Motilium tab p / 10 mg of the film 30 pc

$15.73

Motilium tab p / 10 mg of the film 30 pc

Quantity:

Description

Composition
Active substance:
domperidone 10 mg
Excipients:
lactose monohydrate 54.2 mg corn starch 20 mg microcrystalline cellulose 10 mg 3 mg pregelatinized starch, povidone K90 1.5 mg Magnesium stearate 0.6 mg hydrogenated cotton seed oil 0.5 mg sodium lauryl sulfate 0.15 mg.
Film coating: Hypromellose 2910 5 mPahs 2.2 mg sodium lauryl sulfate 0.05 mg.
Description:
Round biconvex tablets covered ple¬nochnoy shell, from white to pale cream color, with the inscription “JANSSEN” on one side of the tablet and M / 10 on the other. The cross-sectional core of a white tablet.
Product form:
Tablets, film-coated 10mg. 30 tablets in a blister of PVC / Alu. 1 blister together with instructions for use in meditsin¬skomu carton box.
Contraindications
– hypersensitivity to domperidone or any other component of the formulation;
– lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
– prolactinoma;
– simultaneous use of oral forms of ketoconazole, erythromycin or other drugs that increase the interval QT, or potent inhibitors isoenzyme CYP34A, such as fluconazole, voriconazole, clarithromycin, amiodarone, telithromycin, etc. (see sections “Specific guidance”, “Interaction of c others.. drugs “);
– expressed electrolyte disturbances or heart disease, such as chronic heart failure;
– bleeding from the gastrointestinal tract, mechanical intestinal obstruction, perforation of the stomach or intestines;
– liver failure secondary to severe;
– body weight less than 35 kg;
– Children under 12 years of age with a body weight less than 35 kg;
– pregnancy;
– the period of breastfeeding.
Patients with impaired liver function and kidney
Use in patients with renal insufficiency.
Since the half-life of domperidone with severe renal failure (creatinine level at serum> 6 mg / 100 ml, ie. E.,> 0.6 mmol / L) increases, the frequency of the reception MOTILIUM®, coated tablets, should be reduced to 1 or 2 times a day, depending on the disease severity. It is necessary to carry out regular examinations of patients with severe renal insufficiency (see. Section “Pharmacological properties”).
Use in patients with hepatic insufficiency.
Application MOTILIUM® contraindicated in patients with hepatic failure secondary to severe (see. The section “Contra ‘). Patients with mild hepatic insufficiency drug dose correction is not required (see. The section “Pharmacological properties”).
Patients are to be taken with caution
With care – children’s age;
– impaired renal function.
Indications
To facilitate the symptoms of nausea and vomiting.
Interaction with other drugs
Interaction with the following medicines may increase the risk of increasing the interval QT. Contra combination: drugs that increase the interval QT: antiarrhythmic drugs of class IA (e.g., disopyramide, gidrohinidin, quinidine), antiarrhythmic drugs of class III (e.g., amiodarone, dofetidil, dronedarone, ibutilide, sotalol), antipsychotics (e.g., haloperidol, pimozide, sertindole), antidepressants (e.g., citalopram, escitalopram), antibiotics (erythromycin, levofloxacin, moxifloxacin, spiramycin), antifungals (e.g. pentamidine), antimalarials (such as halophilic antrin, Lumefantrine), gastrointestinal drugs (e.g., cisapride, dolasetron, prucalopride), antihistamines (e.g., mehitazin, mizolastine), antineoplastic agents (e.g., toremifene, vandetanib, vincamine), other drugs (e.g., bepridil, difemanila methylsulfate , methadone), potent inhibitors of CYP3A4 (protease inhibitors, azole antifungals, some macrolide antibiotics (erythromycin, clarithromycin, telithromycin) .Nerekomendovannye combination: CYP3A4 moderate inhibitors (diltiazem , Verapamil, certain antibiotics from the macrolide). Combinations to be used with caution: drugs that cause bradycardia and hypokalemia, as well as azithromycin and roxithromycin. Cimetidine, sodium hydrogencarbonate, other antacids and antisecretory drugs reduce the bioavailability of domperidone. Domperidone increase the concentration in plasma: azole antifungals, antibiotics of the macrolide, HIV protease inhibitors, nefazodone. Compatible with antipsychotic drugs (neuroleptics), agonists of dopaminergic receptors (bromocriptine, levodopa). The simultaneous use of paracetamol and digoxin has no effect on the concentration of these drugs in the blood.
Overdose
Overdose symptoms are the most common in infants and children. Signs of overdose are agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.
Treatment of overdose: Symptomatic, there is no specific antidote. Gastric lavage, administration of activated charcoal, in the event of extrapyramidal reactions – anticholinergics, antiparkinsonian agents. Because of the possible increased QT interval should be monitored electrocardiogram (ECG).
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 by the kidneys and intestine is 31% and 66% of the dose when administered, respectively. Percentage of drug excreted unchanged in is small (10% – Displays the intestine and about 1% -pochkami). 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
