Toulalan Davipharm treatments for stomach symptoms (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Itopriide

Ingredient

Composition information	Content
Itopriide	50mg

Uses

indications

Toulalan Davipharm 6x10 is indicated in the following cases:

Treatment of stomach -intestinal symptoms caused by chronic gastritis (abdominal distention, upper abdominal pain, anorexia, heartburn, nausea and vomiting).

Pharmacokology

Mechanism of action:

Itoprid HCl increases the release of acetylcholin (ACH) due to the antagonistic effect of D2 dopamine receptor, and inhibit the decomposition of acetylcholin released by inhibiting acetylcholin esterase, leading to increased gastric and gastrointestinal motility.

Increases stomach - intestinal motility:

Increases stomach motility. Itoprid HCl increases the gastric motility of the dog at the time of waking up, depending on the dose.

Increase the ability to empty the stomach. Itoprid HCl increases the possibility of stomach empty in humans, dogs, and rats.

Reduces vomiting:

Itoprid HCl inhibits vomit in dogs caused by apomorphin, this effect depends on the dose.

Dynamic pharmacokinetics

Serum concentration:

Serum concentration and pharmacokinetics parameters in healthy adults, after a single dose of oral 50 mg of iToprid HCl when hungry are specified in Figure 1 and Table 1.

Figure 1. Serum concentration after a single dose of oral 50 mg of Itoprid HCl (healthy adults when hungry, average value ± s.e.).

Table 1. The pharmacokinetic parameters

dose (mg)

cmax (µg/ml)

TMAX (hour)

auc0-∞ (µg.

t1/2β (now)

0.28 ± 0.02

0.58 ± 0.08

0.75 ± 0.05

5.77 ± 0.33

Distribution:

Results obtained from animal experiments:

The maximum concentration is achieved at almost all tissues from 1 to 2 hours after the single dose of 5 mg/kg 14C-ITOPRID HCl in mice, and 2 hours after oral concentration is high in the kidneys, small intestine, liver, adrenal glands, stomach (according to the degree of decrease from high to low) and the part of the medication goes into the central nervous system, such as brain and spinal cord, very little.

When putting 14C-Itoprid HCl at a dose of 5 mg/kg into the duodenum for rats, radioactive activity concentration in stomach muscles is about 2 times higher than blood levels.

Milk excretion: When taking oral dose of 5 mg/kg 14C-Itoprid HCl for rats, radioactive activity in milk compared to serum is 1.2 times higher than cmax, 2.6 times higher in AUC, and 2.1 times higher in T1/2.

Metabolism and elimination:

At the single dose of 100 mg of ITOPRID HCl for healthy adults (6 men) when hungry, the rate of excretion through the urine within 24 hours after drinking is the highest form of N-Oxide [67.54% of the dose (89.41% of the excretion in the urine)] and then the form of constant drug (4.14%), and the rest is not significant.

In experiments using microsome indicating CYP or Flavin Monooxygenase (FMO), showing that FM01 and FM03 participate in the N-Oxide main metabolites. However, there is no n -oxygenase activity of CYP1A2, -2A6, -2B6, -2C8, -2C9, 2C19, 2D6, 2E1, or 3A4.

Other issues:

Serum protein bonding ratio: The ratio of serum protein bonds is 96% after using a single dose of oral 100 mg of Itoprid HCl for healthy people (6 men) when hungry.

Before taking Toulalan Davipharm treatments for stomach symptoms (6 blisters x 10 tablets)

How to use

Take oral, drink before meals.

Dosage

The usual oral dose for adults is 150 mg of iToprid HCl (3 capsules) per day, divided 3 times, 1 capsule each time, drink before meals.

This dose may be reduced depending on the age and condition of each patient.

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?

No report on human overdose.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Toulalan Davipharm 6x10, you may experience unwanted effects (ADR).

At the time of the drug licensed to circulate in Japan:

Unwanted effects are seen in 14 (2.45%) in 572 patients (19 cases; 3.32%).

Unwanted effects are mainly:

diarrhea (4 cases; 0.7%);

Headache (2 cases; 0.35%);

Abdominal pain (2 cases; 0.35%).

leukopenia (4 cases);

Increase prolactin (2 cases).

At the time of re -evaluation:

Unwanted effects are seen in 74 (1.25%) on 5913 patients (104 cases; 1.76%).

The unwanted effects that have the main abnormalities in testing data are:

diarrhea (13 cases; 0.22%);

abdominal pain (8 cases; 0.14%);

Clinical undesirable effects:

shock and hypersensitivity reaction (unknown incidence):

shock and hypersensitivity reactions may appear, and should monitor patients closely.

Liver and jaundice dysfunction (unknown incidence):

Liver and jaundice disorders with AST (GOT), ALT (GPT) and γ-AGP ... may appear and the patient should be closely monitored.

Other undesirable effects (AR):

0.1%

Gastrointestinal tract: diarrhea, constipation, abdominal pain ...

liver: increase AST (GOT), increase ALT (GPT)

Symptoms of the pagoda (1): trembling ... γ-GTP, increase AI-P ...

Kidney: increase bun, increase creatinin ...

Other types: back pain or chest, fatigue ...

(1) The incompetent ratio is not known because these are spontaneous reports.

(2) If any abnormal signs are detected, it is advisable to have appropriate management measures, such as stopping the drug ...

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

Toulalan Davipharm 6x10 contraindicated in the following cases:

Patients with a history of hypersensitivity to any component of the drug.

Not used for pregnant or lactating women unless really necessary.

Caution when used

should note when used because this drug increases the activity of acetylcholin. Should not be used for long when there is no improvement in the symptoms of the stomach - intestines.

Use drugs for the elderly

Because the physiological function in the elderly decreases, unwanted effects are more likely to occur. Therefore, elderly patients who use this drug should be carefully monitored, if any unwanted effects appear, should use appropriate treatment measures, such as reducing the dose or stopping the drug.

used in pediatrics

The safety of drugs in children has not been determined (there is little clinical evidence).

Caution for excipients

Products containing lactose. Patients with rare genetic diseases with galactose tolerance, lapp lactase deficiency or glucose-galactose absorption disorders should not be used.

Products containing castor oil can cause abdominal pain, diarrhea.

Products containing Polysorbat 80 can cause allergies.

Cautions when distributing drugs

For pills in the click (PTP), instructing the patient to remove the drug from the packaging before use. (There is a report that if the PTP sheet is swallowed, its sharp angle can puncture the esophagus causing very serious complications).

The ability to drive and operate machinery

Unwanted effect as dizzy can occur. The ability to drive and operate machinery may be reduced.

Pregnancy

This drug should only be used in pregnant women, or in women may be pregnant only if the desired benefit of therapy is greater than the risks that may be encountered (the safety of this product in pregnant women has not been determined).

The best period of breastfeeding

It is best not to use this medication during breastfeeding, but if necessary, avoid breastfeeding during treatment. (There has been a report showing that the HCl's ITOPRID is excreted through milk in animal experiments (rats). (See the "pharmacokinetic" section)

Interactive drug

should note when using a combination of ITOPRID HCl with the following drugs:

Drugs

Signs, symptoms and treatment

Mechanism of action and risk factors

Symptoms: can reduce the effect of increasing stomach - intestinal motility of Itoprid (Cholinergic effect)

Mechanism: The inhibitory effect of anti -cholinergic drugs may have a pharmacological effect against the effect of Itoprid

Storage

In a dry place, avoid light, the temperature does not exceed 300C.

Other drugs

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