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Therefore,
the patient should
be cautioned accordingly.
As in the case of other CNS-acting drugs, patients receiving NAVANE
should be cautioned about the possible additive effects (which may
include hypotension) with CNS depressants and with alcohol. Potentiation
of central nervous system depressants (sedatives, tranquilizers,
narcotic analgesics, antihistamines, anaesthetics, and alcohol),
atropine and organophosphorus insecticides, and reversal of epinephrine
effect, have been observed with related drugs.
Neuroleptic Malignant Syndrome (NMS): Neuroleptic malignant syndrome
is a potentially fatal symptom complex that has been reported in
association with antipsychotic drugs, including NAVANE. The 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 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 required 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.
Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of
potentially irreversible, involuntary, dyskinetic movements may
develop in patients treated with neuroleptic (antipsychotic) drugs,
including NAVANE. 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 neuroleptic treatment, which patients are likely to
develop the syndrome. Whether neuroleptic 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 neuroleptic administered
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 neuroleptic
treatment is withdrawn. Neuroleptic treatment itself, however, may
suppress (or partially suppress) the signs and symptoms of the syndrome.
What effect suppression has upon the long-term course of the syndrome
is unknown.
Use in Pregnancy: Safe use of NAVANE in pregnancy has not
been established. It should, therefore, not be used in women of
child-bearing potential unless, in the opinion of the physician,
the expected benefits of the drug outweigh the potential hazard
to the fetus.
PRECAUTIONS
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In consideration
of the known capability of NAVANE (thiothixene) and certain other
antipsychotic drugs to precipitate convulsions, extreme caution
should be used in patients with a history of convulsive disorders
or those in a state of alcohol withdrawal, since it may lower the
convulsive threshold. Although NAVANE potentiates the actions of
the barbiturates, the dosage of the anticonvulsant therapy should
not be reduced when NAVANE is administered concurrently.
Production or aggravation of EKG changes has occurred with thiothixene
and therefore caution should be observed when there is increased
risk to the patient (see "ADVERSE REACTIONS" section).
Though exhibiting rather weak anticholinergic properties, NAVANE
should be used with caution in patients who are known or are suspected
to have glaucoma, and in those who might be exposed to extreme heat
or who are receiving atropine or related drugs.
Undue exposure to sunlight should be avoided. Photosensitive reactions
have been reported in patients on NAVANE.
Rare cases of priapism have been reported with antipsychotic use,
such as NAVANE. This adverse reaction, as with other psychotropic
drugs, did not appear to be dose-dependent and did not correlate
with the duration of treatment.
Hyperglycemia: Diabetic ketoacidosis (DKA) has occurred in patients
with no reported history of hyperglycemia. Patients should have
baseline and periodic monitoring of blood glucose and body weight.
Long-standing hyperprolactinemia when associated with hypogonadism
may lead to decreased bone mineral density in both female and male
subjects.
Neutropenia, granulocytopenia and agranulocytosis have been reported
during antipsychotic use. Therefore, it is recommended that patients
have their complete blood count (CBC) tested prior to starting NAVANE
and then periodically throughout treatment.
Neuroleptic drugs, including NAVANE, may elevate prolactin levels
in humans; the elevation persists during chronic administration.
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.
Careful observation should be made for pigmentary retinopathy, and
lenticular pigmentation (fine Ienticular pigmentation has been noted
in a small number of patients treated with NAVANE for prolonged
periods. Blood dyscrasias (agranulocytosis, pancytopenia, thrombocytopenic
purpura), and liver damage (jaundice, biliary stasis), have been
reported with related drugs.
Caution as well as careful adjustment of the dosages is indicated
when NAVANE is used in conjunction with other CNS depressants.
Hepatic microsomal enzyme inducing agents, such as carbamazepine,
were found to significantly increase the clearance of thiothixene.
Patients receiving these drugs should be observed for signs of reduced
effectiveness of NAVANE.
