Canada - Engels - Health Canada
Page 1 of 19
Prochlorperazine mesylate injection
10 mg/2 mL prochlorperazine as prochlorperazine mesylate
Antipsychotic - Antiemetic
sanofi-aventis Canada Inc.
2150 St. Elzear Blvd. West
October 13, 2006
Laval, Quebec H7L 4A8
Submission Control No.: 107337
s-a version 3.0 dated
Page 2 of 19
NAME OF DRUG
Prochlorperazine mesylate injection
Antipsychotic - Antiemetic
antiemetic and weak sedative activity.
Stemetil has actions similar to those of other phenothiazine derivatives but appears to be less
sedating and to have a weak propensity for causing hypotension or potentiating the effects of
CNS depressants and anesthetics. However, it produces a high incidence of extrapyramidal
Stemetil (prochlorperazine) is indicated in the management of manifestations of psychotic
disorders such as agitation, confusion, delusion, tension and anxiety.
It is also effective in controlling nausea and vomiting due to stimulation of the chemoreceptor
In selected patients, Stemetil may be of value for the relief of excessive anxiety, accompanied by
severe tension and agitation, associated with psychoneurotic or somatic conditions.
Page 3 of 19
Stemetil (prochlorperazine) should not be administered in the presence of circulatory collapse,
altered states of consciousness or comatose states, particularly when these are due to intoxication
central depressant drugs (alcohol, hypnotics,
narcotics, etc.). It is contraindicated in
insufficiency, pheochromocytoma, or in patients with severe cardiovascular disorders or a
history of hypersensitivity to phenothiazine derivatives.
hyperthermic reaction with temperatures above 40
C may occur, sometimes not until 14 to 16
hours after drug administration.
Phenothiazine compounds should not be used in patients receiving large doses of hypnotics, due
to the possibility of potentiation.
Stemetil is contraindicated in children undergoing surgery.
The antiemetic action of Stemetil (prochlorperazine) may mask the signs and symptoms of
overdosage of other drugs and may obscure the diagnosis and treatment of other conditions such
as brain tumor or intestinal obstruction. Therefore the etiology of nausea and vomiting should be
established before using the drug.
The use of this drug may impair the mental and physical abilities required for the performance of
potentially hazardous tasks, such as driving a car or operating machinery. Potentiation of the
effects of alcohol may also occur.
As with other neuroleptics, very rare cases of QT interval prolongation have been reported with
Stemetil. Neuroleptic phenothiazines may potentiate QT interval prolongation, which increases
the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is
potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of
bradycardia, hypokalemia, and congenital or acquired (i.e., drug induced) QT prolongation. If the
clinical situation permits, medical and laboratory evaluations should be performed to rule out
possible risk factors before initiating treatment with a neuroleptic agent and as deemed necessary
during treatment (See also PRECAUTIONS and ADVERSE REACTIONS).
Page 4 of 19
Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some
characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw. The
manifestations may be permanent in some patients. The syndrome may be masked when
treatment is reinstituted, when the dosage is increased or when a switch is made to a different
antipsychotic drug. Stemetil should be prescribed in a manner that is most likely to minimize the
risk of tardive dyskinesia. The lowest effective dose and the shortest duration of treatment should
be used, and treatment should be discontinued at the earliest opportunity, or if a satisfactory
response cannot be obtained. If the signs and symptoms of tardive dyskinesia appear during
treatment, discontinuation of Stemetil should be considered.
patients receiving antipsychotic drugs. NMS is characterized by hyperthermia, muscle rigidity,
altered consciousness, and signs of autonomic instability including irregular blood pressure,
tachycardia, cardiac arrhythmias and diaphoresis. Additional signs may include elevated serum
Hyperthermia is often an early sign of this syndrome. Antipsychotic treatment should be
withdrawn immediately and appropriate supportive therapy and careful monitoring instituted.
Use in pregnancy: Safety for the use of Stemetil (prochlorperazine) during pregnancy has not
been established. Therefore, it is recommended that the drug be given to pregnant patients only
when, in the judgement of the physician, the potential benefit to the patient outweighs the
possible risk to the fetus.
Use in children: The drug should not be used in children under 2 years unless potentially life-
The extrapyramidal symptoms which can occur secondary to Stemetil 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 prochlorperazine should be avoided in
children and adolescents whose signs and symptoms suggest Reye’s syndrome.
antipsychotic medication, may be controlled by increasing the dosage of their anticonvulsant.
