Domstal

General characteristics. Structure:

Active ingredient: 10 mg of a domperidon.

Excipients: lactose, starch, double-base calcium phosphate, gelatin, magnesium stearate, talc.

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.

Stimulates release of prolactin from a hypophysis. 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. Domperidon badly gets through a blood-brain barrier thanks to what use of a domperidon seldom is followed by development of extrapyramidal side effects, especially at adults.

Pharmacokinetics. Absorption. After intake домперидон it is quickly soaked up. Has low bioavailability (about 15%). The lowered acidity of gastric contents reduces absorption of a domperidon. The maximum concentration in plasma is reached in 1 h.

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

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

Removal. 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:

a) A complex of the dispepsichesky symptoms which are associated with the slowed-down gastric emptying, a gastroesophagal reflux, an esophagitis:

• feeling of overflow in epigastriums, feeling of abdominal distention, pain in an upper part of a stomach:
• eructation, meteorism:
• heartburn with throwing or without throwing of contents of a stomach in an oral cavity

b) The nausea and vomiting of a functional, organic, infectious origin caused by radiotheraphy, medicinal therapy or disturbance of a diet and also against the background of dopamine agonists in case of their use at Parkinson's disease (such as L-dopa and Bromocriptinum).

Route of administration and doses:

Inside. 1. 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. If necessary the specified dosage can be doubled.

2. 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. Notes.

At a renal failure reduction of frequency of administration of drug is recommended (see the section "Special Instructions").

Features of use:

At patients with a heavy renal failure (serumal creatinine> of 6 mg / 100 ml, i.e.> 0,6 mmol/l) the elimination half-life 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 the frequency of introduction has to be reduced to 1-2 times a day, depending on weight of insufficiency. Also there can be a need of dose declines. At long therapy patients have to be under regular observation.

Side effects:

From the alimentary system: passing enterospasms.

From a nervous system: extrapyramidal frustration (at children and persons with a hyperpermeability of a blood-brain barrier).

Allergic reactions: skin rash, small tortoiseshell.

Others: giperprolaktinemiya (galactorrhoea, gynecomastia).

Interaction with other medicines:

Cimetidinum, Natrii hydrocarbonas, other antiacid and antisecretory drugs reduce bioavailability of a domperidon.

Anticholinergics neutralize action of a domperidon.

Increase concentration of a domperidon in plasma: antifungal means of an azolovy row, antibiotics from group of macroleads, HIV protease inhibitors, нефазодон.

Contraindications:

Hypersensitivity, gastrointestinal bleeding, mechanical impassability, perforation of a stomach or intestines, prolactin - the cosecreting tumor of a hypophysis (prolaktinom), children's age up to 5 years.

With care - a liver/renal failure.

Overdose:

Symptoms: drowsiness, a disorientation and extrapyramidal reactions (especially at children).

Treatment: reception of absorbent carbon, at emergence of extrapyramidal reactions – anticholinergic, protivoparkinsonichesky, antihistamines.

Storage conditions:

Period of validity - 4 years. Not to apply after the term specified on packaging. To store at   a temperature not above 30 °C in protected from light, the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Tablets of 10 mg. On 10 tablets in blisters from aluminum foil and PVC of a film.
1 or 3 blisters together with the application instruction in a cardboard pack. 4 tablets in the blister from PVC of a film and aluminum foil. 1 blister together with the application instruction in a cardboard pack (a sample not for sale).