Side effects of metoclopramide – NHS

Like all medicines, metoclopramide can cause side effects, although not everyone gets them.

Common side effects

These common side effects of metoclopramide happen in more than 1 in 100 people. They’re usually mild and go away by themselves. There are things you can do to help cope with them:

Feeling sleepy and a lack of energy

Do not drive, cycle or use tools or machinery. Do not drink alcohol, as it will make you feel more tired. If these symptoms get worse or last longer than a few days, talk to your doctor.

Low mood

This should pass after a couple of days but if it does not, speak to your doctor as you may need a different type of anti-sickness medicine.

Feeling dizzy or faint (low blood pressure)

If metoclopramide makes you feel dizzy, stop what you’re doing and sit or lie down until you feel better. Do not drive, ride a bike or use tools or machinery. Do not drink alcohol, as this can make the symptoms worse. This should get better after a few days as your body gets used to the medicine. Speak to your doctor if the problem does not go away after a couple of days or gets worse.

Diarrhoea

Drink lots of fluids, such as water or squash, to avoid dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee. Do not take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor. If you take contraceptive pills and you have severe diarrhoea for more than 24 hours, your contraception may not protect you from pregnancy. Check the pill packet for advice.

Keep taking the medicine, but talk to your doctor or pharmacist if the advice on how to cope does not help and these side effects bother you or do not go away.

Serious side effects

Some people may have serious side effects when taking metoclopramide, but these are rare.

Stop taking metoclopramide and call your doctor or call 111 now if:

• your muscles or eyes start moving in an unusual or uncontrolled way

Immediate action required: Call 999 or go to A&E now if:

• you’ve had a seizure or fit

Serious allergic reaction

In rare cases, metoclopramide may cause a serious allergic reaction (anaphylaxis).

Immediate action required: Call 999 now if:

• your lips, mouth, throat or tongue suddenly become swollen
• you’re breathing very fast or struggling to breathe (you may become very wheezy or feel like you’re choking or gasping for air)
• your throat feels tight or you’re struggling to swallow
• your skin, tongue or lips turn blue, grey or pale (if you have black or brown skin, this may be easier to see on the palms of your hands or soles of your feet)
• you suddenly become very confused, drowsy or dizzy
• someone faints and cannot be woken up
• a child is limp, floppy or not responding like they normally do (their head may fall to the side, backwards or forwards, or they may find it difficult to lift their head or focus on your face)

You or the person who’s unwell may also have a rash that’s swollen, raised, itchy, blistered or peeling.

These can be signs of a serious allergic reaction and may need immediate treatment in hospital.

Other side effects

These are not all the side effects of metoclopramide. For a full list, see the leaflet inside your medicine packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 9 March 2023

Next review due: 9 March 2026

Side Effects, Dosage, Uses, and More

Highlights for metoclopramide

1. Metoclopramide oral tablet is available as both a generic and brand-name drugs. Brand names: Reglan and Metozolv ODT.
2. Metoclopramide also comes in an oral solution as well as injectable forms that are only given to you by a healthcare provider.
3. Metoclopramide oral tablet is used to relieve heartburn caused by gastroesophageal reflux disease (GERD). It’s also used to treat symptoms of diabetic gastroparesis.

FDA Warning: Abuse and dependence

• This drug has a black box warning. This is the most serious warning from the U.S. Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
• Reglan can cause a serious movement disorder called tardive dyskinesia (TD). This condition is often irreversible. There’s no known treatment for TD. The risk of developing TD is increased with longer treatment and increased dosage. To help prevent TD, this drug shouldn’t be used for longer than 12 weeks. If you have symptoms of TD (see below), stop taking this drug and call your doctor right away.

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Other warnings

• Nervous system disorder warning: This drug may cause neuroleptic malignant syndrome (NMS). This is a rare nervous system disorder that may be fatal (cause death). Symptoms include a high body temperature, stiff muscles, confusion, abnormal pulse or blood pressure, fast heart rate, and sweating. Call your doctor right away if you have these symptoms. You’ll have to stop taking this drug if you have this condition.
• Uncontrolled spasms warning: This drug may cause muscle spasms in your face, neck, body, arms, and legs. These spasms can cause abnormal movements and body positions. These are more likely to happen during the first 2 days of your treatment. The risk is higher in children and adults younger than 30 years of age.
• Depression warning: This drug may cause depression. This effect can happen even if you don’t have a history of depression. Your symptoms may be mild to severe, and may include thoughts of suicide. Call your doctor right away if you have signs of depression.

Metoclopramide oral tablet is a prescription drug that’s available as the brand-name drugs Reglan and Metozolv ODT. It’s also available as a generic drug. Generic drugs usually cost less than brand-name versions. In some cases, they may not be available in all strengths or forms as a brand-name drug.

Metoclopramide also comes in an oral solution as well as injectable forms that are only given by a healthcare provider.

Why it’s used

Metoclopramide is used to treat gastroesophageal reflux disease (GERD) that causes symptoms. GERD occurs when acid flows up from your stomach. This causes heartburn. It may also harm your esophagus (the tube that connects your mouth to your stomach). This drug is used to relieve heartburn and heal sores in your esophagus when other treatments haven’t worked.

