Nolpaza medicine 20mg Krka treat gastroesophageal reflux disease (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Pantoprazol

Ingredient

Composition information	Content
Pantoprazol	20mg

Uses

indications

Nolpaza 20mg drug is indicated for adults and children over 12 years old:

Gastroesophageal reflux disease Li: Proton pump inhibitors

ATC code. A02BC02

Mechanism of action:

Pantoprazol is a derivative of benzimidazol - a stomach hydrochloric secretion inhibitor by inhibiting the cell's proton pump into the stomach.

Pantoprazol is converted into an activity form when entering the acid secretary tubes of the stomach into the stomach, inhibiting the H+, K+- Atpase enzyme enzyme, thus preventing the final step in the production of stomach hydrochloric acid. The inhibition depends on the dose and impact on both the basic acid secretion and when the stomach is stimulated for any cause. On most patients, symptoms improved after 2 weeks.

As well as other H2 receptor inhibitors and receptor inhibitors, pantoprazole treatment reduces acid in the stomach and thus increases gastrin. Gastrin increase can be reversed. Because Pantoprazol is close to the enzyme far away from the receptor lies in the cell, therefore can affect the excretion of independent hydrochloride acid with stimulation by other agents (acetylcholin, histamine, gastrin).

Use oral or intravenously evenly effects on the same impact. Gastrin level increases when using pantoprazol. After a short time of use, in most cases the patient does not exceed the upper limit of normal levels. Use for a long time, most cases double the gastrin level. Excessive increase only occurs in some special cases. As a result, there is a slight to medium increase from specific endocrine cells (ECL) in the stomach recorded in a small group of patients using pantoprazol for a long time (benign prostate hyperplasia). However, according to the studies conducted until now, there has not been a formation of the precursor to carcinoid (not typical increase) or gastrin carcinoid in the human stomach as found on animal tests.

During treatment with excreted inhibitors, serum galam increased in response to acid secretion reduction. CGA also increased due to reduced stomach acid. The increase in CGA can hinder the diagnosis of the nerve tumor.

The evidence shows that proton pump inhibitors should be stopped 5 days before 2 weeks when conducting CGA quantitative quantification. This allows the CGA level to increase sharply due to PPI treatment that can return to the reference range.

According to animal studies, prolonged pantoprazol treatment for more than 1 year cannot completely eliminate hormonal indicators of the thyroid.

Pharmacokinetics

absorption

Pantoprazol absorbs quickly and the maximum concentration in plasma is achieved even when taking 1 dose of 20 mg oral. On average, after about 2.0-2.5 hours, the maximum concentration in serum is about 1-1.5 g/mol and does not change after multiple dosage.

The pharmacokinetics of Pantoprazol does not change when used single or multi -dose. In the dose of 10 - 80mg, plasma dynamics of linear pantoprazol after oral use and intravenously.

Birth of tablets is 77%. The absorption simultaneously with food does not affect AUC, CMAX and bioavailability. Only the lag (lag-time) increases when the drug is absorbed simultaneously with food.

Distribution

Pantoprazol binds to 98%plasma proteins. The distribution volume is about 0.15 l/kg.

Extraction of excretion

Pantoprazole metabolizes mainly through the liver by demethylation by CYP2C19 then combined with sulfate, a small part metabolized by oxidizing by CYP3A4. The half -life is about 1 hour and the clearance is about 0.1 l/hour/kg. A few cases of dots dotted due to the specific bond of pantoprazol with the cell's proton pump into the stomach. The metabolites excreted mainly through the kidneys (80%), the rest through the feces. The half -life of the main metabolites is about 1.5 hours.

Patients with liver and kidney failure

Do not reduce the dose of pantoprazol when used in patients with liver and kidney failure (including dialysis patients). As with healthy people, the half -life of Pantoprazol is short. Only a small amount of pantoprazol is separated.

Although the main metabolites have a slow selling time (2-3 hours), the process of export is fast, so the accumulation does not occur. For patients with liver failure (group A and B according to Child), the selling time increases from 3 to 6 hours, AUC increases from 3-5, the maximum concentration in the serum only increases slightly 1.3 times compared to healthy people.

Elderly

ACU and CMAX increase in the elderly compared to young people who are not clinically related.

Other special subjects

In some people deficiency of CYP2C19 enzyme, slow metabolism, pantoprazol metabolism may be mainly catalyzed by CYP3A4. After using a single dose of 40 mg of pantoprazol, the average area under the concentration curve - the time in plasma is approximately 6 times compared to those who do not lack CYP2C19 enzyme, the average plasma peak concentration increases by about 60%.

These findings do not make sense for determining the pantoprazol content.

