Pantoloc 20mg takeda tablets treat gastroesophageal reflux (1 blister x 14 tablets)

Dosage form Box of 1 blister x 14 tablets
Specifications Pantoprazol

Ingredient

Composition information	Content
Pantoprazol	20mg

Uses

Indications

Adults and teenagers/adolescents 12 years and older:

Used in the treatment of symptoms of gastroesophageal reflux disease.

Used in prolonged control and prevention of recurrence in reflux esophagitis.

Adults: Preventing peptic ulcer caused by non -selective steroid anti -inflammatory drugs (NSAIDs) in patients at risk of ulcer and still have to continue treating with NSAIDs.

Pharmacokology

Pharmacological group: Proton pump inhibitors.

Pantoprazole is a substitute of benzimidazole that has the effect of inhibiting the excretion of the stomach hydrochloric acid by inhibiting the proton pump of the stomach cells.

pantoprazole is converted into an active form in acidic environments in stomach walls that have the effect of inhibiting H+/K+ - atpase enzyme, the end stage of the production of hydrochloric acid in the stomach. The inhibition depends on the dose and impact simultaneously on both the basic excretion process and increase the production of hydrochloric acid. In most patients, symptoms are completely lost within 2 weeks. Treatment with pantoprazole can reduce gastric acid, thus increasing the gastrin levels ratio according to the reduced acid concentration.

Increased gastrin concentration is reversible. Because Pantoprazole binds enzymes in a receptor location in the face cell, can cause separate inhibition to excrete hydrochloric acid by stimulating other substances (acetylcholine, histamine, gastrin). This impact is the same even when oral or intravenous treatment.

Gastrin values when hungry increases according to pantoprazole. When used in short, usually these values do not exceed the upper limit of normal levels. In most cases, gastrin levels doubled when long -term treatment. 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 long -term treatment (glandular hyperplasia).

However, according to studies, the formation of carcinoid predecessors (non -typical increase) or stomach carcinoids are noticed in Vivo tests that have not been observed on humans.

cannot completely exclude the effects of long -term treatment with pantoprazole for more than a year on endocrine parameters of the thyroid according to the results in Vivo studies.

Pharmacokinetics

absorption

Pantoprazole is quickly absorbed and reaches the highest concentration in plasma even after taking a single dose of 20 mg. On average, after using about 2 - 2.5 hours, the highest concentration in the serum reaches about 1 - 1.5 μg/ml and these values remain unchanged after use many times.

Dynamic pharmacokinetics do not change after the only dose or repeat. Within the dose of 10 - 80 mg, the kinetics of Pantoprazole in linear plasma are both after oral and intravenously.

absolute bioavailability of tablets is 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

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

Metabolism

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 selling time is about 1 hour and the clearance is about 0.1 l/hour/kg. In some cases, the phenomenon of slow excretion is. Due to the selective cohesion of Pantoprazole into proton pumps in the cells, half a lifetime elimination 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 in the serum and urine is Desmethyl Pantoprazole, the substance will match with sulphate. The sale time of the main metabolic form (about 1.5 hours) is not longer than the sale time of Pantoprazole.

Before taking Pantoloc 20mg takeda tablets treat gastroesophageal reflux (1 blister x 14 tablets)

How to use

Do not chew or crush the pills, should take whole tablets with water before meals an hour.

Dosage

Adults and children aged 12 and older:

Treatment of symptoms of gastroesophageal reflux disease: The recommended dose is 1 tablet of 20 mg/day. In general, symptoms decreased within 2-4 weeks of treatment. If 4 weeks are not enough, just extend the treatment for 4 more weeks to reduce the symptoms back to normal. Once the symptoms have been reduced, the symptoms can be controlled by a course required by 20 mg/day if necessary. It may be necessary to take into account the transfer of treatment with a continuous therapy in case the symptoms are not fully controlled after treatment with the required procedure.

Prolonged control treatment and prevention of recurrence in reflux esophagitis: In prolonged treatment, recommend the maintenance dose of 1 tablet of 20 mg/day, increase the dose to 40 mg/day if there is a recurrence. Pantoloc 40 mg may be used in this case. After controlling the symptoms of a recurrence, the dose can be reduced to 20 mg of pantoprazole.

Adults:

Preventing non -selective steroid anti -inflammatory stomach ulcers (NSAIDs) in patients at risk of ulcer and still have to continue treating with NSAIDs: recommended dose 1 tablet 20 mg/day.

Children under 12 years of age: It is not recommended to use in patients under 12 years of age due to safety and efficiency in this age group.

Patients with liver failure: Do not exceed the dose of 20 mg/day.

Patients with renal failure: No dose adjustment.

Older patients: No dose adjustment.

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? The body response with a dose of up to 240 mg when using intravenous lines for 2 minutes is well tolerated.

Because Pantoprazole is strongly connected to protein, the drug is not easily removed by feces. In case of overdose with signs of clinical poisoning, 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. Do not drink twice as prescribed.

Side Effects

Uncommon, 1/1000

Mental: Sleep disorder.

