Motilium suspension screaming. 1mg / ml 100ml fl

$16.79

Motilium suspension screaming. 1mg / ml 100ml fl

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Description

Composition
Active substance:
1 mg of domperidone.
Excipients:
microcrystalline cellulose and carmellose sodium 12.0 mg, uncrystallized liquid sorbitol 70% 455.4 mg methyl parahydroxybenzoate 1.8 mg propyl parahydroxybenzoate 0.20 mg Sodium saccharinate 0.20 mg, 0.10 mg polysorbate 20, sodium hydroxide is about 10 mcg * water ad 1.0 ml.
* From 0 to 30 micrograms.
Description:
Homogenous white suspension
Product form:
Oral suspension of 1 mg / ml. 100 ml of a dark glass vial with screw cap, protected from accidental opening by children and coated with a schematic representation of the vial opening. One vial with a metering syringe and instructions for use in a cardboard package.
Contraindications
Hypersensitivity to domperidone or any of the components;
prolactin-secreting pituitary tumor (prolactinoma);
concomitant use of oral forms of ketoconazole, erythromycin or other potent inhibitors of isoenzyme CYP3A4, causing elongation interval QTc, such as clarithromycin, itraconazole, fluconazole, posaconazole, ritonavir, saquinavir, amiodarone, telithromycin, telaprevir and voriconazole (see. Forums “special instructions”, ” interaction c other drugs “);
when stimulating gastric motility might be dangerous, such as gastrointestinal bleeding, mechanical obstruction or perforation;
abnormal liver function moderate or severe.
Patients with impaired liver function and kidney
Use in patients with impaired renal function.
Since the half-life of domperidone increases with severe renal dysfunction, with repeated use of the drug Motilium® frequency should be reduced to 1-2 times per day depending on the severity, it can also require dose reduction. When long-term therapy should be routine screening of these patients (see. “Special Instructions” section).
Use in patients with impaired hepatic function.
Application Motilium® contraindicated in patients with moderate (7 – 9 on the classification of Child-Pugh) or severe (> 9 Classification of Child-Pugh) hepatic insufficiency (see section “Contraindications”.). Patients with mild (5 – 6 on the Child-Pugh classification) hepatic insufficiency drug dose correction is not required (see “Pharmacological properties”.).
Carefully:
impaired renal function;
violation of rhythm and conduction of the heart, including the lengthening of the interval QT, electrolyte disturbances, congestive heart failure.
Dosage
1 mg / ml
Indications
1. Complex of dyspeptic symptoms often associated with delayed gastric emptying, gastroesophageal reflux, esophagitis:
– a feeling of fullness in the epigastric pain, early satiety, a feeling of bloating, pain in the upper abdomen;
– belching, flatulence;
– nausea, vomiting;
– heartburn, regurgitation of gastric contents or not.
2. Nausea and vomiting functional, organic, infectious descended Denia caused by radiotherapy, drug therapy or disorder que you. A specific indication is nausea and vomiting caused by dopamine agonists in the case of their use in Parkinson’s disease (such as L-dopa and bromocriptine).
Interaction with other drugs
Anticholinergic drugs may neutralize Motilium® preparation.
The oral bioavailability of the drug decreases Motilium® after prior reception of cimetidine or sodium hydrogencarbonate. Do not take antacids and antisecretory drugs in conjunction with domperidone, as they reduce its bioavailability after oral administration (see. section “Special Instructions”).
A major role in the metabolism of domperidone plays isoenzyme CYP3A4. The results of in vitro studies and clinical experience indicate that the simultaneous use of drugs, which significantly inhibit this isoenzyme may cause an increase in plasma concentrations of domperidone. Therefore, the combined use of domperidone with potent inhibitors of CYP3A4, which, in the received data, causes lengthening of the interval QT, contraindicated. Care must be taken in the combined use of domperidone to be potent inhibitors of CYP3A4, which do not cause prolongation of the interval QT, and with drugs that are, according to the received data, causes lengthening of the interval QT.
