Ozzy-40 Davipharm tablets treat gerd, stomach-duodenal ulcer (3 blisters x 10 tablets)

Pantoprazole inhibits the stomach that secretes basic acid and even when stimulated by any factor. After drinking, the anti -secreting effect of Pantoprazole lasts more than 24 hours. Within 2.5 hours after taking 40 mg of pantoprazole, the acid excretion of the stomach is inhibited about 51%. If you take 40 mg once a day within 7 days, this inhibitor is up to 85%. Excreting stomach acid back to normal within 1 week after stopping Pantoprazole and there is no increase in secretion.

In most patients, symptoms may disappear after 2 weeks of treatment. Like other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces the acid levels in the stomach, thus increasing gastrin corresponding to the reduction of acid levels. The increase in gastrin is reversible.

pantoprazole oral or intravenously for the same effect.

Pantoprazole can inhibit Helicobacter pylori in patients with stomach ulcers - colon and/or orthon -contaminated esophagitis infected this bacteria. Combining pantoprazole treatment with antibiotics (such as amoxicillin, clarithromycin) can except H. pylori accompanied by an ulcer and remission for a long time.

CGA also increases as a decrease in stomach acid. Increasing CGA levels can affect the diagnosis of endocrine nerve tumors. Pantoprazole should be stopped between 5 days and 2 weeks before CGA measurement. This may allow the CGA level may have been wrongly assessed after treatment with proton pump inhibitors back to the reference range.

Pharmacokinetics

absorption

Pantoprazole quickly absorbed after oral and reached the highest concentration in plasma after taking the drug even after taking a 40 mg dose. The peak concentration is about 2–3 ng/ml after about 2.5 hours, this value is maintained after the dose is repeated.

pharmacokinetics do not change after single dose and repeat dose. In the 10 - 80 mg dose, the kinetics of Pantoprazole in linear plasma after oral or intravenously use. Absolute bioavailability of Pantoprazole tablets is about 77%. Food does not affect AUC, CMAX and the use of the drug but can slow down the absorption of the drug.

Distribution

About 98% Pantoprazole attaches to plasma proteins. The distribution volume is about 0.15 l/kg.

Metabolism

Maximum medication is mainly in the liver. Mostly metabolized by demethylation by CYP2C19 and then combined with sulfate, partly transformed by oxidizing by CYP3A4. The main metabolic substance in both serum and urine is Desmethylpantoprazole, which is associated with sulfate.

Elimination

The end of the ending time of Pantoprazole is about 1 hour and the clearance is about 0.1 hours/kg. In some cases, the elimination of drugs is slowed down. Due to the specific connection of Pantoprazole into the proton pump in the stomach wall, the disposal time of Pantoprazole is not correlated with the extension of the acting time (inhibiting acid secretion). About 80% of oral doses are eliminated in the form of non -active metabolites in the urine, the rest is eliminated in the feces. The sale time of the main metabolite (about 1.5 hours) does not last longer than Pantoprazole.

pharmacokinetics on special subjects

Poor drug metabolic people

In some people, because the lack of enzymes CYP2C19 operates due to genetics, slowing down the transformation of pantoprazole. In these people, the transformation of Pantoprazole is mainly catalyzed by CYP3A4 enzyme. After taking the single dose of Pantoprazole 40 mg, the AUC value in people with an enzyme deficiency CYP2C19 is 6 times higher than that of people with enough enzymes. Peak concentration in plasma increased by about 60%. This has no effect on the dose of Pantoprazole.

Hepatic failure

Although cirrhosis patients (Child Pugh A and B) have an increase of waste time from 7 to 9 hours and AUC increased by 5-7 times, the peak concentration in plasma only increased slightly, 1.5 times higher than normal people.

kidney failure

It is not recommended to reduce the dose for patients with renal impairment (including patients with hemorrhage). As well as in healthy adults, Pantoprazole has a short selling time. Only a very small amount of pantoprazole is separated. Although the main metabolic substance is extended to be relatively waste (2-3 hours), the elimination is still fast and therefore there is no drug accumulation.

Elderly

Aurly increased AUC and CMAX in the elderly volunteers compared to young people, without clinical relevance.

