Motilium Janssen oral media treat symptoms of vomiting and nausea (30ml)

Dosage form Bottle
Specifications Domperidone

Ingredient

Composition information	Content
Domperidone	1mg/ml

Uses

Indications

Motilium Siro 30ml drug is indicated in the following cases:

Treatment of vomiting and nausea.

Pharmacokic

domperidon is a dopamine receptor counter anti -vomiting properties. Domperidon does not easily pass through the brain barrier. In domperidon users, especially adults, the extrasic side effects are rare, but domperidon promotes prolactin secretion in the pituitary gland. Anti -vomiting effects may be due to the coordination of peripheral effects (gastric motor increase) and the Dopamine receptor resistance in the CTZ receptor receptor area (Chemoreceptor Trigger Zone) is located outside the bloody brain barrier in the vomit control area of the orelectric.

Animal research shows low concentrations in the brain, indicating the effect of domperidon mainly on peripheral dopamine receptors. Human research shows that drinking domperidon increases the tone of the lower esophagus, improves the movement of the duodenal cave and accelerates the empty process of the stomach. The drug does not images up to the secretion of the stomach.

According to the instructions of ICH - E14, a thorough study of the QT interval has been conducted. This study is a scientific egg test that includes active and placebo comparative drugs performed on healthy people up to 80mg of domperidon a day, (10 or 20mg 4 times daily). This study showed a maximum difference in the change compared to the original of the QT interval between domperidon and placebo -pleasure in the smallest square average of 3.4mili seconds for the dose of 20mg of domperidon 4 times daily at Wednesday, and 90% reliability on both sides (1.0 to 5.9mili seconds) did not exceed 10mili -seconds.

There is no influence on the clinically related QT interval observed in this study when the domperidon is used up to 80mg/day (meaning more than 2 times the maximum dose is recommended). However, two previous medical interactive studies have shown some evidence that extends the QT when using a single domeridon (10mg 4 times a day). The maximum average difference in the time of QTCF between domeridon and placebo is 5.4mili -seconds (95%trust range: - 1.7 to 12.4) and 7.5mili seconds (95%trust range: 0.6 to 14.4).

pharmacokinetic

absorption

Domperidon absorbs rapidly after drinking, with peak plasma concentrations achieved after about 1 hour. Domperidon's CMAX and AUC value increases proportional to the dose range from 10mg to 20mg. Observing the AUC value of Domperidon accumulated 2 to 3 times with the Domperidon dose is repeated 4 times daily (every 5 hours) for 4 days.Domperidon's bioavailability increases in healthy people after drinking after meals, patients complain about digestive should take domperidon before eating 15 - 30 minutes. The acidity in the stomach reduces the absorption of domeridon. Oral bioavailability is reduced if the patient previously taken at the same time cimetidine and sodium. bicarbonate.

Distribution

The ratio of plasma protein binding domeridons is 91 - 93%. Researching the distribution of drugs by marking radioactivity on animals shows that the drug is widely distributed in the body tissue but low concentrations in the brain. A small amount of drugs go through the placenta in the mouse.

Metabolism

Domperidon experiences rapid and high metabolism in the liver with hydroxylation and reducing N - Alkyl. The metabolic experiments on in vitro with previous inhibitors show that CYP3A4 is a major form of Cytochrome P - 450 related to the reducing N - Alkyl of Domperidon, while CYP3A4, CYP1A2 and CYP2E1 are related to the aromatic hydroxylation of Domperidon.

Elimination

Elimination through urine and fertilizer is about 31 and 66% of oral dose. A small part of the drug is excreted in the intact form (10% in feces and 1% in urine). The half -life of plasma after taking the single dose is 7 - 9 hours in healthy people but lasts for severe renal impairment.

Hepatic failure

In patients with average liver failure (PUGH index from 7 to 9, Child - PUGH B), the value of AUC and CMAX of Domperidon is higher in healthy people, respectively 2.9 and 1.5 times. The unite ratio increased by 25% and the half -life lasted 15 to 23 hours. Patients with mild liver function impaired have a slightly lower concentration than healthy people based on CMAX and AUC, without changes in cohesion with protein or semi -cancellation time. Do not study in patients with severe liver failure. Contraindicated to use Motilium in patients with medium or severe liver failure (see contraindicated).

kidney failure

In patients with severe renal impairment, creatinine clearance

Pediatric patients

There is no pharmacokinetic data in pediatric patients.

Before taking Motilium Janssen oral media treat symptoms of vomiting and nausea (30ml)

How to use

Take oral use.

Motilium 30ml should only use the lowest doses effectively in the shortest time to control vomiting and nausea.

Should drink Motilium 30ml before meals. If taken after meals, the drug may be slowly absorbed.

Maximum treatment time should not exceed a week.

Dosage

Adults and adolescents (aged 12 years and older and weighing 35kg or more)

Use 10ml (of 1mg/ml oral fluid) up to 3 times a day with a maximum dose of 30ml/day.

Children

Efficiency of Motilium 30ml in children under 12 years old has not been established.

The effect of Motilium 30ml in minors aged 12 and older weighing less than 35kg has not been established.

