The instruction for medical use
of MOTINORM® medicine
the Trade name
of Motinorm®
the International unlicensed
name Domperidon Lekarstvennaya a form
of the Tablet of 10 mg
Structure
One tablet contains
active agent: domperidon 10 mg,
excipients: lactose, starch corn, metilpara-hydroxybenzoate, propilparagidroksibenzoat, magnesium stearate.
The description
White or almost white round tablets with risky on one party and with an engraving of Medley on another
Pharmacotherapeutic group
Stimulators of motility of digestive tract
the ATX A03FA03 Code
the Pharmacological
Pharmacokinetics VsasyvanieDomperidon properties is quickly absorbed at intake on an empty stomach. The maximum concentration (Cmax) in blood plasma is reached approximately within 30 min. The low absolute bioavailability of a domperidon at intake (about 15%) is caused by extensive primary metabolism in a wall of intestines and liver.
The bioavailability of a domperidon increases at reception after a meal, but patients with complaints from the digestive tract (DT) should accept domperidon in 15-30 min. prior to food. The Gipoatsidnost of gastric juice reduces absorption of a domperidon.
RaspredeleniePri oral administration domperidon does not kumulirut and does not induce own metabolism. Cmax in plasma in 90 min. after reception, equal 21 ng/ml, after 2 weeks reception on 30mg/days, was almost same, as after reception of the first dose (18 ng/ml).
Domperidon for 91-93% contacts proteins of plasma. Concentration of a domperidon in breast milk of the feeding women are 4 times lower, than the corresponding concentration in plasma.
MetabolizmPreparat is metabolized in a liver by hydroxylation and N-dealkylation. At metabolism of drug CYP3A4 is the main isoenzyme of a system of P450 cytochrome participating in process of N-dealkylation of a domperidon whereas CYP3A4, CYP1A2 and CYP2E1 participate in process of aromatic hydroxylation of a domperidon.
It VyvedenieVyvoditsya in not changed view with a stake - 10% and with urine - about 1%. Elimination half-life (T1/2) after reception of a single dose makes the 7-9th of plasma. At patients with a heavy renal failure of T1/2 increases to 20.8 h.
Pharmacodynamics
Antiemetic drug, stimulator of motility of the digestive tract (DT). Domperidon - the antagonist of a dopamine possessing similar to Metoclopramidum and some neuroleptics, antiemetic properties. However, unlike these medicines, domperidon badly gets through a blood-brain barrier. Use of a domperidon seldom is followed by extrapyramidal side effects, especially at adults, but domperidon stimulates prolactin discharge from a hypophysis. Its antiemetic action is caused by a combination of peripheral (gastrokinetichesky) action and antagonism to dopamine receptors in a trigger zone of chemoceptors. At use inside domperidon increases duration of antral and duodenal reductions, accelerates gastric emptying - an exit of liquid and semisolid fractions at healthy people and firm fractions at patients at whom this process was slowed down, and increases pressure of a sphincter of a lower part of a gullet at healthy people. Domperidon has no effect on gastric secretion.
Indications
- nausea, vomiting, a complex of the dispepsichesky symptoms caused
by the slowed-down gastric emptying, a gastroesophageal reflux, an esophagitis (feeling of overflow of a stomach, an eructation, a meteorism, heartburn)
- nausea and vomiting of functional or organic genesis (including in infections, errors in a diet, medicinal or radiation therapy)
- the nausea and vomiting caused by dopamine agonists (levodopa and Bromocriptinum).
The route of administration and doses
the Adult appoint 10 - 20 mg (1-2 tablets) 2 - 3 times a day in 30 min. prior to food.
To children aged from 6 years up to 12 years (with body weight more than 35 kg) appoint in a dose 0.2 - 0.4 mg/kg of weight (5 mg - ½ tablets, 10 mg – 1 tablet), 2 - 3 times a day in 30 minutes prior to food or if necessary before going to bed.
Duration of a course of therapy is established by the doctor individually for each patient.
At repeated prescribing of drug to patients with the profound renal failures the frequency rate of reception should not exceed 1-2 times during the day.
Side effects
seldom
- enterospasms, dryness in a mouth, thirst, diarrhea
- increase in level of prolactin in blood plasma, a galactorrhoea, a gynecomastia, an amenorrhea
very seldom
- extrapyramidal disorders, a headache, nervousness
- rash, urticaria
- lengthening of an interval of QT, ventricular arrhythmias
of the Contraindication
- hypersensitivity to drug
- gastrointestinal bleeding
- impassability of a stomach or intestines
- perforation of a stomach or intestines
- prolactin - the cosecreting hypophysis tumor
- a concomitant use of oral forms of a ketokonazol, erythromycin or other strong inhibitors of an isoenzyme CYP3A4 causing lengthening of an interval of QTc (flukonazol, vorikonazol, klaritromitsin, Amiodaronum and telitromitsin)
- hereditary intolerance of a galactose, lactose, a sprue, a glyukozemiya, a galactosemia
- children's age up to 12 years (with the body weight & lt, 35 kg)
- pregnancy and the period of a lactation.