Metoclopramide is also used to treat diabetic gastroparesis. Gastroparesis happens when your stomach takes too long to empty its contents. Symptoms may include nausea, vomiting, heartburn, loss of appetite, and feeling full long after meals.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications to treat your condition.

How it works

Metoclopramide belongs to classes of drugs called antiemetics and prokinetics. Antiemetics are used to reduce nausea and vomiting, and prokinetics are used to empty the contents of your stomach faster. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

This drug works by emptying the contents of your stomach. It does this by increasing your stomach muscle contractions. This speeds up the movement of food through your stomach and intestines. It also increases the tightness of your lower esophageal sphincter (the muscle connecting your esophagus and stomach). This stops stomach acid from flowing back up to your esophagus.

This drug also prevents nausea and vomiting. It does this by blocking receptors in your body that are responsible for triggering nausea and vomiting.

Metoclopramide oral tablet may cause drowsiness. Some people may have dizziness, nervousness, or headaches after they stop taking this drug. It can also cause other side effects.

More common side effects

The more common side effects of metoclopramide can include:

• headache
• confusion
• trouble sleeping
• dizziness
• restlessness
• sleepiness
• exhaustion

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Depression and suicide. Symptoms can include:
  • sadness
  • lack of motivation
  • thoughts of harming or killing yourself
• Neuroleptic malignant syndrome (nervous system disorder). Symptoms can include:
  • high fever
  • stiff muscles
  • trouble thinking
  • fast or irregular heart rate
  • increased sweating
• Tardive dyskinesia, a movement disorder that can be permanent. Symptoms can include repeated, uncontrollable movements such as:
  • movement in the face, such as blinking, grimacing, or sticking out your tongue
  • slow or fast, jerky movements of the arms and legs
• Parkinsonism (symptoms similar to those caused by Parkinson’s disease). Symptoms can include:
  • shaking
  • body stiffness
  • slow movement
  • trouble keeping your balance
  • blank stare with an open mouth
• Allergic reaction. Symptoms can include:
  • rash
  • hives
  • trouble breathing
  • swelling of your tongue, lips, or throat
• Hyperprolactinemia (increased levels of the hormone prolactin). Symptoms can include:
  • menstrual problems or vaginal dryness in women
  • erectile dysfunction, decreased body hair and muscle mass, and increased breast size in men
• Hallucinations (seeing or hearing things that aren’t there)

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Metoclopramide oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with metoclopramide are listed below.

Interactions that increase your risk of side effects from metoclopramide

Taking metoclopramide with certain medications raises your risk of side effects from metoclopramide. Examples of these drugs include:

• Sedatives, hypnotics, narcotics, antihistamines, and tranquilizers. These include:
  • diazepam
  • lorazepam
  • hydroxyzine
  • phenobarbital
  • promethazine
  • scopolamine
  • eszopiclone
  • temazepam
  • zaleplon
  • zolpidem
  • meperidine
  • propofol
  • meprobamate

Taking any of these drugs with metoclopramide may increase drowsiness.

• Monoamine oxidase inhibitors (MAOIs). These include:
  • isocarboxazid
  • phenylzine
  • rasagiline
  • selegiline
  • tranylcypromine

Taking these drugs with metoclopramide may increase your blood pressure.

Interactions that increase your risk of side effects from other drugs

Taking metoclopramide with certain medications raises your risk of side effects from these drugs. Examples of these drugs include:

• Tetracycline. Metoclopramide increases how much tetracycline your body absorbs. This may increase your risk of side effects of tetracycline, such as diarrhea and vomiting.
• Cyclosporine. Metoclopramide may increase the levels of cyclosporine in your body. This may raise your risk of kidney problems, digestion problems, and tingling (pins and needles) feeling caused by damage to your nerves.
• Insulin. Metoclopramide affects how food moves through your body. This may change your blood sugar levels. You may have higher blood sugar levels because food is moving through your stomach and entering your bloodstream faster. Your doctor may adjust your dose of insulin.

Interactions that can make your drugs less effective

When metoclopramide is used with certain drugs, it may not work as well to treat your condition. Examples of these drugs include:

• Anticholinergics. These include atropine, benztropine, darifenacin, dicyclomine, fesoterodine, glycopyrrolate, hyoscyamine, methscopolamine, oxybutynin, tolterodine, scopolamine, solifenacin, trihexyphenidyl, and trospium.
• Narcotics (pain drugs). These include codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, and oxycodone.

When certain drugs are used with metoclopramide, they may not work as well. This is because the amount of these drugs in your body may be decreased. Examples of these drugs include:

• Digoxin. Your doctor should monitor your digoxin blood levels closely.
• Levodopa. Metoclopramide reduces the effect that levodopa has on your body. Your doctor may avoid using this drug with metoclopramide.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Metoclopramide oral tablet comes with several warnings. Call your doctor if your symptoms don’t improve after taking this drug.

Allergy warning

Metoclopramide can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• rash
• hives
• swelling of your throat or tongue

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Alcohol interaction

Drinking alcohol can increase the side effects of sleepiness, dizziness, and confusion from metoclopramide. If you drink alcohol, talk to your doctor.

Warnings for people with certain health conditions

For people with stomach or intestinal problems: This drug increases the movement of food in your digestive tract. If you have bleeding, tears or holes, or a blockage in your stomach or intestines, taking this drug may be dangerous. Ask your doctor if this drug is safe for you.