Due to a possible additive effect with hypotensive agents, patients
receiving these drugs should be observed closely for signs of excessive
hypotension when thiothixene is added to their drug regimen.
An antiemetic effect observed in animal studies with thiothixene
may also occur in man; therefore, it is possible that NAVANE may
mask signs of overdosage of toxic drugs and it may obscure conditions
such as intestinal obstruction and brain tumor.
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. Periodic blood counts
and liver function tests should be performed. Sudden onset of severe
central nervous system or vasomotor symptoms should be kept in mind.
Non-Teratogenic Effects:
Neonates exposed to antipsychotic drugs (including NAVANE) during
the third trimester of pregnancy are at risk for extrapyramidal
and/or withdrawal symptoms following delivery. There have been reports
of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory
distress and feeding disorder in these neonates. These complications
have varied in severity, while in some cases symptoms have been
self-limited, in other cases neonates have required intensive care
unit support and prolonged hospitalization.
NAVANE should not be used during pregnancy unless the expected benefits
to the mother markedly outweigh the potential risks of the fetus.
ADVERSE
REACTIONS
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Since
NAVANE (thiothixene) has pharmacologic properties similar to those
of the phenothiazine, all the known adverse reactions of that class
of drugs should be borne in mind when NAVANE is used.
Behavioral: The most common side-effects are initial and
transient drowsiness, restlessness and agitation, and insomnia.
(The incidence of sedation appears to be similar to that of the
piperazine group of phenothiazine, but less than that of certain
aliphatic phenothiazine).
Other adverse reactions reported less frequently are weakness or
fatigue, excitement, depression and headache.
Hyperactivity, both psychic and motor, should be considered a pharmacologic
effect of the drug which may be desirable, except in the patient
who is already agitated and excited. Activation of psychotic symptomatology
has been observed, but it usually responds to reduction of dosage
or temporary discontinuation of the drug. Toxic confusional states
may occur on rare occasions.
Neurological: The incidence and nature of extrapyramidal
symptoms, including akathisia, pseudo-Parkinsonism and dystonic
reactions, are similar to those encountered with the piperazine
phenothiazine, but thiothixene is more likely to produce akathisia.
They are usually controlled by reduction of dosage and/or administration
of antiparkinson drugs depending on the type and severity of symptoms.
Cerebral seizures have been reported (see PRECAUTIONS). Phenothiazine
derivatives have been associated with cerebral edema and cerebrospinal
fluid abnormalities.
Hyperreflexia has been reported in infants delivered from mothers
having received structurally related drugs.
Tardive Dyskinesias: Since early detection of tardive dyskinesia
is important, patients should be monitored on an ongoing basis.
It has been reported that fine vermicular movement of the tongue
may be an early sign of the syndrome. If this or any other presentation
of the syndrome is observed, the clinician should consider possible
discontinuation of neuroleptic medication (see WARNINGS).
Neuroleptic Malignant Syndrome (NMS): (See WARNINGS)
Autonomic: Dry mouth, blurred vision, nasal congestion, constipation,
increased sweating, increased salivation, and impotence have occurred
infrequently with NAVANE therapy. Phenothiazines have been associated
with miosis, mydriasis, and adynamic ileus.
Cardiovascular: Tachycardia, hypotension, lightheadedness,
and syncope. In the event hypotension occurs, epinephrine should
not be used as a pressor agent since, a paradoxical further lowering
of blood pressure may result. Nonspecific EKG changes have been
observed in some patients receiving thiothixene. These changes are
usually reversible and frequently disappear on continued thiothixene
therapy. The clinical significance of these changes is not known.
Cardiac arrhythmias, including A-V block, paroxysmal tachycardia
and ventricular fibrillation have been observed with some phenothiazines.
NOTE: Sudden deaths have occasionally been reported in patients
who have received certain phenothiazine derivatives. In some cases
the cause of death was apparently cardiac arrest or asphyxia due
to failure of the cough reflex. In others, the cause could not be
determined nor could it be established that death was due to phenothiazine
administration.
