Domperidone Tablets
Madinglin Duopanlitong Pian
Duo Pan Li Tong Tablets
MA Ding Lin
FUNCTION and INDICATIONS
It’s for indigestion, abdominal distension, belching, nausea, vomiting, abdominal distension and pain.
INGREDIENTS
The main ingredient is domperidone 10 mg. The auxiliary branches are starch, hydrogenated vegetable oil, hydrous lactose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, pregelatinized starch, and sodium lauryl sulfate.
DESCPRIPTION
This product is white tablet.
SPECIFICATION AND PACKAGE
10mg*30 tablets/box.
USAGE AND DOSAGE
Oral. Adults take 1 tablet at a time, 3 times a day, 15-30 minutes before meals.
REFERENCES
ADVERSE REACTION
1.Occasionally dry mouth, headache, insomnia, nervousness, dizziness, drowsiness, fatigue, abdominal cramps, diarrhea, reflux, nausea, heartburn, rash, itching, urticaria, stomatitis, conjunctivitis, etc.
2.Sometimes it leads to increased serum prolactin levels, galactorrhea, feminization of male breasts, irregular menstruation, etc., but it can return to normal after stopping the drug.
3.It has been reported that the daily dose exceeds 30 mg and/or patients with heart disease, tumor patients receiving chemotherapy, patients with serious organic diseases such as electrolyte imbalance, and patients older than 60 years old have severe ventricular arrhythmia or even The risk of sudden cardiac death may increase.
4 Adverse reactions are based on a comprehensive assessment of the existing adverse event information and are considered to be reasonably related to the use of domperidone. In individual cases, the causal relationship with domperidone cannot be reliably determined. Moreover, because clinical trials are conducted under various conditions, the incidence of adverse reactions observed in the clinical trials of one drug cannot be compared with the incidence of adverse reactions observed in the clinical trials of another drug. Direct comparison, and may not reflect the incidence of adverse reactions observed in clinical practice. 4. 1 Clinical trial data: The safety of medication was given to 1,275 subjects with dyspepsia, gastroesophageal reflux disease, irritable bowel syndrome, nausea, vomiting and other related conditions in 31 double-blind, placebo-controlled studies Sexual evaluation. All patients were ≥15 years old and had taken domperidone at least once. The median daily total dose is 30 mg (10-80 mg), and the median exposure period is 28 days (1-28 days). Studies on secondary symptoms caused by diabetic gastroparesis, chemotherapy or Parkinson's syndrome were excluded. Patients who received domperidone treatment in 31 clinical trials (N=1275) reported that ≥1% of adverse reactions were as follows (frequency of adverse reactions): dry mouth (1.7%); adverse reactions of <1% were as follows: lethargy (0.8 %), headache (0.6%6), galactorrhea (0.5%), diarrhea (0.4%), loss of libido (0.2%), rash (0.2%0), breast pain (0.2%), breast tenderness (0.2%), Itching (0.1%), anxiety (0.1%), fatigue (0.1%). In 45 studies that received higher doses of domperidone treatment, longer courses of domperidone treatment, or treatment for other indications including diabetic gastroparesis, the frequency of adverse events was significantly higher (except for dry mouth). Especially the pharmacologically foreseeable events related to the increase of prolactin are more obvious. In addition to the adverse reactions in the 31 studies mentioned above, akathisia, breast secretions, breast enlargement, breast swelling, depression, hypersensitivity, breastfeeding diseases and irregular menstruation were also observed. 4.2 Post-marketing experience: In addition to the adverse reactions reported in the clinical studies listed above, the adverse reactions reported by the post-marketing experience are listed below. Classification according to the frequency of spontaneous reports: the frequency of reports is very rare adverse reactions (<1/10000, including isolated case reports): immediate allergic reactions (including immediate anaphylactic shock), agitation, nervousness, dizziness, and cones Extracorporeal diseases, convulsions, angioedema, urticaria, urinary retention, abnormal liver function tests, elevated blood prolactin; reported frequency of rare adverse reactions (≥1/100000 and <1/1000): gynecomastia, Amenorrhea; adverse reactions with unknown frequency (based on epidemiological data): sudden cardiac death, severe ventricular arrhythmia. 4. In the post-marketing experience, except for extrapyramidal diseases and other central nervous system-related reactions, there is no difference in safety characteristics between adults and children. Extrapyramidal diseases mainly occur in newborns and infants (under 1 year old). Other central nervous system reactions such as convulsions and agitation are also mainly reported in infants and children.
CONTRAINDICATIONS
1.Those who are known to be allergic to domperidone or any component of this product.
2.It is forbidden to increase gastric motility when it is dangerous (for example: gastrointestinal bleeding, mechanical obstruction, perforation).
3.Patients with pituitary tumors (prolactinoma) that secrete prolactin are contraindicated.
4.Patients with pheochromocytoma, breast cancer, mechanical intestinal obstruction, and gastrointestinal bleeding are contraindicated.
5.It is forbidden to use ketoconazole oral preparations, erythromycin or other powerful inhibitors of CYP3A4 enzyme that may prolong the QTc interval (for example: fluconazole, voriconazole, clindamycin, amiodarone, telithromycin) Share.
6. Prohibited for patients with moderate to severe liver dysfunction.
Child medication
Rare neurological side effects in infants and young children. Because the baby's metabolism and fine barrier function have not been fully developed in the first few months after birth, the incidence of neurological side effects is higher than that of children. Therefore, it is recommended that the drug dosage for newborns, infants and young children should be accurately formulated and strictly followed. Overdose may cause neurological side effects, but other reasons should also be considered.