For people with pheochromocytoma (tumor that releases hormones): You shouldn’t use this drug. This drug increases your risk of dangerously high blood pressure. This puts you at risk for a stroke.

For people with seizures: If you have a history of seizures, you shouldn’t use this drug. It may cause you to have more seizures.

For people with drug-induced movement disorders: If you’re taking medications for drug-induced movement disorders, you shouldn’t use this drug. It may increase the severity of the movement disorders.

For people with Parkinson’s disease: This drug may make your Parkinson’s disease symptoms worse.

For people with hypertension (high blood pressure): This drug may increase your blood pressure. Ask your doctor if this drug is safe for you.

For people with liver damage or congestive heart failure: This drug may make liver damage or heart failure worse. It increases fluid buildup in your body. If this happens, call your doctor and stop taking this drug.

For people with kidney problems: You may not be able to clear this drug from your body well. This may increase the levels of this drug in your body. This can cause more side effects. Your doctor may start you on a lower dose.

For people with breast cancer: This drug increases prolactin levels in your body. Prolactin is a hormone that may be responsible for cancerous breast tumors. Tell your doctor if you have a history of breast cancer before starting this drug.

Warnings for other groups

For pregnant women: Studies of metoclopramide in pregnant animals haven’t shown a risk to the fetus. However, there aren’t enough studies done in pregnant women to show if the drug poses a risk to the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus.

For women who are breastfeeding: Metoclopramide passes into breast milk and may cause side effects in a child who is breastfed.

Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

If you’re older than 65 years of age, you should take the lowest dose of metoclopramide that is effective for you. As your dose increases, your risk of symptoms similar to Parkinson’s disease (shaking, body stiffness, moving slowly, and staring blankly with your mouth open) increases. You’re also at a greater risk for uncontrolled movements of your face, tongue, arms, and legs. This effect may be permanent. This drug can also cause confusion in seniors.

For children: This drug hasn’t been studied in children. It shouldn’t be used in people younger than 18 years. This drug may be more likely to cause movement disorders in children than in adults.

This dosage information is for metoclopramide oral tablet. All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

Forms and strengths

Generic: Metoclopramide

• Form: oral tablet
• Strengths: 5 mg, 10 mg

• Form: orally disintegrating tablet
• Strengths: 5 mg, 10 mg

Brand: Reglan

• Form: oral tablet
• Strengths: 5 mg, 10 mg

Brand: Metozolv ODT

• Form: orally disintegrating tablet
• Strength: 5 mg

Dosage for symptomatic gastroesophageal reflux

Adult dosage (ages 18–64 years)

• Typical starting dosage: 10–15 mg taken up to four times per day. You should take this drug 30 minutes before each meal and at bedtime.
• Dosage changes: Your doctor may change your dosage depending on your symptoms, side effects, and response to the drug.
• Length of treatment: You shouldn’t take this drug for longer than 12 weeks.

Child dosage (ages 0–17 years)

It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years of age.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of the drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Dosage for diabetic gastroparesis

Adult dosage (ages 18–64 years)

• Typical starting dosage: 10 mg taken up to four times per day. You should take this drug 30 minutes before each meal and at bedtime.
• Dosage changes: Your doctor may decrease your dosage depending on your symptoms, side effects, and response to the drug.
• Length of treatment: 2–8 weeks

Child dosage (ages 0–17 years)

It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years of age.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of the drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special considerations

If your creatinine clearance is below 60 mL/min, your doctor will give you about half of the typical starting dosage. They may change your dosage based on how your body responds to the drug.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Metoclopramide oral tablet is used for short-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your symptoms may not get better. They may get worse.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of metoclopramide can include:

• drowsiness
• confusion
• abnormal body movements
• muscle stiffness
• uncontrolled movements of your face, tongue, or arms and legs

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. If you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: Your symptoms should improve.

Keep these considerations in mind if your doctor prescribes metoclopramide oral tablet for you.

General

• You shouldn’t take this drug with food. Take it 30 minutes before each meal.
• Take this drug 30 minutes before meals and at bedtime.
• Not every pharmacy stocks metoclopramide disintegrating tablets.

Cutting the tablet

• You can cut the oral tablets.
• You shouldn’t cut the disintegrating tablets. If the tablet breaks or crumbles when you take it out of the package, you should throw it away. Take a new, intact tablet.

Storage

• Store metoclopramide at room temperature. Keep it between 68°F and 77°F (20°C and 25°C).
• Keep this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t hurt your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

You and your doctor should monitor certain health issues. This can help make sure you stay safe while you take this drug. These issues include:

• Mental health and behavioral problems. You and your doctor should watch for any unusual changes in your behavior and mood. This drug can cause new mental health and behavior problems. It may also make problems you already have worse.
• Blood pressure. This drug can increase your blood pressure.
• Weight. This drug may make you lose weight or gain weight.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Metoclopramide – description of the substance, pharmacology, use, contraindications, formula

Contents

• Structural formula

• Russian name

• English name

• Latin name

• chemical name

• Gross formula

• Pharmacological group of the substance Metoclopramide

• Nosological classification

• CAS code

• pharmachologic effect

• Characteristic

• Pharmacology

• The use of the substance Metoclopramide

• Contraindications

• Application restrictions

• Use during pregnancy and lactation

• side effects of metoclopramide

• Interaction

• Overdose

• Dosage and administration

• Precautionary measures

• Trade names with the active substance metoclopramide

Structural formula

Russian name

Metoclopramide

English name

Metoclopramide

Latin name

Metoclopramide ( born Metoclopramidi)

Chemical name

4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide (as hydrochloride)

Gross formula

C _{14 90 074 H 22 ClN 3 O 2}

Pharmacological group of the substance Metoclopramide

Antiemetics

Nosological classification

ICD-10 code list

CAS code

364-62-5

Pharmacological action

Pharmacological action –

prokinetic , anti-hiccup , antiemetic .

