Metoclopramide (Page 3 of 7)

5.8 Effects of the Ability to Drive and Operate Machinery

Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system (CNS) depressants or drugs associated with EPS may increase this effect (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid metoclopramide or the interacting drug, depending on the importance of the drug to the patient [see Drug Interactions (7.1) ].

6 ADVERSE REACTIONS

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 (5.1)]
  • Other extrapyramidal effects [see Warnings and Precautions (5.2) ]
  • Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ]
  • Depression [see Warnings and Precautions (5.4) ]
  • Hypertension [see Warnings and Precautions (5.5) ]
  • Fluid retention [see Warnings and Precautions (5.6) ]
  • Hyperprolactinemia [see Warnings and Precautions (5.7) ]
  • Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8) ]

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 most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide 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 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

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Metoclopramide

Table 3 displays the effects of other drugs on metoclopramide.

Table 3. Effects of Other Drugs on Metoclopramide

Antipsychotics

Clinical Impact

Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS).

Intervention

Avoid concomitant use [see Warnings and Precautions (5.1, 5.2, 5.3)].

Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above

Clinical Impact

Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology (12.3) ].

Intervention

Reduce the metoclopramide dosage [see Dosage and Administration (2.2, 2.3)].

Examples

quinidine, bupropion, fluoxetine, and paroxetine

Monoamine Oxidase Inhibitors

Clinical Impact

Increased risk of hypertension [see Warnings and Precautions (5.5) ].

Intervention

Avoid concomitant use.

Central Nervous System (CNS) Depressants

Clinical Impact

Increased risk of CNS depression [see Warnings and Precautions (5.8) ].

Intervention

Avoid metoclopramide or the interacting drug, depending on the importance of the drug to the patient.

Examples

alcohol, sedatives, hypnotics, opiates and anxiolytics

Drugs that Impair Gastrointestinal Motility

Clinical Impact

Decreased systemic absorption of metoclopramide.

Intervention

Monitor for reduced therapeutic effect.

Examples

antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates

Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations

Clinical Impact

Decreased therapeutic effect of metoclopramide due to opposing effects on dopamine.

Intervention

Monitor for reduced therapeutic effect.

Examples

apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine

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