Medication for elderly patients Medication for elderly patients is the same as that for adults.
The medication for pregnant women and breastfeeding women is unclear.
Warning
1.Pregnant women should use this product with caution, breastfeeding women should stop breastfeeding while using this product.
2.It is recommended that children use domperidone suspension.
3.Heart disease patients (arrhythmia) and tumor patients undergoing chemotherapy should be cautious when applying, which may aggravate heart rhythm disorders.
4.In case of overdose or serious adverse reactions, seek medical attention immediately.
5.Those who are allergic to this product should not use it with caution.
6.It is forbidden to use this product when its properties change.
7.Please keep this product out of reach of children.
8.If you are using other drugs, please consult your physician or pharmacist before using this product.
9.This product contains lactose and may not be suitable for patients with lactose intolerance, galactosemia or glucose/galactose malabsorption.
10. When antacids or drugs that inhibit gastric acid secretion are used in combination with this product, the first two types of drugs should not be taken before meals and should be taken after meals, that is, they should not be taken at the same time with this product.
11. Since domperidone is mainly metabolized in the liver, it should be used with caution in patients with liver damage.
12. The elimination half-life of domperidone in patients with severe renal insufficiency (serum creatinine>6 mg/100ml or >0.6mmol/L) increased from 7.4 hours to 20.8 hours, but its blood concentration was lower than that of healthy volunteers. Since there are very few original drugs excreted by the kidneys, patients with renal insufficiency may not need to adjust the dose for a single dose, but when repeated doses are required, the frequency of medication should be reduced to 1-2 per day based on the severity of renal damage Times.
DRUG INTERACTION
1.It should not be combined with azole antifungal drugs such as ketoconazole and itraconazole, macrolide antibiotics such as erythromycin, HIV protease inhibitor anti-AIDS drugs and nefazodone.
2.Anticholinergic drugs such as Pain, Propamine Bromide, Anisodamine, Belladonna Tablets, etc. will weaken the effect of this product and should not be taken with this product.
3.The simultaneous use of antacids and drugs that inhibit gastric acid secretion can reduce the bioavailability of this product. It is recommended to use it at intervals.
4.When this product is used equivalently with acetaminophen, ampicillin, levodopa, tetracycline, it will increase the absorption rate of these drugs.
5.The combination of calcium antagonists (such as diltiazem and verapamil) and aprepitant will increase the blood concentration of domperidone.
6.When this product is used in combination with digoxin, the absorption of the latter will decrease.
7.Domperidone does not enhance the effect of nerve tranquilizers; this product should not be used simultaneously with monoamine oxidase inhibitor (MAOI).
8.Because domperidone has the effect of promoting gastric motility, it will theoretically affect the absorption of combined oral drugs, especially sustained-release or enteric-coated preparations. However, for patients whose plasma drug concentration of digoxin or acetaminophen is already at a stable level, the combined use of domperidone does not affect their plasma drug concentration.
9.If it is used with other drugs at the same time, drug interaction may occur. Please consult your physician or pharmacist for details. ,
10. 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 the central role, and can be used at the same time.
Overdose
Drug overdose is mainly reported in infants and children. Symptoms of overdose include excitement, altered consciousness, convulsions, disorientation, lethargy, and extrapyramidal reactions. There is no specific rescue medicine for this product. Once the drug is overdose, gastric lavage and activated charcoal may be helpful. It is recommended to carry out close clinical monitoring and supportive therapy. Anticholinergic drugs or anti-Parkinson's drugs may help control extrapyramidal reactions.
Pharmacology and Toxicology
This product directly acts on the gastrointestinal wall, can increase gastrointestinal motility and tension, promote gastric emptying, increase gastric antrum and duodenal motility, coordinate the contraction of the pylorus, and also enhance esophageal motility and lower esophageal sphincter The tension can inhibit nausea and vomiting. This product does not easily penetrate the blood-brain barrier.
Pharmacokinetics
This product is quickly absorbed after oral administration on an empty stomach, and the peak blood concentration can be reached in 30-60 minutes. Decreased stomach acid will affect the absorption of domperidone. The binding rate of domperidone to blood protein is 91-93%. A single oral dose of this product in healthy volunteers has a plasma half-life of 7-9 hours. Patients with severe renal insufficiency have a longer half-life. Almost all of this product is metabolized in the liver. In vitro metabolism tests with diagnostic inhibitors showed that CYP3A4 is the main form of cytochrome P-450 involved in the N-dealkylation of domperidone, and CYP3A4, CYP1A2 and CYP2E1 are involved in the aromatic hydroxylation of domperidone. The total excretion through urine is 31%, and the original medicine accounts for 1%; the total excretion of feces is 66%, and the original medicine accounts for 10%.
STORAGE
Hermetically sealed,keep in cool and dry places.
PERIOD OF VALIDITY
60 months.
CERTIFICATE NO
Stage Food and Drug Administration Approval number:H10910003.
Manufactured
XI’AN YANGSEN PHARMACEUTICAL CO.,LTD
Tips: Please read the directions for use in retail or directed by physician.
Part of the goods frequent replacement of packaging, such as goods and pictures are not exactly the same, please refer to the goods you receive.
General Cautions
Keep away from animals and children.This product has not been evaluated by the FDA. It is not intended to diagnose, treat, cure, or prevent any disease.We highly recommend that you consult with a Traditional Chinese Medical practitioner or physician before taking any products or if you have any questions regarding your health.
