Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

USP PREDNISONE TABLETS

NFPA

PRODUCT USE

Prednisone is a synthetic glucocorticoid which is biologically inert until it is converted
in the liver to prednisolone. Used in the treatment of inflammatory disease, the treatment
of certain allergic disorders and where routine systemic corticosteroid therapy is
indicated (except in adrenal- deficiency states for which its lack of sodium- retaining
properties makes it unsuitable).

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Toxic to aquatic organisms, may cause long- term adverse effects in the aquatic
environment.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Large doses of cellulose may be administered orally as non-nutritive bulk. Doses of up to 30 g/day can be tolerated as bulk laxative. Extremely large oral doses may produce gastrointestinal disturbances.  Bulk laxatives can cause temporary bloating and blockage of the esophagus and/or intestine. As they shorten the time of digestion, the absorption of other drugs will be affected.  As absorption of phosphates from the bowel is poor, poisoning this way is less likely. Effects can include vomiting, tiredness, fever, diarrhea, low blood pressure, slow pulse, cyanosis, spasms of the wrist, coma and severe body spasms.  The corticosteroids cause alterations in metabolism of fats, proteins and carbohydrates, and affect a range of organs in the body including the heart, muscle and kidneys. Blood chemistry may change and there is decreased activity and shrinkage of the thymus gland, adrenal glands, spleen and lymph nodes. The liver becomes enlarged, thyroid activity decreases, and mineral is drawn away from bone. Muscle wasting occurs, and the immune system is adversely affected causing the person to be more susceptible to infections, especially of the eye. Allergies can occur. Wound healing is slowed. In large doses, corticosteroids cause a severe chemical imbalance in the body's minerals, leading to salt and water being retained in the body, causing swelling and high blood pressure. This is more severe when natural rather than synthetic drugs are used. Blood glucose is raised, and in extreme cases the heart may fail. The characteristic "moon-face" appearance may be seen, with weakness of the muscles and bones, high blood pressure, cessation of periods, profuse sweating, mental disturbance, flushing, a humped back, hairiness, and obesity of the trunk with wasting of the arms and limbs ("lemon with matchsticks" shape). These generally improve when treatment is stopped. High pressure in the head, an inflamed pancreas and mental disturbance become more common, and bone tissue may die. The blood also condenses more easily leading to an increased risk of clots. Psychiatric changes include mood swings, personality changes, severe depression and psychosis (hallucinations and delusions). One should be beware of an increased susceptibility to a wide range of infections which may be masked by the ability of corticosteroids to reduce pain, inflammation and fever. Those with ulcers, gastrointestinal disease, kidney impairment, hypothyroidism, high blood pressure, liver damage and osteoporosis may be especially susceptible to the adverse effects of corticosteroids. Prolonged exposure can cause cataracts and eye nerve damage, leading to blindness.  

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.  Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected.  

INHALED

  Inhalation may produce health damage*.  Inhalation of vapors or aerosols (mists, fumes), generated by the material during the course of normal handling, may be damaging to the health of the individual.  The material is not thought to produce respiratory irritation (as classified using animal models). Nevertheless inhalation of the material, especially for prolonged periods, may produce respiratory discomfort and occasionally, distress.  Cellulose, after a single intratracheal dose (15 mg per animal) brought about fibrosing granulomatous bronchioloalveolitis and an increase of IgA production in the bronchioalveolar lavage. Fibrosing alveolitis showed moderate progression as a function of time. Injury of Type I pneumocytes and incomplete repair of Type II pneumocytes were detected. The damage of alveolar epithelium initiated and activated a series of processes that led to definite pulmonary alterations and pulmonary fibrosis leading to disintegration of the alveolo-capillary morphological functional unit.  Tatrai, E. et al: Journal of Applied Toxicology; 16(2) 129-135 (1996)Some health effects associated with wood, cotton, flax, jute and hemp particles or fibres are not attributable to cellulose content but to other substances and/or impurities.  Systemic absorption of aerosols containing corticosteroids may produceadrenal insufficiency and collapse.  

CHRONIC HEALTH EFFECTS

  Sodium phosphate dibasic can cause stones in the kidney, loss of mineral from the bones and loss of thyroid gland function.  Studies indicate that diets containing large amounts of non-absorbable polysaccharides, such as cellulose, might decrease absorption of calcium, magnesium, zinc and phosphorus.  Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.  There has been some concern that this material can cause cancer or mutations but there is not enough data to make an assessment.  There is limited evidence that, skin contact with this product is more likely to cause a sensitization reaction in some persons compared to the general population.  There is some evidence that human exposure to the material may result in developmental toxicity. This evidence is based on animal studies where effects have been observed in the absence of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not secondary non-specific consequences of the other toxic effects.  Exposure to the material for prolonged periods may cause physical defects in the developing embryo (teratogenesis).  Inhalation studies indicate that cellulose fibres may be fibrogenic; this finding continues to be the subject of extensive research. Cellulose is not considered an inert substance because:  ·  in rats, it causes granulomatous fibrosing alveolitis at the end of the third month after exposure,  · in rats there was an increase in the secretion of plasminogen activator and interleukin 1 as well as the release of lactate dehydrogenase from macrophages, in a manner similar to asbestos,  · there were increases in the incidence of obstructive lung diseases and bronchial asthma in humans at work and in the residential environment where exposure to cellulose was common,  · the substance may induce free radical production in human leucocytes.  Cotton dust disease, "byssinosis", is well known among cotton mill workers. Cotton dust consists largely of cellulose fibre. Exposure to two components of the total dust, the "respirable" and "medium" fraction correlated significantly with the prevalence of respiratory symptoms. Inhalation exposure to a concentration of 0.3 to 0.4 mg/m3 of "fly-  free" dust results in a 20% occurrence of byssinosis. "Fly-free" dust is the sum of respirable and medium-length fibres. At 0.46 mg/m3, Grade II byssinosis occurs. A byssinosis (all grades) prevalence of 20%, at 0.3 mg/m3 occurs when the fibre length is less than 15 um (aerodynamic equivalent diameter). Byssinosis is not caused by mechanical irritation but by reactions caused by pharmacologically active substances producing oedema or contraction of the smooth musculature of the airways. The causative agent is suspected to be an endotoxin, in turn, thought to be a cell wall component of bacteria found in cotton. Symptoms of byssinosis include chest tightness, wheezing and dyspnoea. Symptoms usually appear after an absence from work and may subside after 2-days of exposure. As the disease progresses, symptoms may persist for longer periods until they are constant. The individual may eventually exhibit chronic bronchitis and emphysema. Increased physical exertion may produce shortness of breath.