Motilium-M Janssen tablets treat symptoms of vomiting and nausea (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Domperidone maleate

Ingredient

Composition information	Content
Domperidone maleate	10mg

Uses

Indications

Motilium-M drugs are indicated in the following cases:

Treatment of symptoms of vomiting and nausea.

domperidon is not easy through the bloody barrier. In domperidon users, especially adults, the extrasic side effects are very rare, but the domperidon promotes prolactin secretion in the pituitary.

Anti -vomiting effects may be due to the coordination of peripheral effects (gastric hyperactivity) and the Dopamine receptor resistance in the CTZ receptor receptor area (Chemoreceptor Trigger Zone) is located outside the blood -barrier in the vomit controlled area of the pulp.

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 testing test that includes active and placebo comparison drugs performed on healthy people up to 80mg of domperidon a day, (10 or 20mg 4 times daily).

This research shows a maximum difference in the change compared to the original of the QT interval between domperidon and placebo varming according to the minimum square average of 3.4mili -seconds for the dose of 20mg of domperidon 4 times daily at the 4th day, and 90% reliability on both sides (1.0 to 5.9mili seconds) has not exceeded 10mili -seconds.

There is no influence on clinical related QT intervals observed in this study when domeridon is used up to 80mg/day (meaning more than 2 times the maximum dose is recommended).

However, two drug interactive studies have previously pointed out a few evidence that extends the QT distance when using a single domperidon (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 simultaneously 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 metabolism and a lot in the liver with hydroxylation and reducing N - Alkyl.

Metabolic experiments on in vitro with pre -inhibitors show that CYP3A4 is a major form of Cytochrome P - 450 related to Domperidon's Deo - Alkyl of Domperidon, while CYP3A4, CYP1A2 and CYP2E1 are related to Domperidon aromatic hydroxylation.

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 ratio does not increase by 25% and the half -life lasts 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

Because a very small amount of intact drug (about 1%) is excreted through the kidneys, it may not be necessary to adjust the dose when taking single dose on patients with renal impairment. However, when the dose is repeated, the frequency of the dose should be reduced to 1 to 2 times daily depending on the severity of the kidney failure and may need to reduce the dose.

Pediatric patients

There is no pharmacokinetic data in pediatric patients.

Before taking Motilium-M Janssen tablets treat symptoms of vomiting and nausea (10 blisters x 10 tablets)

How to use

Motilium-M drugs for oral use.

Should only use the lowest Motilium-M dose effective in the shortest time to control vomiting and nausea.

Should take Motilium-M before meals. If taken after meals, the drug may be slowly absorbed.

Maximum treatment time should not exceed a week.

Dosage

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

Use 1 tablet 10mg up to 3 times a day with a maximum dose of 30mg/day.

Patients with liver failure

Contraindicated Motilium-M for patients with medium and severe liver 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-M drugs, it should be reduced to 1 to 2 times/day and depending on the degree of renal failure and can be adjusted if necessary.

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. Proposal closely monitoring and supporting treatment for patients.

Cholin anti -secretion or Parkinson treatment drugs can be helpful in controlling foreign reactions.

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-M , 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-M (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 to

Gastrointestinal disorders: dry mouth.

Less, (≥ 1/1,000 to

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.

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-M anti-contraindications 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 average or severe liver failure.

Patients with prolonged heart impulse transmission time, especially QT interval, patients with obvious electrolytes or patients with cardiovascular disease such as congestive heart failure.

Simultaneously used with drugs extending QT.

Simultaneously used with strong CYP3A4 inhibitors (regardless of the effect of extending QT).

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 Motilium-M 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 interference 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-M affect 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 Motilium-M should be used in 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.

Drug interaction

When antacids or anti-secretions are used simultaneously, should not be used at the same time as oral preparations of Motilium-M (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, Vandetanib, 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.

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).

Do not recommend using 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

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.