Ibutop 50 OPV treat gastritis, abdominal distention, abdominal pain, anorexia, heartburn (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Itopriide

Ingredient

Composition information	Content
Itopriide	50mg

Uses

Indications

ibutop 50 treats stomach symptoms caused by chronic gastritis (feeling full of abdominal distention, upper abdominal pain, anorexia, heartburn, nausea and vomiting).

Pharmacokology

Mechanism of action

Itoprid Hydrochlorid increases the release of acetylcholin (ACH) due to the antagonistic effect of D2 dopamine receptor, and inhibit the decomposition of acetylcholine released by inhibiting acetylcholine esterase, leading to increased stomach peristability.

Increases stomach peristalsis

Increases stomach motility. Itoprid Hydrochlorid increases the gastrointestinal motility of the dog at the time of waking, depending on the dose.

Increase the ability to empty the stomach. Itoprid Hydrochlorid increases the ability to stomach empty in humans, dogs, rats.

Reduces vomiting

Itoprid hydrochlorid 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 Hydrochlorid when hungry are indicated in Figure 1 and Table 1:

Results obtained from animal experiments

Distribution

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

When putting 14C-Itoprid Hydrochlorid at a dose of 5 mg/kg into the duodenum, 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 Hydrochlorid for rats, the radioactive activity concentration in milk compared to serum is 1.2 times higher than cmax; 2.6 times higher about AUC; and 2.1 times higher in t1/2.

Serum protein bonding rate is 96% after using a single dose of oral 100 mg of iToprid Hydrochlorid for healthy people (6 men) when hungry.

Metabolism and elimination

At the single dose of 100 mg of iToprid hydrochlorid for healthy adults (6 men) when hungry, the rate of excretion through the urine within 24 hours after the highest oral drink is the N-Oxide format [67.54% of the dose (89.41% of the secretion in the urine)] and then the constant form of drug (4.14%), and the remaining substances are not significant.

In experiments using microsome indicating CYP or Flavin Monooxygenase (FM0), 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.

Before taking Ibutop 50 OPV treat gastritis, abdominal distention, abdominal pain, anorexia, heartburn (2 blisters x 10 tablets)

How to use

Ibutop drugs for oral, should be taken before meals.

Dosage

The usual oral dose for adults is 150 mg of iToprid Hydrochlorid (3 tablets) per day, divided 3 times, 1 tablet each time. This dose may be reduced depending on the age and condition of each patient.

What do

do when overdose? In case of serious overdose, common measures such as gastric lavage and symptomatic treatment should be applied.

What to do when you forget the 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.

Side Effects

When using Ibutop 50, you may experience unwanted effects (ADR).

At the time of the original 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%). The abnormalities of testing data are leukemia (4 cases), increasing prolactin (2 cases) ...

At the time of re -evaluation: Unwanted effects are seen in 74 (1.25%) in 5913 patients (104 cases; 1.76%). The unwanted effects have the abnormalities of testing data are diarrhea (13 cases; 0.22%), abdominal pain (8 cases; 0.14%), constipation (8 cases; 0.14%), increase AST (GOT) (8 cases; 0.14%), increase ALT (GPT) (8 cases; 0.14%) ...

Clinical undesirable effects

shock and hypersensitivity reaction (unknown incidence)

SHOCK AND HIRTHDAY RESPONSIBILITY may appear, and should monitor patients closely. Identify any signs of shock and hypersensitivity reactions, such as hypotension, shortness of breath, laryngeal edema, urticaria, pale and sweating ... Should stop ibutop 50 and have appropriate treatments.

Disorders of liver and jaundice (unknown incidence)

Disorders of liver and jaundice along with AST (GOT), ALT (GPT) and Y-AG ... may appear and patients should be closely monitored. If the above abnormal symptoms are detected, Ibutop should be stopped immediately and have appropriate treatments.

Other undesirable effects (AR)

0.1%≤ AR ≤ 5% AR

unknown incidence (1)

Itching ...

Symptoms of the pagoda (2) (2)

platelet reduction, leukopenia ... Head, uncomfortable feeling, sleep disorders, dizziness ...

(1) The incompetent rate 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 drugs ...

Instructions for handling ADR

Notify the doctor the unwanted effects encountered when using ibutop.

Warnings

Contraindicated

Contraindications for patients with a history of hypersensitivity to any component of the drug. Do not use for pregnant or breastfeeding women unless really necessary.

Caution when using

should note when used because ibutop 50 drugs increase the activity of acetylcholin.

Do not use for a long time without improving the symptoms of stomach.

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, use appropriate treatment measures, such as reducing the dose or stopping the drug.

Pediatric use: The safety of the drug in children has not been determined (there is little clinical evidence).

Pregnancy or lactation

Ibutop 50 should only be used in pregnant women, or in women who may be pregnant only when the desired benefit of therapy is greater than the risks may be encountered (the safety of this drug in pregnant women has not been determined).

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 itoprid hydrochlorid is excreted in milk in animal experiments (rats).

The ability to drive and operate machinery

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

Drug interaction

should note when using ibutop combinations with the following drugs: simultaneous use of Hydrochloride with anti-cholinergic drugs such as: Tiquizium Bromide, Scopolamine Butyl Bromide, Timepidium Bromide ... can reduce the effect of increasing gastrointestinal perchales of Itoprid-effect (effects Due to the inhibitory effects of anti -cholinergic drugs may have pharmacological effects against the effect of itoPrid.

Storage

Store at temperatures below 30 ° C, in a dry place, avoid light.

Expiry date: 36 months from the date of manufacture. Do not take ibutop when expired.

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