Domstal-O

General characteristics. Structure:

Active ingredients: 10 mg of a domperidon, 10 mg of an omeprazol (in the form of kishechnorastvorimy pellets).

Excipients: cellulose microcrystallic, sodium krakhmalglikolit (type A), sodium lauryl sulfate, silicon dioxide colloid anhydrous, talc, magnesium stearate.

Structure of pellets of an omeprazol: mannitol (Е 421), sucrose, sodium hydrophosphate, sodium lauryl sulfate, lactoses monohydrate, calcium carbonate (Е 170), gidroksipropilmetiltsellyuloza, propylene glycol, metakrilatny copolymer (type C), polysorbate 80, diethyl phthalate, sodium hydroxide, starch corn.

The gelatin capsule contains: methylparahydroxybenzoate (Е 218), пропилпарагидроксибензоат (Е 216), dyes: titanium dioxide (Е 171), erythrosine (Е 127), diamond blue (Е 133).

Pharmacological properties:

Pharmacodynamics. The combined medicine which effect is caused by the components which are its part.

Domperidon is the antagonist of receptors of a dopamine, a prokinetic. Domperidon blocks peripheral dopamine receptors, eliminates the inhibiting influence of dopamine on motor function of digestive tract and increases evakuatorny and physical activity of a stomach. Has antiemetic effect, calms a hiccups and eliminates nausea. Badly gets through a blood-brain barrier, practically does not influence dopamine receptors of a brain therefore side effects from the central nervous system, such as dystonia, meet seldom.

Omeprazol treats antiulcerous means which suppress basal and stimulated secretion of hydrochloric acid in obkladkovy cells of a stomach owing to specific action on N-K enzyme - ATP-ase (the proton pump). The anti-secretory effect after reception of an omeprazol develops very quickly within the first hour and remains within a day. Omeprazol thanks to the high lipophilicity easily gets into covering cells of a stomach, concentrates in them and has cytoprotective effect. The inhibiting effect increases in the first 4 days of reception. Secretory activity is normalized in 3-4 days after the termination of administration of drug. Omeprazol does not influence motility of a digestive tract.

Pharmacokinetics. It was not investigated.

Indications to use:

Gastroesophageal reflux disease, peptic ulcer of a stomach and duodenum, in schemes of an eradikation Helicobacter pylori, the slowed-down evacuation of contents of a stomach, гастропарез, functional dyspepsia.

Route of administration and doses:

Capsules accept inside whole, without breaking and without chewing.

The recommended dose depends on character and the course of a disease and is established by the doctor individually. The average recommended dose for adults and children is more senior than 12 years – on 1 capsule 2-3 times a day in 30 minutes prior to food, washing down with a glass of water. In case of need the dose can be increased by the doctor to 2 capsules 2 times a day. The course of treatment is defined by the doctor depending on character and the course of a disease, usually, it makes 4-8 weeks.

In schemes of eradikatsionny therapy appoint 2 capsules 2 times a day in a combination with antibacterial agents.

Features of use:

Use during pregnancy or feeding by a breast. To pregnant women do not apply.

In case of need uses of drug it is necessary to stop feeding by a breast.

Children. Will not appoint to children aged up to 12 years in view of lack of experience of use.

Features of use
Drug contains lactose therefore patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption should not use drug.

Drug contains sucrose that needs to be considered a sick diabetes mellitus.

Domperidon can cause increase in formation of prolactin that causes a galactorrhoea in women and a gynecomastia in men.

Drug should not be used along with antiacid and anti-secretory drugs.

In view of a high metabolic rate of a domperidon in a liver not to use drug the patient with a liver failure.