Pediatric patients

After taking the single dose of 20 - 40 mg pantoprazol for patients 5 - 16 years old, AUC and CMAX are in the range equivalent to adults. After using a single dose of 0.8 or 1.6 mg/kg in children from 2 to 16 years of age, there is no association between age or weight or weight. AUC and the child's distribution volume similar to adults.

Before taking Nolpaza medicine 20mg Krka treat gastroesophageal reflux disease (2 blisters x 14 tablets)

How to use

Nolpaza tablets for oral, no chewing or crushing pills, swallowing all pills with water before eating 1 hour.

Dosage

Adults and children over 12 years old

Gastroesophageal reflux disease:

The recommended dose is 1 tablet of 20 mg Nolpaza daily. Symptoms usually improve after 2-4 weeks, or at most after 4 weeks.

After the symptoms have been relieved, the dose of 20 mg/day can control the recurrence of symptoms if required. Continuous treatment may be considered in case of unsatisfactory symptoms.

Long -term control and prevention of recurrence of reflux esophagitis:

For long -term control, the recommended maintenance dose is 20 mg daily, increasing to 40 mg daily if there is a recurrence. After treatment is recurrent, the dose can be reduced to 20 mg daily.

Adults:

Preventive gastric - duodenal disease prevention due to non -selective anti -inflammatory drugs (NSAIDs) in patients at risk and prolonged use of NSAIDs: The recommended dose is 1 tablet of Nolpaza 20 mg daily.

Elderly people: Unnecessary dose adjustment in elderly patients.

Patients with liver failure: daily dose is 20 mg and do not exceed the fruit for patients with severe liver failure.

Patients with renal failure: Unsurtable dose adjustment in patients with renal function.

Children under 12 years of age: do not recommend using Nolpaza for children under 12 years old because they do not have enough data on safety and efficiency on this object.

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 do

do when using overdose?

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not use double the prescribed dose.

Side Effects

approximately 5% of patients may experience unwanted effects (ADR). The ADR is reported mainly diarrhea and headache, both occur on about 1% of patients taking the drug.

The estimated frequency of ADR is arranged in accordance with the following convention: Common (≥1/100, Common

Gastrointestinal disorders: Powlyp basis.

Mental: Sleep disorders.

Nervous system: headache, dizziness. Itching.

Blood and lymphatic system: granulocyte loss. Sensory.

Blood and lymphatic system: thrombocytopenia, leukopenia, all bloody hemorrhage.

Metabolism and nutrition: Lower blood sodium, lower blood magnesium, lower blood calcium in combination with lower blood magnesium, lower potassium potassium. Lyell, roses are diverse to light sensitivity, semi -exponent lupus skin lesions.

Warnings

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

contraindicated

Nolpaaza tablets are contraindicated in the following case:

Hypersensitivity to any ingredients of the drug, with Benzimidazol or Sorbitol derivatives.

Be cautious when using

This drug is only used by prescription.

Read the instructions carefully before use. If you need more information, please consult your doctor or pharmacist.

Notify the doctor with unwanted effects when using the drug. Leave the medicine out of reach of children.

Do not use overdue drugs printed on the packaging.

Patients with liver failure:

In patients with severe liver failure, regular liver enzymes should be monitored when treated with pantoprazol, especially when long -term treatment. In case of increased liver enzymes should stop using the drug.

Use simultaneously with NSAIDs:

The use of Nolpaza 20 mg to prevent duodenal and duodenum ulcers caused by non -selective nonsteroidal anti -inflammatory drugs (NSAIDs) should be selected for patients who need continuous NSAID treatment and risk of thick skin and intestinal complications. Increased risk should be assessed according to personal risk factors, for example: elderly (> 65 years old), a history of stomach ulcer, duodenum or bleeding on the stomach - bowel.

Symptoms of stomach cancer:

If there is any symptoms of stomach cancer (unintentional weight loss, recurrent vomiting, difficulty swallowing, hemorrhage, anemia, fever) or when suspected stomach ulcers should eliminate malignant treatment due to pantoprazol treatment can cover symptoms and slow down the diagnosis of cancer.

Simultaneous use with Antazanavir:

Concomitant use of Antazanavir with proton pump inhibitors is not recommended. If simultaneous use is required, clinical monitoring should be closely monitored (viral load). Increasing Antanavir dose to 400 mg with 100 mg of Ritonavir. The dose of pantoprazol does not exceed 20 mg per day.

affect the absorption of vitamin B12:

In patients with Zollinger-Elison syndrome and other acid hyperactivity cases that require long-term treatment, pantoprazol as well as other acid-secreting drugs that can reduce the absorption of vitamin B12 (cyanocobalamin) due to drugs that reduce acid secretion in the stomach.

Prolonged treatment:

Special prolonged treatment for more than 1 year needs to be monitored regularly.

