Passazhix, 10 mg, 10 pcs.

Active substance:

 domperidone 10 mg;

Excipients:

potato starch;

lactose;

silicon dioxide colloidal;

collidone 30;

calcium stearate;

sodium dodecyl sulfate;

hydroxypropyl cellulose "Klucel";

twin 80;

titanium dioxide

Passasix is ​​an antiemetic.

Pharmacodynamics

It increases the duration of peristaltic contractions of the antrum of the stomach and duodenum, accelerates gastric emptying if this process slows down, increases the tone of the lower esophageal sphincter, and eliminates the development of nausea and vomiting.

Domperidone penetrates weakly through the BBB (therefore, its use is rarely accompanied by extrapyramidal side effects, especially in adults), but it stimulates the release of prolactin from the pituitary gland. Its antiemetic effect is probably due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the trigger chemoreceptor zone of the medulla oblongata. Domperidone has no effect on gastric secretion.

Pharmacokinetics

After taking the drug inside, domperidone is rapidly absorbed.

It has low bioavailability (about 15%). Reducing the acidity of gastric juice reduces the absorption of domperidone. Cmax in plasma is reached after 1 h.

Domperidone is widely distributed in various tissues, in the brain tissue its concentration is low. Plasma protein binding is 91–93%.

It is subjected to intense metabolism in the intestinal wall and liver.

It is excreted through the intestines (66%) and kidneys (33%), in unchanged form, 10 and 1% of the dose, respectively, are excreted. T1 / 2 - 7–9 hours, with severe renal failure, it lengthens.

• vomiting and nausea of ​​various origins (including against the background of functional and organic diseases, infections, toxemia, radiation therapy, and dietary disorders; 
• drug genesis - taking morphine, apomorphine, levodopa and bromocriptine; 
• when conducting endoscopic and radiopaque (the need to accelerate peristalsis) studies of the gastrointestinal tract; 
• hiccups, gastrointestinal atony (including postoperative);
• dyspeptic disorders on the background of delayed emptying of the stomach, gastroesophageal reflux and esophagitis (a feeling of fullness in the epigastrium, a feeling of bloating, flatulence, gastralgia, heartburn, belching with or without casting gastric contents into the oral cavity).

• established intolerance to the drug and its components;
• prolactin-secreting pituitary tumor (prolactinoma);
• phenylketonuria;
• children under 5 years old and children weighing up to 20 kg.

Passasix should not be used when stimulation of the motor function of the stomach can be dangerous, including with gastrointestinal bleeding, obstruction or perforation.

Precautions: renal / liver failure, lactation, pregnancy.

From the digestive system: transient intestinal cramps.

From the side of the central nervous system: extrapyramidal effects are observed in children and with increased permeability of the BBB. These phenomena are completely reversible and spontaneously disappear after discontinuation of treatment.

From the endocrine system: the drug can induce an increase in the concentration of prolactin in plasma, because the pituitary gland is outside the BBB. In rare cases, this hyperprolactinemia can stimulate the appearance of galactorrhea, gynecomastia and dysmenorrhea.

Allergic reactions: rash, urticaria.

With the simultaneous use of anticholinergics can neutralize the effect of domperidone.

With the simultaneous use of domperidone, antacids reduce its bioavailability.

Based on in vitro studies, it can be assumed that while using drugs with domperidone that significantly inhibit the CYP3A4 isoenzyme (antifungal drugs of the azole group, macrolide antibiotics, HIV protease inhibitors, antidepressant nefazodone), an increase in the concentration of domperidone in the plasma can be observed.

The drug does not affect the concentration of paracetamol and digoxin in the blood. It is possible that domperidone may affect the absorption of drugs used simultaneously inside with a slow release of the active substance or enteric coated.

Inside, before meals in 10-15 minutes.

Chronic dyspepsia: adults - 10 mg (1 tablet) 3 times a day, 15-30 minutes before meals and, if necessary, before bedtime; children over 5 years old - 2.5 mg (1/4 tablet) per 10 kg 3 times a day before meals and, if necessary, before bedtime.

Acute and subacute conditions (primarily nausea and vomiting): adults - 20 mg (2 tablets) 3-4 times a day before meals and at bedtime; children over 5 years old - 5 mg (1/2 tablet) per 10 kg 3-4 times a day before meals and at bedtime.

For patients with renal failure, dose adjustment is necessary, the frequency of administration should not exceed 1-2 times during the day.

The maximum daily dose for adults is 80 mg (8 tablets). The maximum daily dose for children should not exceed 10 mg (1 chewable tablet) per 10 kg.

Symptoms: drowsiness, disorientation and extrapyramidal reactions, especially in children.

Treatment: in case of overdose, the appointment of activated charcoal and careful monitoring are recommended.

Anticholinergics, drugs used to treat parkinsonism, or antihistamines may be effective in the event of extrapyramidal reactions.

With the combined use of the Passasix drug with antacid or antisecretory (m-anticholinergic, H2-histamine receptor blockers, proton pump inhibitors) drugs should be taken after, rather than before, i.e. they should not be taken concomitantly with Passasix.

Use for liver diseases. Given the metabolism of domperidone in the liver, Passasix should be prescribed with caution in patients with liver failure.

Use for kidney disease. In patients with severe renal failure (serum creatinine> 6 mg / 100 ml, i.e.> 0.6 mmol / L), domperidone T1 / 2 increased from 7.4 to 20.8 hours, but the drug concentration in plasma was lower. than healthy volunteers. Since a very small percentage of the drug is excreted by the kidneys unchanged, it is hardly necessary to correct a single dose in patients with renal failure. However, when re-prescribed, the frequency of administration should not exceed 1-2 times during the day, depending on the severity of the insufficiency, and a dose reduction may also be necessary. With prolonged therapy, patients should be monitored regularly.

Impact on the ability to drive a car or other mechanical means. Doperidone does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

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