Patients with liver failure

Motilium 30ml is contraindicated for patients with medium and severe liver failure (see contraindicated). No need to adjust the dose for patients with mild liver failure.

Patients with renal failure

Due to the prolonged domeridon's selling time in patients with severe renal impairment, if it is used to repeat the number of Motilium drugs, it should be reduced to 1 to 2 times/day and depending on the degree of renal failure and may need to reduce the dose.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Symptoms

Overdose is reported mainly in children and children. Symptoms of overdose include agitation, cognitive disorders, convulsions, loss of orientation, sleeping and non -tower reaction.

Treatment

There is no specific antidote for domperidon. In the case of an overdose, it is necessary to take symptomatic treatment immediately. Should monitor the electrocardiogram due to the ability to cause extension of QT. Washing stomach as well as using activated carbon can be useful. Suggest closely monitor and support treatment for patients. Choline anti -secretion or Parkinson treatment may be helpful in controlling the extrasic reactions.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose? If you are forgotten 1 dose, you can skip the dose and continue to use the drug according to the same schedule. Do not double the dose to compensate for the forgotten dose.

Side Effects

When using Motilium Siro, you may experience unwanted effects (ADR).

Domperidon's safety has been evaluated in clinical trials and after -sales experiences. Clinical trials on 1275 patients with indigestion, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), nausea and vomiting or other related pathological conditions in 31 double blind studies, placebo.

All patients aged 15 and older and take at least 1 dose of Motilium (domperidon base). The average daily dose is 30mg (about 10 to 80mg dose), and the average treatment time is 28 days (from 1 to 28 days). These studies eliminate patients with diabetes or have secondary symptoms after chemotherapy or Parkinson's syndrome.

Common, (1/100 ≤ ADR

Gastrointestinal disorders: dry mouth.

Uncommon, (1/1,000 ≤ ADR

Mental disorders: loss of sexual desire, anxiety, movement, stress.

Nervous disorders: dizziness, sleeping, headache, pagoda disorders.

Gastrointestinal disorders: diarrhea.

Skin and subcutaneous tissue disorders: rash, itching, urticaria.

Reproductive and breast disorders: Milk, breast pain, breast sensitive pain.

Systemic disorders and disorders at the place of use: weakness.

Not known

The immune system disorder: Hypersensitivity reaction (including anaphylaxis).

Nervous system disorders: convulsions.

Eye disorders: Against.

Cardiovascular disorders (see warning and caution): ventricular arrhythmia, extension of QTC, torsion, heart sudden heart (see warning and special caution especially).

Skin and subcutaneous disorders: Fedengers.

kidney and urinary disorders: urinary retention.

Reproductive and breast disorders: Big breasts in men, menstruation.

Other indicators: abnormal results in liver function test, hyperlactin blood prolactin.

In 45 tests using domperidon at a higher dosage, longer treatment period and other indications such as diabetes, the frequency of adultery events (except for dry mouth) is higher. This is very obvious for pharmacological events that can predict for increased prolactin. In addition to the reactions listed above, restlessness, breast secretion, big breasts, breast tension, depression, hypercertia, milk disorders, and irregular menstruation have also been recorded.

Periodic disorders occur mainly in babies and young children. The effects related to the central nervous system such as convulsions and anxiety are also reported mainly in children and children.

Harming reaction report

The reaction report is harmful after the drug is licensed to circulate very important to continue monitoring the benefits/risks of the drug. Health workers need to report all the harmful reactions to the National Center or regional center on drug information and monitor the harmful reactions of the drug.

Notify the doctor with unwanted effects when using the drug.

Instructions for processing ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Motilium 30ml drug contraindicated in the following cases:

Knowing hypersensitivity to domperidon or any excipients of the drug.

Prolactin secretion (ProLactinoma).

When stimulating stomach movement can be dangerous such as gastrointestinal bleeding, mechanical bowel obstruction or digestive perforation.

Patients with medium or severe liver failure (see pharmacokinetic properties).

Patients with prolonged heart impulse transmission time, especially QT interval, patients with obvious electrolytes or patients with cardiovascular disease such as congestive heart failure (see warning and caution).

Timultant with drugs that extend QT (see interaction with other drugs and other types of interactions).

Concentrated with strong CYP3A4 inhibitors (regardless of the effect of extending the QT) (see interaction with other drugs and other types of interactions).

Precautions when using

kidney failure

Because the domeridon's sale time is prolonged in patients with severe renal impairment. In the case of repeated use, the frequency of 30ml motilium should be reduced to 1 to 2 times/day depending on the degree of renal failure, and may need to reduce the dose.

Heart effect

domperidon extends the QT interval on the electrocardiogram. In the process of after -sales monitoring, there are very few reports on extending the QT interval and torsion to the use of domperidon. These reports have jamming factors such as electrolytes or simultaneous drugs, (see unwanted effects).

Translation studies show that domeridon may increase the risk of severe ventricular arrhythmia or sudden cardiovascular disease (see unwanted effects). This risk is higher for patients over 60 years old, patients taking daily doses greater than 30mg and patients with simultaneous use of the drug extending the QT or CYP3A4 inhibitors.

