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METOCLOPRAMIDE HYDROCHLORIDE
DIR Classification
Classification:Most-DIR concern
Severity Score:4
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- Neuroleptic Malignant Syndrome
- Metoclopramide may cause a potentially fatal symptom complex called neuroleptic malignant syndrome (NMS). NMS has been reported in association with metoclopramide overdosage and concomitant treatment with another drug associated with NMS. Avoid metoclopramide tablets in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics.
- Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately.
- In the diagnostic evaluation, consider the presence of other serious medical conditions (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, serotonin syndrome, and primary central nervous system pathology.
- Management of NMS includes:
- - Immediate discontinuation of metoclopramide tablets and other drugs not essential to concurrent therapy [see DRUG INTERACTIONS (7.1)].
- - Intensive symptomatic treatment and medical monitoring.
- - Treatment of any concomitant serious medical problems for which specific treatments are available.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
17
42895
Other ADRs
22899
14094380
Odds Ratio = 0.244
Drug Property Information
ATC Code(s):
- A03FA01 - metoclopramide hydrochloride
- A03FA - Propulsives
- A03F - PROPULSIVES
- A03 - DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
- A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:metoclopramide hydrochloride
Active Ingredient UNII:W1792A2RVD
Drugbank ID:DB01233
PubChem Compound:4168
CAS Number:364-62-5
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 30.0 mg/day A03FA01
Chemical Structure: 
SMILE Code:
CCN(CC)CCNC(=O)C1=CC(=C(C=C1OC)N)Cl
CCN(CC)CCNC(=O)C1=CC(=C(C=C1OC)N)Cl
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
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