Primperan medicine 10mg Sanofi Treatment of symptoms of vomiting and nausea (2 blisters x 20 tablets)

Dosage form Box of 2 blisters x 20 tablets
Specifications Metoclopramide

Ingredient

Composition information	Content
Metoclopramide	10mg

Uses

Indications

Primperan 10 mg is indicated in the following cases:

Adults

Treatment of symptoms of vomiting and nausea, including vomiting and nausea due to acute migraine.

Pimperan 10 mg is indicated for children 15-18 years old and weighs over 60 kg

The drug is used as a second -line selection (Second -line) to prevent vomiting and nausea appear late due to chemotherapy. Dopamine, has an impact on intestinal motility.

Anti -vomiting drugs by inhibiting dopamine receptors.

pharmacokinetic

absorption

metoclopramide absorbs very quickly through the gastrointestinal tract. Overall, bioavailability is 80%, but depending on each person because it is related to the metabolic path of the drug through the liver.

Distribution

metoclopramide is widely distributed in tissues. The distribution volume is 2.2 - 3.4 l/kg. The ratio of plasma protein binding is very low. The drug can be through the placenta and excretion through breast milk.

Metabolism

metoclopramide is very small.

Excretion

metoclopramide is excreted mainly in urine in non -alterable or conjugated form with the sulfo group. The sale time is 5 - 6 hours. This time increases when the patient has liver or kidney failure.

Before taking Primperan medicine 10mg Sanofi Treatment of symptoms of vomiting and nausea (2 blisters x 20 tablets)

How to use

Primperan 10 mg is taken orally.

Dosage

Adults

Applies to all indications:

Dosage recommended: 10 mg (1 tablet)/time, up to 3 times/day.

Maximum doses recommend: 30 mg/day or 0.5 mg/kg/day.

Maximum treatment time: 5 days.

Children from 15 - 18 years old and weighing over 60 kg

Preventive vomiting and nausea appear late due to chemotherapy:

Dosage recommended: 10 mg (1 tablet)/time, up to 3 times/day or 0.1 - 0.15 mg/kg/time, up to 3 times/day.

Maximum doses recommend: 30 mg/day or 0.5 mg/kg/day.

Maximum treatment time: 5 days.

Special subjects

Elderly:

Should consider reducing the one -time use of drugs based on liver - kidney and organ function.

kidney failure:

Endenical renal failure (Creatinine clearance

Hepatic failure:

Severe liver failure should reduce the dose of drugs to 50%.

Children:

Do not recommend Primperan 10 mg for children under 15 years old and weighs 60 kg or less due to inappropriate formation.

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

Periodic disorders, drowsiness, reduced cognitive ability, confusion, hallucinations, cardiac arrest, apnea.

Handling

In the event of a pagoda disorder, maybe due to an overdose or not, Metoclopramide should be discontinued and use symptomatic medications including Bezodiazepin in young children and/or anti -cholinergic drugs for Parkinson's treatment in adults. Symptomatic treatment and continuous monitoring of cardiovascular and respiratory functions depending on the patient's clinical condition.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Primperan 10 mg, you may experience unwanted effects (ADR).

The frequency of meeting the following conventions: Very common (> 1/10), common (1/100, 1/10000,

Disorders of hematopoietic disorders and lymphatic systems

Unknown: Blood methemoglobin, may be due to NADH cytochrome B5 Reductase deficiency, especially in infants. Sulfhemoglobin, mainly due to simultaneous use with high -dose sulfur release.

Uncommon: Slow heart rate, especially with intravenous products. Extend the QT interval on the electrocardiogram, the peak.

Uncommon: menstrual loss, hyperkemin blood.

Unknown: Big breasts in men.

Gastrointestinal disorders

Common: diarrhea.

Common: weakness.

Immune disorders

Uncommon: increased sensitivity.

Unknown: Anaphylaxis reaction (including anaphylaxis, especially with intravenous lines).

neurological disorders

Very common: drowsiness, drowsiness.

Common: Periodic dysfunction (especially in children and young people and/or when overdose, even after a single dose), Parkinson's syndrome and standing still.

Uncommon: muscle disorders, movement disorders, reduced cognitive ability.

Rare: convulsions, especially in epilepsy patients.

Unknown: Late movement disorders may not recover, during or after prolonged treatment, especially in elderly patients, malignant neuroleptic syndrome.

Mental disorders

Common: Depression.

Less: illusion.

Rare: Confusion.

Common: hypotension, especially when using intravenous sugar.

The reactions that are related or often occur when high doses include:

Periodic dysfunction: muscle tone disorders or acute movement disorders, Parkinson's syndrome, restless standing, even after using a single dose, especially in children and young people.

Drowsy, reduce cognitive, confused, hallucinations.

Instructions on how to handle 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

Primperan 10 mg drug is contraindicated in the following cases:

Hypersensitivity to metoclopramide or any part of the drug. sedative drugs. Mechanical muscles have increased alternate disorders on this object.