Characteristics

Metoclopramide hydrochloride is a white crystalline substance, odorless, soluble in water, ethanol. pKa – 0.6 and 9.3. Molecular weight 354.3.

Pharmacology

Is a dopamine antagonist (D ₂ ) receptors, as well as serotonin (5-HT ₃ ) receptors (in high doses). Stimulates the motor activity of the upper gastrointestinal tract (including regulates the tone of the lower esophageal sphincter at rest) and normalizes its motor function. It enhances the tone and amplitude of gastric contractions (especially in the antrum), relaxes the sphincter of the pylorus and duodenal bulb, increases peristalsis and accelerates gastric emptying. Normalizes the separation of bile (increases pressure in the gallbladder and bile ducts), reduces spasm of the sphincter of Oddi, eliminates dyskinesia of the gallbladder.

Antiemetic activity is due to the blockade of central and peripheral D ₂ -dopamine receptors, resulting in inhibition of the trigger zone of the vomiting center and a decrease in the perception of signals from afferent visceral nerves. As an antiemetic, it is effective for nausea and vomiting of various etiologies, incl. due to cancer chemotherapy (prevention), associated with anesthesia, side effects of drugs (digitis, cytostatics, anti-tuberculosis drugs, antibiotics, morphine), with liver and kidney diseases, with uremia, craniocerebral injury, with vomiting of pregnant women, with a violation of the diet. In migraine, metoclopramide is used to prevent gastric stasis and nausea, as well as to stimulate the absorption of antimigraine drugs taken orally. Metoclopramide is ineffective in vestibular vomiting.

Suppresses the central and peripheral action of apomorphine, increases the secretion of prolactin, causes a transient increase in the level of aldosterone (a short-term fluid retention is possible), increases the sensitivity of tissues to acetylcholine (the action does not depend on vagal innervation, but is eliminated by anticholinergics).

Quickly and well absorbed after oral administration, max “> C _max is achieved 1-2 hours after taking a single dose, bioavailability is 60-80%. Plasma protein binding is approximately 30%. Easily passes through histohematic barriers, including through the BBB, the placental barrier, penetrates into breast milk. The volume of distribution is 3.5 l / kg. It is biotransformed in the liver. 1/2 “\u003e T _1/2 with normal renal function is 4-6 hours, with impaired renal function – up to 14 hours. Excreted by the kidneys (when taken orally, approximately 85% of the dose appears in the urine unchanged within 72 hours and in the form of sulfate and glucuronide conjugates).

Begins to act 1-3 minutes after IV administration, 10-15 minutes after IM administration, 30-60 minutes after oral administration; effect lasts 1-2 hours

Carcinogenicity, mutagenicity, effect on fertility

In a 77-week study, rats given oral doses of approximately 40 times the MRHD showed an increase in prolactin levels, which remained elevated with chronic administration. An increase in the frequency of neoplasms of the mammary glands in rodents was found with chronic administration of prolactin-stimulating neuroleptics and metoclopramide. However, in clinical and epidemiological studies, no relationship was found between the intake of these drugs and the formation of tumors.

Metoclopramide was not mutagenic in the Ames test.

In experiments on mice, rats and rabbits with intravenous, intramuscular, s / c and oral administration of metoclopramide at doses 12-250 times higher than the human dose, no violations of fertility were detected.

Use of the substance Metoclopramide

Nausea, vomiting, hiccups of various origins (in some cases it can be effective for vomiting caused by radiation therapy or cytostatics), functional digestive disorders, gastroesophageal reflux disease, atony and hypotension of the stomach and duodenum ( including postoperative), biliary dyskinesia, flatulence, exacerbation of peptic ulcer of the stomach and duodenum (as part of complex therapy), preparation for diagnostic studies of the gastrointestinal tract.

Contraindications

Hypersensitivity, bleeding from the gastrointestinal tract, pyloric stenosis, mechanical intestinal obstruction, perforation of the wall of the stomach or intestines (including conditions when increased motor activity of the gastrointestinal tract is undesirable), glaucoma, pheochromocytoma (hypertensive crisis is possible due to release of catecholamines from the tumor), epilepsy (the severity and frequency of epileptic seizures may increase), Parkinson’s disease and other extrapyramidal disorders (possible exacerbation), prolactin-dependent tumors, early childhood up to 2 years (increased risk of dyskinetic syndrome).

Restrictions for use

Bronchial asthma (increased risk of bronchospasm), arterial hypertension (with intravenous administration, the condition may worsen due to the release of catecholamines), liver and / or kidney failure, old age, children under 14 years of age (for parenteral administration ).

