Domperidone Teva coated pills 10mg N30
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Active ingredients
Domperidone
Release form
Pills
Composition
Domperidone maleate 12.73 mg,; which corresponds to the content of Domperidone 10 mg; Excipients: lactose monohydrate 50 mg, corn starch 10 mg, sodium lauryl sulfate 200 μg, povidone K30 3 mg, microcrystalline cellulose 23.32 mg, colloidal silicon dioxide 250 μg, magnesium mkg.; Shell composition: hypromellose 2.8 mg, propylene glycol 300 mcg, talc 700 mcg, titanium dioxide (E171) 1.2 mg.
Pharmacological effect
Domperidone is a dopamine receptor blocker with antiemetic effects. The antiemetic effect is due to a combination of peripheral (gastrokinetic) action and inhibition of dopamine receptors in the trigger zone of the brain chemoreceptors located outside the blood-brain barrier in the areapostrema area. When ingested, domperidone increases the reduced pressure in the esophagus, improves antroduodenal motility and accelerates gastric emptying, without affecting gastric secretion. Domperidone increases the secretion of prolactin in the pituitary gland.
Pharmacokinetics
When ingested on an empty stomach, domperidone is rapidly absorbed, its Cmax in plasma is reached within 30-60 minutes. Low absolute bioavailability after ingestion (about 15%) is due to the effect of "first passage" through the liver. Although in healthy volunteers, the bioavailability of domperidone increases when taken after a meal, patients with complaints from the gastrointestinal tract should take domperidone 15-30 minutes before a meal. With a decrease in the acidity of gastric juice, there is a violation of the absorption of domperidone. Preliminary intake of cimetidine and sodium bicarbonate reduces the bioavailability of domperidone. When ingestion after a meal, a somewhat longer time is required to achieve maximum absorption.; When ingested, domperidone does not accumulate and does not induce its own metabolism. Domperidone is 91-93% bound to plasma proteins. Domperidone is distributed in various tissues of the body, is found in breast milk, but does not penetrate the blood-brain barrier. The concentration of domperidone in breast milk is 10-50% of plasma concentration.; Domperidone metabolism occurs in the liver and in the intestinal wall by hydroxylation and N-dealkylation with the participation of CYP3A4, CYP1A2 and CYP2E1 isoenzymes. kidneys (33%), incl. unchanged (10% and 1%, respectively). T1 / 2 is 7-9 hours; Pharmacokinetics in special groups of patients.In patients with a serum creatinine concentration of more than 0.6 mmol / l T1 / 2 ranges from 7.4 to 20.8 h, while the concentration of domperidone in the blood plasma is reduced.
Indications
Dyspeptic symptoms, such as nausea, vomiting, feeling of fullness in the epigastric region, discomfort in the upper abdomen and regurgitation of gastric contents.
Contraindications
- hypersensitivity to domperidone or any other component of the drug; - prolactin-secreting pituitary tumor (prolactinoma); - gastrointestinal bleeding; - perforation of the gastrointestinal tract; - mechanical bowel obstruction; - hereditary lactose intolerance, lactose deficiency or glucose-galactose malabsorption; - breastfeeding period; - Children weighing less than 35 kg. With caution. Pregnancy, liver failure, renal failure.
Use during pregnancy and lactation
The use of domperidone during pregnancy is allowed only if the expected benefit to the mother outweighs the possible risk to the fetus. At the time of application domperidone breastfeeding should be suspended.
Dosage and administration
Inside before eating, drinking plenty of water.; Adults and children weighing more than 35 kg 1-2 pills 3-4 times a day. The maximum dose is 80 mg per day. The duration of treatment is 4 weeks. Further administration of the drug is possible after consulting a doctor.; Patients with renal insufficiency are recommended to reduce the frequency of taking the drug up to 1-2 times a day.
Side effects
The incidence of adverse reactions is classified according to the WHO recommendations: rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including isolated cases.; From the immune system: very rarely - anaphylaxis, including anaphylactic shock, urticaria and angioedema.; From the endocrine system: rarely - an increase in prolactin concentration.; From the nervous system : very rarely - extrapyramidal disorders. On the part of the digestive system: rarely - gastrointestinal disorders; very rarely - intestinal spasm, diarrhea.; From the skin and subcutaneous tissues: very rarely - itching, rash.; From the reproductive system and mammary glands: rarely - galactorrhea, gynecomastia, amenorrhea.
Overdose
Overdose symptoms include drowsiness, disorientation, and extrapyramidal disorders, especially in children. Treatment: There is no specific antidote. In case of overdose, gastric lavage and the use of activated charcoal can be effective. Careful observation and supportive therapy are recommended.; M-anticholinergic blockers and drugs used to treat parkinsonism may be effective for relief of extrapyramidal disorders.
Interaction with other drugs
M-holinoblokatori can neutralize the action of domperidone.; Do not take antacid and antisecretory drugs simultaneously with domperidone, since they reduce its bioavailability after oral administration. Ketoconazole inhibits CYP3A4-dependent primary metabolism of domperidone, resulting in approximately a threefold increase in Cmax of domperidone and AUC in the plateau phase. The following drugs are also inhibitors of the CYP3A4 isoenzyme: - Macrolide antibiotics; - HIV protease inhibitors; - nefazodone. With the combined use of domperidone at a dose of 10 mg 4 times a day and ketoconazole at a dose of 200 mg 2 times a day, the Q-T interval is extended to 10-20 ms. With monotherapy domperidone in similar doses, and when taking a daily dose of 160 mg, 2 times the maximum allowable, there were no clinically significant changes in the QT interval.; Domperidone may affect the absorption of simultaneously used oral drugs, in particular drugs with a slow release active substance, or drugs, enteric-coated. However, the use of domperidone in patients with paracetamol or selected therapy with digoxin did not affect the concentration of these drugs in the blood. Domperidone can also be combined with: - neuroleptics, whose action it does not enhance; - dopamine receptor agonists (bromocriptine, levodopa), the undesirable peripheral effects of which, such as digestive disorders, nausea, vomiting, it suppresses without neutralizing their basic properties.
special instructions
Domperidone-Teva contains lactose, so it should not be prescribed to patients with lactose intolerance, galactosemia, or impaired absorption of glucose or galactose. insufficiency. When reappointment frequency should be reduced to 1-2 times per day, depending on the severity of failure; a dose reduction may also be required. With prolonged therapy, such patients should be monitored regularly. Taking the drug after a meal slows down its absorption.; Influence on the ability to manage vehicles and work with equipment: no effect.