Medicinal interactions
the Concomitant use of drug with opioid analgetics and anticholinergic drugs can neutralize Motinorm's action.
At simultaneous use with Motinorm antiacid and anti-secretory drugs reduce its bioavailability.
At simultaneous use with Motinorm of the medicines considerably inhibiting SYRZA4 enzyme (antifungal drugs of group of azoles, antibiotics from group of macroleads, HIV protease inhibitors, antidepressant nefazodon) increase in level of a domperidon in plasma can be observed.
Domperidon does not influence paracetamol level in blood.
Motinorm can reduce bioavailability of digoxin which dose has to be adjusted.
Motinorm can influence absorption applied at the same time in drugs with the slowed-down release of active agent or covered with a kishechnorastvorimy cover.
Fenotiazin at a concomitant use with drug can cause extrapyramidal symptoms.
The concomitant use of Bromocriptinum with Motinorm leads to a giperprolaktinemiya.
Special instructions
With care appoint drug to patients with the profound abnormal liver functions. At prolonged use of drug the regular medical observation is necessary.
Fast advance of food on digestive tract causes the necessity in correction of dosing of insulin at diabetics.
At patients with a heavy renal failure, elimination half-life of drug increases that demands at repeated prescribing of drug of reduction of frequency of introduction up to one or two times a day.
Features of influence on ability to control of motor transport and potentially dangerous mechanisms
Drug does not affect ability to run motor transport and potentially dangerous mechanisms.
Overdose
Symptoms: drowsiness, disorientation, extrapyramidal disorders.
Treatment: careful observation, intake of activated carbon, in case of extrapyramidal disturbances use of the anticholinergic drugs which are used for treatment of parkinsonism or antihistaminic drugs with anticholinergic properties.
A form of release and packing
On 10 tablets in blister strip packaging from printing aluminum foil.
On 1 and 3 planimetric packs together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
Storage conditions
In the dry, protected from light place, at a temperature not over 25 ºС. To store out of children's reach!
A period of storage
4 years
not to use drug after an expiration date.
Prescription status
According to the prescription
of Proizvoditel Medley Pharmasyyutikalz Ltd, India
Medlya House, D2, MIDS an eriya, Anderi (E), Mumbai-400 093, India.
The owner of the registration certificate
of Medley Pharmasyyutikalz Ltd, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of Medley Pharmasyyutikalz Ltd Almaty, Kurmangaza St. 48 and, office 9 the 050000 Phone number Index (727) 2729871, 2615141 Fax number (727) 2614466 E-mail address:
To Develop registration1@kazeuropharm.com
of MOTINORM® medicine
the Trade name
of Motinorm®
the International unlicensed
name Domperidon Lekarstvennaya a form
of the Tablet of 10 mg
Structure
One tablet contains
active agent: domperidon 10 mg,
excipients: lactose, starch corn, metilpara-hydroxybenzoate, propilparagidroksibenzoat, magnesium stearate.
The description
White or almost white round tablets with risky on one party and with an engraving of Medley on another
Pharmacotherapeutic group
Stimulators of motility of digestive tract
the ATX A03FA03 Code
the Pharmacological
Pharmacokinetics VsasyvanieDomperidon properties is quickly absorbed at intake on an empty stomach. The maximum concentration (Cmax) in blood plasma is reached approximately within 30 min. The low absolute bioavailability of a domperidon at intake (about 15%) is caused by extensive primary metabolism in a wall of intestines and liver.
The bioavailability of a domperidon increases at reception after a meal, but patients with complaints from the digestive tract (DT) should accept domperidon in 15-30 min. prior to food. The Gipoatsidnost of gastric juice reduces absorption of a domperidon.
RaspredeleniePri oral administration domperidon does not kumulirut and does not induce own metabolism. Cmax in plasma in 90 min. after reception, equal 21 ng/ml, after 2 weeks reception on 30mg/days, was almost same, as after reception of the first dose (18 ng/ml).
Domperidon for 91-93% contacts proteins of plasma. Concentration of a domperidon in breast milk of the feeding women are 4 times lower, than the corresponding concentration in plasma.
MetabolizmPreparat is metabolized in a liver by hydroxylation and N-dealkylation. At metabolism of drug CYP3A4 is the main isoenzyme of a system of P450 cytochrome participating in process of N-dealkylation of a domperidon whereas CYP3A4, CYP1A2 and CYP2E1 participate in process of aromatic hydroxylation of a domperidon.
It VyvedenieVyvoditsya in not changed view with a stake - 10% and with urine - about 1%. Elimination half-life (T1/2) after reception of a single dose makes the 7-9th of plasma. At patients with a heavy renal failure of T1/2 increases to 20.8 h.
