Pills Reprat 40mg Delorbis treat gastroesophageal reflux, esophagus (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Pantoprazol

Ingredient

Composition information	Content
Pantoprazol	40mg

Uses

indications

Reprat 40mg-Delorbis drugs are indicated in the following cases:

Adults and teenagers aged 12 years and older:

Treatment gastroesophageal reflux - esophagus.

Adults:

Coordinate with the appropriate antibiotic therapy to kill Helicobacter pylori (H.pylori) in patients with gastric ulcer caused by H. Pylori. A benzimidazole derivative inhibits the excretion of hydrochloric acid in the stomach by inhibiting proton pump specific in the wall cell.

pantoprazol is transformed into an active form in the acidic environment in the cell into, where the enzyme inhibitor H+, K+-atpase, meaning that at the end in the process of hydrochloric acid secretion in the stomach. The inhibition depends on the dose and affects both common acid secretion mechanisms and stimulant agents. As well as proton pump inhibitors (PPI) and other H2 receptor inhibitors, the pantoprazol treatment reduces acid in the stomach and thus increases gastric pH corresponding to the reduction of acid. The increase in gastric juice is recovered. Because Pantoprazol is connected to the enzyme near the cell receptor level, the drug can inhibit hydrochloric acid secretion regardless of stimulation by other drugs (acetylcholin, histamine , gastrin). The effect of oral medication and intravenously is the same.

Gastrin value increases with pantoprazol. When treated short, most cases do not exceed the normal limit. When long -term treatment, Gastrin doubled in most cases. However, excessive increase only occurs in special cases. There is an increase in specific endocrine cells (ECL) from mild to medium in a few cases when long -term treatment (easily leading to gland hyperplasia). However, according to studies conducted so far, the formation of money lesions (non -typical hyperplasia) or stomach tumors found in animal tests is not seen in humans.

According to results from animal studies, it is not possible to completely eliminate the effect of long -term treatment> 1 year with pantoprazol on thyroid endocrine values.

Pharmacokinetics

absorption

Pantoprazol is quickly absorbed and achieved a maximum concentration in plasma even after taking a single dose of 40 mg. After drinking, the maximum concentration in the serum is reached from 2 - 3 mcg/ml for about 2.5 hours. Pharmacokinetics do not change after one use or repeat use.

In the 10 - 80 mg dose, pantoprazol kinetics in plasma are linear when used orally and intravenously. Reprat's absolute bioavailability is about 77%. Simultaneous use with food does not affect AUC, the maximum concentration in plasma and bioavailability, only absorption time will increase.

Distribution

Pantoprazol is connected to serum protein about 98%. The distribution volume is about 0.15 I/kg.

Metabolism

Pantoprazol is metabolized mainly in the liver. The metabolic line is Demethylation by CYP2C19, which is the link with sulphate, another metabolic line is oxidation by CYP3A4.

Elimination

Elimination mainly in the kidneys (about 80%) is largely in the form of metabolites, the rest is eliminated through feces. The final sale time of Pantoprazol and the main metabolites Desmethylpantoprazole are about 1 hour and 1.5 hours respectively. The clearance is about 0.1 l/h/kg. There are several cases of slow elimination. Due to the specific connection of Pantoprazol with proton pump in the cell wall, the semi -waste time is not correlated with the time of inhibiting acid secretion (longer).

Characteristics in patients/groups of special patients

About 3% of the European population lacks a CYP2C19 function enzyme and are called poor metabolic people. In these people, the transformation of Pantoprazol is probably mainly catalyzed by CYP3A4. After taking a single dose of 40 mg of pantoprazol, AUC in people metabolizes is about 6 times higher than people with enzymes CYP2C19 (people with strong metabolism). The average peak concentration in plasma increased by about 60%. However, these findings do not make sense to the dose of pantoprazol.

When using Pantoprazol for patients with renal function, do not recommend the decrease in the dose (including patients who are getting hematoma). For healthy people, the time for selling short pantoprazol. Only a very small amount of pantoprazol is separated. Although the main metabolites have the time to sell daif How How are they are still fast and therefore there is no drug accumulation.

In the elderly volunteers, AUC and CMAX increases compared to young people, but it does not speak about clinical relevance.

Children

After giving children from 5 to 16 years old to take single dose 20 or 40 mg pantoprazol, AUC and CMAX are within the corresponding range as adults. After an intravenous injection of a single dose of 0.8 or 1.6 mg/kg for children from 5 to 16 years old, there is no significant link between pantoprazol and age or weight. AUC and integral distribution in accordance with the data in adults.