At patients with a heavy renal failure (plasma creatinine more than 6 mg / 100 ml, i.e. more than 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 a blood plasma was lower, than at healthy volunteers. As the insignificant percent of drug is removed by kidneys in not changed state, the single dose can be not adjusted. But at prolonged use of a domperidon it is necessary to reduce the frequency of administration of drug to 1 - 2 times a day depending on weight of disturbances of functions of kidneys. Also there can be a need for a dose decline therefore with care to apply to patients with a renal failure and a delay of liquid. At long therapy patients have to be under constant observation of the doctor.

Domperidon patients should apply with care with risk factors of prolongation of an interval of QT, including a hypopotassemia, a heavy hypomagnesiemia, organic heart diseases, a concomitant use of the medicines extending QT interval.

At patients with a pheochromocytoma at use of a domperidon hypertensive crises are possible.

In the absence of improvement within 2 weeks, it is necessary to see a doctor surely.

Use with CYP3A4 inhibitors.

It is necessary to avoid joint oral administration of a ketokonazol, erythromycin and other CYP3A4 inhibitors, QTc extending an interval (see the section "Interaction with Other Medicines and Other Types of Interactions").

Omeprazol. Before the beginning and after completion of therapy omeprazoly it is necessary to make an endoscopic research to exclude cases of not diagnosed malignant process as treatment omeprazoly can disguise symptoms and delay the correct diagnosis.

Omeprazol can reduce cyanocobalamine absorption. As neurologic manifestations can arise also without hematologic changes, it is necessary to carry out monitoring of patients for detection of pernicious anemia.

Decrease in acidity of a stomach at use of inhibitors of a proton pomp increases quantity of bacteria in a digestive tract. At treatment by drugs which reduce acidity of a stomach the risk of developing of infections of digestive tract, such as Salmonella or Campylobacter can increase.

Ability to influence speed of response at control of motor transport or work with other mechanisms. During treatment by drug it is necessary to abstain from control of motor transport and work with other mechanisms.

Side effects:

Most of patients well transfer drug. At use of drug the side reactions caused by action of each of active ingredients are possible.

From immune system: allergic reactions, anaphylactic reactions, including an acute anaphylaxis, a Quincke's disease, a bronchospasm, urticaria, fever.

Mental disorders: nervousness, agitation, a reversible loss of consciousness, reversible conditions of a disorientation, aggression, a depression, a hallucination, it is preferential at patients in a serious condition.

From a nervous system: dryness in a mouth, a headache, sleeplessness, dizziness, thirst, slackness, irritability, paresthesia.

From cardiovascular system: hypostases, heart consciousness, disturbance of frequency and rhythm of cordial reductions (lengthening of an interval of QT, ventricular arrhythmias).

From a digestive tract: abdominal pain, diarrhea, vomiting, appetite changes, nausea, heartburn, lock, short-term intestinal spasms, vomiting, abdominal distention, stomatitis, gastrointestinal candidiasis.

From skin: an itch, skin rashes, urticaria, dermatitis, the increased photosensitivity, a multiformny exudative erythema, Stephens-Johnson's syndrome, a toxic epidermal necrolysis and a hair loss, an alopecia.

From reproductive system: the galactorrhoea, a gynecomastia, an amenorrhea, decrease in a libido, increase in mammary glands, seldom arise owing to a giperprolaktinemiya. To the increased level of prolactin can bring домперидон as the hypophysis is out of a blood-brain barrier.

From an urinary system: urination, dysuria, renal failure, intersticial nephrite.

From a musculoskeletal system: onychalgia, adynamy, arthralgia, muscular weakness, mialgiya, arthritic and mialgichesky symptoms.

Gepatobiliarny frustration: increase in enzymes of a liver, encephalopathy at patients with the existing serious illness of a liver, hepatitis with or without jaundice, a liver failure.

From system of blood: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

Laboratory indicators: increase in the ALT, nuclear Heating Plant level and cholesterol.

The extrapyramidal phenomena were observed very seldom at newborns and babies, and especially at adults. These side reactions disappear spontaneously and it is completely possible rather after the treatment termination. Other side effects connected with a nervous system – spasms, agitation and drowsiness were observed very seldom.

