Domperidone-Teva - Instructions For Use, Reviews, Price, Analogs Of Tablets

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Domperidone-Teva

Domperidone-Teva: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Domperidone-Teva

ATX code: A03FA03

Active ingredient: domperidone (Domperidone)

Manufacturer: TEVA Pharmaceutical Plant Ltd. Co. (TEVA Pharmaceutical Works Private, Ltd. Co.) (Hungary)

Description and photo update: 2020-17-07

Prices in pharmacies: from 159 rubles.

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Domperidone-Teva is an antiemetic drug; centrally acting dopamine receptor antagonist.

Release form and composition

The drug is produced in the form of film-coated tablets: round, biconvex, with "Do 10" engraved on one side; the shell is from white to almost white, the core on the cross section is white (10 pcs. in blisters made of PVC film / aluminum foil, in a cardboard box 1 or 3 blisters and instructions for use of Domperidone-Teva).

Composition for 1 tablet:

• active substance: domperidone - 10 mg (in the form of domperidone maleate - 12.73 mg);
• auxiliary ingredients: lactose monohydrate - 50 mg; corn starch - 10 mg; sodium lauryl sulfate - 0.2 mg; povidone K30 - 3 mg; microcrystalline cellulose - 23.32 mg; colloidal silicon dioxide - 0.25 mg; magnesium stearate - 0.5 mg;
• film shell: hypromellose - 2.8 mg; talc - 0.7 mg; propylene glycol - 0.3 mg; titanium dioxide (E171) - 1.2 mg.

Pharmacological properties

Pharmacodynamics

The active component of Domperidone-Teva, domperidone, is a dopamine receptor blocker. It has an antiemetic effect due to a combination of a peripheral (gastrokinetic) effect and inhibition of dopamine receptors in the chemoreceptor trigger zone of the brain located in the area postrema, an area outside the blood-brain barrier.

When taken orally, domperidone increases the reduced pressure in the esophagus, enhances the motility (tone and amplitude of contractions) of the digestive tract, improves antroduodenal coordination, thereby accelerating gastric emptying, but does not affect gastric secretion. Domperidone-Teva helps to increase the intensity of prolactin secretion in the pituitary gland.

Pharmacokinetics

The main pharmacokinetic characteristics of domperidone:

• absorption: oral administration on an empty stomach ensures rapid absorption of domperidone, the time to reach C _max (maximum concentration) in plasma is 30-60 minutes. Taking Domperidone-Tev after meals slightly increases the time to reach C _max. The low degree of absolute bioavailability (~ 15%) determines the effect of the first passage through the liver;
• distribution: domperidone binds to plasma proteins at 91–93%. It is distributed in tissues and organs, but does not cross the blood-brain barrier. Penetrates into breast milk at a concentration of 10-50% of the plasma level. When taken orally, the substance does not cumulate, there is no autoinduction of metabolism;
• metabolism: domperidone is biotransformed by hydroxylation and N-dealkylation in the liver and intestinal wall with the participation of cytochrome P ₄₅₀ isoenzymes 3A4, 1A2 and 2E1;
• excretion: domperidone is excreted by the intestines - 66% (including in unchanged form - 10%) and by the kidneys - 33% (including in unchanged form - 1%). T _1/2 (half-life) is from 7 to 9 hours.

Despite the fact that the bioavailability of domperidone in healthy volunteers increases with the use of Domperidone-Teva after meals, patients with problems with the function of the digestive tract should take tablets 15-30 minutes before meals. A decrease in gastric acidity impairs the absorption of domperidone; the previous intake of sodium bicarbonate and cimetidine reduces its bioavailability.

Indications for use

Domperidone-Teva is used to treat dyspeptic symptoms: nausea, vomiting, a feeling of fullness in the epigastric region, discomfort in the upper abdomen and regurgitation of gastric contents.

