Product Overview
[Drug Name]
Generic Name: Itopride Hydrochloride Dispersible Tablets
Trade Name: Disha/Weitai
English Name: Itopride Hydrochloride Dispersible Tablets
Chinese Pinyin: Yansuan Yituobili Fensanpian
[Ingredients]
The main ingredient of this product is itopride hydrochloride.
[Properties]
This product is a white or off-white dispersible tablet.
[Indications]
This product is indicated for various symptoms associated with functional dyspepsia, such as upper abdominal discomfort, postprandial fullness, early satiety, loss of appetite, nausea, and vomiting.
[Dosage and Administration]
Oral: Adults, one 50mg tablet three times daily, 15-30 minutes before meals; or as directed by a physician.
[Adverse Reactions]
1. Allergic symptoms: rash, fever, itching, etc.
2. Digestive System: diarrhea, abdominal pain, constipation, increased salivation, etc.
3. Neuropsychiatric System: headache, tingling, sleep disturbances, dizziness, etc.
4. Hematologic System: leukopenia. Discontinue use if abnormalities are confirmed.
5. Rarely, elevated blood urea nitrogen (BUN) and creatinine levels may occur. Elevated AST, ALT, and prolactin levels (within the normal range) have been reported.
6. Other: chest and back pain, fatigue, numbness in the fingers, hand tremors, etc.
[Contraindications]
1. Contraindicated in patients with allergies to this product's ingredients.
2. Contraindicated in the presence of gastrointestinal bleeding, mechanical obstruction, or perforation.
[Precautions]
1. This product may enhance the effects of acetylcholine, so caution should be exercised during use.
2. If this product is ineffective, avoid long-term, unintended use.
3. Use with caution in patients with severe hepatic or renal impairment.
4. Discontinue use if prolonged QTc interval is observed on the electrocardiogram (ECG).
[Use in Special Populations]
Precautions for use in children:
Safety data for this product in children have not been established; therefore, use should be avoided.
Precautions for Pregnancy and Lactation:
1. Since safety in pregnant women has not been confirmed, administration to pregnant women or women of childbearing potential should only be considered when the therapeutic benefits outweigh the risks.
2. Because this product has been reported to transfer into breast milk in animal studies (rat studies), breastfeeding should be avoided while taking this medication.
Precautions for Elderly Patients:
Since elderly individuals are more susceptible to adverse reactions due to decreased physiological function, they should be carefully observed after taking this product. If any adverse reactions occur, measures such as dose reduction or discontinuation should be taken.
[Drug Interactions]
Since anticholinergic drugs such as tiquinolone bromide, scopolamine butylbromide, and thiophene bromide may weaken the gastrointestinal motility-promoting effects of this product, this product should be avoided in combination with these drugs.
[Pharmacological Actions]
Itopride hydrochloride increases acetylcholine release by antagonizing dopamine D2 receptors. It also inhibits the breakdown of released acetylcholine by inhibiting acetylcholinesterase, thereby enhancing gastric and duodenal motility. This product has a positive gastric motility effect, enhancing gastric and duodenal contractility, accelerating gastric emptying, and suppressing vomiting.
[Storage]
Store tightly closed
[Specifications]
50mg x 12 tablets
[Packaging]
Box
[Expiration Date]
24 months
[Approval Number]
National Medicine Standard H20031270
[Manufacturer]
Disha Pharmaceutical Group Co., Ltd.
