What Medicine Can Do!
Welcome to my site. I will tell you the story of what happened to my husband because of medicine and an allergic reaction to Thorazine. This may shock you more than you will ever know, but doctors have known for decades that Thorazine can cause neuroleptic problems and parkinson's symptoms in patients.
It all started in December 2001. My husband came home from work with the flu bug, and was down for a week. After a few days, he started to feel better when he took a turn for the worst, and developed pneumonia. After a couple of days of vomiting and continuous hiccups, we went to an Urgent Care center to find out why he was getting worse. By this time, he was unable to walk without support, dehydrated, and confused. The doctor checked him out, did x-rays and said that he had pneumonia. Well, he gave him 2 liters of IV fluids and some Phenergan to calm his hiccups and confusion. Then he got really "nutty". He started to act strange, kissed the nurses hand, and tried to pull out his IV. The doctor had the nurse give him an injection of Benedryl to conteract the Phenergan. He said that he was having an allergic reaction to the Phenergan and not to ever give him that family of medicines again. While he was telling me this, he was writing him out a prescription for another medicine (Thorazine) to take at home.
I went and got the medicine filled and gave it to him according to the instructions. Everything was fine until he finished the medicine. Then two days later, he started acting strange again. He didn't know where he was, who I was, or what he was doing. I took him to the ER that night when he said that his head felt like it was about to explode, it hurt so bad. The doctor in the ER did some test to see if the pneumonia had gotten worse, but it hadn't. He gave him some Benedryl and said that he was having an allergic reaction to the Thorazine. When I got him home and settled, I immediately went to the internet to check on the Thorazine and see what it was so that I would know tell the doctors that he was allergic to it. Turns out the Thorazine is a phenothiazine just like the Phenergan. YES, THAT'S RIGHT THE DOCTOR GAVE HIM THE SAME FAMILY OF MEDICINES. Well, that was what started it all.
It wasn't long until he couldn't seem to remember things that he did or said the day before. There were times when he couldn't remember who I was (thought I was his ex-wife). Now, it is December of 2005, and we are all learning to cope with the issues that this problem has brought up. First, he was diagnosed by the family physician with Extrapyramidal Disorder. For those of you who don't know, it has several of the symptoms of Parkinson's. He also has ataxia, which means that when he walks, he falls to the right side. He can't walk much any more, mostly has to use a wheelchair unless I am there to help him. If he trys to walk without assitance, he will take 2 steps and fall. He has tremors all of the time. They started him on 4- 1 mg. pills of Clonazepam to control his tremors and now he is up to 14 a day. He also has problems with his feet swelling so bad that the capillaries in them bust.
We had several test done by several different Neurologist and Pychoneurologist and not one could tell us for sure what is wrong and to what extent. Our family doctor says that his problems are permenant and progressive. He will never get any better.
He has good days and bad days. Some times he can stay up all day and play games on the computer. Some times he doesn't sleep but 3 hours a night. Some times he sleeps for 12 hours. He has finally come to realize that he won't get any better and is only getting worse.
While I was doing all my research on the internet, I came across some very interesting information.
Back in the 1950's, they created Thorazine and immediately patients bagan to has adverse side effects. This is the FDA information on Thorazine. You can access it by going to http://www.fda.gov/cder/foi/label/2001/11120s86lbl.pdf
THORAZINE®
brand of
chlorpromazine
antipsychotic• tranquilizer • antiemetic
DESCRIPTION
Thorazine (chlorpromazine)
ACTIONS
The precise mechanism whereby the therapeutic effects of chlorpromazine are produced is not known. The
principal pharmacological actions are psychotropic. It also exerts sedative and antiemetic activity. Chlorpromazine has actions at all levels of the central nervous system--primarily at subcortical levels--as well as
on multiple organ systems. Chlorpromazine has strong antiadrenergic and weaker peripheral anticholinergic
activity; ganglionic blocking action is relatively slight. It also possesses slight antihistaminic and antiserotonin
activity.