Among CYP3A4 strong inhibitors include:
• azole antifungals such as fluconazole *, itraconazole, ketoconazole * and voriconazole *;
• Antibiotics, macrolides such as clarithromycin * and erythromycin *;
• HIV protease inhibitors such as amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir;
• calcium antagonists such as diltiazem and verapamil;
• Amiodarone *;
• aprepitant;
• Nefazodone.
• telithromycin *
(Formulations asterisk further lengthen the interval QTc (see. The section “Contra ‘)).
Several studies have pharmacokinetic and pharmacodynamic interactions of domperidone with oral ketoconazole or oral erythromycin in healthy volunteers have shown that these drugs significantly inhibited the primary metabolism of domperidone exercised isoenzyme CYP3A4.
When simultaneous administration of 10 mg of domperidone 4 times a day, and 200 mg of ketoconazole 2 times a day interval QTc prolongation observed on average 9.8 ms over the entire period of observation, at certain moments changes ranged from 1.2 to 17.5 msec. When simultaneous administration of 10 mg of domperidone 4 times a day, and 500 mg of erythromycin 3 times daily observed lengthening QTc interval on average 9.9 ms over the entire period of observation, at certain moments of change varied between 1.6 and 14.3 ms. In each of these studies Cmax and AUC of domperidone were increased about three times (see. The section “Contra ‘).
At the present time it is not known what kind of contribution to the change in the QTc interval is made higher plasma concentrations of domperidone.
In these studies, monotherapy with domperidone (10 mg four times a day) resulted in a lengthening of QTc interval 1.6 msec (ketoconazole study) and 2.5 ms (research erythromycin), whereas ketoconazole monotherapy (200 mg twice daily) monotherapy and erythromycin (500 mg tid) resulted in a lengthening of the QTc interval 3.8 and 4.9 ms, respectively, during the whole period of observation.
In another study using multiple doses in healthy volunteers, were found significant elongation QTc interval during stationary monotherapy domperidone (40 mg four times a day, the total daily dose is 160 mg, which suschestenno exceeds the recommended maximum daily dose). In this case, domperidone plasma concentrations were similar to those in studies of interaction with other drugs domperidone.
Combined use of anticholinergic drugs (e.g., dextromethorphan, diphenhydramine) may hinder the development antidispepticheskih Motilium® effects.
Theoretically, since Motilium® has gastrokinetic action, it could affect the absorption of both an oral preparations, particularly preparations with sustained release of active substances, or preparations, enteric-coated. However, the use of domperidone in patients while taking paracetamol or digoxin did not affect the levels of these drugs in the blood.
Motilium® can be taken together with:
• neuroleptics, the action of which it does not increase;
• with dopaminergic receptor agonists (bromocriptine, levodopa) because it inhibits their unwanted peripheral effects such as digestive disorders, nausea and vomiting, without affecting their central effects.
Overdose
Symptoms.
Cases of overdose have been observed mainly in infants and older children. Overdose symptoms may include irritability, change of consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.
Treatment.
Domperidone specific antidote does not exist. In case of overdose recommended gastric lavage for one hour after drug administration and the use of activated carbon. It is recommended to closely monitor the condition of the patient and supportive therapy. Anticholinergic drugs, drugs used to treat Parkinsonism, or antihistamines may not be effective in extrapyramidal reactions.
pharmachologic effect
Pharmacological group:
Antiemetic – central dopamine receptor blocker
Pharmacodynamics:
Domperidone – dopamine antagonist that has antiemetic properties. Domperidone does not penetrate the blood-brain barrier. Use of domperidone rarely accompanied by extrapyramidal side effects especially in adults, but domperidone stimulates prolactin release from the pituitary. Its antiemetic effect may be due to a combination of peripheral (gastrokinetic) action and antagonism of dopamine receptors in the chemoreceptor trigger zone, which is outside the blood-brain barrier. Studies in animals and low concentrations of drug detected in the brain, suggest domperidone predominantly peripheral action on dopamine receptors.
Applications inside domperidone increases the duration of antral and duodenal contractions, accelerates gastric emptying and increases the pressure of the lower esophageal sphincter. Domperidone has no effect on gastric secretion.