Contraindications

Absolute:

• prolactinoma (prolactin-secreting pituitary tumor);
• bleeding in the lumen of the gastrointestinal tract (gastrointestinal tract);
• perforation of the gastrointestinal tract;
• mechanical intestinal obstruction;
• moderate and severe liver failure;
• lengthening of the intervals of cardiac conduction, especially the QTc interval, severe electrolyte imbalance or concomitant heart diseases such as CHF (chronic heart failure);
• concomitant oral administration of ketoconazole, erythromycin or other potent inhibitors of the cytochrome P ₄₅₀ 3A4 isoenzyme (CYPZA4) that prolong the QT interval, for example, fluconazole, clotrimazole, clarithromycin, amiodarone or telithromycin;
• genetically determined lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• breast-feeding;
• children under 12 years of age, child's body weight less than 35 kg;
• established hypersensitivity to domperidone or auxiliary components in the drug.

With caution, Domperidone-Teva is recommended to be taken in case of renal failure, simultaneously with drugs that induce the development of bradycardia and hypokalemia, with macrolides that prolong the QT interval (azithromycin and roxithromycin), as well as during pregnancy.

Domperidone-Teva, instructions for use: method and dosage

Domperidone-Teva tablets are intended for oral administration. They should be taken before meals with plenty of water. Taking the drug after meals may slow down its absorption somewhat.

Adults and adolescents over 12 years old with a body weight of 35 kg or more are recommended to take 1 tablet 3 times a day.

The maximum daily dose is 30 mg. The duration of the course should not exceed 7 days. If necessary, further use of the drug is possible after a medical consultation.

It is important to take the tablets at the set time. If the time of taking the planned dose is missed, it must be excluded and treatment should be continued as usual. You should not duplicate Domperidone-Tev's intake to make up for the missed dose.

Side effects

The classification scale for the frequency of undesirable side effects: very often - not less than 1/10; often (from ≥ 1/100 to <1/10); infrequently (from ≥ 1/1000 to <1/100); rarely (from ≥ 1/10 000 to <1/1000); extremely rare (less than 1/10 000); with an unknown frequency - it is not possible to determine the frequency based on the available data.

Adverse reactions from systems and organs, the development of which is possible when taking Domperidone-Teva:

• immune system: extremely rarely - allergic reactions (including anaphylaxis, anaphylactic shock), anaphylactoid reactions, angioedema;
• endocrine system: rarely - an increase in the concentration of prolactin;
• nervous system: extremely rarely - extrapyramidal disorders, nervousness, convulsions, agitation, drowsiness, headache; with an unknown frequency - restless legs syndrome (in patients with Parkinson's disease - exacerbation);
• cardiovascular system: with unknown frequency - lengthening of the QT interval, ventricular arrhythmia, SCD (sudden cardiac death);
• digestive system: rarely - gastrointestinal disorders; extremely rare - diarrhea, intestinal spasm;
• skin and subcutaneous fat: extremely rare - itching, rash, urticaria;
• reproductive system and mammary gland: rarely - gynecomastia, galactorrhea, amenorrhea;
• laboratory data: extremely rarely - deviation from the norm in the indicators of liver function tests.

Since the pituitary gland is outside the blood-brain barrier, domperidone is able to cause an increase in the concentration of prolactin. Occasionally drug-induced hyperprolactinemia leads to the development of neuroendocrine side effects such as gynecomastia, galactorrhea, and amenorrhea. Extrapyramidal adverse reactions are very rare in newborns and infants and, in exceptional cases, in adults. They are resolved spontaneously and completely, immediately after the termination of taking Domperidone-Teva.

Other side effects from the nervous system - convulsions, agitation, drowsiness - also develop extremely rarely, mainly in infants and children.

Overdose

Symptoms of domperidone overdose are drowsiness, disorientation and extrapyramidal disorders, especially in children.

In case of intoxication, gastric lavage and intake of activated charcoal can be effective, after which the patient requires careful medical supervision and supportive treatment. The relief of extrapyramidal disorders is recommended with the help of m-anticholinergics and drugs used for the treatment of parkinsonism.

The specific antidote for domperidone is unknown.

special instructions

Patients with hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption should not take Domperidone-Teva tablets, as they contain milk sugar.

