Gimoti

Gimoti Professional Information

SIDE EFFECTS

The following adverse reactions are described, or described in greater detail, in other sections of the labeling:

• Tardive dyskinesia [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Other extrapyramidal effects [see WARNINGS AND PRECAUTIONS]
• Neuroleptic malignant syndrome [see WARNINGS AND PRECAUTIONS]
• Depression [see WARNINGS AND PRECAUTIONS]
• Hypertension [see WARNINGS AND PRECAUTIONS]
• Fluid retention [see WARNINGS AND PRECAUTIONS]
• Hyperprolactinemia [see WARNINGS AND PRECAUTIONS]
• Effects on the ability to drive and operate machinery [see WARNINGS AND PRECAUTIONS]

The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The safety of GIMOTI was evaluated in clinical trials of patients with gastroparesis and established in clinical trials of oral metoclopramide.

Safety Of GIMOTI

In a randomized, placebo-controlled clinical trial of 190 male and female patients of GIMOTI 14 mg, a slightly lower than recommended dosage, administered nasally four times daily for 4 weeks, dysgeusia was the most commonly reported adverse reaction (15% of GIMOTI-treated patients and 4% of placebo-treated patients). Other adverse reactions were similar to those reported for oral metoclopramide.

Safety Of Oral Metoclopramide

The most common adverse reactions (in approximately 10% of patients receiving the recommended oral metoclopramide dosage of 10 mg four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of metoclopramide administration.

Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches.

Central Nervous System Disorders

• Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms
• Convulsive seizures
• Hallucinations
• Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received metoclopramide orally 10 mg four times daily. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently.
• Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents)

Endocrine Disorders

Fluid retention secondary to transient elevation of aldosterone, galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia

Cardiovascular Disorders

Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention

Gastrointestinal Disorders

Nausea, bowel disturbances (primarily diarrhea) Hepatic Disorders: Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential

Renal And Urinary Disorders

Urinary frequency, urinary incontinence

Hematologic Disorders

Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia

Hypersensitivity Reactions

Bronchospasm (especially in patients with a history of asthma), urticaria, rash, angioedema, including glossal or laryngeal edema

Eye Disorders

Visual disturbances

Metabolism Disorders

Porphyria

Read the entire FDA prescribing information for Gimoti (Metoclopramide Nasal Spray)

&Copy; Gimoti Patient Information is supplied by Cerner Multum, Inc. and Gimoti Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.