Pharmacokinetics:
When receiving domperidone fasting rapidly absorbed after oral administration, peak plasma concentrations are reached within 30 – 60 minutes. Low absolute bioavailability of domperidone when administered (approximately 15%) is associated with the intensive first-pass metabolism in the gut wall and liver.
Domperidone should be taken for 15 – 30 minutes before meals. Reducing the acidity in the stomach leads to poor absorption of domperidone. Oral bioavailability is reduced by preliminary admission of cimetidine and sodium bicarbonate. When taken after a meal the drug to achieve maximum absorption takes more time, and the area under the curve (AUC) increases slightly.
When ingestion of domperidone does not accumulate or induce its own metabolism; peak plasma level of 21 ng / ml 90 minutes after 2 weeks of oral administration of the drug at a dose of 30 mg per day was almost the same as the level of 18 ng / ml after administration of the first dose. Domperidone binds to the plasma protein at 91 – 93%. drug distribution studies with radiolabeled in animals have shown its wide tissue distribution, but low concentrations in the brain. Small amounts of drug cross the placenta in rats.
Domperidone undergoes rapid and extensively metabolized by hydroxylation and N-dealkylation. in vitro metabolism study with diagnostic inhibitors revealed that CYP3A4 isozyme is the major form of cytochrome P450 involved in the N-dealkylation of domperidone, whereas isozymes CYP3A4, CYP1A2 and CYP2E1 involved in the hydroxylation of aromatic domperidone.
Excretion of urine and feces was 31% and 66% of the dose when administered, respectively. Percentage of drug excreted unchanged in is small (10% – faeces and approximately 1% – in the urine). The plasma half-life after a single oral administration of 7 – 9 hours in healthy volunteers, but is increased in patients with severe renal insufficiency.
In such patients (serum creatinine> 6 mg / 100 ml, ie. E.> 0.6 mmol / L) increased the half-life of domperidone from 7.4 to 20.8 hours, but the concentration of drug in plasma is lower than that of patients with normal renal function. A small amount of the unchanged drug (about 1%) excreted by the kidneys.
In patients with impaired liver function moderate severity (score 7 – 9 points on a scale Child-Pugh), the AUC and Cmax of domperidone were 2.9 and 1.5 times higher than in healthy volunteers, respectively. Percentage of unbound fraction was increased by 25% and the half-life was increased from 15 to 23 hours. In patients with mild hepatic impairment observed several reduce systemic levels of the drug compared to those of healthy volunteers based on Cmax and AUC, without being bound to proteins or change in half-life. Patients with severe hepatic impairment have not been studied.
Pregnancy and breast-feeding
Pregnancy
Data on the use of domperidone during pregnancy is not enough. To date there is no evidence of an increased risk of malformations in humans. However, Motilium® should be administered during pregnancy only if its use is justified by the expected therapeutic benefit.
Lactation
Number of domperidone, which can enter the body of the child with breast milk is small. Maximum relative dose for infants (%) estimated at about 0.1% of the dosage adopted mother based on body weight. It is not known whether this level has a negative effect on the newborn. In this regard, when applying Motilium® during lactation should stop breastfeeding.
Conditions of supply of pharmacies
On prescription
side effects
According to clinical studies
Adverse reactions observed in> 1% of patients taking Motilium®: depression, anxiety, decreased or absent libido, headache, somnolence, akathisia, diarrhea, dry mouth, rash, itching, breast enlargement / gynecomastia, pain and sensitivity breast tenderness, galactorrhea, menstrual disorders and amenorrhea, impaired lactation, asthenia.
Adverse reactions observed in
The following adverse effects were classified as follows: very often (> 10%), frequent (> 1%, 0.1% and 0.01%, but
According spontaneous reports of adverse events identified in the post-registration period of the drug
Violations by the immune system. Very rare: anaphylactic reactions, including anaphylactic shock.
Mental disorders. Very rarely: irritability (predominantly in infants and children), nervousness.
Disorders of the nervous system. Very rare: dizziness, extrapyramidal disorders and convulsions (mainly in infants and children).