Endocrine; Hyperprolactinemia, lactation, menstrual irregularities,
moderate breast enlargement and amenorrhea have occurred in a small
percentage of females receiving thiothixene. If persistent, this
may necessitate a reduction in dosage or the discontinuation of
therapy. Phenothiazines have been associated with false positive
pregnancy tests, gynecomastia, hypoglycemia, hyperglycemia, and
glycosuria.
Allergic: Rash, pruritus, urticaria, and rare cases of anaphylaxis
have been reported with thiothixene. Undue exposure to sunlight
should be avoided. Although not experienced with NAVANE, exfoliative
dermatitis, contact dermatitis (in nursing personnel), have been
reported with certain phenothiazines.
Hematologic: As is true with certain other antipsychotic
drugs, leukopenia and leucocytosis, which are usually transient,
can occur occasionally with thiothixene. Other antipsychotic drugs
have been associated with agranulocytosis, eosinophilia, hemolytic
anemia, thrombocytopenia and pancytopenia.
Hepatic: Elevations of serum transaminase and alkaline phosphatase,
usually transient, have been infrequently observed in some patients.
No clinically confirmed cases of jaundice attributable to thiothixene
have been reported.
Ophthalmologic: Fine lenticular pigmentation has been noted
after prolonged therapy.
Other: Hyperpyrexia, anorexia, nausea, vomiting, diarrhea,
increase in appetite and weight, weakness or fatigue, polydipsia
and peripheral edema. Although not reported with thiothixene, evidence
indicates there is a relationship between phenothiazine therapy
and the occurrence of a systemic lupus erythematosus-like syndrome.
Patients should be advised of the risk of severe constipation during
NAVANE treatment, and that they should tell their doctor if constipation
occurs or worsens, as they may need laxatives.
SYMPTOMS
AND TREATMENT OF OVERDOSAGE
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Symptoms: Manifestations
include muscular twitching, drowsiness, and dizziness. Symptoms
of gross overdosage may include CNS depression, rigidity, weakness,
torticollis, tremor, salivation, dysphagia, hypotension, disturbances
of gait, or coma.
Treatment: Essentially symptomatic and supportive. Early
gastric lavage may be helpful. Keep patient under careful observation
and maintain an open airway, since involvement of the extrapyramidal
system may produce dysphagia and respiratory difficulty in severe
overdosage. If hypotension occurs, the standard measures for managing
circulatory shock should be used (I.V. fluids and/or vasoconstrictors).
If a vasoconstrictor is needed, levarterenol and phenylephrine are
the most suitable drugs. Other pressor agents, including epinephrine,
are not recommended, since phenothiazine derivatives may reverse
the usual pressor elevating action of these agents and cause further
lowering of blood pressure.
If CNS depression is present, recommended stimulants include caffeine
and sodium benzoate. Picrotoxin or pentylenetetrazol should be avoided.
Extrapyramidal symptoms may be treated with antiparkinson drugs.
There are no data on the use of peritoneal or hemodialysis, but
they are known to be of little value in phenothiazine intoxication.
DOSAGE
AND ADMINISTRATION
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The
use of NAVANE (thiothixene) in children under 12 years of age is
not recommended, as safety and efficacy data for its use have not
yet been accumulated in sufficient quantities. (See CONTRAINDICATIONS).
Oral: The usual optimal dosage of NAVANE is in the range
of 15 to 30 mg daily. In most conditions, the initial dosage should
be 5-10 mg daily. The dosage should be gradually increased to the
optimally effective level based on patient response. An increase
to 60 mg/day may be necessary; however, exceeding a total daily
dosage of 60 mg/day rarely increases beneficial response. Patients
on the average therapeutic dosage may be maintained on once-a-day
therapy. Higher dosage can be given in two or three equally divided
doses. The dosage should be reduced to the lowest possible maintenance
level as soon as possible.