Others: the general weakness, the increased perspiration, peripheral hypostases, a vision disorder, changes of taste and a hyponatremia, conjunctivitis.

Interaction with other medicines:

Domperidon. Anticholinergic drugs can neutralize effect of drug of a domperidon. Bioavailability of drug decreases at its reception after Cimetidinum or Natrii hydrocarbonas. It is not necessary to accept antiacid and anti-secretory drugs along with domperidony as they reduce its bioavailability after intake.

The main way of metabolic transformations of a domperidon occurs with the participation of an isoenzyme of CYP 3A4 of system of P450 cytochrome therefore at the simultaneous use of a domperidon and medicines considerably inhibiting this isoenzyme increase in level of a domperidon in a blood plasma is possible. Examples of inhibitors of an isoenzyme of CYP 3A4 are the following medicines: antifungal drugs of an azolovy row (fluconazole, итраконазол, кетоконазол, вориконазол), antibiotics of group of macroleads (кларитромицин, erythromycin), HIV protease inhibitors (ампренавир, атазанавир, фозампренавір, индинавир, нелфинавир, ритонавир, саквинавир), antagonists of calcium (diltiazem, verapamil), Amiodaronum, aprep_tant, нефазодон, телитромицин.

At simultaneous use of drug with m cholinolytics and narcotic analgetics influence of a domperidon on a motor evakuatornuyu activity of a stomach and intestines decreases.

Simultaneous use with ketokonazoly, erythromycin or other potential CYP3A04 inhibitors can lead to increase in an interval of QT.

At simultaneous use of a domperidon in a dose of 10 mg 4 times a day and a ketokonazol in a dose of 200 mg twice a day are observed lengthenings of an interval of QT on 10-20 ms. At monotherapy domperidony both in similar dosages, and at reception of a daily dose of 160 mg (that is twice higher than the most admissible daily dose), clinically significant changes of an interval of QT were not observed.

Digoxin or paracetamol at a concomitant use of a domperidon does not influence the level of these drugs in blood.

Domperidon can be also combined with neuroleptics which action he does not strengthen, agonists of dopaminergic receptors (Bromocriptinum, L-finish singing) which undesirable peripheral effects, such as digestion disturbances, nausea, vomiting, it suppresses, without neutralizing their main properties.

It is necessary to appoint with care домперидон in combination with inhibitors of a monoaminooxidase (MAO).

Omeprazol. The lowered acidity of a stomach can influence absorption of some drugs.

As well as at use of other blockers of acids and antacids, at treatment omeprazoly absorption of a ketokonazol and itrakonazol decreases. The area under a curve "concentration time" (AUC) and the maximum concentration in a blood plasma (Cmax) of an itrakonazol authentically decreases to nearly 60% at simultaneous use of an omeprazol.

Interactions with antacids at the accompanying introduction were not observed. Also any interaction with food, alcohol is noted.

Omeprazol can cause a delay of removal of diazepam, warfarin and drugs which are intensively metabolized by oxidation in a liver (P450 2C19 cytochrome). Though there was a concentration of Phenytoinum in a research at use of an omeprazol in a dose of 20 mg once a day it did not change, recommended to control Phenytoinum level, and also peroral anticoagulants and if necessary to reduce a dosage. Increases effect of coumarins and dipheninum.

The accompanying treatment does not influence coagulation time at continuous administration of warfarin.

However in case of simultaneous use of an omeprazol and a klaritromitsin their concentration grow in a blood plasma.

Omeprazol can reduce absorption of a ketokonazol, ampicillin, iron preparations.

About interaction with metronidazole or amoxicillin still it was not reported. These antimicrobic connections apply together with H. pylori, omeprazoly for destruction.

Results of researches of various interactions between omeprazoly and other drugs showed what омепразол in doses of 20-40 mg does not influence relevant isoforms of P450 cytochrome.