INDICATIONS
For the treatment of schizophrenia.
To control nausea and vomiting.
For relief of restlessness and apprehension before surgery.
For acute intermittent porphyria.
As an adjunct in the treatment of tetanus.
To control the manifestations of the manic type of manic-depressive illness.
For relief of intractable hiccups.
For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness
and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term
treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders
consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood
lability and poor frustration tolerance.
CONTRAINDICATIONS
Do not use in patients with known hypersensitivity to phenothiazines.
Do not use in comatose states or in the presence of large amounts of central nervous system depressants
(alcohol, barbiturates, narcotics, etc.).
WARNINGS:
The extrapyramidal symptoms which can occur secondary to Thorazine (chlorpromazine) may be
confused with the central nervous system signs of an undiagnosed primary disease responsible for the
vomiting, e.g., Reye's syndrome or other encephalopathy. The use of Thorazine and other potential
hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest
Reye's syndrome.
Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary,
dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the
syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon
prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop
the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is
unknown.
Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to
increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the
patient increase. However, the syndrome can develop, although much less commonly, after relatively brief
treatment periods at low doses.
There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit,
partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may
suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the
underlying disease process. The effect that symptomatic suppression has upon the long-term course of the
syndrome is unknown.
Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the
occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who
suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and, 2) for whom alternative,
equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do
require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory
clinical response should be sought. The need for continued treatment should be reassessed periodically.
If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should
be considered. However, some patients may require treatment despite the presence of the syndrome.
For further information about the description of tardive dyskinesia and its clinical detection, please refer to the
sections on PRECAUTIONS and ADVERSE REACTIONS.
Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as
Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical
manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic
instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important
to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic
infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important
considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and
primary central nervous system (CNS) pathology.
The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs
not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3)
treatment of any concomitant serious medical problems for which specific treatments are available. There is no
general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug
therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS
have been reported.
An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion,
extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients
treated with lithium plus an antipsychotic. In some instances, the syndrome was followed by irreversible brain
damage. Because of a possible causal relationship between these events and the concomitant administration of
lithium and antipsychotics, patients receiving such combined therapy should be monitored closely for early
evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic
syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS).
Thorazine (chlorpromazine) ampuls and multi-dose vials contain sodium bisulfite and sodium sulfite, sulfites that
may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic
episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is
unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Patients with bone marrow depression or who have previously demonstrated a hypersensitivity reaction (e.g.,
blood dyscrasias, jaundice) with a phenothiazine should not receive any phenothiazine, including Thorazine,
unless in the judgment of the physician the potential benefits of treatment outweigh the possible hazard.
Thorazine may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore,
caution patients about activities requiring alertness (e.g., operating vehicles or machinery).
The use of alcohol with this drug should be avoided due to possible additive effects and hypotension.
Thorazine may counteract the antihypertensive effect of guanethidine and related compounds.
Usage in Pregnancy: Safety for the use of Thorazine (chlorpromazine) during pregnancy has not been
established. Therefore, it is not recommended that the drug be given to pregnant patients except when, in the
judgment of the physician, it is essential. The potential benefits should clearly outweigh possible hazards. There
are reported instances of prolonged jaundice, extrapyramidal signs, hyperreflexia or hyporeflexia in newborn
infants whose mothers received phenothiazines.
Reproductive studies in rodents have demonstrated potential for embryotoxicity, increased neonatal mortality
and nursing transfer of the drug. Tests in the offspring of the drug-treated rodents demonstrate decreased
performance. The possibility of permanent neurological damage cannot be excluded.
Nursing Mothers: There is evidence that chlorpromazine is excreted in the breast milk of nursing mothers.
Because of the potential for serious adverse reactions in nursing infants from chlorpromazine, a decision should
be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the
drug to the mother.
