Product Overview
[Drug Name]
Generic Name: Itopride Hydrochloride Granules
Trade Name: Jiangbo
English Name: Itopride Hydrochloride Granules
Chinese Pinyin: Yansuan Yituobili Keli
[Ingredients]
N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide hydrochloride
[Properties]
This product is white or off-white granules.
[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 administration: 1 50mg sachet 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 and Neurological Symptoms: Headache, tingling, sleep disturbances, dizziness, etc.
4. Hematological 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 Symptoms: 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 patients with gastrointestinal bleeding, mechanical obstruction, or perforation.
[Precautions]
1. This product may enhance the effects of acetylcholine; therefore, 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. If prolonged QTc interval is observed on the electrocardiogram (ECG) during use, discontinue use.
[Use in Special Populations]
Precautions for Children:
Safety data for this product in children have not been established; use should be avoided.
Precautions for Pregnancy and Lactation:
1. Because the safety of this drug in pregnant women has not been confirmed, it should only be administered to pregnant women or women of childbearing potential when the therapeutic benefits outweigh the risks.
2. Because this drug has been reported to be transferred into breast milk in animal studies (rat studies), breastfeeding should be avoided while taking this drug.
Precautions for Elderly Patients:
Due to decreased physiological function in the elderly, adverse reactions are more common. Therefore, elderly patients should be carefully observed after taking this drug. If adverse reactions occur, the dosage should be reduced or the drug should be discontinued.
[Drug Interactions]
Because this drug may weaken the gastrointestinal motility-promoting effects of anticholinergic drugs such as tiquinolone bromide, scopolamine butylbromide, and thiophene bromide, it 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 increasing gastric and duodenal motility. This product has a beneficial effect on gastric motility, enhancing gastric and duodenal contractions, accelerating gastric emptying, and suppressing vomiting.
[Storage]
Store in a sealed container.
[Specification]
50 mg
[Packaging]
Aluminum foil bag, 9 bags/box
[Expiry Date]
24 months
[Approval Number]
National Medicine Standard H20050932
[Manufacturer]
Company Name: Laiyang Jiangbo Pharmaceutical Co., Ltd.