Children

After using a single dose of Pantoprazole 20 mg or 40 mg for children 5 - 16 years old, AUC and CMAX values ​​are similar to adults at both doses. After using a single dose of 0.8 or 1.6 mg/kg pantoprazole intravenously for children 2 - 16 years old, not significant relevant between Pantoprazole clearance with age or weight. AUC and the integral distribution are similar to adults.

Be cautious when using

When there are warning symptoms (such as unintentional weight loss, periodic recurrent vomiting, difficulty swallowing, vomiting of blood, anemia or defecation of black stool) and when suspected or gastric ulcer, it is necessary to eliminate malignant diseases (such as cancer) because the drug can cover symptoms and slow down the diagnosis. Consider further survey if the symptoms are prolonged even though it has been properly treated.

Hepatic failure

In patients with severe liver failure, periodic monitoring of liver enzyme should be conducted during treatment with pantoprazole, especially when taking a prolonged drug. Stop treatment if you see increased liver enzymes.

kidney failure

Most studies do not see the pharmacokinetic change of Pantoprazole. It is not recommended to adjust the dose in this patient group. However, only oral dose should only be up to 40 mg.

Coordination treatment

When combined treatment, summarizing the product characteristics of the corresponding preparations should be considered.

Used in combination with Atazanavir

It is not recommended to simultaneously use Pantoprazole and Atazanavir. If required to be used at the same time closely monitor, increase the dose of Atazanavir to 400 mg in combination with 100 mg of ritonavir, should not be used Pantoprazole more than 20 mg.

Vitamin B12 absorption

In patients with Zollinger -Ellison syndrome and other conditions of increased diseases need prolonged treatment, such as other antacids, Pantoprazole can reduce the absorption of vitamin B12 (cyanocobalamin) due to the effect of reducing gastric acid. It is necessary to consider when taking the drug for patients with a reduced vitamin B12 reserve or risk factors that reduce the absorption of vitamin B12 when treated for prolonged treatment or see the corresponding clinical symptoms.

Subclinical tests

Increased chromographin A (CGA) can hinder the diagnosis of endocrine nerve tumors. To avoid this effect, stop Pantoprazole at least 5 days before CGA test. If the CGA and Gastrin levels have not yet returned to the reference range after the initial measurement, it should be repeated after 14 days of stopping treatment with proton pump inhibitors. Prolonged treatment patients (especially over 1 year) should be monitored regularly.

Risk of fracture

When using proton pump inhibitors, especially when taking high doses and prolonging ≥ 1 year, it may increase the risk of pelvic fractures, wrist or spine due to osteoporosis, mainly occurs in the elderly or people with risk factors available. The mechanism of this phenomenon has not been explained, but it may be due to reduction in unanimidated calcium absorption due to gastric pH increase.

The lowest dosage recommendation works in the shortest possible time, suitable for clinical status. Patients at risk of osteoporosis should use enough calcium and vitamin D, assess bone condition and care according to clinical instructions.

Gastrointestinal infections

Proton pump inhibitors may increase the number of bacteria that are usually present in the above gastrointestinal tract. Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infections such as Samonella and Campylobacter.

may increase the risk of diarrhea due to Clostridium difficile when using proton pump inhibitors.

Magnesi blood (with or asymptomatic)

There have been cases of severe magnesi in patients treated with proton pump inhibitors such as pantoprazole for at least 3 months and in most cases of use lasting for more than 1 year. The serious manifestation of the blood magnesi such as fatigue, spasticity, delirium, convulsions, dizziness and ventricular arrhythmia may occur, but these symptoms may not be clear and overlooked. In patients most affected, the condition of hypoglycemia can be improved after stopping the drug and supplementing Magnesi.

For patients who are likely to be treated with prolonged proton pump inhibitors, or use in combination with digoxin or other drugs that can cause other blood magnesium (such as diuretics), should conduct testing and assessment of blood magnesium levels before starting treatment and periodically during treatment with proton pump inhibitors, including Pantoprazole.

Lupus erythematosus in skin (SCLE)

There has been a SCLE report in patients using proton pump inhibitors. If the damage occurs, especially the skin in direct sun exposure to the sun, with joint pain, it is recommended that patients see a doctor and consider stopping the drug for the patient. The patient had a history of SCLE after taking a proton pump inhibitor that could increase the risk of SCLE with other proton pump inhibitors.