PRECAUTIONS
General
Given the likelihood that some patients exposed chronically to antipsychotics will develop tardive dyskinesia, it is
advised that all patients in whom chronic use is contemplated be given, if possible, full information about this
risk. The decision to inform patients and/or their guardians must obviously take into account the clinical
circumstances and the competency of the patient to understand the information provided.
Thorazine (chlorpromazine) should be administered cautiously to persons with cardiovascular, liver or renal
disease. There is evidence that patients with a history of hepatic encephalopathy due to cirrhosis have increased
sensitivity to the CNS effects of Thorazine (i.e., impaired cerebration and abnormal slowing of the EEG).
Because of its CNS depressant effect, Thorazine should be used with caution in patients with chronic respiratory
disorders such as severe asthma, emphysema and acute respiratory infections, particularly in children (1 to 12
years of age).
Because Thorazine can suppress the cough reflex, aspiration of vomitus is possible.
Thorazine (chlorpromazine) prolongs and intensifies the action of CNS depressants such as anesthetics,
barbiturates and narcotics. When Thorazine is administered concomitantly, about 1 / 4 to 1 / 2 the usual dosage
of such agents is required. When Thorazine is not being administered to reduce requirements of CNS
depressants, it is best to stop such depressants before starting Thorazine treatment. These agents may
subsequently be reinstated at low doses and increased as needed.
Note: Thorazine does not intensify the anticonvulsant action of barbiturates. Therefore, dosage of
anticonvulsants, including barbiturates, should not be reduced if Thorazine is started. Instead, start Thorazine at
low doses and increase as needed.
Use with caution in persons who will be exposed to extreme heat, organophosphorus insecticides, and in
persons receiving atropine or related drugs.
Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture
experiments indicate that approximately 1 / 3 of human breast cancers are prolactin-dependent in vitro, a factor
of potential importance if the prescribing of these drugs is contemplated in a patient with a previously detected
breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia and impotence have
been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An
increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs.
Neither clinical nor epidemiologic studies conducted to date, however, have shown an association between
chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too
limited to be conclusive at this time.
Chromosomal aberrations in spermatocytes and abnormal sperm have been demonstrated in rodents treated
with certain antipsychotics.
As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, chlorpromazine should be used
with caution in patients with glaucoma.
Chlorpromazine diminishes the effect of oral anticoagulants.
Phenothiazines can produce alpha-adrenergic blockade.
Chlorpromazine may lower the convulsive threshold; dosage adjustments of anticonvulsants may be necessary.
Potentiation of anticonvulsant effects does not occur. However, it has been reported that chlorpromazine may
interfere with the metabolism of Dilantin® * and thus precipitate Dilantin toxicity.
Concomitant administration with propranolol results in increased plasma levels of both drugs.
Thiazide diuretics may accentuate the orthostatic hypotension that may occur with phenothiazines.
The presence of phenothiazines may produce false-positive phenylketonuria (PKU) test results.
Drugs which lower the seizure threshold, including phenothiazine derivatives, should not be used with
Amipaque®† . As with other phenothiazine derivatives, Thorazine should be discontinued at least 48 hours
before myelography, should not be resumed for at least 24 hours postprocedure, and should not be used for the
control of nausea and vomiting occurring either prior to myelography or postprocedure with Amipaque .
Long-Term Therapy: To lessen the likelihood of adverse reactions related to cumulative drug effect, patients
with a history of long-term therapy with Thorazine and/or other antipsychotics should be evaluated periodically to
decide whether the maintenance dosage could be lowered or drug therapy discontinued.
Antiemetic Effect: The antiemetic action of Thorazine may mask the signs and symptoms of overdosage of
other drugs and may obscure the diagnosis and treatment of other conditions such as intestinal obstruction,
brain tumor and Reye's syndrome. (See WARNINGS .)
When Thorazine is used with cancer chemotherapeutic drugs, vomiting as a sign of the toxicity of these agents
may be obscured by the antiemetic effect of Thorazine .