Patients with a familial history of seizures or febrile convulsions are more likely to develop
seizures than those who have no such history.
Page 5 of 19
Phenothiazines may increase the effects of general anesthetics, opiates, barbiturates, and other
CNS depressants and the doses of these drugs should be reduced if administered concomitantly
with Stemetil (prochlorperazine).
On long-term therapy, particularly during the first two or three months, it is advisable to perform
periodic liver function tests and blood counts as cholestatic jaundice and blood dyscrasias may
occur, necessitating discontinuation of treatment. Renal function should be monitored and, if
BUN (blood urea nitrogen) becomes abnormal, treatment should be discontinued.
To lessen the likelihood of adverse reactions related to drug accumulation, patients on long-term
therapy, particularly on high doses, should be evaluated periodically to decide whether the
maintenance dosage could be lowered or drug therapy discontinued.
Because of its anticholinergic action, Stemetil should be used with great caution in patients with
glaucoma or prostatic hypertrophy.
The effects of anticholinergic drugs may be potentiated by prochlorperazine. Paralytic ileus, even
Retinal changes, lenticular and corneal deposits and abnormal skin pigmentation have been
observed with other phenothiazines and may occur after prolonged therapy. The possibility of
persistent tardive dyskinesia should also be borne in mind when patients are under long-term
Patients receiving prochlorperazine should be cautioned against exposure to extreme heat or
False positive or negative pregnancy tests have occurred in patients receiving phenothiazine
Hypotension and electrocardiographic changes, particularly non-specific and usually reversible
Q and T wave distortions, have been associated with the administration of phenothiazines.
cardiovascular and cerebrovascular disorders.
exacerbated, in particular, in the presence of bradycardia, hypokalemia, and congenital or
Page 6 of 19
Unexpected, sudden deaths have occurred in hospitalized patients treated with phenothiazines.
Previous brain damage or seizures may predispose. High doses should be avoided in known
seizure patients. Sudden exacerbations of psychotic behavior patterns occurred in several patients
shortly before death. Acute fulminating pneumonia or pneumonitis and aspiration of gastric
contents also were observed. Therefore, the physician also should keep in mind the possible
development of “silent pneumonias”.
Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration.
Tissue culture experiments indicate that approximately one-third of human breast cancers are
prolactin-dependent in vitro, a factor of potential importance if the prescription 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 neuroleptic drugs.
Neither clinical studies, nor epidemiologic studies conducted to date, however, have shown an
association between chronic administration of these drugs and mammary tumorogenesis; the
available evidence is considered too limited to be conclusive at this time.
Withdrawal Emergent Neurological Signs: Abrupt withdrawal after short-term administration of
antipsychotic drugs does not generally pose problems. However, transient dyskinetic signs are
experienced by some patients on maintenance therapy after abrupt withdrawal. The signs are
very similar to those described under Tardive Dyskinesia, except for duration. Although it is not
known whether gradual withdrawal of antipsychotic drugs will decrease the incidence of
withdrawal emergent neurological signs, gradual withdrawal would appear to be advisable.
Older Patients: The incidence of adverse reactions may be greater in patients over 55 years of
age since the half-lives of antipsychotic drugs are often prolonged. To minimize this possibility,
the maintenance dosage should be reduced to the lowest effective level as soon as possible after
initial titration and periodically reviewed.
Since psychiatric syndromes in the elderly can be caused by drugs or organic disease, withdrawal
of the precipitating drug or treatment of the medical condition should supersede initiation of
antipsychotic medication. These agents should not be used for non-psychiatric conditions for
which other drugs are available, since the elderly are especially prone to develop adverse effects
from antipsychotic drugs.
Children: Children with an acute febrile illness or suffering from dehydration seem to be much
more susceptible than adults to neuromuscular reactions, particularly dystonias. In such patients,
the drug should be used under close supervision and at low doses.
Page 7 of 19
Adverse reactions with different phenothiazines vary in type, frequency, and mechanism of
occurrence, i.e., some are dose-related, while others involve individual patient sensitivity. Some
adverse reactions may be more likely to occur with greater intensity, in patients with special
Not all of the following adverse reactions have been observed with every phenothiazine
derivative, but they have been reported with one or more and should be borne in mind when
drugs of this class are administered:
dyskinesia, oculogyric crises, opisthotonos, hyperreflexia and sialorrhea. EEG changes, disturbed
temperature regulation and seizures have also been encountered.