Domperidone is excreted unchanged by the kidneys in a small amount, therefore it is assumed that there is no need to adjust a single dose in the treatment of patients with renal insufficiency. In case of repeated use, the frequency of administration is recommended to be reduced to 1–2 times a day, depending on the severity of renal dysfunction. In addition, dose reduction may be necessary. Long-term therapy of patients in this group requires regular medical supervision.

It is important to consider that taking the tablets after meals slows down the absorption of domperidone.

Taking Domperidone-Teva may cause prolongation of the QT interval on the ECG (electrocardiogram). According to the data of post-registration observation, lengthening of the QT interval and ventricular tachycardia of the "pirouette" type were observed in very rare cases, mainly in patients with concomitant risk factors, disorders of water and electrolyte balance and with the combined use of drugs that contribute to the development of such adverse reactions.

In the course of epidemiological studies, a connection was established between the use of domperidone and an increased risk of developing serious cardiac arrhythmias (ventricular arrhythmias) and SCD. The following factors increased the likelihood of developing cardiac disorders: age over 60 years; taking domperidone at a dose of more than 30 mg / day; concomitant use with drugs that lengthen the QT interval or CYP3A4 inhibitors.

Domperidone-Teva in the treatment of adult patients and adolescents over 12 years old should be used in the minimum effective dose.

Due to the increased risk of ventricular arrhythmias, Domperidone-Teva is contraindicated to take: patients with a history of prolonged cardiac conduction intervals (especially the QTc interval); with severe violations of the water and electrolyte balance (hypokalemia, hyperkalemia, hypomagnesemia) or bradycardia; with concomitant heart disease (for example, CHF). Disorders of water and electrolyte metabolism (hypokalemia, hyperkalemia, hypomagnesemia) and bradycardia are known as pathologies that contribute to an increase in proarrhythmogenic risk.

If signs and symptoms appear that indicate the development of cardiac arrhythmias, taking Domperidone-Teva should be discontinued and consult a specialist.

Patients should immediately inform their doctor about any cardiac abnormalities.

Influence on the ability to drive vehicles and complex mechanisms

Due to the risk of extrapyramidal disorders, drowsiness, seizures, headache, caution should be exercised during therapy with Domperidone-Teva if increased concentration of attention and high speed of psychomotor reactions are required. For example, while driving or engaging in other potentially hazardous activities.

Application during pregnancy and lactation

Post-registration data on the use of domperidone in pregnant women are limited. In a study on animals, reproductive toxicity was established in the case of using high doses of a substance that is also toxic to the female's body. The degree of possible risk to humans has not been established. In this regard, Domperidone-Teva during pregnancy is prescribed only if the potential therapeutic benefit for the mother is justified.

In lactating female rats, domperidone is excreted in breast milk mainly in the form of metabolites. C _max after oral administration or intravenous administration at a dose of 2.5 mg / kg is 40 and 800 ng / ml, respectively. It was found that in women, the substance is also excreted in breast milk. While breastfeeding, infants can receive ˂ 0.1% of the maternal dose, based on body weight. Therefore, one should not exclude the possibility of developing undesirable side effects in the child, especially cardiological. After assessing the benefits of breastfeeding for the child and the importance of therapy for the mother, a decision is made to stop breastfeeding or to cancel / interrupt domperidone therapy.

The presence of risk factors for QTc interval prolongation in breastfed infants requires caution.

Pediatric use

In pediatric practice, the use of Domperidone-Teva for the treatment of children under 12 years of age and with a child's body weight of less than 35 kg is contraindicated.

With impaired renal function

Patients with renal impairment should take Domperidone-Teva tablets with caution. It is recommended to reduce the frequency of administration to 1–2 times a day.

For violations of liver function

Domperidone-Teva is contraindicated in patients with moderate to severe hepatic impairment.

Hepatic insufficiency of mild severity does not require dose adjustment of domperidone.

Use in the elderly

In the course of epidemiological studies, it was found that in patients over 60 years of age, when using Domperidone-Teva, the likelihood of developing serious ventricular arrhythmias and SCD increases.

Drug interactions

Domperidone is metabolized mainly with the participation of CURZA4. In an in vitro study, it was found that combined use with strong inhibitors of this enzyme increases the concentration of domperidone in blood plasma.