Intramuscular: For control of acute symptomatology or in
patients unable to take oral medication, the usual dose is 4 mg
of NAVANE intramuscular solution administered two or four times
daily. Most patients are controlled on a total daily dose of 16
to 20 mg but effective doses have ranged from 6 to 30 mg daily.
Dosage may be increased or decreased depending upon response. NAVANE
should be administered by deep intramuscular injection preferably
in the upper outer quadrant of the buttock (i.e., gluteus maximus)
or the mid-lateral thigh and preferably at four-hour intervals.
The deltoid area should be used only if well developed, such as
in certain adults and older children, and then only with caution
to avoid radial nerve injury. Intramuscular injections should not
be made into the lower and mid-thirds of the upper arm. As with
all intramuscular injections, aspiration is necessary to help avoid
inadvertent injection into a blood vessel. Once satisfactory control
of severe symptoms has been achieved, therapy should be continued
with one of the oral forms of NAVANE.
AVAILABILITY
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2 mg (white) capsules, bottles of
100; 5 mg (orange and white) capsules, bottles of 100; 10 mg (orange)
capsules, bottles of 100.
CHEMISTRY
AND PHARMACOLOGY
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NAVANE (thiothixene) is an antipsychotic drug. Specifically,
it is the cis isomer of N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)-propylidene]thioxanthene-2-sulfonamide.
Psychopharmacologic studies of thiothixene in animals reveal that
it exerts several actions generally considered characteristic of
antipsychotic drugs. It blocks conditioned avoidance behavior in
rats and monkeys, various central stimulant actions of amphetamine
in mice and rats, and apomorphine-induced emesis in dogs.
Thiothixene suppresses conditioned avoidance behavior in rats at
intraperitoneal doses of about 3.2 mg/kg. Escape behavior, however,
is virtually unimpaired, even at 32 mg/kg. Similarly, thiothixene
blocks the motor stimulation, mortality and characteristic stereotypy
produced by amphetamine. Thermoregulation is virtually unaffected.
Like many phenothiazine derivatives thiothixene induces catalepsy
in rats and both catalepsy and tremors in dogs and monkeys. Thiothixene
does not cause loss of righting reflex at sublethal doses, nor does
it induce skeletal muscle flaccidity. The hypnotic potentiating
effect of thiothixene is relatively low.
Thiothixene causes only a slight hypotensive effect in unanesthetized
dogs, even after 10 mg/kg orally. In anesthetized dogs, even after
intravenous doses of 4 mg/kg, thiothixene also exerts only a mild
hypotensive effect. At this same dose thiothixene reduces the pressor
effects of epinephrine, norepinephrine and histamine without affecting
the response of acetylcholine or angiotensin.
Thiothixene is essentially ineffective as an anticonvulsant, analgesic
or diuretic. Its smooth-muscle spasmolytic effects against contractions
elicited by acetylcholine, serotonin and especially histamine are
relatively weak. The cortical evoked response of cats to thiothixene
was similar to their response to other psychotropic drugs.
The overall pattern of effects produced by thiothixene in experimental
animals appears to resemble closely that of thioproperazine.
Absorption and Distribution: Studies on excreta and bile
in animals indicate that thiothixene is rapidly metabolized to a
wide variety of compounds. Very little unchanged drug is recovered.
It must therefore be noted that, from a time soon after absorption,
the compounds being measured are primarily the metabolites of thiothixene
rather than the parent drug. Thiothixene, like other tricyclic psychotherapeutic
agents, appears to be well absorbed orally. Accordingly, although
a number of metabolites are seen, very little unchanged drug is
found in the feces after oral dosing and 65% of the orally administered
radioactivity is recovered in the bile of a rat carrying a bile
fistula. Thus the liver plays a dominant role in the disposal of
the drug.
