Passage - instructions for use, dose, side effects, contraindications

Increases the duration of peristaltic contractions of the antral part of the stomach and duodenum, accelerates the emptying of the stomach in case of slowing of this process, increases the tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting.

Domperidone weakly penetrates the blood-brain barrier, so the use of domperidone is rarely accompanied by extrapyramidal side effects, especially in adults, but domperidone 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 chemoreceptor trigger zone. Domperidone has no effect on gastric secretion.

Pharmacokinetics:

Suction

After taking the drug inside domperidone quickly absorbed. It has low bioavailability (about 15%). Reducing the acidity of gastric juice reduces the absorption of domperidone. The maximum concentration in the plasma is achieved after 1 hour.

Distribution

Domperidone is widely distributed in various tissues, in the brain tissues its concentration is low. The connection with plasma proteins is 91-93%.

Metabolism

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

Excretion

It is excreted through the intestine (66%) and kidneys (33%), in unchanged form, respectively, 10% and 1% of the dose value. The half-life is 7-9 hours, with prolonged renal failure, it lengthens.

Indications:

a) Complex of dyspeptic symptoms, often associated with delayed emptying of the stomach, gastroesophageal reflux, esophagitis:

- a feeling of overflow in the epigastrium, a sensation of bloating, pain in the upper part abdomen;

- eructation, flatulence;

- heartburn with casting or without casting the contents of the stomach into the mouth.

b) Nausea and vomiting of a functional, organic, infectious origin caused by radiotherapy, drug therapy or a diet disorder, and against dopamine agonists when used in Parkinson's disease (such as L-opa and bromocriptine).

Contraindications:

Established intolerance of the drug, prolactin-secreting tumor of the pituitary (prolactinoma), children under 5 years.

Do not use Passage, when stimulation of the motor function of the stomach can be dangerous, incl. with gastrointestinal bleeding, mechanical obstruction or perforation.

Pregnancy and lactation:

When administered to animals in doses up to 160 mg / kg / day domperidone did not have a teratogenic effect. However, like most drugs, Passenger should be prescribed during the first trimester of pregnancy only if its use is justified by the expected therapeutic benefit. To date, there is no evidence of an increased risk of developmental malformations in humans.

In women, concentrations of domperidone in breast milk are 4 times lower than the corresponding concentrations in plasma. It is not known whether this level has a negative effect on newborns. Therefore, if the mother accepts Passage, breast-feeding is not recommended, except when the expected benefit justifies the potential risk.

Dosing and Administration:

1. Chronic dyspepsia.

Adults: 10 mg (1 tablet) 3 times a day, 15-30 minutes before meals and, if necessary, before bed.

Children over 5 years: 2.5 mg per 10 kg of body weight. 3 times a day before meals and, if necessary, before bedtime.

If necessary, the indicated dosage can be doubled.

2. Acute and subacute conditions (primarily nausea and vomiting).

Adults: 20 mg (2 tablets) 3-4 times daily before meals and at bedtime.

Children over 5 years: 5 mg per 10 kg of body weight, 3-4 times a day before meals and at bedtime.

Notes

It is recommended that oral use of Passage before meals. When taking the drug after a meal, absorption is somewhat slowed down.

In renal failure, a reduction in the frequency of taking the drug is recommended (see section "Special instructions").

Side effects:

Side effects are rare, there have been exceptional cases of transient intestinal spasms.

Extrapyramidal phenomena are observed in children and with increased permeability of the blood-brain barrier. These phenomena are completely reversible and spontaneously disappear after discontinuation of treatment.

Since the pituitary gland is outside the blood-brain barrier, Passagex can induce an increase in the level of prolactin in the plasma.In rare cases, this hyperprolactinemia can stimulate the appearance of galactorrhea, gynecomastia and dysmenorrhea.

There were rare allergic reactions, such as rashes and hives.

Overdose:

Symptoms of an overdose may be drowsiness, disorientation and extrapyramidal reactions, especially in children.

Treatment: In case of an overdose, the use of activated carbon and careful observation are recommended. Anticholinergics, drugs used to treat parkinsonism, or antihistamines may be effective in the occurrence of extrapyramidal reactions.

Interaction:

With simultaneous use of anticholinergic drugs can neutralize the effect of Passage.

With simultaneous use with Passage antacid and antisecretory drugs reduce its bioavailability. H

and based on research in vitro it can be assumed that with the simultaneous use with Passage of drugs that significantly inhibit the enzyme cytochrome CYP3A4 (antifungal preparations of the azole group, antibiotics from the macrolide group, HIV protease inhibitors,antidepressant nefazodone), there may be an increase in the level of domperidone in plasma.

The drug does not affect the level of paracetamol and digoxin in the blood.

It is possible that Passagex can influence the absorption of concomitantly administered drugs with sustained release of the active substance or coated with an enteric coating.

Special instructions:

With the combined use of Passage with antacid or antisecretory drugs, the latter should be taken after meals, and not before meals, i.e. they should not be taken at the same time as Passage.

Application for liver diseases

Given the metabolism of domperidone in the liver, caution should be given to patients with hepatic insufficiency.

Application in diseases of the kidneys

In patients with severe renal insufficiency (serum creatinine> 6 mg / 100 ml, ie> 0.6 mmol / L), the half-life of domperidone increased from 7.4 to 20.8 hours, but plasma concentrations were lower than in 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 insufficiency.However, with a repeated appointment, the frequency of administration should be reduced to 1-2 times per day, depending on the severity of the insufficiency, it may also be necessary to reduce the dose. With prolonged therapy, patients should be under regular supervision.

Effect on the ability to drive transp. cf. and fur:

Domperidone does not disrupt the speed of psychomotor reactions.

Form release / dosage:Tablets are chewable, 10 mg.

Packaging:

For 4, 6, 10 chewable tablets 10 mg in a planar cell package.

For 1, 2, 3, 4 or 5 contour mesh packages, together with the instruction for use, are placed in packs of cardboard.

Storage conditions:

In a dry place, protected from light, out of reach of children, at a temperature not exceeding 25 ° C.

Shelf life:

2 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-000660

Date of registration:25.06.2010

Expiration Date:Unlimited

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia

Information update date: & nbsp18.01.2016

Illustrated instructions

Instructions

Passenger (Passagix)