Domperidone Tablets
Function and Efficacy
This product is a peripheral dopamine receptor blocker that acts directly on the gastrointestinal wall, can increase the tension of the lower esophageal sphincter, prevent gastroesophageal reflux, enhance gastric peristalsis, promote gastric emptying, coordinate gastric and duodenal movements, inhibit nausea and vomiting, and effectively prevent bile reflux without affecting gastric juice secretion. This product is not easy to pass through the blood-cerebrospinal fluid barrier and has no inhibitory effect on dopamine receptors in the brain. Therefore, there are no extrapyramidal and other neurological and psychiatric adverse reactions.
Ingredients
The main ingredient is 10 mg of domperidone, and the auxiliary ingredients are starch, hydrogenated vegetable oil, hydrated lactose, magnesium stearate, microcrystalline cellulose, polyvinyl pyrrolidone, pregelatinized starch, and sodium lauryl sulfate.
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| DomperidoneIngredients |
This product is a peripheral dopamine receptor blocker that acts directly on the gastrointestinal wall, can increase the tension of the lower esophageal sphincter, prevent gastroesophageal reflux, enhance gastric peristalsis, promote gastric emptying, coordinate gastric and duodenal movements, inhibit nausea and vomiting, and effectively prevent bile reflux without affecting gastric juice secretion. This product is not easy to pass through the blood-cerebrospinal fluid barrier and has no inhibitory effect on dopamine receptors in the brain. Therefore, there are no extrapyramidal and other neurological and psychiatric adverse reactions. More |
57808-66-9 | 19 |
Appearance
This product is white tablets.
Indication
Used for indigestion, abdominal distension, belching, nausea, vomiting, and abdominal pain.
Usage and Dosage
Oral administration. Adults: 3 to 4 times a day, 10 mg each time, the dose can be doubled if necessary or follow the doctor's advice; Children: 3 to 4 times a day, 0.3 mg per kilogram of body weight each time, this product should be taken 15 to 30 minutes before meals.
Adverse Reactions
1. Occasionally mild abdominal cramps, dry mouth, rash, headache, diarrhea, nervousness, fatigue, drowsiness, dizziness, etc. may occur; 2. Sometimes serum prolactin levels may increase, galactorrhea, and gynecomastia may occur, but these symptoms will return to normal after stopping the drug; 3. Amenorrhea may occur in rare cases; 4. Extrapyramidal side effects (such as drooling, hand tremors, etc.) may occur in extremely rare cases, and these symptoms will recover completely on their own after stopping the drug.
Precautions
1. Those who are known to be allergic to domperidone or any of the ingredients of this product. 2. Contraindicated when increasing gastric motility may be dangerous (e.g. gastrointestinal bleeding, mechanical obstruction, perforation). 3. Contraindicated in patients with pituitary tumors (prolactinomas) that secrete prolactin. 4. Contraindicated in patients with pheochromocytoma, breast cancer, mechanical intestinal obstruction, and gastrointestinal bleeding. 5. Contraindicated in combination with oral ketoconazole, erythromycin, or other strong inhibitors of CYP3A4 enzymes that may prolong the QTc interval (e.g. fluconazole, voriconazole, clindamycin, amiodarone, telithromycin).
Special Population Medication
Precautions for children: Children under 1 year old have an incompletely developed blood-cerebrospinal fluid barrier, so the possibility of central nervous system side effects on infants under 1 year old cannot be ruled out. Precautions for pregnancy and lactation: Pregnant women should use with caution. Lactating women should stop breastfeeding while using this product. Precautions for the elderly:
Drug Interactions
1. Anticholinergic drugs such as acetaminophen, propantheline bromide, scopolamine, belladonna tablets, etc. will weaken the effect of this product and should not be taken at the same time; 2. When this product is used together with acetaminophen, ampicillin, levodopa, tetracycline, etc., the absorption rate of these drugs will increase; 3. Antacids and anti-secretory drugs will reduce the oral bioavailability of domperidone and should not be taken with this product at the same time; 4. Domperidone is mainly metabolized by CYP3A4 enzyme. In vitro test data show that co-administration with drugs that significantly inhibit CYP3A4 enzymes will lead to an increase in the blood concentration of domperidone; examples of CYP3A4 enzyme inhibitors are as follows: azole antifungal drugs, macrolide antibiotics, HIV protease inhibitors, nefazodone. In a test conducted on healthy volunteers with ketoconazole oral preparations, ketoconazole significantly inhibited the first-pass effect of domperidone mediated by CYP3A4, resulting in a 3-fold increase in the Cmax and AUC of domperidone at steady state. In the domperidone-ketoconazole interaction study, it was observed that the combined use of domperidone (10 mg/time, 4 times/day) and ketoconazole (200 mg/time, 2 times/day) would increase the QT interval by 10-20 milliseconds. This phenomenon was not found when domperidone was used alone (10 mg/time, 4 times/day). The mechanism of QT interval prolongation caused by the combination of these two drugs is still unclear, and the pharmacokinetic data of domperidone cannot explain this phenomenon. In another repeated dose study using healthy volunteers, no significant changes in the QT interval were observed when domperidone monotherapy dosed up to 40 mg/time, 4 times/day (160 mg per day, 2 times the maximum daily dose). The plasma concentration of domperidone in this study was similar to that in the previous domperidone-ketoconazole interaction study. 5. Because domperidone has a gastric motility-promoting effect, it can theoretically affect the absorption of oral drugs used in combination, especially sustained-release or enteric-coated preparations. When this product is used in combination with digoxin, the absorption of the latter will be reduced; 6. Domperidone does not enhance the effect of neuroleptics; 7. Domperidone will reduce the peripheral side effects of dopaminergic agonists (such as bromocriptine, levodopa), such as gastrointestinal symptoms, nausea and vomiting, but will not antagonize their central effects; 8. If you are taking other medicines, please consult a physician or pharmacist before using this product.
Storage
Keep away from light and store in a sealed container.
Packaging Specification
5 mg
Validity Period
60 months.