Pronunciation:

met-oh-KLOE-pra-mide hye-droe-KLOR-ide

Brand Names:

• Gimoti

Dosage Forms:

• Spray

Warnings:

Metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dosage. Discontinue metoclopramide in patients who develop signs or symptoms of tardive dyskinesia. Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the risk of developing tardive dyskinesia with longer-term use .

Classifications:

Therapeutic—

Antiemetic

Pharmacologic—

Metoclopramide

Uses of This Medicine:

Metoclopramide nasal spray is used to treat the symptoms of slow stomach emptying (gastroparesis) in patients with diabetes. It works by increasing the movements or contractions of the stomach and intestines. It relieves symptoms such as nausea, vomiting, heartburn, a feeling of fullness after meals, and loss of appetite.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use of metoclopramide nasal spray in children is not recommended. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metoclopramide nasal spray in the elderly. However, elderly patients are more likely to have unwanted effects (eg, tardive dyskinesia) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Brexpiprazole
• Cariprazine
• Chlorpromazine
• Chlorprothixene
• Citalopram
• Clomipramine
• Clozapine
• Desipramine
• Dibenzepin
• Doxepin
• Escitalopram
• Fluphenazine
• Fluvoxamine
• Haloperidol
• Iloperidone
• Imipramine
• Loxapine
• Lurasidone
• Melitracen
• Mesoridazine
• Methotrimeprazine
• Molindone
• Nortriptyline
• Olanzapine
• Opipramol
• Paliperidone
• Periciazine
• Perphenazine
• Pimavanserin
• Pimozide
• Prochlorperazine
• Promazine
• Protriptyline
• Quetiapine
• Risperidone
• Sertindole
• Sertraline
• Sulpiride
• Thioridazine
• Thiothixene
• Tianeptine
• Trifluoperazine
• Triflupromazine
• Trimipramine
• Vilazodone
• Vortioxetine
• Ziprasidone
• Zuclopenthixol

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acepromazine
• Alfentanil
• Alprazolam
• Amantadine
• Amobarbital
• Anileridine
• Apomorphine
• Baclofen
• Benperidol
• Benzhydrocodone
• Benztropine
• Biperiden
• Bromazepam
• Bromocriptine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Cabergoline
• Calcium Oxybate
• Carbidopa
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Cyclobenzaprine
• Cyclosporine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Digoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Droperidol
• Enflurane
• Entacapone
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Fluoxetine
• Flurazepam
• Fluspirilene
• Fospropofol
• Furazolidone
• Halazepam
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iproniazid
• Isocarboxazid
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Levodopa
• Levorphanol
• Linezolid
• Lorazepam
• Magnesium Oxybate
• Meclizine
• Melperone
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methylene Blue
• Midazolam
• Moclobemide
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nialamide
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Opicapone
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Pergolide
• Phenelzine
• Phenobarbital
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Pramipexole
• Prazepam
• Primidone
• Procarbazine
• Procyclidine
• Promethazine
• Propofol
• Quazepam
• Quinidine
• Ramelteon
• Rasagiline
• Remifentanil
• Remoxipride
• Rivastigmine
• Ropinirole
• Rotigotine
• Safinamide
• Secobarbital
• Selegiline
• Sirolimus
• Sodium Oxybate
• Sufentanil
• Suvorexant
• Tacrolimus
• Tapentadol
• Temazepam
• Terbinafine
• Thiethylperazine
• Thiopental
• Thiopropazate
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Triazolam
• Trifluperidol
• Trihexyphenidyl
• Trimeprazine
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Didanosine
• Mivacurium
• Succinylcholine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, history of or
• Breast cancer, prolactin-dependent or
• Cirrhosis (liver disease) or
• Congestive heart failure or
• Depression or history of or
• Diabetes or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Neuroleptic malignant syndrome, history of or
• Parkinson's disease—Use with caution. May make these conditions worse.

• CYP2D6 poor metabolizers or
• Kidney disease, moderate or severe or
• Liver disease, moderate or severe—Use is not recommended in patients with these conditions.

• G6PD deficiency (an enzyme problem) or
• NADH cytochrome reductase deficiency (an enzyme problem)—May increase the risk for blood problems (eg, methemoglobinemia, sulfhemoglobinemia, hemolytic anemia).

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Pheochromocytoma (adrenal gland tumor) or
• Seizures or epilepsy or
• Stomach or bowel problems (eg, bleeding, blockage, perforation) or
• Tardive dyskinesia, history of—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have questions.