Abrupt Withdrawal: Like other phenothiazines, Thorazine (chlorpromazine) is not known to cause psychic
dependence and does not produce tolerance or addiction. There may be, however, following abrupt withdrawal
of high-dose therapy, some symptoms resembling those of physical dependence such as gastritis, nausea and
vomiting, dizziness and tremulousness. These symptoms can usually be avoided or reduced by gradual
reduction of the dosage or by continuing concomitant anti-parkinsonism agents for several weeks after
Thorazine is withdrawn.
ADVERSE REACTIONS
Note: Some adverse effects of Thorazine may be more likely to occur, or occur with greater intensity, in patients
with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced
severe hypotension following recommended doses.
Drowsiness, usually mild to moderate, may occur, particularly during the first or second week, after which it
generally disappears. If troublesome, dosage may be lowered.
B Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a
sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture
resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal
damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been
reported.
There is no conclusive evidence that preexisting liver disease makes patients more susceptible to jaundice.
Alcoholics with cirrhosis have been successfully treated with Thorazine (chlorpromazine) without complications.
Nevertheless, the medication should be used cautiously in patients with liver disease. Patients who have
experienced jaundice with a phenothiazine should not, if possible, be reexposed to Thorazine or other
phenothiazines.
If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an
abnormality, stop treatment.
Liver function tests in jaundice induced by the drug may mimic extrahepatic obstruction; withhold exploratory
laparotomy until extrahepatic obstruction is confirmed.
Hematological Disorders, including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic
anemia, thrombocytopenic purpura and pancytopenia have been reported.
Agranulocytosis --Warn patients to report the sudden appearance of sore throat or other signs of infection. If
white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other
suitable therapy.
Most cases have occurred between the fourth and tenth weeks of therapy; patients should be watched closely
during that period.
Moderate suppression of white blood cells is not an indication for stopping treatment unless accompanied by the
symptoms described above.
Cardiovascular:
Hypotensive Effects --Postural hypotension, simple tachycardia, momentary fainting and dizziness may occur
after the first injection; occasionally after subsequent injections; rarely, after the first oral dose. Usually recovery
is spontaneous and symptoms disappear within 1 / 2 to 2 hours. Occasionally, these effects may be more severe
and prolonged, producing a shock-like condition.
To minimize hypotension after injection, keep patient lying down and observe for at least 1 / 2 hour. To control
hypotension, place patient in head-low position with legs raised. If a vasoconstrictor is required, Levophed® ***
and Neo-Synephrine® § are the most suitable. Other pressor agents, including epinephrine, should not be used
as they may cause a paradoxical further lowering of blood pressure.
EKG Changes --particularly nonspecific, usually reversible Q and T wave distortions--have been observed in
some patients receiving phenothiazine tranquilizers, including Thorazine (chlorpromazine).
Note: Sudden death, apparently due to cardiac arrest, has been reported.
CNS Reactions:
Neuromuscular (Extrapyramidal) Reactions --Neuromuscular reactions include dystonias, motor restlessness,
pseudo-parkinsonism and tardive dyskinesia, and appear to be dose-related. They are discussed in the following
paragraphs:
Dystonias: Symptoms may include spasm of the neck muscles, sometimes progressing to acute, reversible
torticollis; extensor rigidity of back muscles, sometimes progressing to opisthotonos; carpopedal spasm, trismus,
swallowing difficulty, oculogyric crisis and protrusion of the tongue.
These usually subside within a few hours, and almost always within 24 to 48 hours after the drug has been
discontinued.
In mild cases, reassurance or a barbiturate is often sufficient. In moderate cases, barbiturates will usually bring
rapid relief. In more severe adult cases, the administration of an anti-parkinsonism agent, except levodopa,
usually produces rapid reversal of symptoms. In children (1 to 12 years of age), reassurance and barbiturates
will usually control symptoms. (Or, parenteral Benadryl® ll may be useful. See Benadryl prescribing information
for appropriate children's dosage.) If appropriate treatment with anti-parkinsonism agents or Benadryl fails to
reverse the signs and symptoms, the diagnosis should be reevaluated.
Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed
when needed. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children
or pregnant patients, the drug should not be reinstituted.
Motor Restlessness: Symptoms may include agitation or jitteriness and sometimes insomnia. These symptoms
often disappear spontaneously. At times these symptoms may be similar to the original neurotic or psychotic
symptoms. Dosage should not be increased until these side effects have subsided.
If these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change
of drug. Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful.
Pseudo-parkinsonism: Symptoms may include: mask-like facies, drooling, tremors, pillrolling motion,
cogwheel rigidity and shuffling gait. In most cases these symptoms are readily controlled when an antiparkinsonism
agent is administered concomitantly. Anti-parkinsonism agents should be used only when
required. Generally, therapy of a few weeks to 2 or 3 months will suffice. After this time patients should be
evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in
antipsychotic-induced pseudo-parkinsonism.) Occasionally it is necessary to lower the dosage of Thorazine
(chlorpromazine) or to discontinue the drug.
Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on longterm
therapy or may appear after drug therapy has been discontinued. The syndrome can also develop,
although much less frequently, after relatively brief treatment periods at low doses. This syndrome appears in all
age groups. Although its prevalence appears to be highest among elderly patients, especially elderly women, it
is impossible to rely upon prevalence estimates to predict at the inception of antipsychotic treatment which
patients are likely to develop the syndrome. The symptoms are persistent and in some patients appear to be
irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or
jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these
may be accompanied by involuntary movements of extremities. In rare instances, these involuntary movements
of the extremities are the only manifestations of tardive dyskinesia. A variant of tardive dyskinesia, tardive
dystonia, has also been described.
There is no known effective treatment for tardive dyskinesia; anti-parkinsonism agents do not alleviate the
symptoms of this syndrome. If clinically feasible, it is suggested that all antipsychotic agents be discontinued if
these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or
switch to a different antipsychotic agent, the syndrome may be masked.
It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if
the medication is stopped at that time the syndrome may not develop.
Adverse Behavioral Effects --Psychotic symptoms and catatonic-like states have been reported rarely.
Other CNS Effects-- Neuroleptic Malignant Syndrome (NMS) has been reported in association with
antipsychotic drugs. (See WARNINGS .)
Cerebral edema has been reported.
Convulsive seizures (petit mal and grand mal) have been reported, particularly in patients with EEG
abnormalities or history of such disorders.
Abnormality of the cerebrospinal fluid proteins has also been reported.
Allergic Reactions of a mild urticarial type or photosensitivity are seen. Avoid undue exposure to sun. More
severe reactions, including exfoliative dermatitis, have been reported occasionally.
Contact dermatitis has been reported in nursing personnel; accordingly, the use of rubber gloves when
administering Thorazine liquid or injectable is recommended.
In addition, asthma, laryngeal edema, angioneurotic edema and anaphylactoid reactions have been reported.
Endocrine Disorders: Lactation and moderate breast engorgement may occur in females on large doses. If
persistent, lower dosage or withdraw drug. False-positive pregnancy tests have been reported, but are less likely
to occur when a serum test is used. Amenorrhea and gynecomastia have also been reported. Hyperglycemia,
hypoglycemia and glycosuria have been reported.
Autonomic Reactions: Occasional dry mouth; nasal congestion; nausea; obstipation; constipation; adynamic
ileus; urinary retention; priapism; miosis and mydriasis, atonic colon, ejaculatory disorders/impotence.
Special Considerations in Long-Term Therapy: Skin pigmentation and ocular changes have occurred in some
patients taking substantial doses of Thorazine (chlorpromazine) for prolonged periods.
Skin Pigmentation --Rare instances of skin pigmentation have been observed in hospitalized mental patients,
primarily females who have received the drug usually for 3 years or more in dosages ranging from 500 mg to
1500 mg daily. The pigmentary changes, restricted to exposed areas of the body, range from an almost
imperceptible darkening of the skin to a slate gray color, sometimes with a violet hue. Histological examination
reveals a pigment, chiefly in the dermis, which is probably a melanin-like complex. The pigmentation may fade
following discontinuance of the drug.