Use in pregnancy and lactation

In experiments on mice, rats and rabbits with intravenous, intramuscular, s / c and oral administration of metoclopramide at doses 12–250 times higher than the human dose, fetus was not identified.

In pregnancy, use only if necessary (adequate and strictly controlled studies in humans have not been conducted).

FDA fetal category B.

Although no complications have been reported in humans, use with caution during breastfeeding (passes into breast milk).

Side effects of the substance Metoclopramide

The frequency of side effects correlates with the dose and duration of the drug.

From the nervous system and sensory organs: restlessness (about 10%), drowsiness (about 10%, more often when taking high doses), unusual fatigue or weakness (about 10%). Extrapyramidal disorders, incl. acute dystonic reactions (0.2% at doses of 30-40 mg / day), such as convulsive twitching of the facial muscles, trismus, opisthotonus, muscle hypertonicity, spastic torticollis, extraocular muscle spasm (including oculogeric crisis), rhythmic protrusion language, bulbar type of speech; rarely – stridor and dyspnea, possibly due to laryngospasm. Parkinsonian symptoms: bradykinesia, tremor, muscle rigidity – a manifestation of dopamine-blocking action, the risk of development in children and adolescents increases when the dose exceeds 0.5 g / kg / day. Tardive dyskinesia, including involuntary movements of the tongue, puffing of the cheeks, uncontrolled chewing movements, uncontrolled movements of the arms and legs (see also “Precautions”). Insomnia, headache, dizziness, disorientation, depression (symptoms were moderate to severe and included suicidal thoughts and suicide), anxiety, confusion, tinnitus; rarely – hallucinations. There are rare reports of the development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, impaired consciousness, autonomic disorders) (see also “Precautions”).

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): hypotension/hypertension, tachycardia/bradycardia, fluid retention.

From the digestive tract: constipation/diarrhea, dry mouth; rarely – hepatotoxicity (jaundice, impaired liver function – if metoclopramide was used together with other hepatotoxic drugs).

Allergic reactions: urticaria.

Others: frequent urination, urinary incontinence, with long-term use in high doses – gynecomastia, galactorrhea, menstrual irregularities, asymptomatic mild hyperemia of the nasal mucosa, agranulocytosis.

Methemoglobinemia has been reported in preterm and term neonates treated intramuscularly with metoclopramide 1–2 mg/kg/day for 3 or more days.

Interactions

Antipsychotics (especially phenothiazines and butyrophenone derivatives) increase the likelihood of developing extrapyramidal disorders. With simultaneous use reduces the effectiveness of levodopa. When taken with drugs that cause CNS depression – increased sedation. When co-administered with cyclosporine, the reduction in gastric emptying time caused by metoclopramide may increase the bioavailability of cyclosporine (monitoring of cyclosporine concentrations may be necessary). May reduce gastric absorption of digoxin (adjustment of digoxin dose may be necessary). May accelerate the absorption of mexiletine. Accelerates the absorption of paracetamol, tetracycline. Co-administration with alcohol may enhance the inhibitory effect of alcohol or metoclopramide on the central nervous system, as well as accelerate the removal of alcohol from the stomach, thus probably increasing the rate and extent of its absorption in the small intestine. Combined use with drugs containing opioids can block the effect of metoclopramide on gastrointestinal motility. Simultaneous use with metoclopramide may reduce the effect of cimetidine due to a decrease in its absorption.

Overdose

Symptoms: hypersomnia, confusion, extrapyramidal disorders.

Treatment: discontinuation of the drug (symptoms disappear within 24 hours after the end of the dose).

Method of administration and doses

Inside, in / m, in / in. Adults: Orally, 5-10 mg 3 times daily before meals; IM or IV – 10 mg; the maximum single dose is 20 mg, the maximum daily dose is 60 mg (for all routes of administration). Children over 2 years old – depending on age. For patients with hepatic insufficiency, the initial dose is reduced by 2 times due to an increase in 1/2 “\u003e T _1/2 . In case of impaired renal function, the dose is selected depending on creatinine clearance.

Precautions

Patients with hypersensitivity to procaine or procainamide may be hypersensitive to metoclopramide.

Should not be given after gastrointestinal surgery (such as pyloroplasty or intestinal anastomosis) as muscle contractions prevent suture healing.

Metoclopramide should only be used in patients with a history of depression if the expected benefit outweighs the potential risk.

Extrapyramidal disorders may occur with the use of metoclopramide at therapeutic doses in patients of any age (see also “Side Effects”). However, more often they occur when taking high doses. Extrapyramidal symptoms, expressed mainly as acute dystonic reactions, manifested in the first 24-48 hours of treatment, more often occurred in adolescents and adults under 30 years of age.

Parkinson’s symptoms usually occur within the first 6 months of starting treatment, but may occur over a longer period of time. These symptoms disappeared, as a rule, within 2-3 months after discontinuation of metoclopramide.