Precautions when using

neurological disorders

There may be symptoms of pagoda disorders, common in children and young people and/or high doses. These reactions occur in the early stages of drug use, some cases occur after a single dose. Should stop the drug as soon as there is a expression of the percentage disorders. In most cases, these symptoms are completely lost after stopping the drug. However, some cases need to use symptomatic medication (benzodiazepine in children and/or anti -antacids of Parkinson's treatment on adults).

The distance between the doses is at least 6 hours, including vomiting or do not use one of the drugs to avoid the risk of overdose.

Prolonged treatment with Metoclopramide can cause late movement disorders, many cases of non -recovery, especially in the elderly. Therefore, do not extend the treatment period for more than 3 months.

It is necessary to stop taking the drug as soon as there are clinically late movement disorders.

Malignant neuroleptic syndrome has been reported to Metoclopramide for use as well as lungs suitable for other sedatives. Patients need to stop the drug and take appropriate treatment as soon as the manifestations of malignant neurolithic syndrome.

Be careful to monitor patients with neuropathy and patients being treated with medications with central effects.

metoclopramide can worsen Parkinson's symptoms.

Methemoglobin blood

Some cases of blood methemoglobin may be associated with NADH Cytochrome 65 Reductase deficiency. When a patient has lactose, a blood methemoglobin should be stopped, and it is necessary to stop the drug and take appropriate treatments such as methylene green. In these cases, never reusing Metoclopramide for patients.

cardiovascular disorders

Some cases of serious adverse reactions on the heart have been reported including circulatory, serious slow heart rate, cardiac arrest and extension of QT after injection Metoclopramide, especially intravenous injection.

Be careful to monitor patients using Metoclopramide, especially in the case of using intravenous tract for the elderly, patients with heart disease disorders (including extension of QT), patients with electrolyte disorders, bradycardia and patients with other drugs that are at risk of extending QT.

kidney failure or liver failure

Recommendations to reduce the dose in patients with serious liver or liver failure.

Do not use medication if gaclactose intolerance or lactase enzyme deficiency or malposure syndrome or galactose (rare metabolic disease).

The ability to drive and operate machinery

metoclopramide can cause drowsiness, dizziness, movement disorders, muscle disorders and can affect vision and ability to drive as well as operate the drug users of drug users.

Pregnancy

Many data on pregnant women (with over 1,000 exposure cases) shows that metoclopramide does not cause teratogenic or toxicity to the fetus, so it can be used during pregnancy if necessary.

Due to the pharmacological properties of Metoclopramide similar to sedatives, the use of drugs at the end of pregnancy may cause a risk of peripheral syndrome in the child. Therefore, avoid using metoclopramide at the end of pregnancy; In case of drug use, closely monitor the above manifestations.

Breastfeeding period

metoclopramide excreting small amounts into breast milk, so breastfed babies are at risk of adverse drug reactions. Therefore, it is not recommended to use Metoclopramide during breastfeeding. In women breastfeeding using Metoclopramide, it is necessary to consider stopping the drug.

Drug interaction

Coordination in contraindications

Contraindicated Metoclopramide combination with levodopa or dopamine owners due to antagonism.

Coordination should be avoided

Alcohol can increase the central neurological inhibition effect of Metoclopramide.

Coordination should be considered

Because metoclopramide increases the peristalsis of metoclopramide, it can change the absorption of some drugs.

anti -cholinergic drugs and Morphine derivatives: can fight the image of Metoclopramide about the effect on the gastrointestinal motility.

Central painkillers (Morphine derivatives, anti -anxiety drugs, sedatives, antidepressants, H1 anti -histamine drugs, barbiturate, clonidine and related drugs): The combination of central analgesics and Metoclopramide may increase mental influence.

Sedative: Metoclopramide may increase the effects of neuroleptics and cause foreign disorders.

Serotonergic drugs: Metoclopramide combination and serotonergic drugs such as Serotonin (SSRIs) are able to increase the risk of serotonin syndrome.

Digoxin: Metoclopramide can reduce the bioavailability of digoxin. When used in combination, plasma digoxin concentration should be closely monitored.

Cyclosporin: Metoclopramide increases the bioavailability of cyclosporin (increasing CMAX to 46% and increasing exposure to 22%). When used in combination, plasma cyclosporin levels should be closely monitored. The consequences of this interaction are clinically.

Mivacurium and Suxamethonium: Metoclopramide can extend the neurological effect of Miracurium and Suxamethonium (through plasma cholinesterase inhibitors).

Strong CYP2D6 inhibitors: such as fluoxetine and paroxetin increase the level of exposure to Metoclopramide in patients. Although the clinical consequences of interaction are not well known, it is necessary to closely monitor patients to detect adverse reactions. In the case of acute migraine, Metoclopramide can be used with oral painkillers and increases the absorption of these painkillers.

Storage

Store drugs at temperatures not exceeding 30 ° C.

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