Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

OPIPRAMOL HYDROCHLORIDE

NFPA

PRODUCT USE

A tricyclic antidepressant used in the treatment of endogenous depression and has been
given as an antipsychotic. CAUTION: May modify behaviour and state of alertness; exposed
individuals taking charge of vehicles or machinery should be warned of the hazards.

SYNONYMS

C23-H29-N3-O.2HCl, "4-(3-(5H-dibenz[b, f]azepin-5-yl)propyl)-1-piperazineethanol
dihydrochloride", "4-(3-(5H-dibenz[b, f]azepin-5-yl)propyl)-1-piperazineethanol
dihydrochloride", "5-(gamma-(beta-hydroxyethylpiperazino)propyl)-5H-dibenzo[b, f]azepine
HCl", "5-(gamma-(beta-hydroxyethylpiperazino)propyl)-5H-dibenzo[b, f]azepine HCl", "N-[3-
[4-(2-hydroxyethyl)piperazino]propyl]iminostilbene hydrochloride", "N-[3-[4-(2-
hydroxyethyl)piperazino]propyl]iminostilbene hydrochloride", "4-[3-(5H-dibenzo[b,
f]azepin-5-yl)propyl-1-(2-hydroxyethyl)piperazine HCl", "4-[3-(5H-dibenzo[b, f]azepin-5-
yl)propyl-1-(2-hydroxyethyl)piperazine HCl", "opipramol dihydrochloride", Dinsidon,
Ensidon, G-33040, Insidon, Insidone, "Insidon Dihydrochloride", Nisidana, Pramolan,
"tricyclic antidepressant"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Harmful if swallowed.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious damage to the health of the individual.  Side effects of tricyclic antidepressants include dry mouth, sour or metallic taste, constipation, retention of urine, blurred vision and changes in focusing, palpitations, and fast heart beat. Gastrointestinal disturbances (including nausea and vomiting), drowsiness, tremor, low blood pressure when standing, dizziness, sweating, weakness and fatigue, inco-ordination, epilepsy-like seizures, and speech difficulties may occur. Allergic skin reactions and sensitivity to light have been reported, as well as jaundice and blood disorders. Effects on the heart muscle may produce conduction defects and irregularities in heart beat. Endocrine effects may produce changes in sexdrive, impotence, enlarged breasts and copious milk production. Changes in blood sugar levels and reduced levels of antidiuretic hormone may also occur. Overdose may produce excitement and restlessness with dry mouth, dilated pupils, increased heart rate, retention of urine and absence of bowel sounds. More sever poisoning may produce convulsions and muscle spasms, low blood pressure and depression of breathing and the heart. There may be life-threatening heartbeat irregularities that occurs some days after apparent recovery.  A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been associated with the use of antipsychotic drugs. Clinical manifestations include hyperpyrexia, muscle rigidity, altered mental state, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.Antipsychotic drug therapy may also produce potentially irreversible, involuntary, dyskinetic movements, especially in the elderly and in particular, in elderly women. The development of this syndrome appears to be related to the duration of treatment and the total cumulative dose of antipsychotic drugs administered; the syndrome can, however, develop after relatively brief treatment periods at low doses.Other side-effects of drug therapy may include a disruption to the body's ability to reduce body core temperature and dysphagia (oesophageal dysmotility and aspiration - aspiration pneumonia is a common cause of morbidity or mortality in elderly patients especially those with advanced Alzheimer's dementia).  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may produce transient discomfort characterized by tearing or conjunctival redness (as with windburn).  

SKIN

  The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  Open cuts, abraded or irritated skin should not be exposed to this material.  Toxic effects may result from skin absorption.  

INHALED

  The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting.  Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability if excessive concentrations of particulate are inhaled.  

CHRONIC HEALTH EFFECTS

  Principal routes of exposure are by accidental skin and eye contact andinhalation of generated dusts.  Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. Increases in mammary neoplasms have been found in rodents after chronic administration of antipsychotic drugs and are considered to be prolactin-mediated.  Increased prolactin levels in serum are a secondary consequence of chronic dopamine antagonism of pituitary lactotrophs.  The relevance of the increased incidence of prolactin-mediated mammary gland tumours in rats, to human risk, is unknown.  Reproductive and developmental toxicity may also result from exposure to dopamine antagonists; these may result from elevation of serum prolactin. Effects may include prolonged oestrus, pre-implantation loss and alterations to the length of the gestational cycle.