Persistent Tardive Dyskinesia: As with other antipsychotic agents, tardive dyskinesia may occur
in patients on long-term therapy or may be observed after drug therapy has been discontinued.
The risk seems to be greater in elderly patients on high doses, especially females. 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 the extremities.
There is no known effective treatment for tardive dyskinesia; antiparkinsonian agents usually do
not alleviate the symptoms of this syndrome. 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. The physician may be able to reduce the risk of this syndrome by minimizing the
unnecessary use of neuroleptic drugs and reducing the dose or discontinuing the drug, if possible,
when manifestations of this syndrome are recognized, particularly in patients over the age of 50.
reported and may, in severe cases, necessitate reduction in dosage. As with other phenothiazine
derivatives, reactivation or aggravation of psychotic processes may be encountered. Paradoxical
effects such as agitation, anxiety, restlessness, excitement and bizarre dreams, have been
Autonomic Nervous System: Dry mouth, nasal congestion, headache, nausea, constipation,
congestion, and urinary incontinence have been observed.
Page 8 of 19
Patients with pheochromocytoma, cerebral vascular or renal insufficiency, or a severe cardiac
reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensive
reactions with phenothiazine compounds, and should therefore be observed closely when the
drug is administered. Should hypotension occur in patients receiving Stemetil (prochlorperazine)
and a vasopressor agent be required i.v. norepinephrine or phenylephrine should be used, and not
epinephrine, since phenothiazine derivatives can reverse the pressor effect of the latter drug.
Other autonomic reactions which have occurred with phenothiazines are salivation, polyuria,
glaucoma, bladder paralysis, adynamic ileus, and fecal compaction.
Metabolic and Endocrine: Anorexia, menstrual irregularities, impotence, and increased thirst,
weight changes, increased appetite, peripheral edema, galactorrhea, gynecomastia, and changes
in libido have also occurred in patients receiving phenothiazine therapy.
Allergic or Toxic: Pruritus, dermatitis, rash, erythema, urticaria, seborrhea, eczema, exfoliative
dermatitis, and photosensitivity. The possibility of an anaphylactoid reaction should be borne in
Blood dyscrasias including leukopenia, agranulocytosis, pancytopenia, thrombocytopenic or
phenothiazine therapy. Routine blood counts are therefore advisable during prolonged therapy.
If any soreness of the mouth, gums or throat or any symptoms of upper respiratory infection
discontinued and other appropriate measures instituted immediately.
Cholestatic jaundice and biliary stasis may be encountered, particularly during the first months of
therapy, and require immediate discontinuation of treatment.
phenothiazine derivatives : headache, asthma, laryngeal, cerebral and angioneurotic edema,
altered cerebrospinal fluid proteins, systemic lupus erythematosus-like syndrome, hyperpyrexia,
ECG and WEG changes and hypotension severe enough to cause fatal cardiac arrest. Skin
pigmentation, epithelial keratopathy, lenticular, and corneal deposits have been associated with
Very rare cases of QT interval prolongation have been reported. There have been isolated
PRECAUTIONS) as well as cases of unexplained sudden death, in patients receiving neuroleptic
Page 9 of 19
Sudden, unexpected and unexplained deaths have been reported in hospitalized psychotic
patients receiving phenothiazines. Previous brain damage or seizures may be predisposing
factors; high doses should be avoided in known seizure patients. Several patients have shown
flare-ups of psychotic behavior patterns shortly before deaths. Autopsy findings have usually
Potentiation of CNS depressants (barbiturates, narcotics, analgesics, alcohol, antihistamines),
SYMPTOMS AND TREATMENT OF OVERDOSAGE
Symptoms: Primarily extrapyramidal reactions, CNS depression which may vary from simple
lethargy to coma. Agitation and restlessness may also occur. Other possible manifestations
include convulsions, fever and autonomic reactions such as hypotension, dry mouth and ileus.
Treatment: Essentially symptomatic and supportive. Early gastric lavage may be helpful.
Maintain an open airway. If hypotension occurs, the standard measures for managing circulatory
shock should be initiated; if a pressor agent is required give norepinephrine or phenylephrine and
not epinephrine as it may further depress the blood pressure. Extrapyramidal reactions should be
treated with an antiparkinsonian agent.
Centrally, acting emetics will be ineffective because of prochlorperazine’s antiemetic action.