According to the results of separate studies with the participation of healthy volunteers of the pharmacokinetic and pharmacodynamic interactions of domperidone in vivo with ketoconazole or erythromycin taken orally, a significant degree of inhibition of CYPZA4-mediated first-pass metabolism of domperidone was confirmed by these substances.

Studies have been conducted to assess the risk of QT interval prolongation as a result of pharmacodynamic and / or pharmacokinetic interactions of domperidone with ketoconazole and erythromycin. Joint oral administration of domperidone 10 mg 4 times / day and ketoconazole 200 mg 2 times / day demonstrated an average prolongation of the QT interval during the entire observation period at the level of 9.8 ms, with variability in the range of individual time points from 1.2 to 17. 5 ms. A similar administration of domperidone with erythromycin orally at a dose of 500 mg 3 times / day during the observation period showed an average QT lengthening of 9.9 ms, with a variability in the range of individual time points from 1.6 to 14.3 ms. In each of these studies, C _maxand AUC (area under the plasma concentration-time pharmacokinetic curve) of domperidone at equilibrium were increased by about 3 times. In the framework of these studies, with domperidone monotherapy (oral administration of 10 mg 4 times / day), the increase in the mean QTc interval was 1.6 ms in experiments with ketoconazole, and 2.5 ms in experiments with erythromycin. Moreover, during the entire observation period with monotherapy with ketoconazole and erythromycin in the described doses, the increase in the QTc interval was 3.8 and 4.9 ms, respectively.

It is contraindicated to use domperidone in conjunction with the following drugs:

• drugs that lengthen the QTc interval: class IA antiarrhythmics (hydroquinidine, disopyramide, quinidine); class III antiarrhythmics (amiodarone, dronedarone, dofetilide, ibutilide, sotalol);
• antipsychotic drugs: haloperidol, sertindole, pimozide;
• antidepressants: citalopram, escitalopram;
• antibiotics: erythromycin, moxifloxacin, levofloxacin, spiramycin;
• antifungal drugs: pentamidine;
• antimalarial drugs: halofantrine, lumefantrine;
• gastrointestinal agents: cisapride, dolasetron, prucaloprid;
• antihistamines: mequitazine, mizolastine;
• drugs for the treatment of cancer: vandetanib, vincamine, toremifene;
• other medicines: diphemanil, bepridil, methadone;
• potent inhibitors of CYP3A4 (regardless of the degree of prolongation of the QT interval): inhibitors of HIV protease; azole antifungal agents for systemic use; some macrolides (erythromycin, clarithromycin, telithromycin).

It is not recommended to use domperidone in combination with moderate CYP3A4 inhibitors - diltiazem, verapamil and some macrolides.

The simultaneous use of Domperidone-Teva with drugs that induce bradycardia and hypokalemia and macrolides that prolong the QT interval (azithromycin and roxithromycin) requires caution.

The above list of medicines is typical but not exhaustive.

Analogs

Domperidone-Teva analogs are Domstal, Domet, Domridon, Domperidon, Domperidon-Xanthis, Motilak, Motilium, Motilium Express, Motiject, Motinorm, Motonium, Motogastrik, Passages, etc.

Terms and conditions of storage

Store at temperatures up to 25 ° С out of the reach of children.

Shelf life is 4 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Domperidone-Teva

According to reviews, Domperidone-Teva is an effective drug that helps with digestive problems. It relieves intestinal pains, nausea, a feeling of heaviness in the stomach, improves digestion, and relieves belching. Patients note the convenient form of release, the small size of the tablet is easy to swallow, and the absence of any taste. The product is cheaper than many analogues.

There are no complaints about side effects; in isolated cases, a weak effect of Domperidone-Teva is indicated as a disadvantage.

Price for Domperidone-Teva in pharmacies

The approximate price of Domperidone-Teva, film-coated tablets, 10 mg, for 30 pcs. in the package - 157-188 rubles.

Domperidone-Teva: prices in online pharmacies

Drug name Price Pharmacy

Domperidone-Teva 10 mg film-coated tablets 30 pcs. 159 r Buy

Domperidone-teva tablets p.p. 10mg 30pcs 192 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!