Domperidone

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Dosage and Administration

Adverse reactions

According to clinical studies

Undesirable reactions observed in ≥ 1% patients treated with Motilium®: depression, anxiety, decreased or no libido, headache, drowsiness, akathisia, dry mouth, diarrhea, rash, itching, galactorrhea, gynecomastia, pain and sensitivity in the breast, menstrual cycle and amenorrhea , lactation, asthenia.

Adverse reactions observed in <1% of patients taking Motilium®: hypersensitivity, urticaria, swelling and discharge from the mammary glands.

According to spontaneous reports of adverse events

The following undesirable effects were classified as follows:very frequent (≥ 10 %), frequent (≥ 1%, but <10%),not frequent (≥ 0.1%, but <1%),rare(≥ 0.01%, but very rare (

Immune system disorders. Very rare: anaphylactic reactions, including anaphylactic shock.

Mental disorders. Very rarely: agitation, nervousness (mainly in newborns and children).

Nervous system disorders. Very rarely: extrapyramidal disorders, convulsions (mainly in newborns and children).

Violations of the cardiovascular system. Very rare: prolonged QT interval, ventricular arrhythmia *, sudden coronary death *.

Violations of the skin and subcutaneous tissue. Very rarely: angioedema, urticaria.

Disturbances from the kidneys and urinary tract. Very rarely: urinary retention.

Laboratory and instrumental data. Very rarely: deviations in laboratory parameters of liver function, increased blood prolactin levels.

* Some epidemiological studies have shown that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden death. The risk of occurrence of these phenomena is more likely in patients over 60 years of age and in patients taking the drug in a daily dose of more than 30 mg. The use of domperidone in the lowest effective dose in adults and children is recommended.

Contraindications

- established intolerance to the drug and its components;

- prolactin-secreting pituitary tumor (prolactinoma);

- simultaneous administration of oral forms of ketoconazole, erythromycin or other potent inhibitors of the CYP3A4 isoenzyme causing prolongation of the QT interval, such as fluconazole, voriconazole, clarithromycin, amiodarone, and telithromycin (see "Interactions");

- gastrointestinal bleeding, mechanical obstruction or perforation (i.e., when stimulation of the motor function of the stomach can be dangerous);

- children's age up to 5 years (for this dosage form);

- dysfunction of the liver moderate and severe;

- Phenylketonuria.

- renal dysfunction;

Drug interactions

Anticholinergic drugs can neutralize the effect of the drug Motilium®. The bioavailability of the drug Motilium® when administered orally is reduced after the previous intake of cimetidine or sodium bicarbonate. Do not take antacid and antisecretory drugs simultaneously with domperidone, as they reduce its bioavailability after ingestion (see section "Special instructions").

The main role in the metabolism of domperidone is CYP3A4 isoenzyme. The results of invitro studies and clinical experience show that the simultaneous use of drugs that significantly inhibit this isoenzyme may cause an increase in plasma domperidone concentrations. The potent inhibitors of CYP3A4 include:

- Azole antifungals, such as fluconazole *, itraconazole, ketoconazole *, and voriconazole *;

- Macrolide antibiotics, such as clarithromycin * and erythromycin *;

- HIV protease inhibitors, for example, amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir;

- Calcium antagonists, such as diltiazem and verapamil;

- Amiodarone *;

- aprepitant;

- Nefazodone;

- Telithromycin *.

(Preparations marked with an Golden Star, in addition, lengthen the QT interval [see section "Contraindications"].

In a number of studies on pharmacokinetic and pharmacodynamic interactions of domperidone with ketoconazole and erythromycin when ingested in healthy volunteers, it has been shown that these drugs significantly inhibit first-pass metabolism through the CYP3A4 isoenzyme. With simultaneous administration of 10 mg of domperidone 4 times a day and 200 mg of ketoconazole 2 times a day, the QT interval was lengthened by an average of 9.8 ms during the entire observation period, at certain points changes ranged from 1.2 to 17.5 ms. With simultaneous administration of 10 mg of domperidone 4 times a day and 500 mg of erythromycin 3 times a day, the QT interval was lengthened by an average of 9.9 ms during the entire observation period, at certain points changes ranged from 1.6 to 14.3 ms. In each of these studies, Cmax and AUC of domperidone were increased about three times (see section "Contraindications").

At present, it is not known what contribution to the change in the QT interval is made by increased concentrations of domperidone in the plasma.

In these studies, domperidone monotherapy (10 mg four times a day) resulted in a prolongation of the QT interval of 1.6 ms (ketoconazole study) and 2.5 ms (erythromycin study), while ketoconazole monotherapy (200 mg twice a day) and erythromycin monotherapy (500 mg three times a day) led to a prolongation of the QT interval by 3.8 and 4.9 ms, respectively, during the entire observation period.

In another study using multiple doses in healthy volunteers, no significant lengthening of the QT interval was found during inpatient domperidone monotherapy (40 mg four times a day, total daily dose of 160 mg, which is 2 times the recommended maximum daily dose). At the same time, plasma domperidone concentrations were similar to those in studies of domperidone interaction with other drugs. Theoretically, since Motilium® has a gastrokinetic effect, it could affect the absorption of simultaneously used oral preparations, in particular, drugs with a prolonged release of the active substance or preparations coated with an enteric-soluble coating. However, the use of domperidone in patients with paracetamol or digoxin did not affect the level of these drugs in the blood.

Motilium® can be taken simultaneously with:

- neuroleptics, whose action it does not enhance;

- with dopaminergic receptor agonists (bromocriptine, levodopa), because it inhibits their unwanted peripheral effects, such as digestive disorders, nausea and vomiting, without affecting their central effects.

Pregnancy and Lactation

Special instructions

Overdosage

• Brand name: Motilium
• Active ingredient: Domperidone
• Dosage form: White or almost white round lozenges.
• Manufacturer: Catalent UK Swindon Zaydis Limited / Janssen-Cilag
• Country of Origin: Great Britain