Data from FDA - Curated by EPG Health - Last updated 20 December 2016
PRECAUTIONS Leukopenia, Neutropenia and Agranulocytosis In clinical trial and postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.
Possible risk factors for leukopenia/neutropenia include preexisting
USP and have their WBC followed until recovery.
General Given the likelihood that some patients exposed chronically to
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.
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
Because of its CNS depressant effect, chlorpromazine should be used with
Chlorpromazine prolongs and intensifies the action of CNS depressants such as anesthetics, barbiturates and
When chlorpromazine is administered concomitantly, about 1/4 to 1/2
When chlorpromazine is not being administered to reduce requirements of CNS depressants,
These agents may subsequently be reinstated at low doses and
Chlorpromazine does not intensify the anti-convulsant action of barbiturates.
Therefore, dosage of anticonvulsants, including barbiturates, should not be
Instead, start chlorpromazine at low doses and increase as
Antipsychotic drugs elevate prolactin levels; the elevation persists during
Tissue culture experiments indicate that approximately one-third of
Neither clinical nor epidemiologic studies conducted to date, however, have shown an association between
As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, chlorpromazine should be used with
Phenothiazines can produce alpha-adrenergic blockade.
Chlorpromazine may lower the convulsive threshold; dosage
Potentiation of anticonvulsant effects does not occur.
However, it has been reported that chlorpromazine may interfere with the metabolism of phenytoin and thus precipitate phenytoin toxicity.
Concomitant administration with propranolol results in
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 metrizamide.
As with other phenothiazine derivatives,
Long-Term Therapy To lessen the likelihood of
Antiemetic Effect The antiemetic action of chlorpromazine may mask the signs and symptoms of overdosage of other drugs and
) When chlorpromazine is used with
Abrupt Withdrawal Like other phenothiazines, chlorpromazine is not known to cause psychic dependence and does not produce tolerance or addiction.
There may be, however, following
Jaundice 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
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 chlorpromazine or other phenothiazines.
If fever with grippe-like symptoms occurs,
If tests indicate an
Liver function tests in jaundice induced by the drug may mimic extrahepatic
Agranulocytosis Warn patients to report the sudden appearance of
Most cases have occurred between the 4th and 10th weeks of therapy;
Cardiovascular Hypotensive Effects Postural hypotension,
Usually recovery is spontaneous and
To control hypotension,
If a vasoconstrictor is required,
Other pressor agents, including epinephrine, should not be used as they may cause a
Changes Particularly nonspecific, usually reversible Q and T wave
CNS Reactions Extrapyramidal Symptoms Neuromuscular reactions include dystonias, motor
They are discussed in the following paragraphs: Dystonia Class effect: Symptoms of dystonia,
Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat,
While these symptoms can occur at low doses, they occur more frequently and with
At times, these symptoms may be similar to the original
Pseudo-parkinsonism Symptoms may include: mask-like facies, drooling,
In most cases, these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly.
Anti-parkinsonism agents should be used only when
Generally, therapy of a few weeks to 2 or
After this time patients should be evaluated to determine their
Occasionally, it is necessary to lower the dosage of chlorpromazine or to
Tardive Dyskinesia As with all antipsychotic agents, tardive dyskinesia may appear in some patients on
This syndrome appears in all age groups.
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.
A variant of tardive dyskinesia, tardive dystonia, has also been described.
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
Other CNS Effects Neuroleptic
) Cerebral edema has been reported.
Convulsive seizures (petit mal and grand mal) have been reported, particularly in
Contact dermatitis has been reported in nursing personnel; accordingly, the use of rubber gloves when administering chlorpromazine liquid or injectable is
In addition, asthma, laryngeal edema, angioneurotic edema and anaphylactoid reactions have been reported.
False-positive pregnancy tests have been reported, but are less likely to occur when
Amenorrhea and gynecomastia have also been reported.
Hyperglycemia, hypoglycemia and glycosuria have been reported.
Autonomic Reactions Occasional dry mouth; nasal
The pigmentary changes,
Histological examination reveals a pigment, chiefly in the dermis, which is probably a melanin-like complex.
Ocular Changes Ocular changes have occurred more frequently than skin pigmentation and have been observed both in pigmented and nonpigmented patients receiving chlorpromazine, usually for 2 years or more in dosages of 300 mg daily and higher.
Eye changes are characterized by deposition of
The nature of the eye deposits has not yet been determined.
In addition to these corneal and lenticular changes, epithelial keratopathy and pigmentary retinopathy have been reported.
Reports suggest that
Since the occurrence of eye changes seems to be related to dosage levels and/or duration of therapy, it is suggested that
Etiology The etiology of both of
If either of these reactions is observed, the physician should weigh the
Hyperpyrexia has been reported.
Peripheral edema and a systemic lupus erythematosus-like syndrome have been reported.
There have been occasional reports of sudden
In some cases,
In continued therapy, gradually reduce dosage to the lowest
The 100 mg and 200 mg tablets are for use in
Elderly Patients In general,
Outpatients 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d.
After 1 or 2 days,
Subsequent doses should be oral, 25 to 50 mg t.i.d.
If symptoms persist for 2 to 3 days, parenteral therapy is indicated.
Pediatric Patients (6 months to 12 years of age) Chlorpromazine should generally not be used in pediatric patients under 6 months of age except where potentially lifesaving.
It should not be used in conditions for which specific pediatric dosages have not been
Oral: 1/4 mg/lb body weight q4 to 6h, p.r.n. (e.g., for 40 lb child - 10 mg q4 to 6h).
Hospitalized Patients As with outpatients, start with
The duration of activity following intramuscular administration may last up to 12 hours.
Subsequent doses may be given by the same route if necessary.
Oral: 1/4 mg/lb body weight (e.g., 40 lb child - 10 mg q4 to 6h).
|Date Last Revised||26-02-2013|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.|
|Marketing authorisation holder||NCS HealthCare of KY, Inc dba Vangard Labs|
Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of
Over the course of a typical 10-week
Although the causes of
Observational studies suggest that, similar to atypical antipsychotic drugs,
The extent to which the findings of