Limited experience indicates that phenothiazines are not dialyzable.
DOSAGE AND ADMINISTRATION
Begin with the lowest recommended dosage. Adjust to response of the individual.
Rectal route - To control nausea, vomiting or excessive anxiety : usually 5 to 10 mg, 3 or 4 times
daily; in mild cases, a single dose of 5 to 10 mg is often adequate.
Parenteral route - I.M. Dosage: The drug is given by deep intramuscular injection. Total daily
dosage rarely exceeds 40 mg, except in severe psychiatric cases. When control is achieved, the
oral route should be substituted. To control nausea, vomiting or excessive anxiety: 5 to 10 mg, 2
or 3 times a day. In psychiatry, for the immediate control of severely disturbed patients, 10 to 20
mg initially, repeated every 2 to 4 hours until control is obtained. More than 3 or 4 doses are
seldom necessary. The patients should be kept in bed and under medical supervision. In surgery :
5 to 10 mg I.M., 1 to 2 hours before anesthesia. Repeat once during surgery, if necessary. Post-
operatively, the same dose of 5 to 10 mg I.M. may be given to control acute symptoms and
Page 10 of 19
repeated, if necessary, every 3 to 4 hours (maximum, 40 mg daily).
I.V. Infusion: During and after surgery, Stemetil may be given I.V. in the infusion solution at a
concentration of 20 mg per liter. Total daily dose rarely exceeds 30 mg.
Daily dosage, administered in divided doses, should be based on body weight rather than on age,
and should not be exceeded. Do not administer to children under 2 years of age or 9 kg of body
weight. Occasionally the patient may react to the drug with signs of restlessness and excitement;
if this occurs, treatment should be discontinued.
For severe nausea and vomiting, and in child psychiatry: calculate each dose on the basis of 0.13
mg/kg of body weight and give by deep I.M. injection. Control is usually obtained with one dose.
When further therapy is needed, transfer the patient to an oral form at an equal or higher dose.
Page 11 of 19
Clear, pale yellow, viscous liquid
Insoluble in water and freely soluble in alcohol, chloroform and ether.
White or almost white powder
Very soluble in water; sparingly soluble in alcohol; slightly soluble in
chloroform; practically insoluble in ether.
2.0 to 3.0
Page 12 of 19
: Each mL contains: prochlorperazine base 5 mg (as the mesylate). Non-medicinal
ingredients: sodium chloride, sodium citrate, sodium sulphite anhydrous and water for injection.
: Each rectal suppository contains: prochlorperazine base 10 mg. Non-medicinal
ingredients: hydrogenated vegetable glycerides.
Stability and storage recommendations:
Stemetil (prochlorperazine) suppositories and Stemetil (prochlorperazine mesylate) injectable
should be stored at 15
C. Protect from light.
AVAILABILITY OF DOSAGE FORMS
Stemetil (prochlorperazine base) 5 mg/mL (as mesylate) injectable is available in amber glass
ampoules of 2 mL in boxes of 10 ampoules.
Stemetil (prochlorperazine base) 10 mg suppositories are available in boxes of 10 suppositories.
The pharmacologic profile of prochlorperazine in experimental animals is similar to that of other
phenothiazines. The following findings relate to animal studies in which prochlorperazine and
prochlorperazine, based on the potentiating effects of ether anesthesia and morphine analgesia, is
conditioned avoidance in rats is approximately one and a half times greater than chlorpromazine.
The cataleptic effects of prochlorperazine are slightly greater than those of chlorpromazine but
both compounds appear to be equi-effective in reducing motor activity.
The antiemetic effect of prochlorperazine, determined by the apoamorphine-induced vomiting in
dogs, is four to six times greater than that of chlorpromazine. Chlorpromazine exerts more potent
In rats, prochlorperazine administered intraperitoneally distributes in all body tissues. The liver
and spleen appear to store greater concentrations of the drug than other organs. Prochlorperazine
enters the entero-hepatic circulation and is excreted chiefly in the feces. Less than 25 % of an
intra peritoneal dose in rats is excreted in the urine.
Page 13 of 19
The following LD
values have been obtained in mice for prochlorperazine.
- 90 mg/kg
- 400 mg/kg
- P.O. - 800 mg/kg
Administration of prochlorperazine to rats, 50 mg/kg P.O, daily for one month produced no
disturbances of liver or kidney functions and no blood or bone-marrow alterations. All the
animals survived without loss of weight, and appeared normal. Histological examination of
kidney, liver, lung, and spleen did not reveal any toxic lesions.