The high initial drug levels in the stomach of rats after oral administration
of thiothixene are reminiscent of results obtained with chlorpromazine
in mice. The high drug concentrations in the lung reported for chlorpromazine,
thioridazine, perphenazine and prochlorperazine, however were not
found with thiothixene. Brain tissue also contained relatively little
S35 thiothixene. Low levels of drug in the brain have also been
noted with trifluoperazine, chlorpromazine and thioridazine. Thiothixene
and its metabolites are rapidly cleared from all tissues with the
exception of the liver. Low peak serum concentrations are reached
shortly after thiothixene administration and decline rapidly, but
detectable amounts are still present 5 days after administration.
The absorption, distribution and metabolism of thiothixene administered
orally or parenterally are not significantly different.
TOXICOLOGY
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Extensive animal toxicologic
studies of NAVANE (thiothixene) have been completed. The LD50''s
(mg/kg) were: Oral, mice, male 820, female 2090; rats, male 1300,
female 1980; dogs 500; IP, mice 530, rats 900. The LD50 (mg/kg)
of NAVANE Oral Concentrate was: Oral, mice, male 203. Death could
not be produced in male rats at maximally tolerated fluid volumes
of 20 ml/kg (equivalent to 100 mg/kg thiothixene base). The intravenous
LD50 of NAVANE Intramuscular Solution in male mice and rats was
25.4 and approximately 28 mg/kg respectively. Transient anemia and/or
leukopenia have occurred in dogs at doses of 12.5 mg/kg and greater.
This was not seen in rats and monkeys. Daily doses of 12.5 mg/kg
or more over a prolonged period in the dog have produced elevations
of alkaline phosphatase and transaminases and microscopic changes
in the liver. Similar microscopic changes in the liver were also
seen in rats after prolonged dosage of 50 mg/kg. There were no effects
on liver function tests and no microscopic changes in the liver
in monkeys. All these effects occurred at dosages 25 to 100 times
higher than the usual optimal clinical dose. No ocular toxicity
was noted in any of the animal studies with NAVANE even after administration
of the drug at doses up to 100 mg/kg/day for periods up to 18 months.
Lactation was noted in the rat (in males and females at doses of
5 mg/kg/day and above), the dog (one female at 6 mg/kg/day), and
the monkey (one female at 25 mg/kg/day). These effects have been
described with other psychotherapeutic agents.
Two dogs receiving intravenous injections of 15 mg/kg/day for 12
days showed severe venous and local irritation, making further injections
impossible. Histopathologically, focal areas of acute hepatocellular
necrosis were observed in both dogs, and suppression of spermatogenesis
was seen in the male. In another study, 15 mg/kg/day i.v. could
only be given for 6 days due to the appearance of venous irritation
and thrombus formation. Lower doses of 0.5 and 2 mg/kg/day for 30
days produced, with less frequency, similar, but less severe changes.
A vehicle control group showed minimal local irritation. In two
additional studies in dogs, intravenous doses of 0.5-5 mg/kg/day
for 15 days also produced some local irritation, including thrombus
formation. Tremors, decreased activity and respiration, circling,
biting, ataxia and prostration were noted following the injection
of 5 mg/kg in one of the studies. These effects, however, were reversible
and completely regressed within 30 minutes.
In rats, intramuscular injection of thiothixene parenteral solution,
given at doses of 50, 25 or 5 mg/kg/day for five days, is irritating,
producing muscle necrosis with localized swelling. Intramuscular
injections for more than 5 days were not feasible because of irritation
greatly magnified because of the large volumes involved.
In the animal reproductive studies with NAVANE, there was some decrease
in conception rate, litter size, and the resorption rate in rats
and rabbits which has been commonly reported with other psychotherapeutic
agents. After repeated oral administration of NAVANE to rats (5
to 15, mg/kg/day), rabbits (3 to 50 mg/kg/day), and monkeys (1 to
3 mg/kg/day) before and during gestation, no teratogenic effects
were seen.
BIBLIOGRAPHY
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1. McEvoy GK, Miller JL, Snow EK, et al. AHFS Drug Information.
American Society of Health-System Pharmacists, Inc., p.2334-2336,
(2002).