Use domperidon with the lowest doses effectively in adults and children.

Contraindicated domperidon for patients with prolonged heart impulsive transmission time, especially QT interval, patients with clear electrolytes (hypotension, hyperkalemia, hypoglycemia), slow heartbeat or patients with cardiovascular disease such as congestive heart failure due to increased risk of ventricular arrhythmia (see contraindication). Electrolyte disorders (hypotension, hyperkalemia, blood hypoglycemia) or slow heart rate have been known as a factor that increases the risk of arrhythmia.

Need to stop treatment with domperidon and exchange with health workers if there are any symptoms or signs that may be related to arrhythmia.

Advise patients to quickly report any symptoms on the heart.

Used with apomorphin

Contraindicated to use domperidon with drugs that extend the QT range including apomorphin, unless the benefits are simultaneously with apomorphin that is superior to the risk and only be careful when used simultaneously in the apomorphin drug information is strictly followed. Please refer to apomorphin.

Children

Although the nervous side effects are rare (see unwanted effects), the risk of side effects on nerves is higher in young children due to the metabolic function and brain barrier have not been fully developed in the first months of life. Therefore, it is recommended to determine the correct doses and closely monitor when used for babies, children and children (see the dose and how to use).

Overdose can cause pagans in children, but also consider other causes.

Attention when using

The epidemic contains sorbitol so it may not be suitable for Sorbitol -intolered people.

The ability to drive and operate machinery

Dizziness and sleeping chicken have been recorded when using domperidon (see unwanted effects). Therefore, patients are advised not to drive or operate machinery or participate in other activities that require mental alertness and coordination until they know how Motilium 30ml affects them.

Pregnancy

There is little data after bringing the drug to the market about the use of domperidon in pregnant women. A mouse study showed toxicity on the reproductive system at high doses in the mother mouse. The potential risk in people is not known. Therefore, only 30ml Motilium during pregnancy when evaluating and prognosing the benefits of treatment.

Breastfeeding period

domperidon excreted through breast milk and breastfed babies receive less than 0.1% dose according to the mother's weight. The adverse effects, especially the effect on the heart, can still occur after a baby breastfed. The benefits of breastfeeding and the benefits of mothers treat to decide to stop breastfeeding or stop/avoid domeridon treatment. Caution should be careful in case of risk factors that extend the QT range in breastfeeding.

Medicinal interaction

When antacids or anti -secretions are used simultaneously, should not be used at the same time as oral preparations of Motilium 30ml (domperidon base), meaning these drugs should be used after meals and should not be used before meals.

Simultaneously used with levodopa

Although the adjustment of the Levodopa dose is considered unnecessary, the increase in plasma concentrations (up to 30% - 40%) has been recorded when used simultaneously domperidon with levodopa.

The main metabolic path of the domperidon is through CYP3A4. In vitro research data shows that these medications are simultaneously inhibiting strong enzymes that can lead to an increase in plasma domeridon levels.

Increase the risk of extending the QT distance due to pharmacokinetics or pharmacokinetic energy.

Contraindicated to use with the following drugs

Medications that extend QTC (risk of torsion).

Anti -arrhythmia IA (for example: disopyramid, hydroquinidin, quinidine).

Anti -arrhythmia group III (for example: Amiodaron, Dofetilid, Droneedaron, Ibutilid, Sotalol).

Some anti -psychotic drugs (for example: Haloperidol, Pimozid, Sertttol).

Some antidepressants (e.g. citalopram, Escitalopram).

Some antibiotics (for example: erythromycin, levofloxacin, moxifloxacin, spiramycin).

Some antivistity drugs (for example: fluconazole, pentamidin).

Some malaria treatments (especially: halofantrin, lumefantrin).

Some gastrointestinal drugs (for example: Cisaprid, Dolasetron, Prucaloprid).

Some antihistamine resistance (e.g. mequitazin, mizolastin).

Some cancer treatment drugs (for example: Toremifen, VNDetanib, Vincamin).

Some other drugs (for example: Bepridil, Diphemanil, Methadon).

apomorphin unless the benefits are superior to the risk and only be careful when used and strictly followed. Please refer to apomorphin information).

Strong CYP3A4 inhibitors (regardless of the effect of extending QT), for example:

Protease inhibitors (for example: Ritonavir, Saquinavir, Telaprevir).

Azol -body antifungal drugs (for example: Itraconazole, ketoconazole, Posaconazole, Voriconazole).

Some macrolid groups (erythromycin, clarithromycin and telithromycin).

It is not recommended to simultaneously use the following drugs

Average CYP3A4 inhibitors, for example: diltiazem, verapamil and some macrolid drug groups.

Use cautiously when used simultaneously with the following drugs

Slow heart rate, medications that reduce blood potassium and some of the following macrols contribute to extending QT interval: azithromycin and Roxithromycin (CLATHROMYCIN contraindicated as a powerful CYP3A4 inhibitor).

The list of substances above is representative and incomplete drugs.

Storage

Store temperature not exceeding 300C.

Other drugs

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