In the dog, daily doses of 30 mg/kg for one month produced no mortality and all the animals
appeared normal throughout treatment. They showed only a slight loss of weight, but no
disturbances of liver or kidney functions. Histological examination revealed no abnormalities.
Prochlorperazine administered to pregnant rabbits and rats at dosage levels approximately 80 to
100 times the human therapeutic dose, produced no teratogenic effects.
Page 14 of 19
Baker FM, Cook P. Compazine complications; A review. J Natl Med Assoc 1981;73:409-
Carter CH. Prochlorperazine in emotionally disturbed, mentally defective children. Southern
Courvoisier S, Ducrot R, Fournet J, Julou L. Proprietes pharmacodynamiques generales de la
prochlorpemazine (6140 R.P.). Cr Soc Biol 1957;41:1144-8.
Cubeddu LX. QT prolongation and fatal arrhythmias: a review of clinical implications and
effects of drugs. American Journal of Therapeutics 2003;10(6):452-7.
Fenichel RR, Malik M, Antzelevitch C, Sanguinetti M, Roden DM, Priori SG, et al. Drug-
induced torsades de pointes and implications for drug development. J Cardiovasc Electr
Frytak S, Moertel CG, O’Fallon JR, Rubin J, Creagan ET, O'Connell MJ, et al. Delta-9
comparison with prochlorperazine and a placebo. Ann Intern Med 1979;91:825-30.
Giffen MR. Emotional dysfunction and the use of psychopharmacological drugs in a military
theater. Mil Med 1961;126:199-203.
Goldberg HL, Finnerty RJ. Double-blind Study of prochlorperazine, oblordiazepoxide and
Kenbubpha K, Silpakit C. Association between antipsychotics and sudden death in psychotic
in-patients. International Medical Journal 2002;9(1):27-31.
Lankamp DJ, Willemse J, Pikaar SA, van Heyst AN. Prochlorperazine in childhood : side
effects. Clin Neurol Neurosurg 1977;80:264-71.
Lapierre J, Amin M, Hattangadi S. Prochlorperazine - A review of the literature since 1956.
Can Psychiatr Assoc J 1969;14:267-74.
Loeser EA, Bennett G, Stanley TU, Machin R. Comparison of droperidol, haloperidol and
prochlorperazine as postoperative anti-emetics. Can Anaesth Soc J 1979;26:125-7.
Page 15 of 19
Mehtonen OP, Aranko K, Malkonen L, Vapaatalo H. A survey of sudden death associated
with the use of antipsycgotic or antidepressant drugs: 49 cases in Finland. Acta Psychiatr
Milkovich L, Van Den Berg BJ. An evaluation of the teratogenicity of certain antinauseant
drugs. Am J Obstet Gynecol 1976;125:244-8.
Peikes IL. Nausea and vomiting of pregnancy treated with a sustained-release form of
prochlorperazine. Clin Med 1957;4:1385-7.
Ray WA, Meredith S, Thapa PB, Meador KG, Hall K, Mur
ay KT. Antipsychotics and the
risk of sudden cardiac death. Arch Gen Psychiat 2001;58(12):1161-7.
unexplained death in psychiatric in-patients. Brit J Psychiat 2002;180:515-22.
Prochlorperazine, chlordiazepoxide and placebo in anxious outpatients. Current Therapeutic
Research, Clinical & Experimental 1981;29:156-64.
Steele N, Gralla RJ, Braun DW, Young CW. Double-blind comparison of the antiemetic
effects of nabilone and prochlorperazine on chemotherapy-induced emesis. Cancer Treat Rep
Taylor DM. Antipsychotics and QT prolongation. Acta Psychiat Scand 2003;107(2):85-95.
Teal N. Maintenance therapy for mental patients. Postgrad Med 1958;24:638-47.
Ungerleider JT, Andrysiak T, Fairbanks L, Sarna G, Jamison K Cannabis and cancer
Zeltser D, Justo D, Halkin A, Prokhorov V, Heller K, Viskin S. Torsade de pointes due to
IMPORTANT: PLEASE READ
Page 16 of 19
Prochlorperazine mesylate injection
This leaflet is designed specifically for Consumers. This
leaflet is a summary and will not tell you everything about
. Contact your doctor or pharmacist if you have
any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
is used to treat symptoms of psychotic disorders such
as agitation, confusion, delusion, tension and anxiety.
is also used for the control of nausea and vomiting.