Violations by the cardiovascular system. Very rare: lengthening of the interval QT, serious ventricular arrhythmia *, sudden cardiac death *.
Violations of the skin and subcutaneous tissue. Very rare: urticaria, angioneurotic edema.
Violations of the kidneys and urinary tract. Very rare: urinary retention.
Laboratory and instrumental data. Very rare: laboratory abnormalities of liver function, increased blood prolactin levels.
Adverse reactions identified in the post-registration clinical studies
Violations by the immune system. Frequency unknown: anaphylactic reactions including anaphylactic shock.
Mental disorders. Uncommon: irritability (predominantly in infants and children), nervousness.
Disorders of the nervous system. Common: dizziness. Rare: convulsions (especially in infants and children). Frequency unknown: extrapyramidal disorder (especially in infants and children).
Violations by the cardiovascular system. Frequency unknown: lengthening of the interval QT, serious ventricular arrhythmia *, sudden cardiac death *.
Violations of the skin and subcutaneous tissue. Frequency unknown: angioedema.
Violations of the kidneys and urinary tract. Uncommon: urinary retention.
Laboratory and instrumental data. Uncommon: laboratory abnormalities of liver function. Rare: increase in blood prolactin levels.
* In some epidemiological studies have shown that the use of domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden death. The risk of these events is more likely in patients older than 60 years and in patients taking the drug at a daily dose of 30 mg. It recommended the use of domperidone in the lowest effective dose in adults and children.
special instructions
In a joint application Motilium® drug with antacids or antisecretory drugs should be taken after the last, and not to eat, that is, should not be taken simultaneously with the preparation Motilium®.
Oral suspension Motilium® comprises sorbitol and is not recommended for patients with intolerance receiving sorbitol.
Use in children
Motilium® in rare cases can cause neurological side effects (see. The section “Side effect”). The risk of neurological side effects in young children higher as metabolic functions and the blood-brain barrier in the first months of life are not fully developed. In this connection, it should be very accurate calculation of the dose of the drug Motilium® for newborns, infants and young children of preschool age, and strictly adhere to this dose (see. Section “Dosage and administration”). Neurological adverse effects may be caused by an overdose of the drug in children, but it is necessary to take into account other possible causes such effects.
Used in diseases of the cardiovascular system
Some epidemiological studies have shown that the use of domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see. The section “Side effects”). The risk may be more likely in patients older than 60 years and in patients taking the drug at daily doses greater than 30 mg. Patients older than 60 years before taking Motilium® should consult with a doctor (see. Section “Dosage and administration”).
Use of domperidone and other drugs that lead to a lengthening of the interval QTc, is not recommended for patients with existing conduction disturbances, in particular, elongation interval QTc, and in patients with severe disorders of electrolyte balance (hypokalemia, hyperkalemia, hypomagnesaemia) or bradycardia, or in patients with concomitant heart diseases such as congestive heart failure. As it is known, on a background of electrolyte balance and bradycardia and increased risk of arrhythmia.
В случае появления признаков или симптомов, которые могут быть связаны с сердечной аритмией, терапию Мотилиум® необходимо прекратить и проконсультироваться у врача.
Применение при заболеваниях почек.
Так как очень небольшой процент препарата выводится почками в неизмененном виде, то коррекция разовой дозы у больных с почечной недостаточностью не требуется. Однако при повторном назначении Мотилиум® частота применения должна быть снижена до одного-двух раз в сутки, в зависимости от тяжести нарушений функции почек (см. раздел «Способ применения и дозы»). При длительной терапии пациенты должны находиться под регулярным наблюдением.
Потенциал лекарственного взаимодействия
Основной путь метаболизма домперидона осуществляется посредством CYP3A4. In vitro данные и результаты исследований у человека показывают, что сопутствующее применение лекарственных средств, значительно ингибирующих этот фермент, может сопровождаться увеличением концентраций домперидона в плазме. Сочетанное применение домперидона с сильнодействующими ингибиторами CYP3A4, которые, по полученным данным, вызывают удлинение интервала QT противопоказано (см. «Противопоказания»).