Treatment with metoclopramide may lead to tardive dyskinesia , often irreversible (see also “Side Effects”). The risk of developing tardive dyskinesia and the likelihood that it will become irreversible increases with the duration of treatment and the total cumulative dose. If patients develop symptoms of tardive dyskinesia, metoclopramide therapy should be discontinued. In some patients, symptoms may disappear partially or completely within a few weeks or months after drug withdrawal. No specific studies have been conducted regarding the risk of developing tardive dyskinesia with metoclopramide therapy, but one published study reports that the prevalence of this complication is approximately 20% among patients treated with metoclopramide for at least 12 weeks. In this regard, the duration of continuous treatment should not exceed 12 weeks, except in rare cases when the therapeutic effect is believed to outweigh the risk of developing this serious complication. Tardive dyskinesia often develops in elderly patients, women and patients with diabetes mellitus.

There have been rare reports of a potentially fatal symptom complex – neuroleptic malignant syndrome (NZS) associated with treatment with metoclopramide (see also “Side Effects”). Clinical manifestations of NZS include hyperthermia, muscle rigidity, impaired consciousness, and autonomic instability (irregular pulse or unstable blood pressure, tachycardia, increased sweating, arrhythmia). With the development of NSD, immediate cancellation of metoclopramide and other drugs that are not necessary for concomitant therapy, intensive symptomatic therapy and monitoring is necessary.

In the presence of metoclopramide, laboratory parameters may be distorted, such as liver function tests, aldosterone and prolactin levels in blood serum.

During treatment with metoclopramide, alcoholic beverages should not be consumed to avoid the risk of complications.

The possibility of reduced concentration and increased reaction time during treatment should be taken into account (it is better to refuse to drive a car and work with potentially dangerous equipment).

Trade names with active substance Metoclopramide

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Lek. form
All lek. forms solution for intravenous and intramuscular administration solution for injection solution for oral administration substance substance-powder tablets

Dosage
All dosages 0. 5% 1 mg/ml 10 mg 5 mg/ml No dosage

Manufacturer
All manufacturers Akrikhin JSC Beijing Tayang Pharmaceutical Industry Co. Biochemical and Synthetic Product Biosintez JSC Biochemist JSC Biochemist JSC Biochemist JSC Borisov Plant of Medicinal Products JSC (JSC “BZMP”) Bryntsalov-A JSC Bryntsalov-A JSC Bryntsalov-A PJSC Welfarm LLC Ipka Laboratories Ltd. Lundbeck Pharmaceuticals Itali S.p.A Merkle Moscow Endocrine Plant FSUE Novosibhimfarm AO Novosibhimfarm OAO Renovation of PFC JSC Renewal of PFC ZAO Ozon OOO Ozon Pharm OOO Pliva Hrvatska d.o.o. Polpharma S.A., Poland Pharmaceutical plant Promed Exports Pvt. Ltd. CSP Oui Pharmaceutical Co. Sotex PharmFirma Teva Pharmaceutical plant JSC Ellara LLC Eskom NPK JSC

Cerucal 10mg/2ml 2ml №10 solution for injection. Metoclopramide hydrochloride

monohydrate metoclopramide hydrochloride 10 mg),

excipients

should be taken into account in the composition of the medicinal product: sodium sulfite anhydrous 0. 25 mg . disodium ethylenediaminetetraacetate, sodium chloride, water for injection.

Description of appearance, smell, taste

Clear, colorless liquid.

Dosage form, dosage

Injection solution, 10 mg/2 ml

Pharmacotherapeutic group

Digestive tract and metabolism. Drugs for the treatment of functional gastrointestinal disorders. Gastrointestinal motility stimulants. Metoclopramide.

ATC code A03FA01

Indications for use

• Prevention of postoperative nausea and vomiting
• Symptomatic treatment of nausea and vomiting, including nausea and vomiting in acute migraine
• prevention of nausea and vomiting induced by radiation therapy.

Use in children (2 to 18 years):

• Prevention of delayed chemotherapy-induced nausea and vomiting as a second-line option
• Treatment of post-operative nausea and vomiting as a second-line option

Checklist before use substance or any of the excipients

– gastrointestinal bleeding, gastrointestinal perforation, or mechanical ileus, which poses a risk to gastrointestinal motility.

– confirmed or suspected pheochromocytoma, due to the risk of severe attacks of arterial hypertension.

– history of tardive dyskinesia due to neuroleptics or metoclopramide.

– epilepsy (increased frequency and intensity of seizures)

– Parkinson’s disease

– concomitant use with levodopa or dopaminergic agonists history of uktase.

– use in children under 2 years

– I and III trimesters of pregnancy and lactation

Precautions for use

Neurological disorders

Extrapyramidal disorders may occur, especially in children and young people and/or when using high doses of metoclopramide. These reactions usually occur at the beginning of treatment and may occur after a single injection. Metoclopramide should be discontinued immediately if symptoms of extrapyramidal disorders occur. These symptoms are usually completely reversible upon discontinuation of treatment, but symptomatic treatment may be required (benzodiazepines in children and/or antiparkinsonian anticholinergics in adults).

To reduce the risk of overdose, the time interval between injections should not be less than 6 hours.

Long-term treatment with metoclopramide can lead to tardive dyskinesia, potentially irreversible, especially in the elderly. Treatment should not exceed three months due to the risk of tardive dyskinesia. Treatment should be discontinued when clinical signs of tardive dyskinesia develop.

Neuroleptic malignant syndrome may occur when metoclopramide is taken in combination with neuroleptics, as well as when metoclopramide is used alone. You should immediately stop taking the drug in case of symptoms of neuroleptic malignant syndrome and start appropriate treatment.