Ask your doctor if you have any questions about why Stemetil
has been prescribed to you.
What it does:
reduce and control psychotic symptoms
control nausea and vomiting
When it should not be used:
Do not use Stemetil
Are allergic to Stemetil
to phenothiazines (a type of
antipsychotic) or to any of the ingredients in the product
(see the section “
What the non-medicinal ingredients
Have a sudden blood circulation failure or are in an altered
state of consciousness or coma, especially if these were
caused by alcohol or drugs
Suffer from severe depression
Have liver disease
Have a blood disorder
Have kidney problems
Have pheochromocytoma (a tumour of the adrenal gland)
Have severe heart or blood vessel disorders
Have or have had brain damage
Are taking high doses of drugs that cause you to sleep
is not indicated for use in children undergoing a
What the medicinal ingredient is:
What the nonmedicinal ingredients are:
Suppositories: hydrogenated vegetable glycerides
Injection: Sodium chloride, sodium citrate, sodium sulphite
anhydrous and water for injection.
What dosage forms it comes in:
Suppositories 10 mg
Injection: 10 mg/2 mL prochlorperazine as prochlorperazine
WARNINGS AND PRECAUTIONS
At the beginning of treatment, Stemetil
may cause some people
to become drowsy or less alert. You should not drive a car,
operate machinery or participate in activities requiring alertness
until you are sure Stemetil
does not affect you.
You should use
extra care not to be exposed to extreme heat or
some type of insecticides. Check with your doctor or pharmacist.
Children seem to be more susceptible than adult to some side
should not be used in children under 2 years old
unless the doctor decides that Stemetil
The incidence of adverse reactions may be greater in patients over
55 years of age. The lowest effective dose should be used to
reduce the risk of having adverse reactions.
If you experience severe constipation and you are elderly, please
consult your doctor as soon as possible.
Tardive dyskinesia, neuroleptic malignant syndrome cardiac, eye,
skin and respiratory problems may occur in some patients taking
(see the section
“SIDE EFFECTS AND WHAT TO
IMPORTANT: PLEASE READ
Page 17 of 19
DO ABOUT THEM”
Before using Stemetil
, tell your doctor if you:
Have heart or blood vessel disease
Have cerebrovascular (blood vessels of the brain) disorder
Have constipation or intestinal blockage
Have or have had a brain tumour or brain damage
Suffer from an enlarged prostate (Benign Prostatic
Suffer from an increase pressure within the eyes
Have or have had seizure disorders (e.g. epilepsy or have
members of your family with seizure disorders)
Have or have had breast cancer
Plan to have surgery (or a procedure requiring
Are or are planning to become pregnant
During long-term treatment, blood, liver, and kidney tests
should be done at regular intervals.
INTERACTIONS WITH THIS MEDICATION
can add to the effects of alcohol. You should avoid
consuming alcoholic beverages while on Stemetil
Before using any prescription, over-the-counter medicines or
herbal products, check with your doctor or your pharmacist.
can add to the effects of other drugs that cause
drowsiness. Some examples of drugs that can cause drowsiness
Drugs for allergies
Drugs for insomnia
Drugs for pain
Drugs for seizure
Drugs for depression
Drugs for mental illness
may cause a false pregnancy test result. Please check
with your doctor if this happens.
PROPER USE OF THIS MEDICATION
Your doctor has decided the best dose for you based on your
individual situation and needs. It is important to take Stemetil
way your doctor told you. Your doctor may increase or decrease
your dose depending on your response.
You may experience side effects if the drug is stopped suddenly.
Contact your physician before stopping your drug.
Rectal route: To control nausea, vomiting or anxiety, the usual
dose is 5 to 10 mg, 3 or 4 times daily; in mild cases, a single dose
of 5 to 10 mg is often adequate.
Injection in the muscle: Total daily dose rarely exceeds 40 mg,
except in severe cases.
Injection in the vein: Stemetil
may be given as an injection in the
vein during and after surgery. The Stemetil
is diluted in a solution and injected slowly in a vein. Total daily
dose rarely exceeds 30 mg.
should not be given to children under 2 years of age or 9
kg of body weight. Occasionally, the children may react to the
drug with signs of restlessness and excitement; if this occurs,
treatment should be stopped.