Ocular Changes --Ocular changes have occurred more frequently than skin pigmentation and have been
observed both in pigmented and nonpigmented patients receiving Thorazine (chlorpromazine) usually for 2
years or more in dosages of 300 mg daily and higher. Eye changes are characterized by deposition of fine
particulate matter in the lens and cornea. In more advanced cases, star-shaped opacities have also been
observed in the anterior portion of the lens. The nature of the eye deposits has not yet been determined. A small
number of patients with more severe ocular changes have had some visual impairment. In addition to these
corneal and lenticular changes, epithelial keratopathy and pigmentary retinopathy have been reported. Reports
suggest that the eye lesions may regress after withdrawal of the drug.
Since the occurrence of eye changes seems to be related to dosage levels and/or duration of therapy, it is
suggested that long-term patients on moderate to high dosage levels have periodic ocular examinations.
Etiology --The etiology of both of these reactions is not clear, but exposure to light, along with dosage/duration
of therapy, appears to be the most significant factor. If either of these reactions is observed, the physician should
weigh the benefits of continued therapy against the possible risks and, on the merits of the individual case,
determine whether or not to continue present therapy, lower the dosage, or withdraw the drug.
Other Adverse Reactions: Mild fever may occur after large I.M. doses. Hyperpyrexia has been reported.
Increases in appetite and weight sometimes occur. Peripheral edema and a systemic lupus erythematosus-like
syndrome have been reported.
Note: There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases,
the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex.
OVERDOSAGE
(See also ADVERSE REACTIONS .)
SYMPTOMS--Primarily symptoms of central nervous system depression to the point of somnolence or coma.
Hypotension and extrapyramidal symptoms.
Other possible manifestations include agitation and restlessness, convulsions, fever, autonomic reactions such
as dry mouth and ileus, EKG changes and cardiac arrhythmias.
TREATMENT--It is important to determine other medications taken by the patient since multiple drug therapy is
common in overdosage situations. Treatment is essentially symptomatic and supportive. Early gastric lavage is
helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal
mechanism may produce dysphagia and respiratory difficulty in severe overdosage. Do not attempt to induce
emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus.
Extrapyramidal symptoms may be treated with anti-parkinsonism drugs, barbiturates, or Benadryl . See
prescribing information for these products. Care should be taken to avoid increasing respiratory depression.
If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate
is recommended. Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be
avoided.
If hypotension occurs, the standard measures for managing circulatory shock should be initiated. If it is desirable
to administer a vasoconstrictor, Levophed and Neo-Synephrine are most suitable. Other pressor agents,
including epinephrine, are not recommended because phenothiazine derivatives may reverse the usual elevating
action of these agents and cause a further lowering of blood pressure.
Limited experience indicates that phenothiazines are not dialyzable.
Special note on Spansule® capsules --Since much of the Spansule capsule medication is coated for gradual
release, therapy directed at reversing the effects of the ingested drug and at supporting the patient should be
continued for as long as overdosage symptoms remain. Saline cathartics are useful for hastening evacuation of
pellets that have not already released medication.
WARNING: Thorazine® Spansule capsules are manufactured with carbon tetrachloride and methyl chloroform,
substances which harm public health and environment by destroying ozone in the upper atmosphere.
With all of this in mind, why do the doctors prescribe this stuff and why would the FDA still allow it to be sold.
Not only that, but I have a problem with the fact that since we could not prove it was the Thorazine that caused his problems instead of the Phenergan, the doctor gets away with destroying my husbands life and dreams.
If one of us gave a medicine to someone that we knew they were allergic to, then they would arrest us for attempted murdered. However, because he is a doctor, he gets away with it. Let me tell you, I now check out all of our medicines before I take them. I guess that is why they call it "practicing" Medicine.