Pantoloc 40mg takeda tablets treat reflux esophagitis (1 blister x 7 tablets)

pantoprazole is converted into an active form in the acidic environment in the cells into stomach walls to cause an inhibition of enzyme H+, K+–atpase, the final stage of producing hydrochloric acid in the stomach. The inhibition depends on the dose and simultaneously acting on the basic excretory process and the production of hydrochloride acid.

In most patients, symptoms of complete loss within 2 weeks.

As well as other H2 receptor inhibitors and receptor inhibitors, Pantoprazole can help reduce stomach acid, thus increasing gastrin concentration according to the reduced acid levels. Increased gastrin concentration is reversible. Because Pantoprazole binds enzymes in a receptor location in the facial cell, can cause separate inhibition with the excretion of hydrochloride acid by stimulating other substances (such as acetylcholine, histamine, gastamine). This impact is the same even when oral or intravenous treatment.

pharmacokinetic

absorption

Pantoprazole is quickly absorbed and achieved the highest concentration in plasma even after taking a single dose of 40mg. On average, after using about 2.5 hours, the highest concentration in the serum reaches about 2 - 3µg/ml and these values ​​remain unchanged after use many times.

Dynamic pharmacokinetics do not change after the only dose or repeat. Within 10 - 80mg dose, pantoprazole dynamics 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 therefore does not affect bioavailability

Distribution

Pantoprazole ratio combined with plasma proteins is about 98%. The distribution volume is about 0.15l/kg.

Metabolism

The drug is metabolized almost completely through the liver. The main metabolic line is methyl by CYP2C19 and then combined with sulfate, a metabolic line is different from oxidation by CYP3A4.

Elimination

Selling time is about 1 hour and the clearance is about 0.1L/hour/kg.

In some cases, the phenomenon of slow excretion is. Due to the selective cohesion of Pantoprazole into proton pumps in the cells, the sale time of the drug is not correlated with the ability to extend the impact of the drug (acid excretion inhibitor).

The metabolites of Pantoprazole are excreted mainly through the kidneys (about 80%), the rest is eliminated through feces.

The main metabolic form of both serum and urine is Desmethylpantoprazole, the substance will match with sulfate. The sale time of the main metabolic form (about 1.5 hours) is not longer than the sale time of Pantoprazole.

Treatment of stomach ulcers

One tablet per day. In some cases such as not responding to treatment, double the dose may be doubled (2 tablets/day). Treatment of stomach ulcers is usually 4 weeks. If not enough, the results are usually achieved after another 4 weeks of treatment.

Treatment of duodenal ulcer

One tablet per day. In some cases such as not responding to treatment, double the dose may be doubled (2 tablets/day). The duodenal ulcer usually caught within 2 weeks. If not enough, the results are usually achieved after another 2 weeks of treatment.

Treatment of Zollinger - Ellison syndrome and conditions increased pathology

Should start at a dose of 80mg/day (1 capsule 2 times/day). Then increase or decrease the dose depending on the results of measuring the concentration of gastric acid secretion. The temporary dose may be increased over 160mg/day but not treated longer than the necessary time for stomach acid to be adjusted. Adjust the appropriate treatment time for clinical treatment needs.

Hepatic failure

Do not exceed the dose of 20mg/day pantoprazole in patients with severe liver failure. Pantoloc 40mg is not used in combination treatment to eradicate Helicobacter pylori for patients with a degrees of liver dysfunction from medium to severe, because there is no data on the effectiveness and safety of Pantoprazole in combination treatment for these patients.

kidney failure

Unsurting dose adjustment in patients with renal function. Pantoloc 40mg is not used in combination treatment to kill Helicobacter pylores, patients with kidney function because there is currently no data on effectiveness and safety of Pantoloc 40mg in combination treatment in these patients.

Elderly

Unnecessary dose adjustment in elderly patients.

Children under 12 years old

Not recommended for use due to safety and efficiency data is limited in this age group.

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, in addition to symptomatic treatment and supportive treatment, no specific treatment recommendations can be given.

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. Note that it should not be used double the prescribed dose.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Precautions when using

liver failure

In patients with severe liver failure, liver enzyme should be monitored during pantoprazole treatment, especially when used in the long term. In the case of increased liver enzyme, treatment must be stopped.

Coordination treatment

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

Malignant stomach disease

Meet symptoms with Pantoprazole can cover symptoms of malignant stomach disease and delay diagnosis. When there is any warning symptom (such as noticeable weight loss, recurrent vomiting, difficulty swallowing, vomiting, anemia or black stool) and when suspected or showing stomach ulcers, diagnosis of malignant ulcer must be conducted. Additional studies should be conducted to evaluate if the warning symptoms continue despite appropriate treatment.

Combined with HIV Protease inhibitors

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

Effects on the absorption of vitamin B12

In patients with Zollinger - Elison syndrome and other conditions of increased diseases need long -term treatment, Pantoprazole as well as all other acid secretion inhibitors can reduce the absorption of vitamin B12 (cyanocobalamine) due to reduction or deficiency of gastric 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

Pantoprazole as well as all other proton pump inhibitors (PPI) can be expected to increase the number of bacteria that are often present in the gastrointestinal tract. The treatment with Pantoloc 40mg can lead to a slight increase in the risk of gastrointestinal infections due to bacteria such as Salmonella and Campylobacter or C. Difficile.

Magnesi hypoglycemia

Severe reduction of severe blood magnesia has been reported in many patients treated with proton pump inhibitors (PPIS) such as Pantoprazole for at least 3 months and in most cases in 1 year.

