Passazhix, 10 mg 10 pcs

Passazhix is an antiemetic.

Pharmacodynamics

Lengthens the duration of peristaltic contraction of the antral stomach and duodenum, accelerates gastric emptying in case this process is delayed, increases lower esophageal sphincter tone, eliminates development of nausea and vomiting.

Domperidone poorly penetrates through the GEB (so its use is rarely accompanied by extrapyramidal side effects, especially in adults), but it stimulates prolactin release 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

Domperidone is rapidly absorbed after oral administration.

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

Domperidone is widely distributed in various tissues, in the brain tissue its concentration is low. Binding to plasma proteins is 91-93%.

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

It is excreted by the intestine (66%) and the kidneys (33%), respectively 10 and 1% of the dose is excreted unchanged. T1/2 is 7-9 hours; in case of marked renal insufficiency it is prolonged.

Indications

Active ingredient

Composition

Active ingredient:

domperidone 10 mg;

Ancillary substances:

potato starch;

lactose;

colloidal silicon dioxide;

collidone 30;

calcium stearate;

sodium dodecyl sulfate;

clucel oxypropylcellulose;

Tween 80;

Titanium dioxide

How to take, the dosage

Overly, before meals 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 of age – 2.5 mg (1/4 tablet) per 10 kg 3 times a day before meals and, if necessary, before bedtime.

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

In patients with renal insufficiency the dose should be corrected, 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.

Interaction

In concomitant use anticholinergic drugs may neutralize the effect of domperidone.

In concomitant use with domperidone, antacids decrease its bioavailability.

On the basis of the in vitro studies it may be assumed that concomitant use of drugs that significantly inhibit CYP3A4 isoenzyme (antifungal drugs of azole group, antibiotics from macrolide group, HIV protease inhibitors, antidepressant nefazodone) with domperidone may cause increase of plasma concentration of domperidone.

The drug does not affect the concentrations of paracetamol and digoxin in blood. It is possible that domperidone may affect absorption of simultaneously administered drugs with delayed release of active substance or coated with enteric coating.

Special Instructions

When the drug Passagex is used in combination with antacids 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 Passagex.

Application in liver disease. Given the metabolism of domperidone in the liver, caution should be exercised when prescribing the drug Passazhix in patients with hepatic impairment.

Application in renal disease. 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 h, but plasma concentrations of the drug 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 correct the single dose in patients with renal failure. However, when repeatedly prescribed, the frequency of administration should not exceed 1-2 times a day, depending on the severity of the failure, it may also be necessary to reduce the dose. Patients should be monitored regularly during long-term therapy.

Impact on the ability to drive a vehicle or other motor vehicles.Domperidone does not affect the ability to drive vehicles and engage in other potentially dangerous activities that require high concentration and quick psychomotor reactions.

Contraindications

Passazhix should not be used when stimulation of gastric motility may be dangerous, including gastrointestinal bleeding, mechanical obstruction, or perforation.

With caution: renal/liver failure, lactation, pregnancy.

Side effects

Digestive system disorders: transient intestinal spasms.

CNS disorders: extrapyramidal phenomena are observed in children and with increased GEB permeability. These phenomena are completely reversible and disappear spontaneously after discontinuation of treatment.

Endocrine system disorders: the drug may induce increased concentration of prolactin in plasma, since pituitary gland is located outside the barrier. In rare cases, this hyperprolactinemia may stimulate the appearance of galactorrhea, gynecomastia and dysmenorrhea.

Allergic reactions: rash, urticaria.

Overdose

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

Treatment: in case of overdose, administration of activated charcoal and close monitoring is recommended.

Anticholinergic agents, drugs used to treat parkinsonism, or antihistamines may be effective if extrapyramidal reactions occur.

Similarities