Injection in the muscle
may be given as an injection in the muscle to control
severe nausea and vomiting or in psychiatry. The dose is based on
the body weight
If you have taken too much Stemetil
, immediately see your
doctor or go to your nearest hospital emergency department. Do
this even if there are no signs of discomfort or poisoning. The
signs if you have taken too much Stemetil
may vary from
drowsiness to coma. Agitation and restlessness may also occur.
Other possible reactions include confusion, drowsiness, fever, low
blood pressure, dry mouth and intestinal obstruction.
IMPORTANT: PLEASE READ
Page 18 of 19
SIDE EFFECTS AND WHAT TO DO ABOUT
Stemetil®, like any medication, may cause some side effects.
Discuss with your doctor if you do experience side effects.
Side effects include:
Agitation, anxiety, bizarre dreams, dizziness, excitement,
Appetite changes, constipation, dizziness, dryness of the
nausea, vomiting, sweating, urinary incontinence, weight
Changes in libido, impotence, increase of the breast size in
men, lactation, menstrual irregularities, peripheral oedema
(swelling of the legs, ankles, and feet).
Your skin may be more sensitive to sunlight
Side effects that might need a reduction in your dose are:
Drowsiness, fatigue, insomnia, sad mood, sleep
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Talk with your
Symptom / effect
See text below for details
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Talk with your
a) Extrapyramidal reactions
. The signs and symptoms of
extrapyramidal reactions include tremor, muscle stiffness, body
spasm, impairment of voluntary movement, upward eye rolling,
exaggeration of reflexes or drooling. Tell your doctor if you
experience any of these side effects. Your medication might have
to be reduced.
b) Allergic Reactions
:: You may develop an allergy to Stemetil
for example skin rash, redness or itching. Consult your doctor
immediately if you develop an allergy to Stemetil
c) Blood, liver and lung disorders
have been associated with this
class of drug. It is important that you tell your doctor at once
about any unexplained symptom you might experience. Examples
of this are soreness of the mouth, gums or throat or any symptoms
of upper respiratory infection, unexplained fever, itching, flu-like
symptoms, coughing, abdominal pain, jaundice.
d) Cardiac disorders
: Low blood pressure and fainting have been
reported. Uncommonly, Stemetil
may cause the heartbeat to
become faster or irregular. Check immediately with your doctor if
these side effects occur.
e) Eye disorders:
Blurred vision has been observed. Other eye
disorders are reported, specifically after long-term administration.
Consult you doctor if you experience any vision problems.
f) Neuroleptic malignant syndrome
:Another possible serious
unwanted effect is the neuroleptic malignant syndrome. Signs and
symptoms of the neuroleptic malignant syndrome include severe
muscle stiffness, increased sweating, fever, fast or irregular
heartbeat, high or low blood pressure, difficult or fast breathing
and confusion. If any of the above side effects occur, consult your
g) Tardive dyskinesia
may occur in some patients on long-term
therapy or after they stop using Stemetil
. Signs of tardive
dyskinesia include muscle twitching or uncontrolled movements
of the mouth, tongue, face or jaw (e.g., protrusion of tongue,
IMPORTANT: PLEASE READ
Page 19 of 19
puffing of cheeks, puckering of mouth, chewing movements).
Sometimes, these may be accompanied by involuntary
movements of the extremities. In some patients, this side effect
may not go away after they stop using Stemetil
. These effects
are rare and usually appear only after long-term therapy at high
doses. Elderly patients may be at higher risk. Tell your doctor
immediately if you experience any muscle twitching or
abnormal body movements.
This is not a complete list of side effects. For any unexpected
effects while taking Stemetil
, contact your doctor or
HOW TO STORE IT
suppositories and injection should be stored at room
temperature between 15°C and 25°C.
Protect from exposure to light.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on
serious and unexpected effects of drugs . If you suspect you
have had a serious or unexpected reaction to this drug you may
notify Health Canada by:
By email: email@example.com
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact
your physician or pharmacist.
Your physician, nurse and pharmacist are always your best source
of information about your condition and treatment. If you have
additional questions or concerns, be sure
to ask them.
This document plus the full product monograph is available upon
request to the sponsor, sanofi-aventis Canada Inc., 2150 St Elzear
Blvd. West , Laval , Quebec H7L 4A8, at:
This leaflet was prepared by sanofi-aventis Canada Inc..
Last revised: October 13, 2006