2. Ereshefsky L, Saklad,SR, Watanabe
MD, et al. Thiothixene Pharamcokinetic Interactions: A study of
Hepatic Enzyme Inducers, Clearance Inhibitors, and Demographic Variables.
J Clin Psychopharm, 11(5):296-301, (1991)
3. Lazarus, A. Syndrome Malin During
Treatment with Thiothixene and ECT. Neuroleptic Malignant Syndrome
or Malignant Hyperthermia. Annals of Clinical Psychiatry. 3: 287-290.
(1991).
4. Hollister L, Lombrozo L, Huang
CC. Plasma concentrations of Thiothixene and Clinical response in
Treatment-resistant schizophrenics. Int Clin Psychopharm. 2: 77-82
(1987)
5. Huang, CC, Gerhardstein RP, Kim
DY, Hollister L. Treatment-resistant Schizophrenia: Controlled study
of Moderate-and High-dose Thiothixene. Int Clin Psychopharm. 2:
69-75. (1987)
6. Yesavage JA, Tanke ED, Sheikh JI.
Tardive Dyskinesia and Steady-state Serum levels of Thiothixene.
Arch Gen Psychiatry. 44:913-915. (1987).
7. Goldberg SC, Schulz C, Schulz PM,
Resnick RJ, Hamer RM, Friedel RO. Borderline and Schizotypal Personality
disorders treated with low dose thiothixene vs Placebo. Arch Gen
Psychiatry. 43:680-686. (1986)
8. Kim DY, Hollister LE. Drug-Refractory
Chronic Schizophrenics: Doses and Plasma Concentrations of Thiothixene.
J Clin Psychopharm. 4(1):32-35, (1984)
9. Ban, TA. Psychopharmacology of
Thiothixene (raven Press, New York), p.39-45, (1978)
PART
III: CONSUMER INFORMATION
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Navane
Thiothixene
This leaflet is part III of a three-part
"Product Monograph" published when Navane was approved for
sale in Canada and is designed specifically for Consumers. This leaflet
is a summary and will not tell you everything about Navane. Contact
your doctor or pharmacist if you have any questions about the drug.
What the medication
is used for:
NAVANE is used to treat schizophrenia and other psychotic disorders.
What it does:
Navane is an antipsychotic medication which affects chemicals
in the brain that allow communication between nerve cells (neurotransmitters).
These chemicals are called dopamine and serotonin. Exactly how Navane
works is unknown. However, it seems to readjust the balance of dopamine
and serotonin.
When it should not be used:
You should not use Navane if you have:
oAn allergy to thiothixene, to any of its ingredients or to
phenothiazines
o A medical condition known as pheochromocytoma (a tumor of the
adrenal gland)
o A severe heart or blood vessel disorder
o Severe kidney problems
o Had brain damage
o Liver disease
o A blood cell disorder such as anemia, low white blood cell counts,
or low platelets
o Drowsiness, slow breathing, weak pulse
o Decreased alertness caused by taking certain medications or drinking
alcohol
o You are going to receive anesthesia in the spine or for a region
(such as an arm, leg or the lower part of your body)
o You are under 12 years old
.
What the medicinal ingredient is:
Thiothixene
What the nonmedicinal ingredients are:
Corn starch, gelatin (bovine), lactose, magnesium stearate, silicon
dioxide, sodium lauryl sulphate, titanium dioxide. The 5mg and 10mg
capsules also contain FD&C yellow #6 and FD&C red # 3.
What dosage forms it comes in:
Capsules: 2mg, 5mg and 10mg
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Serious Warnings and Precautions
Studies with various medicines of the group to which NAVANE
belongs, when used in the elderly patients with dementia,
have been associated with an increased rate of death. NAVANE
is not indicated in elderly patients with dementia.
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BEFORE you use Navanel talk to
your doctor or pharmacist if:
- You have heart disease, glaucoma or prostatic hypertrophy
- You are addicted to alcohol. You should not take Navane if you
are under the effects of alcohol.