Before taking Pills Reprat 40mg Delorbis treat gastroesophageal reflux, esophagus (2 blisters x 10 tablets)

How to use

Take oral use. Take the whole tablet 1 hour before meals, do not chew or crush the pill.

Dosage

Adults and teenagers aged 12 and older:

Treatment of gastroesophageal reflux disease: 1 tablet/day. The dose can be doubled (2 capsules/day) in some special cases, especially when not responding to other treatments. Treatment time is usually 4 weeks, if not enough, can continue treatment for 4 more weeks.

Adults:

Coordinate with antibiotics to kill H. pylori:

In patients with peptic and duodenal ulcer patients with positive H. pylori, the treatment of PPI and antibiotics can kill the pathogens. National advice/advice should be considered for bacterial resistance and appropriate antibacterial use and indications. Depending on the trend of drug resistance, recommend the following combination to kill H. pylori:

1 tablet of reprat x 2 times/day + 1000 mg amoxicillin x 2 times/day. + 500 mg clarithromycin x 2 times/day)

1 tablet of reprat x 2 times/day + 400 - 500 mg metronidazol (or 500 mg tinidazol) x 2 times/day + 250 - 500 mg clarithromycin x 2 times/day

1 tablet of reprat x 2 times/day + 1000 mg of amoxicillin x 2 times/day 2 times Metronidazol (or 500 mg Tinidazol) x 2 times/day

In combination therapy to kill H. pylori, should use a second reprat tablet 1 hour before dinner. Coordination therapy is applied in 7-14 days. If Pantoprazol is indicated for continuing treatment to ensure healing ulcers, the recommended dose should be considered for stomach -duodenal ulcer.

In patients with stomach and duodenum ulcer with negative H. pylori test, the following dose is applied for single -treatment Reprat therapy:

Treatment of stomach ulcer: 1 tablet/day. The dose can be doubled (2 capsules/day) in some special cases, especially when not responding to other treatments. Treatment time is usually 4 weeks, if not enough, can continue treatment for 4 more weeks.

Treatment of duodenal ulcer: 1 tablet/day. The dose can be doubled (2 capsules/day) in some special cases, especially when not responding to other treatments. The treatment time is usually 2 weeks, if not enough, can continue treatment for another 2 weeks.

Treatment of Zollinger Ellison syndrome and other pathological increased conditions: 2 tablets/day starting dose, then adjustable dose as required. There is a temporary increase in pantoprazol doses> 160 mg, should not be applied longer than necessary to control the acid fully. With a dosage> 2 capsules/day, it should be divided into 2 drinks. The treatment time for Zollinger Ellison syndrome and other conditions of increased diseases is unlimited and should be under clinical needs.

Children

Children Other objects

Elderly: No dose adjustment.

Hepatic failure: Maximum dose of 20 mg/day (1 pantoprazol 20 mg) in patients with severe liver failure. Do not use reprat in combination treatment to kill H. pylori in patients with severe liver dysfunction, because there is no data on safety and effectiveness of reprat in combination treatment for these patients.

Renal failure: No dose adjustment in patients with renal function. Do not use reprat in combination treatment to kill H. pylori in patients with renal function, because there is no data on safety and effectiveness of Reprat in combination treatment for these 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?

In case of overdose with clinical poisoning signs, applying supportive measures and symptomatic treatment. There is no specific treatment. Because pantoprazol is heavily connected to plasma proteins, the drug is not easy to separate.

Side Effects

When using a Reprat 40mg-Delorbis, you may experience unwanted effects (ADR).

Uncommon, 1/1000

Neurological: headache , dizziness, sleep disorders. Live.

immune: Hypersensitivity (including anaphylaxis and anaphylaxis ). bilirubin.

Blood: platelets, leukopenia.

Metabolic: Hypogonyal hypoglycemia, hypoglycemia. Interstitial .

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Reprat 40mg-Delorbis drugs are contraindicated in the following cases:

Hypersensitivity to active ingredients, derivatives of benzimidazol or any ingredients of the drug.

Be cautious when using

liver failure

Must regularly monitor liver enzymes in patients with severe liver failure during treatment with pantoprazol, especially when used for long term. In case of increased liver enzymes, treatment should be stopped.

Coordination therapy

In combination therapy, it is important to pay attention to the characteristics of combined drugs.

Presentation of warning symptoms

When there is any warning symptoms such as significant weight loss, non -intentional, repeated vomiting, difficulty swallowing, vomiting of blood, anemia or blood melanin and when suspected or gastric ulcer, eliminate evil tumors, because the treatment with Pantoprazol can reduce symptoms and slow down the diagnosis. If the symptoms remain, despite being fully treated, it is necessary to understand the cause.