Omeprazol does not interact with CYP1A2 (caffeine, acetphenetidiene, theophylline), CYP2C9 (S-warfarin, piroxicam, diclofenac, Naproxenum), CYP2D6 (метопролол, propranolol), CYP2E1 (ethanol), CYP3A (cyclosporine, lidocaine, квинидин, oestradiol, erythromycin, будесонид), theophylline, h_n_d_ny, antacids.

It was noted that омепразол interacts with some anti-retrovirus means. The clinical importance and the mechanism of such interaction are not always known. Increase gastric рН during use of an omeprazol can change absorption of anti-retrovirus drugs. Other mechanism of interaction is possible through CYP2C19. In case of use of some anti-retrovirus means, such as нелфинавир, reduced levels of the last in blood serum at simultaneous use were noted with omeprazoly. Therefore the accompanying use of an omeprazol and nelfinavir is not recommended. It was reported about increase in levels in serum of other anti-retrovirus means, such as саквинавир. There are also other anti-retrovirus drugs, at simultaneous use with omeprazoly levels of which in blood serum remained invariable.

The accompanying use of an omeprazol (40 mg of 1 times a day) from atazanaviry 300 mg / ритонавиром 100 mg led to essential decrease in influence of an atazanavir (about 75% decrease in AUC, Cmax and Cmin). Increase in a dose of an atazanavir to 400 mg did not compensate impact of an omeprazol on influence of an atazanavir. Inhibitors of the proton pump, including омепразол, should not be applied together with atazanoviry (see the section "Contraindications").

The accompanying use of an omeprazol with takrolimusy can lead to increase in concentration of a takrolimus in blood serum. At the beginning or after completion of treatment omeprazoly it is recommended to watch concentration of a takrolimus in a blood plasma.

There are no interactions with p_roksikamy, diclofenac or Naproxenum. It is impossible to exclude interactions with drugs which oppress P450 cytochrome.

At simultaneous use of an omeprazol and CYP2C19 and CYP3A4 inhibitors, to a vorikonazol exposure of an omeprazol more than twice increases. However it is not necessary to increase a dose of an omeprazol.

Contraindications:

Hypersensitivity to a domperidon, an omeprazola, to the replaced benzimidazoles or other components of drug. Prolactin-secretory tumor of a hypophysis (prolaktinom). Cases when stimulation of motor activity of a digestive tract can be dangerous (for example, gastrointestinal bleedings, mechanical intestinal impassability, perforation of a stomach or intestines). Liver and renal failure. Simultaneous use of peroral forms of a ketokonazol, erythromycin or other strong CYP 3A4 inhibitors, medicines which extend an interval of QT, such as флуконазол, вориконазол, кларитромицин, Amiodaronum, телитромицин (see the sections "Features of Use" and "Interaction with Other Medicines and Other Types of Interactions"). Simultaneous use with atazanaviry. Pregnancy and period of feeding by a breast. Children's age up to 12 years.

Overdose:

The overdose caused by action of a domperidon. Symptoms: drowsiness, disorientation, extrapyramidal frustration.

Treatment: drug withdrawal, reception of absorbent carbon. For elimination of extrapyramidal symptomatology use holinoblokiruyushchy drugs, means for treatment of parkinsonism or antihistaminic drugs with anticholinergic action.

The overdose caused by action of an omeprazol. Are described overdose by a single dose of an omeprazol to 560 mg. In cases of overdose of an omeprazol nausea, vomiting, dizziness, an abdominal cavity pain, diarrhea, a headache are described. In isolated cases apathy, a depression, confusion of consciousness were observed. All symptoms which are observed at overdose of an omeprazol have fleeting character. Speed of removal remains invariable at exceeding of a dosage (kinetics of the first order) and does not demand special treatment.

Treatment – symptomatic.

Storage conditions:

To store in the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules in a strip, on 3 or 5 strips in a cardboard pack.