When prescribing the drug, special attention should be paid to patients with concomitant neurological diseases, and patients receiving treatment with other drugs that act on the central nervous system. Metoclopramide may increase the symptoms of Parkinson’s disease.

Methemoglobinemia

Although there have been no reports of metoclopramide provoking episodes of methemoglobinemia, if it develops (especially in individuals with a deficiency of NADP-cytochrome-b5), its use should be stopped and the introduction of methylene blue should be started.

Cardiovascular diseases

There are isolated cases of cardiovascular failure, severe bradycardia (up to cardiac arrest), and QT interval prolongation after intravenous administration of metoclopramide.

Administer intravenously to elderly patients, patients with cardiac conduction disorders (including QT interval prolongation), patients with uncorrected electrolyte imbalance, those with bradycardia and taking other drugs that prolong the QT interval.

IV metoclopramide should be given slowly (at least 3 minutes) to reduce the risk of side effects (eg, hypotension, akathisia).

Patients with impaired renal and hepatic function

When using the drug in patients with impaired renal function and in patients with severe hepatic impairment, a dose reduction is recommended.

Hypokalemia

In patients with impaired renal function, hypokalemia may occur during treatment with metoclopramide, since the medicinal product increases plasma aldosterone concentration and reduces sodium excretion.

Depression

Patients with a history of depression, especially moderate or severe depression accompanied by suicidal tendencies, may experience relapse during treatment with metoclopramide. Before starting treatment, it is necessary to weigh the ratio of the potential benefit of treatment to the possible risk.

Endocrine disorders

Metoclopramide causes a transient increase in aldosterone levels

plasma. This can lead to fluid retention, especially in patients with cirrhosis or congestive heart failure.

In vitro studies of found that approximately 1/3 of breast cancers are prolactin dependent. Metoclopramide increases the level of prolactin, so the drug should be used with extreme caution.

Interactions with other drugs

Metoclopramide is not compatible with alkaline infusion solutions;

Combination to avoid

Alcohol increases the sedative effect of metoclopramide.

Combination to be taken into account

Metoclopramide increases the absorption of diazepam, tetracycline, ampicillin, paracetamol, acetylsalicylic acid, levodopa, ethanol; slows down the absorption of digoxin and cimetidine.

Anticholinergics and morphine derivatives

Anticholinergics and morphine derivatives may be mutually antagonistic to metoclopramide in their effect on gastrointestinal motility.

Depressants that depress the activity of the central nervous system (morphine derivatives, tranquilizers, sedative blockers of H1 histamine receptors, sedative antidepressants, barbiturates, clonidine and the like potentiate the action of metoclopramide.

Antipsychotics

900 54 When metoclopramide is used in combination with other antipsychotics, it may there is a cumulative effect and the appearance of extrapyramidal disorders.0055

Serotonergic drugs

Use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.

Digoxin

Metoclopramide may decrease the bioavailability of digoxin. Close monitoring of plasma digoxin concentrations is required.

Cyclosporine

Metoclopramide increases the bioavailability of cyclosporine (C _max by 46% and effect by 22%). Close monitoring of plasma ciclosporin concentrations is required.

Mivacurium and suxamethonium

Metoclopramide injections may prolong the duration of neuromuscular blockade (by inhibiting plasma cholinesterase).

Strong inhibitors of CYP2D6

Metoclopramide exposure is increased when co-administered with strong inhibitors of CYP2D6 such as fluoxetine and paroxetine

MAO inhibitors

In hypertensive patients treated with MAO inhibitors (monoamine oxidase inhibitors), metoclopramide potentiates the action of inhibitors MAO.

Special warnings

Excipients

The drug contains less than 1 mmol (23 mg)/dose of sodium, i. e. practically free of sodium.

During pregnancy or lactation

A large number of data on the use of the drug in pregnant women (more than 1000 cases of use) indicate the absence of malformations and toxic effects on the fetus. Metoclopramide can be used during pregnancy only for strict health reasons. Given the pharmacological properties of the drug (as for neuroleptics), when using metoclopramide in late pregnancy, extrapyramidal symptoms in newborns cannot be excluded. Metoclopramide should not be used in late pregnancy. When using metoclopramide, newborns should be monitored.

Metoclopramide is excreted in breast milk and is not recommended during breastfeeding.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

When taking the drug, you should avoid potentially hazardous activities that require increased attention, quick mental and motor reactions (driving vehicles, etc. ).

Directions for use

Dosage regimen

The solution can be administered intravenously or intramuscularly. Intravenous doses should be given as a slow bolus injection (over 3 minutes).

Adults: Cerucal ^® -Teva is administered intravenously or intramuscularly at 10 mg 1-3 times a day. The maximum single dose is 10 mg, the maximum daily dose is 30 mg.

Children aged 2 to 5 years: maximum single dose is

0.1 to 0.15 mg/kg body weight. The maximum daily dose is 0.5 mg/kg body weight.

Children aged 5 to 9 years: 2.5 mg to 5 mg depending on weight. The maximum daily dose is not more than 15 mg.

Children aged 9 to 18 years: maximum single dose 5 mg, maximum daily dose 30 mg.

Children aged 15 to 18 years: over 60 kg: maximum single dose 10 mg, maximum daily dose 30 mg.