Необходимо соблюдать осторожность при совместном применении домперидона с сильнодействующими ингибиторами CYP3A4, которые не вызывают удлинение интервала QT, такими, как индинавир, и необходим тщательный мониторинг пациентов на предмет возникновения признаков или симптомов нежелательных реакций (см. «Взаимодействие с другими лекарственными средствами»).
Необходимо соблюдать осторожность при сочетанном применении домперидона с лекарственными средствами, которые, по полученным данным, вызывают удлинение интервала QT, и необходим тщательный мониторинг пациентов на предмет возникновения признаков или симптомов сердечно-сосудистых нежелательных реакций.
Примеры таких лекарственных средств:
• антиаритмические средства класса IA (например, дизопирамид, хинидин);
• антиаритмические средства класса III (например, амиодарон, дофетилид, дронедарон, ибутилид, соталол);
• определенные антипсихотики (например, галоперидол, пимозид, сертиндол);
• определенные антидепрессанты (например, циталопрам, эсциталопрам);
• определенные антибиотики (например, левофлоксацин, моксифлоксацин);
• определенные противогрибковые средства (например, пентамидин);
• определенные противомалярийные средства (например, галофантрин);
• определенные желудочно-кишечные лекарственные средства (например, доласетрон);
• определенные противоопухолевые лекарственные средства (например, торемифен, вандетаниб);
• некоторые другие лекарственные средства (например, бепридил, метадон).
Если лекарственное средство пришло в негодность, или истек срок годности – не выливайте его в сточные воды и на улицу! Place the drug in the bag and place in the trash. These measures will help protect the environment!
Влияние на способность вождения транспорта
Необходимо соблюдать осторожность при управлении транспортными средствами и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций в связи с риском развития побочных реакций, которые могут влиять на указанные способности.
Storage conditions
Store at a temperature of from 15 to 30 ° C.
Keep out of the reach of children.
Dosing and Administration
Рекомендуется принимать Мотилиум® до еды, в случае приема после еды абсорбция домперидона немного замедляется.
Взрослые и подростки старше 12 лет и дети с массой тела 35 кг и более:
10 мл 3 раза в сутки. Максимальная суточная доза – 30 мл (30 мг).
Младенцы и дети до 12 лет с массой тела менее 35 кг:
0,25 на 1 кг массы тела 3–4 раза в сутки. Максимальная суточная доза домперидона – 30 мл (30 мг).
Мотилиум® должен применяться в наименьшей эффективной дозировке.
Для определения дозы используйте шкалу массы тела ребенка “0–20 kg” на шприце.
У детей передозировка может вызвать нарушения со стороны нервной системы (см. «Передозировка»).
Дозу следует определять очень тщательно, с учетом массы тела и, не превышая рекомендованную максимальную суточную дозировку.
У пациентов всех возрастных категорий обычно для терапии острой тошноты и рвоты максимальная продолжительность непрерывного приема препарата не должна превышать одну неделю. Если тошнота и рвота продолжаются дольше одной недели, пациенту следует повторно проконсультироваться со своим врачом. По другим показаниям продолжительность терапии составляет 4 недели. Если симптомы не исчезают в течение 4 недель, необходимо провести повторное обследование пациента и оценить необходимость в продолжении терапии.
Использование у пациентов с нарушениями функции почек
Поскольку период полувыведения домперидона увеличивается при тяжелых нарушениях функции почек, при повторном применении частота приема препарата Мотилиум® должна быть снижена до 1–2 раз в сутки в зависимости от тяжести нарушений, может также потребоваться снижение дозы. При длительной терапии следует проводить регулярное обследование таких пациентов (см. раздел «Особые указания»).
Использование у пациентов с нарушениями функции печени
Применение Мотилиум® противопоказано у пациентов со среднетяжелой (7 – 9 по классификации Чайлд-Пью) или тяжелой (> 9 по классификации Чайлд-Пью) печеночной недостаточностью (см. раздел «Противопоказания»). У пациентов с легкой (5 – 6 по классификации Чайлд-Пью) печеночной недостаточностью коррекции дозы препарата не требуется (см. раздел «Фармакологические свойства»).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

JOHNSON

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