Пассажикс

General characteristics. Structure:

Active ingredient: 10 mg of a domperidon in 1 tablet.

Excipients: aspartame, лактитол, ксилитол, magnesium stearate, menthol.

Eliminates weight in a stomach, abdominal distention, has antiemetic effect, calms a hiccups and in certain cases nausea.

Pharmacological properties:

Pharmacodynamics. Increases duration of peristaltic reductions of antral department of a stomach and duodenum, accelerates gastric emptying in case of delay of this process, raises a tone of the lower esophageal sphincter, eliminates development of nausea and vomiting.

Domperidon poorly gets through a blood-brain barrier (GEB) therefore use of a domperidon seldom is followed by extrapyramidal side effects, especially at adults, but домперидон stimulates release of prolactin from a hypophysis. Its antiemetic action, perhaps, is caused by a combination of peripheral (gastrokinetichesky) action and antagonism to dopamine receptors in a trigger zone of chemoceptors. Domperidon has no effect on gastric secretion.

Pharmacokinetics. After administration of drug inside домперидон it is quickly soaked up. Has low bioavailability (about 15%). Decrease in acidity of a gastric juice reduces absorption of a domperidon. The maximum concentration in plasma is reached in 1 h.

Domperidon is widely distributed in various fabrics, in brain tissues its concentration is small. Communication with proteins of plasma makes 91-93%.

Is exposed to intensive metabolism in a wall of intestines and liver.

It is removed through intestines (66%) and kidneys (33%), in not changed look 10% and 1% of dose size are removed, respectively. The elimination half-life makes 7-9 h, at the expressed renal failure it is extended.

Indications to use:

- vomiting and nausea of various genesis (including against the background of functional and organic diseases, infections, at a toxaemia, radiation therapy, disturbances of a diet, medicinal genesis - reception of morphine, Apomorphinum, levodopa and Bromocriptinum;

- when carrying out endoscopic and X-ray contrast researches of the digestive tract (DT), a hiccups, a GIT atony (including postoperative); need of acceleration of a vermicular movement when carrying out X-ray contrast researches GITs;

- dispeptic disturbances against the background of the slowed-down oprozhneniye of a stomach, a gastroesophageal reflux and an esophagitis, feeling of overflow in epigastriums, feeling of abdominal distention, a meteorism, a gastralgia, heartburn, an eructation with throwing or without throwing of gastric contents in an oral cavity.

Route of administration and doses:

Use of drug of Passazhiks, chewable tablets, to food in 10-15 minutes is recommended.

Chronic dyspepsia. Adults: on 10 mg (1 tablet) 3 times a day, in 15-30 min. prior to food and in case of need, before going to bed.

Children are more senior than 5 years: on 2,5 mg on 10 kg of body weight 3 times a day to food and in case of need before going to bed.

Acute and subacute states (first of all nausea and vomiting). Adults: on 20 mg (2 tablets) 3-4 times a day to food and before going to bed.

Children are more senior than 5 years: on 5 mg on 10 kg of body weight, 3-4 times a day before food and before going to bed.

Dose adjustment is necessary for patients with a renal failure, frequency rate of reception should not exceed 1-2 times during the day.

The maximum daily dose for adults - 80 mg (8 tablets). The maximum daily dose for children should not exceed 10 mg (1 chewable tablet) on 10 kg of body weight.

Features of use:

Use at pregnancy and a lactation: Use of drug of Passazhiks at pregnancy is not recommended (because of insufficiency of data).

At women of concentration of a domperidon in breast milk is 4 times lower, than the corresponding concentration in plasma. It is unknown whether this level makes negative impact on newborns. In need of use of drug in the period of a lactation breastfeeding needs to be stopped.

At the combined use of drug of Passazhiks with antiacid or anti-secretory (M-cholinolytics, H2-histamine blockers, inhibitors of a proton pomp) drugs the last should be accepted after food, but not to food, i.e. they should not be accepted along with drug of Passazhiks.

Use at liver diseases. Considering metabolism of a domperidon in a liver, it is necessary to appoint with care drug of Passazhiks sick with a liver failure.

Use at diseases of kidneys. At patients with a heavy renal failure (serumal creatinine> of 6 mg / 100 ml, i.e.> 0,6 mmol/l) T1/2 of a domperidon increased from 7,4 to 20,8 o'clock, but concentration of drug in plasma were lower, than at healthy volunteers. As very small percent of drug is removed by kidneys in not changed look, correction of a single dose at patients with a renal failure is hardly necessary. However at repeated appointment frequency rate of reception should not exceed 1-2 times during the day depending on weight of insufficiency, there can also be a need for a dose decline. At long therapy patients have to be under regular observation.

Influence on ability to driving or other mechanical means. Domperidon does not influence ability to manage vehicles and occupations other, potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From the alimentary system: passing enterospasms.

From the central nervous system (CNS): the extrapyramidal phenomena are observed at children and at GEB hyperpermeability. These phenomena are completely reversible and spontaneously disappear after the treatment termination.

From endocrine system: Пассажикс can induce increase in concentration of prolactin in plasma as the hypophysis is out of GEB. In rare instances this giperprolaktinemiya can stimulate emergence of a galactorrhoea, gynecomastia and dysmenorrhea.

Allergic reactions: rash, urticaria.

Interaction with other medicines:

At simultaneous use anticholinergic drugs can neutralize action of a domperidon.

At simultaneous use with domperidony antiacid drugs reduce its bioavailability.

On the basis of the researches in vitro it is possible to assume that at simultaneous use with domperidony the HP considerably inhibiting CYP3A4 isoenzyme (antifungal groups of azoles of drug, antibiotics from group of macroleads, HIV protease inhibitors, antidepressant нефазодон) increase in concentration of a domperidon in plasma can be observed.

Drug does not influence concentration of paracetamol and digoxin in blood.

It is not excluded that домперидон can influence absorption applied at the same time in drugs with the slowed-down release of active agent or covered with a kishechnorastvorimy cover.

Contraindications:

Hypersensitivity, prolactin - the cosecreting tumor of a hypophysis (prolaktinom), children's age (up to 5 years and to children with body weight to 20 kg), fenilketonuriyaiya.

It is not necessary to apply Passazhiks when stimulation of motive function of a stomach can be dangerous, including at gastrointestinal bleeding, mechanical impassability or perforation.

Use with care: renal/liver failure, lactation period, pregnancy.

Overdose:

Symptoms: Drowsiness, a disorientation and extrapyramidal reactions, especially at children can be symptoms of overdose.

Treatment: in case of overdose use of absorbent carbon and careful observation is recommended. Anticholinergics, the drugs used for treatment of parkinsonism or antihistaminic drugs can be effective at emergence of extrapyramidal reactions.

Storage conditions:

In the dry, protected from light place at a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 3 years. Not to use after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Tablets chewing 10 mg. On 4, 6, 10 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 4 or 5 blister strip packagings together with the application instruction place in a pack from a cardboard.