Simultaneously used with Atazanavir

It is not recommended to simultaneously use Atazanavir with PPI. If the combination of Atazanavir with PPI is necessary, it is recommended to be closely monitored (blood virus level) when increasing atazanavir to 400 mg and 100 mg of ritonavir. The dose of pantoprazol should not exceed 20 mg/day.

Effects on the absorption of vitamin B12

In patients with Zollinger Ellison syndrome and other conditions of increased diseases need long -term treatment, as well as acid secretion, pantoprazol can reduce the absorption of vitamin B12 (cyanocobalamin) due to reduced or short of gastric acid, so be cautious in patients with reduced reserves or have risks of reducing absorption of vitamin B12 when long -term treatment or clinical symptoms.

Long -term treatment

In long -term treatment, especially when treated> 1 year, it is necessary to monitor patients regularly.

Gastrointestinal infections

Like other PPIs, Pantoprazol may increase the amount of normal bacteria present in the above digestive tract. Treatment with reprat can lead to slight increase in the risk of digestive infections caused by bacteria such as Salmonella and Campylobacter.

Magnesium reduction

There have been reports that have severe reduced blood magnesium in patients treated with PPI such as Reprat, for at least 3 months, and in most cases in 1 year. The serious manifestations of blood magnesium decreased such as fatigue, muscle spasms, delirium, convulsions, dizziness and ventricular arrhythmia may occur but may be mild and not noticed. In most patients who experience reducing blood magnesium will be improved after being supplemented with magnesium and stop using PPI. For patients who need long -term treatment or PPI users with digoxin or with drugs that can cause blood magnesium (such as diuretics), should consider measuring magnesium before starting treatment and periodically during the treatment with PPI.

PPIs, especially when taking high doses and prolonged treatment time (over 1 year), can slightly increase the risk of pelvic, wrist and spine fractures, mainly in the elderly or have other risk factors. Some surveys show that PPIs may increase the risk of entire fractures from 10 - 40%, which can also be due to other risk factors. Patients at risk of osteoporosis should be treated for treatment under the current instructions and should use enough vitamin D and calcium.

The ability to drive and operate machinery

adverse effects such as dizziness and then visual disorders may occur. If encountered, patients should not drive or operate machinery.

Pregnancy

There is no sufficient data on the use of pantoprazol in pregnant women. Animal studies show that there is reproductive toxicity. Unknown risk in humans. Do not use reprat during pregnancy unless really necessary.

Lactation period

Animal studies show Pantoprazol secreted into breast milk. There has been a report on the mother's milk. Therefore, it is possible to continue/stop breastfeeding or continue/stop using Reprat to consider the benefit of breastfeeding on the baby and the benefits of a reprat therapy and the mother.

Drug interaction

Due to the ability to inhibit acid secretion in the stomach strong and prolonged, Pantoprazole can reduce the absorption of drugs that depend on the stomach pH, such as Azol antifungal (Ketoconazol, iTraconazol, Posaconazol ), Erlotinib.

Simultaneous use of Atazanavir and other HIV medications with absorption depends on the stomach pH with proton pump inhibitors that can lead to a significant reduction in the bioavailability of HIV medications and can affect the effectiveness of these drugs. Therefore, it is not recommended to use proton pump inhibitors with Atazanavir.

Although there is no interaction when using phenprocoumon or warfarin simultaneously in clinical pharmaceutical studies. However, in some special cases, changing the INR index is reported when used simultaneously. Therefore, it is recommended to monitor Prothrombin/indicators in patients treated with anticoagulants (phenprocoumon or warfarin) after starting, termination or while using Pantoprazol.

Pantoprazol is strongly metabolized in the liver through the P450 enzyme system. The metabolic line is Demethyl turned by CYP2C19 and other metabolic lines including oxidation by CYP3A4. Studies on interactive drugs with specialized drugs through these lines (such as carbamazepin, diazepam , glibenclamid, nifedipine and oral contraceptives containing levonorgestrel and ethinyl estradiol) do not detect clinical interactions.

The results from a series of interactive studies prove that Pantoprazol does not affect the metabolism of active ingredients metabolized by CYP1A2 (such as caffeine, Theophylllin), CYP2C9 (such as Piroxicam, Diclofenac, Naproxen), CYP2D6 (such as Metoprolol), CYP2E1 (such as ETHANOL) or does Digoxin is related to p-glycoprotein. There is no interaction when used simultaneously with anti -acid agents. Interactive studies are also conducted when using Pantoprazol simultaneously with corresponding antibiotics (clarithromycin, metronidazol, amoxicillin ) cannot find clinical interactions related.

Storage

Storage in original packaging, at a temperature not exceeding 300C.

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