Stomach atrophy

There has been a report of gastric tremons when gastric biopsy in patients treated for prolonged treatment with pantoprazole, especially in patients with H. pylori positive.

Acute interstitial nephritis

There has been acute nephritis reports in patients using proton pump inhibitors, including pantoprazole.

Cancer risk

Due to the chronic properties of gastroesophageal reflux disease, it may need to be used for pantoprazole. In long -term studies on rodents, Pantoprazole is a carcinogen and causes rare forms of gastrointestinal tumors. The involvement of these findings for tumor growth in unknown people.

Mannitol -containing drugs can cause light laxative.

To be out of reach of children.

The ability to drive and operate machines

pantoprazole does not affect or affect the ability to drive and operate machinery. Unwanted effects such as dizziness and visual disorders may occur. If there is an influence, it is recommended that patients should not participate in dangerous activities that need alertness such as working on high, operating machinery or driving train.

Pregnancy

Not enough data on the use of pantoprazole for pregnant women. Animal research shows reproductive toxicity. The risk is unknown. Do not use pantoprazole for pregnant women unless really needed.

The period of breastfeeding

Animal research shows that Pantoprazole secretes breast milk. There has been a pantoprazole report on milk in humans. Therefore, it is necessary to decide to stop breastfeeding or stopping the drug, depending on the importance of the medication for the mother and the benefit of breastfeeding.

Drug interaction

The effect of pantoprazole on the dynamics of other drugs

Due to the effect of strong and prolonged acid secretion, Pantoprazole can reduce the absorption of some bio -use drugs depending on the stomach acid, such as some antifungal drugs Azole (ketoconazole, iTraconazole, posaconazole) and some other drugs such as Erlotinib.

HIV treatment (Atazanavir)

Simultaneous use of Atazanavir and other HIV treatments with pH absorption with proton pump inhibitors can significantly reduce the bioavailability of HIV treatment drugs and can affect the effectiveness of these drugs. Therefore, it is not recommended to simultaneously use proton and Atazanavir inhibitors.

anticoagulant drugs (phenprocoumon or warfarin)

Inrend and prothrombin time when using warfarin simultaneously with proton pump inhibitors can cause abnormal bleeding and death. Follow the INR and the prothrombin time at the beginning and at the end of the treatment, or while the unknown use is regular pantoprazole in patients taking warfarin or other cooumarin derivatives.

clopidogrel

Simultaneous use of pantoprazole and clopidogrel in healthy people does not see clinical effects on the concentration of the active metabolites of clopidogrel or clopidogrel in plasma reduces platelet inhibition effects. No dose adjustment when using clopidogrel and pantoprazole simultaneously.

Positive positive test in urine

There has been a fake positive report for Tetrahydrocannabinol (THC) in urine in patients who are taking proton pump inhibitors. Consider using specific methods to verify positive results.

methotrexate

Increased methotrexate levels in some patients when using high -dose methotrexate (e.g. 300 mg) with proton pump inhibitors. Consider temporary suspension of pantoprazole when prescribing high doses of methotrexate (as in the treatment of cancer, psoriasis) for patients.

Other drug interactive studies

Pantoprazole metabolizes mainly in the liver through the cytochrome p450 enzyme system. The metabolic path is Demethyl turned by CYP2C19 and other metabolic lines include oxidation by CYP3A4.

Interactive research with drugs also metabolizes these lines such as carbamazepine, diazepam, glibenelamid, nifedipine, and oral contraceptives containing levonorgestrel and ethinyl oestradiol without clinical drug interactions.

pantoprazole does not affect the metabolism of substances metabolized by CYP1A2 (such as caffeine, Theophyllline), CYP2C9 (such as metoprolol), CYP2E1 (such as ethanol) or does not hinder the absorption of P-Glycoprotein of Digoxin.

There is no drug interaction when used simultaneously with antacids.

Drug interactive studies have been conducted when used simultaneously pantoprazole with corresponding antibiotics (clarithromycin, metronidazole, amoxycillin) does not show clinical related drug interactions.