Take this medicine at least 30 minutes before each meal and at bedtime.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.

To use the spray bottle:

• Prime the nasal spray bottle before using it for the first time or if it has been 2 weeks since you last used it.
• To prime, place your index and middle finger on each side of the finger flange and your thumb on the bottom of the bottle. Turning the nozzle away from your face, press down on the flange 10 times until a spray appears. Do not spray into your eyes.
• Insert the nozzle tip under one of your nostrils, then tilt your head slightly forward so the nozzle tip is aimed away from the center of your nose.
• Close the other nostril with your other index finger and press down firmly on the flange until it stops moving to deliver a full dose.
• Release the flange and breathe in gently through the open nostril.
• Remove the nozzle tip and breathe out slowly through your mouth.
• After using the nasal spray, wipe the tip of the nozzle with a clean tissue and put the cap back on.
• If the nozzle becomes clogged, pull it up from the bottle and soak it in warm water. Do not insert a pin or other sharp object to unblock the nozzle. Dry the nozzle at room temperature then place it back on the bottle.

Do not use this medicine for longer than 8 weeks. If you are taking any other medicine containing metoclopramide, do not use it for longer than 12 weeks.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):
  • For diabetic gastroparesis:
    • Adults less than 65 years of age—1 spray in one nostril 4 times a day for 2 to 8 weeks. Each spray contains 15 milligrams (mg) of metoclopramide.
    • Adults 65 years of age and older and children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you are unsure that the spray entered the nose, do not repeat the dose. Take the next dose at the scheduled time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused medicine 4 weeks after opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs. The risk of tardive dyskinesia is higher if you use this medicine for longer than 8 weeks or if you take other medicines containing metoclopramide for more than 12 weeks. Treatment for longer than 12 weeks should be avoided in all but rare cases.

Tell your doctor right away if you have inability to move the eyes, increased blinking or spasms of the eyelid, trouble with breathing, speaking, or swallowing, uncontrolled tongue movements, uncontrolled twisting movements of the neck, trunk, arms, or legs, unusual facial expressions, or weakness of the arms and legs.

Check with your doctor right away if you have seizures, difficulty with breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Metoclopramide may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may increases your risk of having fluid retention (swelling) and volume overload, especially if you have cirrhosis (liver disease) or heart failure. Check with your doctor right away if you have a decrease in the amount of urine, noisy, rattling breathing, swelling of the fingers, hands, feet, or lower legs, trouble breathing at rest, or weight gain.

This medicine may increase prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with metoclopramide may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may make you dizzy, drowsy, or have trouble with thinking or controlling body movements. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Changes in behavior

discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

thoughts of killing oneself

tiredness

trouble concentrating

trouble sleeping

Incidence not known

Agitation

black, tarry stools

bluish-colored lips, fingernails, or palms

blurred vision

chest pain or tightness

chills

clay-colored stools

confusion

cough

dark urine

decreased urine output

diarrhea

dilated neck veins

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast or slow heartbeat

fever

fluid-filled skin blisters

general feeling of tiredness or weakness

headache

hoarseness

inability to move the eyes

inability to sit still

increased blinking or spasms of the eyelid

increased need to urinate

increased sweating

irregular breathing

itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

lip smacking or puckering

loss of balance control

loss of bladder control

lower back or side pain

mask-like face

nausea

need to keep moving

nervousness

noisy, rattling breathing

overactive reflexes

painful or difficult urination

pale skin

passing urine more often

poor coordination

pounding in the ears

pounding, slow heartbeat

puffing of the cheeks

rapid or worm-like movements of the tongue

restlessness

seeing, hearing, or feeling things that are not there

seizures

sensitivity of the skin to the sun

severe muscle stiffness

shivering

shuffling walk

slowed movements

slurred speech

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sticking out of the tongue

stomach pain or tenderness

swelling of the breasts or breast soreness in both females and males

swelling of the face, fingers, feet, or lower legs

talking or acting with excitement you cannot control

thinning of the skin

tic-like (jerky) movements of the head, face, mouth, and neck

trembling and shaking of the fingers and hands

trouble in breathing, speaking, or swallowing

trouble breathing at rest

twitching

uncontrolled chewing movements

uncontrolled movements of the arms and legs

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual bleeding or bruising

unusual facial expressions

vomiting

weight gain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in or loss of taste

drowsiness

loss of strength or energy

muscle pain or weakness

unusual weak feeling

Incidence not known

Absent, missed, or irregular menstrual periods

decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

unexpected or excess milk flow from breasts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.