- You are pregnant. Navane should not be used during pregnancy unless
your doctor considers the benefits to you markedly outweigh the
potential risks to the fetus
- You are taking barbiturates, painkillers , narcotics or, antihistamines
or other drugs that make you drowsy.
- You have any allergies to this drug or its ingredients
- You have or ever had a blackout or seizure
- You are breast feeding.
Navane may impair the mental and/or
physical abilities required for the performance of potentially hazardous
tasks such as driving a car or operating machinery, especially during
the first few days of therapy. You should be cautious when performing
potentially hazardous tasks.
Effects on Newborns:
In some cases babies born to a mother taking Navane during pregnancy
have experienced symptoms that are severe and require the newborn
to be hospitalized. Sometimes, the symptoms may resolve on their
own. Be prepared to seek immediate emergency medical attention for
your newborn if they have difficulty breathing, are overly sleepy,
have muscle stiffness, or floppy muscles (like a rag doll), are
shaking, or are having difficulty feeding.
People who take Navane are cautioned:
- Against exposure to extreme heat
- That drugs such as Navane increase the toxicity of certain types
of insecticides ("organophosphorous" insecticides) including
insecticides for agriculture (farming), treating animals (flea and
tick control) and for treating pests around the house and garden.
Be cautious if you must use these products while taking Navane.
- To avoid unnecessary exposure to sunlight
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INTERACTIONS
WITH THIS MEDICATION
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Navane can add to the effects of alcohol.
You should avoid consuming alcoholic beverages while on Navane therapy.
Tell your doctor about all your prescription and over-the-counter
medications, vitamins, minerals, herbal products (such as St. John's
Wort), and drugs prescribed by other doctors. Do not start a new
medication without telling your doctor.
Before using Navane, tell your doctor if you regularly use other
medicines that make you sleepy (such as cold or allergy medicine,
narcotic pain medicine, sleeping pills, muscle relaxants, and medicine
for seizures, depression, or anxiety). You should not take Navane
if you have drowsiness caused by other medications.
Drugs that may interact with Navane include:
anti-anxiety agents, antidepressants, muscle relaxants, anti-seizure
medicine, high blood pressure medicine, cabergoline, metrizamide,
guanethidine, guanadrel, grepafloxacin, sparfloxacin, lithium, cisapride,
atropine-like drugs, narcotic pain relievers (e.g., codeine), drugs
used to aid sleep, drowsiness-causing antihistamines (e.g., diphenhydramine),
other drugs that may make you drowsy and carbamazepine.
Many cough-and-cold products contain ingredients that may add a
drowsiness effect. Before using cough-and-cold medications, ask
your doctor or pharmacist about the safe use of those products.
Do not start or stop any medicine without doctor or pharmacist approval.
This list is not complete and there may be other drugs that can
interact with Navane.
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PROPER
USE OF THIS MEDICATION
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Take this medication by mouth
exactly as prescribed. During the first few days your doctor may
gradually increase your dose to allow your body to adjust to the
medication. Do not take this more often or increase your dose without
consulting your doctor. Your condition will not improve any faster
but the risk of serious side effects will be increased. Do not stop
taking this drug suddenly without your doctor's approval.
Your doctor will decide which dose is best for you.
Usual dose:
Usual Adult Initial dose: 5 to 10 mg once a day.
Usual adult optimal dose: 15 to 30
mg once a day. This dose could be increased by your physician.
Doses up to 60 mg a day can be divided in equal doses and given
twice or three times a day.
Overdose:
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In case of drug overdose, contact
a health care practitioner, hospital emergency department
or regional Poison Control Centre immediately, even if there
are no symptoms.
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Overdose symptoms may include agitation, and confusion, drowsiness,
dizziness, muscle stiffness or twitching, increased salivation,
trouble swallowing, weakness, loss of balance or coordination, and
fainting.
Missed Dose:
Take the missed dose as soon as you remember. If it is almost time
for your next dose, wait until then to take the medicine and skip
the missed dose. Do not double your dose to make up the missed dose.