Symptoms of severe blood magnesia reduced blood such as fatigue, spasticity, delirium, convulsions, dizziness, dizziness and ventricular arrhythmia may occur but these symptoms may start silently and be ignored.

In most of the affected patients, lowering blood magmesi is improved when supplemented with magnesi and stopped using PPI.

For patients expected to be treated for a long time or use PPIS with digoxin or the drug can cause blood magnesium (such as diuretics), health experts should consider measuring magnesium levels before starting treatment with PPI and periodically during treatment.

fracture

Proton pump inhibitors, especially when used in high doses and long -term treatment (> 1 year), can moderate the risk of hip, wrist and spine fractures, mostly in the elderly or in patients with other risk factors.

Observing studies show that proton pump inhibitors can increase the risk of fractures by 10 - 40%. Some of these increase cases may be due to other factors.

Patients with osteoporosis should be taken care of under the current clinical instructions and they should be fully used for 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 skin -exposed skin areas and if the symptoms of joint pain are accompanied by symptoms, patients should contact the medical staff in time and the medical staff should consider stopping using Pantoloc.

Patients with the skin of the skin of the skin after the previous treatment with proton pump inhibitors may increase the risk of the skin of the skin of the skin with other Proton pump inhibitors.

The ability to drive and operate machinery

pantoprazole does not have or negligible effect on the ability to drive or operate machinery.

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

Pregnancy

A average data on pregnant women (about 300 - 1000 pregnant women) shows that there is no deformity or toxicity on the fetal/newborn of Pantoloc 40mg.

Animal studies have shown toxicity to reproduction.

Potential risk to people has not been clarified. So as a cautious measure, avoid using pantoloc 40mg during pregnancy unless really necessary.

Breastfeeding period

Animal studies have shown pantoprazole excretion into milk. There is currently no enough data on the excretion of Pantoprazole in breast milk but the excretion of breast 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 treating with Pantoloc, which should be based on the benefits of breastfeeding and the benefits of Pantoloc treatment on the mother.

Drug interaction

Pharmacokinetic drugs absorbing pH

Due to the prolonged gastric acid secretion effect, Pantoprazole can reduce the absorption of drugs that depend on the stomach pH, ​​for example, some antifungal drugs Azole such as Ketoconazole, Itraconazole, Posaconazole and other drugs such as Erlotinib.

HIV Protease inhibitors

It is not recommended to simultaneously use Pantoprazole with HIV Protease inhibitors that have a pH absorption like Atazanavir due to significantly reducing the bioavailability of these drugs. If the combination of HIV protease inhibitors is not avoided with proton pump inhibitors, clinical monitoring recommendations (for example, strict viral load). The dose of pantoprazole should not exceed 20mg daily. May also need to adjust the dose of HIV Protease inhibitors.

anticoagulant drugs (phenprocoumon or warfarin)

Simultaneous use of pantoprazole with warfarin or phenprocoumon does not affect the pharmacokinetics of warfarin, phenprocoumon or the INR index. However, there have been reports on Inr and prothrombin time in patients using proton and warfarin or phenprocoumon inhibitors. The increase in Inr and prothrombin time can lead to abnormal bleeding and even death. Patients treated with pantoprazole and warfarin or phenprocoumon may need to be monitored in the level of Inr and prothrombin.

methotrexate

There has been a report on the combination of high doses of methotrexate (e.g. 300mg) with proton pump inhibitors that increase methotrexate levels. So when using a combination of high doses of methotrexate, for example, cancer treatment and psoriasis, can temporarily stop using Pantoprazole.

clopidogrel

Simultaneous use of pantoprazole and clopidogrel on healthy people does not cause clinical significance on the transformation into the activity form of clopidogrel or platelet inhibitor caused by clopidogrel. It is not necessary to adjust the clopidogrel dose when used with the approved pantoprazole dose.

Sucralfate

The ability to slow down and reduce the bioavailability of proton pump inhibitors (such as Lansoprazole, Omeprazole). Use proton pump inhibitors at least 30 minutes before using sucralfate.

Pantoprazole is strongly metabolized in the liver through the cytochrome P450 enzyme system. The main metabolic line is methyl by CYP2C19 and other metabolic lines include oxidation by CYP3A4.

Studies on interaction with drugs have also been metabolized through these roads such as carbamazepine, diazepam, glibenclamide, nifedipine and oral contraceptives containing levonorgestrel and ethinyl oestradiol without detecting clinical significance. However, the interaction of Pantoprazole with other drugs or compounds that is metabolized by the same enzyme system can be excluded.

Results from a series of interactive studies prove that Pantoprazole does not affect the metabolism of active ingredients metabolized by CYP1A2 (such as caffeine, Theophyllline), CYP2C9 (such as piroxicam, diclofenac, Naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ETHANOL) or does not prevent the absorption of revenue. Digoxin is related to p-glycoprotein.

No clinical interactions are found to simultaneously use pantoprazole with corresponding antibiotics ( clarithromycin , metronidazole, amoxicillin).

CYP2C19 inhibitors such as fluvoxamid may increase the body exposure of Pantoprazole.

may consider reducing the dose for patients with long -term pantoprazoel treatment or high doses or liver failure.

Enzyme -induced touch agents on CYP2C19 and CYP3A4 such as Rifampicin and St John’s Wort (Hypericum Perforatum) can reduce plasma concentrations of ppi transformed through these enzymes.