Nervous system: headache, dizziness.

Digestive system: diarrhea, nausea, vomiting, bloating, flatulence, constipation, dry mouth, abdominal pain, discomfort.

Skin and subcutaneous tissue: rash, itching.

musculoskeletal joints: hip fracture, wrist bone, spinal bone.

weakness, fatigue.

Instructions on how to handle ADR

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.

Warnings

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

Contraindicated

hypersensitivity to pantoprazole, drugs of benzimidazole groups or any excipients.

Be cautious when used

In patients with severe liver failure, monitoring liver enzymes regularly during treatment, especially when used in long term. If increased liver enzyme, treatment must be stopped.

The use of Pantoloc 20 mg to prevent peptic ulcer because NSAIDs should be very limited in patients who still have to continue treating with NSAIDs and patients at risk of increasing gastrointestinal complications. The increase in risks must be assessed according to high risk factors on each individual (old age> 65 years old, people with a history of stomach or duodenal ulcer or above gastrointestinal bleeding).

Pantoprazole can cover symptoms of malignant stomach disease and delay diagnosis. When there is any warning symptoms (noticeable weight loss without intentional, recurrent vomiting, difficulty swallowing, vomiting, anemia or black stool) and when suspected or showing stomach ulcers, diagnostic diagnosis eliminates malignant ulcers. An additional test should be conducted to evaluate if the warning symptoms continue despite the appropriate treatment.

It is not recommended to use a combination of pantoprazole with HIV protease inhibitors that can absorb stomach pH (Atazanavir ...) due to significantly reducing the bioavailability of these drugs.

In patients with Zollinger - Ellison syndrome and other conditions of increased diseases that need long -term treatment, pantoprazole and all other acid secretions can reduce the absorption of vitamin B12 (cyanocobalamin) due to reduction or deficiency of gastric chlohydric acid. This should be considered in patients with reduced reserves in the body or risk factors that reduce the absorption of vitamin B12 when treated long -term or if clinical symptoms are found.

In long -term treatment, especially for more than 1 year, regular patient supervision.

Pantoloc treatment may slightly increase the risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter, C. Difficile.

can reduce severe blood magnesium in many patients treated with PPI for at least three months, and most are in one year. Symptoms of severe blood magnesium (fatigue, spasticity, delusion, convulsions, dizziness/dizziness, ventricular arrhythmia) may occur but these symptoms may start silently and be ignored. In most patients, lowering blood magnesium is improved when supplemented with magnesium and stopped using PPI.

For patients who are expected to treat long -term or use ppi with digoxin or drugs that can cause blood magnesium (diuretics), should measure magnesium levels before and during treatment.

PPI, especially when used in high doses and long -term (> 1 year), can slightly increase the risk of hip, wrist and spine fractures, mainly in the elderly or in patients with other risk factors. Patients at risk of osteoporosis should be taken care of under the current clinical instructions and need to supplement vitamin D, calcium.

PPI is related to rare cases of lupus erythematosus on skin levels (SCLE). If the damage occurs, especially in the skin -exposed skin areas, and with symptoms of joint pain, patients should look for timely medical assistance and medical staff should consider stopping Pantoloc. Patients with lupus erythematosus on the skin after the previous treatment with PPI may increase the risk of lupus erythema on the skin level with other PPIs.

The ability to drive and operate machinery

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

If side effects occur such as dizziness and visual disorders, do not drive or operate machinery.

pregnancy

A average data on women shows that there is no deformity or toxicity on Pantoloc's fetus/newborn/newborn. In vivo studies show toxicity to reproduction.

Should avoid using Pantoloc during pregnancy.

The period of breastfeeding

In vivo studies show that pantoprazole secretes milk. There is not enough data on the excretion of Pantoprazole into breast milk but cannot rule out the risk for babies/children. Therefore, it is necessary to decide to stop breastfeeding or stop/abstain from pantoloc.

Drug interaction

pantoprazole can reduce the absorption of oral bio -use drugs dependent on gastric pH (Azol antifungal drugs such as ketoconazole, iTraconazole, posaconazole, erlotinib, HIV protease inhibitors such as Atazanavir). The dose of Pantoprazole should not exceed 20 mg daily and monitor patients closely.

There have been reports on Inr and prothrombin increase in patients with simultaneous use of PPI and Warfarin or phenprocoumon. It is necessary to monitor these indicators when treated with pantoprazole and warfarin/phenprocoumon.

Do not combine high doses of methotrexate (300mg) with ppi due to increased methotrexate levels in some patients.

Sucralfat slowed down the absorption and reduction of PPI's use, should use PPI at least 30 minutes before using sucralfat.

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. Pantoprazole cannot exclude drug interaction with other drugs or compounds that are metabolized by the same enzyme system.

CYP2C19 inhibitors (fluvoxamine) may increase the body exposure of Pantoprazole. Consider reducing the dose for patients with long -term pantoprazole or liver failure.

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

Storage

Store at temperatures below 30 ° C.

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