment. The duodenal ulcer usually cures within 2 weeks. If the 2 -week treatment period is not enough, the results are usually achieved after another 2 weeks of treatment.

Treatment of Zollinger - Ellison syndrome and other pathological excretion conditions

In long -lasting control treatment for Zollinger - Ellison syndrome and the situation of increased diseases of pathology, patients should start treatment at a dose of 80 mg/ day (2 pantogas 40/ day). Then increase or decrease the dose as required by measuring the concentration of gastric acid secretion to orient. With a dose of over 80 mg/ day, it is necessary to divide and take the drug 2 times. Can temporarily increase the dose of 160 mg of pantoprazol but not treat longer than the necessary time for stomach acid to be adjusted.

Without limiting the treatment time for Zollinger - Ellison syndrome and the situation of increased diseases, should adjust the time appropriate to the clinical treatment needs.

Special subjects

Children under 12 years old

Pantogas 40 is not recommended for use in children under 12 years of age due to safety and efficiency data in this age group.

Hepatic failure

Do not exceed the daily dose of 20 mg of pantoprazol (1 tablet of 20 mg of pantoprazol) in patients with severe liver failure. Pantogas 40 is not used in combination treatment to eradicate H. pylori for patients with liver dysfunction from medium to severe, because there is no data on the effectiveness and safety of Pantoprazol in combination treatment for these patients.

kidney failure

Unsurting dose adjustment in patients with renal function. Pantogas 40 is not used in Helicobacter pylori treatment in patients with renal function because there is currently no data on effectiveness and safety of Pantogas 40 in combined treatment in these patients.

Elderly

Unnecessary dose adjustment in elderly patients.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Systemic response to a dose of up to 240 mg when using intravenous lines for 2 minutes is well tolerated.

Because Pantoprazol is strongly connected to protein, the drug is not easily removed by feces.

In case of overdose with clinical poisoning signs, in addition to symptomatic treatment and supportive treatment, no specific treatment recommendations can be given.

In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Notify the physician with unwanted effects when using the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

liver failure

In patients with severe liver failure, liver enzymes should be monitored during pantoprazol treatment, especially long -term use. In case of increased liver enzyme, treatment must be stopped.

Coordination treatment

In case of coordination treatment, a summary of product characteristics of each drug.

Malignant stomach disease

Meet symptoms with Pantoprazol can cover symptoms of malignant stomach disease and delay diagnosis. When there is any warning symptoms (such as noticeable weight loss, recurrent vomiting, difficulty swallowing, vomiting, anemia, black stool) and when suspected or showing stomach ulcers, diagnostic diagnosis of malignant ulcer.

It is necessary to conduct additional studies to assess if the warning symptoms continue despite having appropriate treatment.

combined with HIV Protease inhibitors

It is not recommended to use a combination of pantoprazol with HIV protease inhibitors, but the ability to absorb depends on the stomach pH like Atazanavir due to significantly reducing the bioavailability of these drugs.

Influence on the absorption of vitamin B12

In patients with Zollinger - Ellison syndrome and other conditions of increased diseases that need long -term treatment, pantoprazol, as well as all other acid secretions can reduce the absorption of vitamin B12 (cyanocobalamin) due to reduced hydrochloric acid gastric or lack of acid hydrochloric acid. This should be considered in patients who have reduced body reserves or risk factors that reduce the absorption of vitamin B12 when treated long -term or if observed with clinical symptoms.

Long -term treatment

In long -term treatment, especially when the treatment time exceeds 1 year, it is necessary to monitor patients regularly.

Gastrointestinal infections caused by bacteria

Pantogas treatment can lead to a slight increase in the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. Difficile.

Magnesi blood

Severe blood magnesia reduction has been reported in patients treated with proton pump inhibitors (PPIS) such as Pantoprazol for at least three months, and in most cases in a year. Symptoms of severe magnesi hypoglycemia such as fatigue, spasticity, delirium, convulsions, dizziness and ventricular arrhythmia may occur but these symptoms may start silently and be overlooked. In most affected patients, reducing blood magnesium is improved after supplementing magnesi and stopping using PPIS.

For patients who are expected to treat long -term or use PPIS with digoxin or drugs that can cause reducing blood magnesium (e.g. diuretics), medical staff should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

fracture

Proton pump inhibitors, especially if high doses and prolonged doses (over 1 year), may increase the risk of hip, wrist and spinal bone fractures, mainly in the elderly or in patients with other risk factors. Many observation studies show that the risk of fractures is about 10-40%. Part of this increase rate may be due to other risk factors. Patients at risk of osteoporosis should be taken care of under the current clinical instructions and should be fully supplemented with vitamin D and calcium.

Lupus erythematosus (SCLE)

Proton pump inhibitors are associated with rare cases of lupus erythematosus on the skin. If the damage occurs, especially in the areas of the sun exposed to the sun, and if the symptoms of joint pain are accompanied by symptoms of joint pain, patients should look for timely medical assistance and medical staff should consider stopping Pantogas. Patients with high -level lupus erythematosus after the previous treatment with proton pump inhibitors may increase the risk of lupus erythema on the skin with other proton pump inhibitors.

The effect of the drug on driving and operating machinery

pantoprazol does not have or negligible effect on the ability to drive or operate machines.

The unwanted reactions of the drug such as dizziness and visual disorders may occur. If affected, patients should not drive or operate machinery.

Use drugs for women during pregnancy and lactation

Pregnant women

A average data on pregnant women (about 300 - 1000 pregnant women) shows no deformities or toxicity on the fetal/infant of Pantoprazol.

Animal studies have shown toxicity to reproduction.

As a cautious measure, avoid using pantoprazol during pregnancy.

breastfeeding women

Animal studies have shown Pantoprazol excreted into milk. There is not enough data on the excretion of Pantoprazol into breast milk but the excretion of milk has been reported. Can not rule out the risk for infants/young children. Therefore, it is necessary to decide to stop breastfeeding or stop/abstain from pantoprazol treatment, which should be based on the benefits of breastfeeding and the benefits of pantoprazol treatment on the mother.

fertility

There is no evidence of fertility impairment after using pantoprazol in animal research.

Interactive drug

Due to the deep and prolonged gastric secretion effect, Pantoprazole can affect the absorption of oral -oriented drugs depending on the stomach pH, ​​for example some Azol antifungal drugs such as ketoconazol, iTraconazole, Posaconazol and other drugs such as erlotinib.

HIV protease inhibitors

It is not recommended to simultaneously use Pantoprazol with HIV Protease inhibitors, but the ability to have the ability to absorb depends on the gastric pH like Atazanavir due to significantly reducing the bioavailability of these drugs.

If it is not avoided the combination of HIV Protease inhibitors with proton pump inhibitors, clinical monitoring recommendations (for example: strict viral load). The dose of pantoprazol should not exceed 20 mg daily. May also need to adjust the dose of HIV Protease inhibitors.