Pharmacodynamics
Antiemetic drug, stimulator of motility of the digestive tract (DT). Domperidon - the antagonist of a dopamine possessing similar to Metoclopramidum and some neuroleptics, antiemetic properties. However, unlike these medicines, domperidon badly gets through a blood-brain barrier. Use of a domperidon seldom is followed by extrapyramidal side effects, especially at adults, but domperidon stimulates prolactin discharge from a hypophysis. Its antiemetic action is caused by a combination of peripheral (gastrokinetichesky) action and antagonism to dopamine receptors in a trigger zone of chemoceptors. At use inside domperidon increases duration of antral and duodenal reductions, accelerates gastric emptying - an exit of liquid and semisolid fractions at healthy people and firm fractions at patients at whom this process was slowed down, and increases pressure of a sphincter of a lower part of a gullet at healthy people. Domperidon has no effect on gastric secretion.
Indications
- nausea, vomiting, a complex of the dispepsichesky symptoms caused
by the slowed-down gastric emptying, a gastroesophageal reflux, an esophagitis (feeling of overflow of a stomach, an eructation, a meteorism, heartburn)
- nausea and vomiting of functional or organic genesis (including in infections, errors in a diet, medicinal or radiation therapy)
- the nausea and vomiting caused by dopamine agonists (levodopa and Bromocriptinum).
The route of administration and doses
the Adult appoint 10 - 20 mg (1-2 tablets) 2 - 3 times a day in 30 min. prior to food.
To children aged from 6 years up to 12 years (with body weight more than 35 kg) appoint in a dose 0.2 - 0.4 mg/kg of weight (5 mg - ½ tablets, 10 mg – 1 tablet), 2 - 3 times a day in 30 minutes prior to food or if necessary before going to bed.
Duration of a course of therapy is established by the doctor individually for each patient.
At repeated prescribing of drug to patients with the profound renal failures the frequency rate of reception should not exceed 1-2 times during the day.
Side effects
seldom
- enterospasms, dryness in a mouth, thirst, diarrhea
- increase in level of prolactin in blood plasma, a galactorrhoea, a gynecomastia, an amenorrhea
very seldom
- extrapyramidal disorders, a headache, nervousness
- rash, urticaria
- lengthening of an interval of QT, ventricular arrhythmias
of the Contraindication
- hypersensitivity to drug
- gastrointestinal bleeding
- impassability of a stomach or intestines
- perforation of a stomach or intestines
- prolactin - the cosecreting hypophysis tumor
- a concomitant use of oral forms of a ketokonazol, erythromycin or other strong inhibitors of an isoenzyme CYP3A4 causing lengthening of an interval of QTc (flukonazol, vorikonazol, klaritromitsin, Amiodaronum and telitromitsin)
- hereditary intolerance of a galactose, lactose, a sprue, a glyukozemiya, a galactosemia
- children's age up to 12 years (with the body weight & lt, 35 kg)
- pregnancy and the period of a lactation.
Medicinal interactions
the Concomitant use of drug with opioid analgetics and anticholinergic drugs can neutralize Motinorm's action.
At simultaneous use with Motinorm antiacid and anti-secretory drugs reduce its bioavailability.
At simultaneous use with Motinorm of the medicines considerably inhibiting SYRZA4 enzyme (antifungal drugs of group of azoles, antibiotics from group of macroleads, HIV protease inhibitors, antidepressant nefazodon) increase in level of a domperidon in plasma can be observed.
Domperidon does not influence paracetamol level in blood.
Motinorm can reduce bioavailability of digoxin which dose has to be adjusted.
Motinorm can influence absorption applied at the same time in drugs with the slowed-down release of active agent or covered with a kishechnorastvorimy cover.
Fenotiazin at a concomitant use with drug can cause extrapyramidal symptoms.
The concomitant use of Bromocriptinum with Motinorm leads to a giperprolaktinemiya.
Special instructions
With care appoint drug to patients with the profound abnormal liver functions. At prolonged use of drug the regular medical observation is necessary.
Fast advance of food on digestive tract causes the necessity in correction of dosing of insulin at diabetics.
At patients with a heavy renal failure, elimination half-life of drug increases that demands at repeated prescribing of drug of reduction of frequency of introduction up to one or two times a day.
Features of influence on ability to control of motor transport and potentially dangerous mechanisms
Drug does not affect ability to run motor transport and potentially dangerous mechanisms.
Overdose
Symptoms: drowsiness, disorientation, extrapyramidal disorders.
Treatment: careful observation, intake of activated carbon, in case of extrapyramidal disturbances use of the anticholinergic drugs which are used for treatment of parkinsonism or antihistaminic drugs with anticholinergic properties.
A form of release and packing
On 10 tablets in blister strip packaging from printing aluminum foil.
On 1 and 3 planimetric packs together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
Storage conditions
In the dry, protected from light place, at a temperature not over 25 ºС. To store out of children's reach!
A period of storage
4 years
not to use drug after an expiration date.
Prescription status
According to the prescription
of Proizvoditel Medley Pharmasyyutikalz Ltd, India
Medlya House, D2, MIDS an eriya, Anderi (E), Mumbai-400 093, India.
The owner of the registration certificate
of Medley Pharmasyyutikalz Ltd, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of Medley Pharmasyyutikalz Ltd Almaty, Kurmangaza St. 48 and, office 9 the 050000 Phone number Index (727) 2729871, 2615141 Fax number (727) 2614466 E-mail address:
To Develop registration1@kazeuropharm.com
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