Domperidone, tablets 10 mg, 30 pcs.

Domperidone is an antiemetic. It has antiemetic effect, calms hiccups and eliminates nausea in some cases. The action is due to blockade of central dopamine receptors. Due to this, inhibitory influence of dopamine on motor function of gastrointestinal tract is eliminated and evacuatory and motility activity of the stomach is increased.

Pharmacokinetics

Absorption after oral administration, on an empty stomach is fast (intake after meal, decreased acidity of gastric juice slows and reduces absorption). Cmax is reached after 1 hour. Bioavailability is 15% (effect of “first passage” through the liver). Binding with plasma proteins is 90%.

It penetrates into different tissues, passes poorly through the barrier. Metabolized in liver and intestinal wall (by hydroxylation and N-dealkylation). It is excreted through the intestine at 66% and by kidneys at 33%, including unchanged at 10% and 1%. T1/2 is 7-9 hours; in case of manifested CKD it is prolonged.

Indications

Nausea, vomiting, hiccups of various genesis (during toxemia, radiation therapy, dietary disorders, taking some drugs /morphine/, endoscopic and X-ray contrast studies, in the postoperative period).

Postoperative hypotension and atony of the stomach and intestines, biliary dyskinesia, flatulence, reflux esophagitis, cholecystitis, cholangitis, various types of dyspepsia. Nausea and vomiting caused by taking dopaminomimetics.

Active ingredient

Composition

Active substance:

domperidone10 mg;

Assisted substances:

MCC, 60 mg;

Pregelatinized starch, 19.46 mg;

Colloidal silica (aerosil) – 0.09 mg;

Magnesium stearate – 0.45 mg;

Polyvinyl alcohol – 1.44 mg;

Macrogol (polyethylene glycol) – 0.73 mg;

talc – 0.53 mg;

titanium dioxide – 0.9 mg

How to take, the dosage

Ingestion, 15-20 minutes before a meal. Adults and children over 5 years of age in chronic dyspeptic complaints – 10 mg 3-4 times a day, including before bedtime if necessary.

In case of severe nausea and vomiting, 20 mg 3-4 times a day, the last dose before bedtime.

The maximum daily dose is 80 mg.

In patients with renal insufficiency, a dose adjustment is necessary; the number of doses should not exceed 1-2 times during the day.

Interaction

In concomitant use with antacids, antisecretory drugs (including cimetidine, sodium hydrocarbonate) the bioavailability of domperidone decreases.

In concomitant use with anticholinergic drugs the effect of domperidone is inhibited.

As domperidone is metabolized mainly with participation of CYP3A4 isoenzyme it is considered that simultaneous use of domperidone and inhibitors of this isoenzyme (including antifungal drugs of azole group, antibiotics of macrolide group, HIV protease inhibitors, nefasodone) may increase plasma level of domperidone.

Contraindications

Gastrointestinal bleeding, mechanical intestinal obstruction, gastric or intestinal perforation, prolactinoma, children under 1 year of age (under 5 years and children with body weight under 20 kg – for tablets), hypersensitivity to domperidone, pregnancy, lactation (breastfeeding) period.

Side effects

CNS disorders: rarely – increased excitability and/or extrapyramidal disorders, headache.

Digestive system disorders: spasms of the smooth muscles of the gastrointestinal tract, dry mouth, thirst.

Allergic reactions: itching, rash, urticaria.

Others: increase in plasma prolactin levels, galactorrhea, gynecomastia.

Similarities