The maximum duration of treatment is 48 hours for the treatment of established POT.

The maximum duration of treatment is 5 days to prevent delayed chemotherapy-induced nausea and vomiting (CINV).

Dosing table: Dosing table:

90 561 5

Upper GI tract examination
Adults: Cerucal ^® -Teva is prescribed 10 mg, 10 minutes before the start of the examination, intravenously, slowly (for 3 minutes).

Children aged 2 to 18 years : Cerucal ^® -Teva is prescribed at 0.1 mg/kg body weight, 10 minutes before the start of the examination, intravenously, slowly (for 3 minutes).

For nausea and vomiting caused by cytostatic drugs Cerucal ^® -Teva is prescribed intravenously by drip:

Scheme 1

Short-term drip infusion (within 15 minutes) at a dose of 2 mg/kg of body weight half an hour before the start of treatment with a cytostatic agent, and also after 1 ½,3 ½ , 5 ½, and 8 ½ hours after cytostatic application.

Scheme 2 24 hours after the use of a cytostatic agent.

It is recommended for infusions to dilute the injection solution of Cerucal ^® -Teva in 50 ml of isotonic sodium chloride solution or 50% glucose solution.

Special patient populations

Elderly

Dose reduction in elderly patients should be considered based on renal and hepatic function and general condition.

In patients with severe hepatic insufficiency with ascites due to an increase in half-life, use half the dose. In patients from severe liver failure should be monitored for side effects. In case of their occurrence, the use of the drug is immediately stopped.

The duration of treatment with cytostatic therapy depends on the severity and course of the disease and is determined by the doctor.

The maximum recommended duration of treatment is 5 days .

Patients with impaired renal function require adjustment of the dosing regimen in accordance with creatinine clearance.

Children

Metoclopramide is contraindicated in children under 1 year of age.

Method and route of administration

Cerulin ^® is administered intramuscularly (IM) or intravenously (IV).

IV injections should be given as a slow bolus (at least 3 minutes).

Frequency of administration with indication of the time of administration

The required minimum interval between doses should be 6 hours, in case of loss of the drug due to vomiting

Measures to be taken in case of overdose 90 064

Symptoms : drowsiness, confusion, irritability, restlessness, convulsions, extrapyramidal movement disorders, dysfunction of the cardiovascular system with bradycardia, decrease or increase in blood pressure.

In mild forms of poisoning, the symptoms disappear 24 hours after drug withdrawal. Depending on the severity of the symptoms, it is recommended to establish monitoring of the patient’s vital functions. Deaths in overdose of the drug have not been identified.

Treatment: symptomatic. Extrapyramidal disorders are eliminated by the slow administration of biperiden (adult doses – 2. 5 – 5 mg). Biperiden is administered only in a hospital, under the supervision of a doctor. Diazepam can be used to calm the patient. When large doses of metoclopramide are ingested, gastric lavage is done, activated charcoal and sodium sulfate are used.

Description of adverse reactions that occur with the standard use of drugs and measures to be taken in this case

In general, the frequency of reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most cases the data do not allow an estimate of frequency:

Very common (≥ 1/10)

– drowsiness

Common (≥ 1/100, <1/10)

– diarrhea

– asthenia

– extrapyramidal disorders (especially in children and young people and / or when the recommended dose is exceeded, even after a single dose of the drug), parkinsonism, akathisia

– depression

– hypotension, especially with intravenous venous administration

Rare (≥ 1/1000, <1/100)

– galactorrhea

– convulsions, especially in patients with epilepsy

– confusion

Uncommon (≥ 1/1000, < 1/100)

– bradycardia, especially when administered intravenously

– amenorrhea, hyperprolactinemia

– hypersensitivity

– dystonia (including visual disturbances and oculogyric crisis), dyskinesia

– decreased level of consciousness

– hallucinations

Rare (≥ 1 /10,000, < 1/1000)

– galactorrhea

– convulsions, especially in patients with epilepsy

– confusion

Unknown

– methemoglobinemia

– cardiac arrest occurring soon after injection,

– atrioventricular block, prolongation of the QT interval

– gynecomastia

– anaphylactic reactions ( including anaphylactic shock) especially when administered intravenously

– tardive dyskinesia, which may be permanent, during or after long-term treatment, especially in elderly patients, neuroleptic malignant syndrome

– shock, syncope after injections

– acute arterial hypertension in patients with pheochromocytoma

– skin reactions such as rash, pruritus, angioedema and urticaria

* Endocrine disorders during long-term treatment associated with hyperprolactin emia (amenorrhea, galactorrhea, gynecomastia).

The following reactions, sometimes associated, occur more frequently with high doses:

– extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonism, akathisia, even after a single dose of the drug, especially in children and young adults

– drowsiness, depression of consciousness, confusion, hallucinations. drugs

RSE on REM “National Center for Expertise of Medicines and Medical Devices” Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan

http://www.ndda.kz

Additional information

Release form and packaging

2 ml of the drug is placed in clear, colorless glass ampoules. 10 ampoules are placed in a blister pack made of polyvinyl chloride film. 1 pack, together with instructions for medical use in the state and Russian languages, is placed in a pack of cardboard.

Shelf life

5 years

Do not use after the expiry date.