MOTILIUM® contraindicated during pregnancy and lactation.
Conditions of supply of pharmacies
On prescription.
side effects
According to clinical studies
Adverse reactions observed in> 1% of patients treated with Motilium: depression, anxiety, decreased or absent libido, headache, somnolence, akathisia, diarrhea, rash, itching, breast enlargement / gynecomastia, pain and sensitivity in the breast, galactorrhoea , 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 adverse event messages
Violations by the immune system. Very rare: anaphylactic reactions, including anaphylactic shock.
Mental disorders. Very rarely: irritability, nervousness, irritability.
Disorders of the nervous system. Very rare: drowsiness, headache, dizziness, extrapyramidal disorder and seizures.
Violations by the cardiovascular system. Frequency not known: ventricular arrhythmia *, ventricular tachycardia of the type “pirouette”, 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, hyperprolactinemia.
* 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.
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, nervousness.
Disorders of the nervous system. Common: dizziness. Rare: convulsions. Frequency unknown: extrapyramidal disorders.
Violations by the cardiovascular system. Frequency not known: ventricular arrhythmia *, ventricular tachycardia of the type “pirouette”, sudden cardiac death *.
Disorders of the gastrointestinal tract. Frequency unknown: a dry mouth.
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: hyperprolactinaemia.
* 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
Domperidone is not recommended for the prevention of nausea and vomiting after anesthesia. With long-term drug therapy, patients should be under regular medical supervision.
Domperidone can cause QT interval prolongation on an electrocardiogram. During post-marketing studies in patients treated with domperidone, in rare cases, an increase in the QT interval and the occurrence of ventricular tachycardia type “pirouette”. These adverse reactions have been observed mainly in patients with risk factors for patients with severe electrolyte disorders or taking concomitant medications that increase the QT interval.
In some studies it was shown that the use of domperidone may cause an increased risk of ventricular fibrillation or of sudden cardiac death (especially in patients over 60 years, or in the application of a single dose of 30 mg, and in patients simultaneously receiving drugs that increase the interval QT, or CYP3A4 inhibitors).
Use of domperidone and other drugs which may cause lengthening of the interval QT, in patients with severe electrolyte disorders (hypo- and hyperkalemia, hypomagnesaemia) or patients with heart disease, such as chronic heart failure. It has been shown that the presence of the patient’s electrolyte abnormalities (hypo- and hyperkalemia, hypomagnesemia) and bradycardia may increase the risk of arrhythmias. Domperidone should be discontinued if there are any symptoms that may be associated with heart rhythm disturbances. In this case, you should consult with your doctor.
With simultaneous use of domperidone enhances the effect of neuroleptics. With the simultaneous application of the drug with dopaminergic receptor agonists (bromocriptine, levodopa) domperidone inhibits unwanted peripheral effects of the latter, such as indigestion, nausea and vomiting, without affecting their central effects. The drug is recommended to take the lowest effective dose.
If the drug became useless or expired shelf life – do not throw it in the waste water and the street! Place the drug in the bag and place in the trash. These measures will help protect the environment!
Impact on the ability to drive vehicles
Caution should be exercised when driving and busy with other potentially hazardous activities that require high concentration and psychomotor speed reactions due to the risk of adverse reactions, which may affect these abilities.
Storage conditions
Store at a temperature of from 15 to 30 ° C.
Keep out of the reach of children.
Dosing and Administration
Inside. MOTILIUM® advised to take the tablets for 15 – 30 minutes before meals, in the case of taking the medication after a meal can slow down the absorption of domperidone.
Adults and children over 12 years weighing 35 kg or more
1 tablet (10 mg) 3 times a day with a maximum daily dose of 3 tablets (30 mg).
Children up to 12 years and weighing 35 kg or more
1 tablet (10 mg) 3 times a day with a maximum daily dose of 3 tablets (30 mg).
In pediatric practice, mainly to be used MOTILIUM® suspension.
Continuous Reception MOTILIUM® without consulting a doctor should not exceed the duration of 7 days. If necessary, your doctor may prolong the course of treatment.
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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