Gastrointestinal infections caused by bacteria:

Pantoprazol is like other ppi drugs, which can increase the unexpected number of bacteria in the above digestive tract. Treatment with Nolpaza can lead to a slight increase in the risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and C. Difficile.

Magnesium reduction:

Severe blood magnesium decreased has been reported in patients treated with Pantoprazol for at least 3 months and most patients treated for 1 year. The serious manifestations of the blood magnesium such as fatigue, lumbar pain, delirium, convulsions, dizziness and ventricular arrhyths may occur, but they often manifest silently and may be missed. Hypergenia reduction may be improved after adding magnesium and stopping PPI treatment. Patients with long -term treatment with ppi and digoxin or other medications that reduce blood magnesium such as diuretics need to be monitored blood magnesium levels before starting PPI and periodic treatment during treatment.

Fracture:

Proton pump inhibitors, especially if high doses and. Over 1 year, it may increase the risk of hip, wrist, spine fractures, mainly in the elderly or people with other risk factors. Studies show that PPI increases the risk of fractures by 10 - 40%.

Patients with osteoporosis risk need to be taken care of and supplemented with calcium, vitamin D.

Selling lupus skin lesions (SCLE):

There are very few reports that shows that SCLE is related to proton pump inhibitors. However, if the lesions occur, especially in the skin exposed to the sun, accompanied by joint pain, the patient should immediately notify the doctor. Consider stopping PPL if necessary.

affect test results:

Increased chronograpnin levels can hinder the diagnosis of nerve tumors, so it is necessary to stop the drug at least 5 days before CGA testing. If CGA and Gastrin do not return to the scope of reference after the first measurement, the measurement must be repeated 14 days after stopping treatment with PPI.

Nolpaza contains sorbitol:

Nolpaza contains sorbitol, patients with rare genetic problems in absorption of fructose should not use the drug.

Using drugs for women during pregnancy and lactation

Using drugs for pregnant women

There is no clinical data on pregnant women. Animal research shows reproductive toxicity. Nolpaza should not be used for pregnant women unless it is really necessary.

Using medicine for breastfeeding women

Animal research shows pantoprazol excreted through breast milk. Need to consider the benefits - the risk of the drug for the mother to decide the use of the drug.

The effect of drugs on driving and operating machinery

Unwanted effects such as dizziness and blurred vision may occur. If affected, patients should not drive and operate machinery.

Drug interaction

The effect of pantoprazol on the absorption of other drugs:

Due to the prolonged pantoprazol's acid secretion, it affects the absorption of biochemical drugs that depend on gastric pH such as some antifungal drugs belonging to the azol group (ketoconazol, otraconazole, posaconazole) and other drugs such as erlotinib.

HIV treatment drugs (Antazanavir):

Simultaneous use of proton pump inhibitors with Antazanavir and other HIV medications with pH absorption can reduce the bioavailability of HIV medications. Do not simultaneously inhibit the proton pump with antazanavir.

Coumarin anticoagulants (phenprocoumon or warfarin):

Although there is no interaction when used simultaneously with phenprocoumon or warfarin in clinical pharmacokinetic studies, some cases have changed in the reported INR. Therefore, patients are treated with Coumarin anticoagulants (phenprocoumon or warfarin) should track prothrombin/INR time at the beginning, end or when using unethical pantoprazol.

methotrexate:

Use high doses of methotrexate (300 mg) along with proton pump inhibitors that have been reported to increase methotrexate levels in some patients. Therefore, on patients who need high doses of methotrexate (cancer, waving candles) should consider suspending pantoprazol if necessary.

Other interactions:

Pantoprazol metabolizes mostly through the liver through the cytochrom P450 enzyme system. The main metabolic path is Demethyl Hoa by CYP2P19, a small part of oxidized by CYP3A4 and metabolized through other enzymes. Research on drugs also metabolized through this road such as carbamazepin, diazepam, glibenclamide, nifedipine, and a oral contraceptive containing levonorgestrell and ethinyl oestradiol without any interaction.

Results from studies show that Pantoprazol does not affect the metabolism of active ingredients metabolized through CYP1A2 (caffein, Theophylllin), CYP2C9 (Piroxicam, Diclofenac, Naproxen), CYP2D6 (Metoprolol), CYP2E1 (ETHANOL) and does not affect P -Glycoprotein related to consumption to consumption to consumption to consumption to consumption to consumption to consumption to crucial contents to crucial contents to crucial contents absorb Digoxin.

There is no interaction when used simultaneously with antacids. Studies conducted between patoprazol and antibiotics (clarithromycin, metronidazol, amoxicillin) show no clinical interactions.

Storage

Leave a cool place, avoid light, temperature below 30⁰C, avoid moisture.

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