Metoclopramide-Intranasal

Metoclopramide Intranasal is a prescription medication used for the treatment of gastroparesis.

• Metoclopramide Intranasal is available under the following different brand names: Gimoti

Common side effects of Metoclopramide Intranasal include:

• changes in taste,
• headache, and 

Serious side effects of Metoclopramide Intranasal include:

• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

Rare side effects of Metoclopramide Intranasal include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intranasal solution

• 15 mg/actuation

Each bottle contains 9.8 mL

Gastroparesis

Adult and geriatric dosage

• Aged below 65 years
  • 1 spray (15 mg) in 1 nostril, 30 min before each meal and at bedtime (up to 4x/day) for 2-8 weeks, depending on symptomatic response
• Aged above 65 years
  • If receiving an alternative metoclopramide product at a stable dose of 10 mg four times daily, may be switched to Metoclopramide Intranasal 1 spray (15 mg) in 1 nostril, 30 min before each meal and at bedtime (up to 4x/day) for 2-8 weeks, depending on symptomatic response

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Metoclopramide Intranasal has severe interactions with no other drugs.
• Metoclopramide Intranasal has serious interactions with at least 232 other drugs.
• Metoclopramide Intranasal has moderate interactions with at least 35 other drugs.
• Metoclopramide Intranasal has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• History of TD or dystonic reaction to metoclopramide
• When stimulation of GI motility might be dangerous (eg, GI hemorrhage, mechanical obstruction, perforation)
• Pheochromocytoma or other catecholamine-releasing paragangliomas
• Epilepsy
• Hypersensitivity to metoclopramide

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Metoclopramide Intranasal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Metoclopramide Intranasal?”

Cautions

• Can cause TD, a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities
• In addition to TD, may cause other extrapyramidal symptoms (EPSs), parkinsonian symptoms, and motor restlessness; advise patients to seek immediate medical attention if such symptoms occur and to discontinue treatment
• Depression has occurred with and without a history of depression; avoid use with a history of depression
• May produce transient increases in plasma aldosterone and increased risk for fluid retention and volume; caution in patients at risk of fluid overload (heart failure or cirrhosis); discontinue if any of these adverse reactions occur
• Mental and/or physical abilities required for the performance of hazardous tasks (eg, operating machinery, driving a motor vehicle) may be impaired
• Not recommended with moderate or severe renal or hepatic impairment, patients who are CYP2D6 poor metabolizers, or coadministration with strong CYP2D6 inhibitors; increased exposure to metoclopramide due to reduced metabolism or excretion may lead to increased adverse reactions, including TD
• Neuroleptic malignant syndrome
  • Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdosage and concomitant treatment with another drug associated with NMS
  • Avoid in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics
  • Management of NMS includes
    • Immediately discontinue other drugs not essential to concurrent therapy
    • Intensive symptomatic treatment and medical monitoring
    • Treatment of any concomitant serious medical problems for which specific treatments are available
• Hypertension
  • May elevate blood pressure
  • Hypertensive crises also reported in patients with undiagnosed pheochromocytoma
  • Contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas
  • Discontinue treatment in any patient with a rapid rise in blood pressure
• Hyperprolactinemia
  • May elevate prolactin levels
  • Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone and eventually may inhibit reproductive function by impairing gonadal steroidogenesis in both females and males
  • Galactorrhea, amenorrhea, gynecomastia, and impotence reported with prolactin-elevating drugs
• Drug interaction overview
  • Metoclopramide is a CYP2D6 substrate
  • Strong CYP2D6 inhibitors
    • Not recommended
    • Coadministration with CYP2D6 inhibitors may increase plasma concentrations of metoclopramide
• CNS depressants
  • Avoid the use of Metoclopramide Intranasal or interacting drug, depending on the importance of the drug to the patient
  • Coadministration with CNS depressants may increase the effects of CNS depression
• Antipsychotics
  • Avoid coadministration
  • Coadministration with antipsychotics may enhance the frequency and severity of TD, other EPSs, and NMS
• Monoamine oxidase inhibitors (MAOIs)
  • Avoid coadministration
  • Coadministration of MAOIs may increase the risk of hypertension
• Drugs that may impair GI motility
  • Coadministration may decrease systemic absorption of metoclopramide
  • Monitor for reduced therapeutic effect
• Dopamine agonists and other drugs that increase dopamine concentrations
  • Avoid use
  • Coadministration may have opposing effects on each other
• Succinylcholine or mivacurium
  • Metoclopramide may enhance the neuromuscular-blocking effect of succinylcholine or mivacurium; monitor for signs and symptoms of prolonged neuromuscular blockade
  • Drugs with absorption altered due to increased GI motility
  • Increased GI motility by metoclopramide may impact the absorption of other drugs, leading to decreased or increased drug exposure
  • Monitor the therapeutic effect of the drugs with altered absorption
• Insulin
  • Increased GI motility by metoclopramide may increase the delivery of food to the intestines and increase blood glucose
  • Monitor blood glucose and adjust insulin dosage regimen as needed

Pregnancy and Lactation

• Published studies do not report a consistent pattern or a consistently increased risk of adverse pregnancy-related outcomes with oral use of metoclopramide during pregnancy
• However, available data from a case report of use in pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• There are potential risks to the neonate following exposure in utero to metoclopramide during delivery
• Clinical considerations
  • Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery
  • Monitor neonates for extrapyramidal signs
• Lactation
  • No data is available on the presence in human milk following nasal administration
  • However, published data report the presence in human milk in variable amounts following oral administration
  • Breastfed infants exposed to metoclopramide have experienced GI adverse reactions, including intestinal discomfort and increased intestinal gas formation
• Clinical considerations
  • Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (eg, dystonias) and methemoglobinemia