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SIDE
EFFECTS AND WHAT TO DO ABOUT THEM
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Like other medications, Navane may cause some side effects. These
side effects may be minor and temporary. However, some may be serious
and need medical attention.
Side effects may include: sweating, urinary incontinence, dizziness,
drowsiness, restlessness, agitation, depression, cramps, seizures,
dry mouth, drooling, nasal congestion, nausea and vomiting, headache,
menstrual changes, change in libido, impotence, swelling of the breasts
and milk production in both men and women, weight changes and blurred
vision, your skin may become more sensitive to sunburn, or you may
have difficulty sleeping.
If any of these affects you severely, tell your doctor.
Your doctor should check your body weight before starting Navane
and continue to monitor it for as long as you are being treated.
Your doctor should take blood tests before starting Navane. They
will monitor blood sugar, your liver and the number of infection fighting
white blood cells. Your doctor should continue to monitor your blood
for as long as you are being treated.
If you have high levels of prolactin (measured with a blood test)
and a condition called hypogonadism you may be at increased risk of
breaking a bone due to osteoporosis. This occurs in both men and women.
|
SERIOUS SIDE
EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
|
|
Symptom
/ effect
|
Talk
with your doctor or pharmacist
|
Stop
taking drug and seek immediate emergency medical attention
|
|
Only
if severe
|
In
all cases
|
|
|
Unknown
|
Allergic
Reaction: rash, hives, swelling of the face, lips, tongue or
throat, difficulty swallowing or breathing |
|
|
|
|
|
Neuroleptic
Malignant Syndrome: any group of symptoms which may include
high fever, sweating, stiff muscles, fast heartbeat, fast breathing
and feeling confused, drowsy or agitated |
|
|
|
| Extrapyramidal
Symptoms: muscle stiffness, body spasms, upward eye rolling,
exaggeration of reflexes, drooling, difficulty moving how and
when you want. |
|
|
|
| Fast
or irregular heartbeat |
|
|
|
| Seizures
or fits |
|
|
|
| Long-lasting
(greater than 4 hours in duration) and painful erection of penis |
|
|
|
| Tardive
Dyskinesia: uncontrollable movements or twitches of the body,
face, eyes or tongue, stretching the neck and body |
|
|
|
| Low
Blood Pressure: feeling of Lightheadedness or fainting especially
when getting up from a lying or sitting position |
|
|
|
| High
Blood Pressure: headaches, vision disorders, nausea and vomiting |
|
|
|
| Decreased
sweating |
|
|
|
| Jaundice:
yellow colour to skin and eyes, dark urine |
|
|
|
| Respiratory
Infection: fever, flu-like symptoms, coughing, difficult or
fast breathing |
|
|
|
| New
or worsening constipation |
|
|
|
| Akathisia:
a feeling of restlessness, inability to remain motionless |
|
|
|
| Vision
Changes: blurred vision, glaucoma or other eye disorder |
|
|
|
| Increased
Blood Sugar: frequent urination, thirst and hunger |
|
|
|
This is not a complete list of side effects. For any unexpected
effects while taking Navane, contact your doctor or pharmacist.
Store this medication at room temperature between 15 and 30 °C
away from heat and light. Do not store in the bathroom. Keep this
and all medications out of the reach and sight of children.
|
REPORTING SUSPECTED SIDE
EFFECTS
You can report any suspected
adverse reactions associated with the use of health products
to the Canada Vigilance Program by one of the following 3
ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
-Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the
adverse reaction reporting guidelines are available on the
MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the
management of side effects, contact your health professional.
The Canada Vigilance Program does not provide medical advice.
|
This document plus the full product
monograph, prepared for health professionals can be found at:
http://www.website.document
or by contacting the sponsor, ERFA Canada Inc., at:
1-800-922-3133
This leaflet was prepared by ERFA
Canada Inc.
Last revised: OCT 25, 2011.
|
