Passagix, 10mg Chewable tablets 10pcs

Composition

Active ingredient:

domperidone 10 mg;

Auxiliary substances:

potato starch;

lactose;

colloidal silicon dioxide;

collidone 30;

calcium stearate;

sodium dodecyl sulfate;

oxypropylcellulose “Klucel”;

tween 80;

titanium dioxide

Pharmacological action

Passazhiks – antiemetic.

Pharmacodynamics

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

Domperidone weakly penetrates 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 may be 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 oral use, 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, and its concentration in brain tissues is low. Binding to plasma proteins is 91-93%.

It undergoes intensive metabolism in the intestinal wall and liver.

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

Indications

• nausea and vomiting of various origins (including on the background of functional and organic diseases, infections, with toxemia, radiation therapy, human diet;
• medicinal Genesis — receiving morphine, apomorphine, levodopa and bromocriptine;
• when carrying out endoscopic and radio-opaque (the necessity to accelerate peristalsis) studies of the gastrointestinal tract;
• hiccup, atonic gastrointestinal tract (including postoperative);
• dyspeptic disorders on the background of delayed gastric emptying, gastroesophageal reflux and esophagitis (a feeling of fullness in the epigastrium, feeling of bloating, flatulence, gastralgia, flatulence, belching with reflux or no reflux of gastric contents into the mouth).

Contraindications

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

Do not use Passagix when stimulating the motor function of the stomach can be dangerous, including with gastrointestinal bleeding, mechanical obstruction or perforation.

With caution:  renal / hepatic insufficiency, lactation, pregnancy.

Side effects

From the digestive system:  transient intestinal spasms.

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

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

Allergic reactions:  rash, urticaria.

Interaction

When used concomitantly, anticholinergic drugs can neutralize the effect of domperidone.

When used concomitantly with domperidone, antacids reduce its bioavailability.

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

The drug does not affect the concentrations of paracetamol and digoxin in the blood. It is possible that domperidone may affect the absorption of concomitantly administered oral preparations with a delayed release of the Active ingredient or coated with an enteric coating.

How to take, course of use and dosage

Inside,10-15 minutes before meals.

Chronic dyspepsia:  adults — 10 mg (1 tablet) 3 times a day,15-30 minutes before meals and, if necessary, before bedtime; children older than 5 years-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 before bedtime; children older than 5 years – 5 mg (1/2 tablet) per 10 kg 3-4 times a day before meals and before bedtime.

For patients with renal insufficiency, dose adjustment is necessary, the frequency of use 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.

Overdose

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

Treatment:  in case of overdose, the use of activated carbon and close monitoring are recommended.

Anticholinergics, medications used to treat parkinsonism, or antihistamines may be effective when extrapyramidal reactions occur.

Special instructions

When combined with antacid or antisecretory drugs (m-cholinolytics, H2-histamine receptor blockers, proton pump inhibitors), the latter should be taken after, and not before meals, i. e. they should not be taken simultaneously with the drug Passage.

Use in liver diseases. Given the metabolism of domperidone in the liver, caution should be exercised when prescribing Passagix to patients with hepatic insufficiency.

Use in kidney diseases. In patients with severe renal insufficiency (serum creatinine >6 mg/100 ml, i. e. >>0.6 mmol/L), the T1/2 of domperidone increased from 7.4 to 20.8 hours, but the drug concentrations in plasma were lower than in healthy volunteers. Since a very small percentage of the drug is excreted unchanged by the kidneys, it is hardly necessary to adjust the single dose in patients with renal insufficiency. However, with repeated use, the frequency of use should not exceed 1-2 times during the day, depending on the severity of insufficiency, and it may also be necessary to reduce the dose. With long-term therapy, patients should be regularly monitored.

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

Composition

Tablet Form of production

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Domperidone

Dosage form

Tablets

Description

For adults as prescribed by a doctor, for pregnant women as prescribed by a doctor

Indications

Flatulence, Reflux Esophagitis, Intestinal infections