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Chlorpromazine is indicated in requital for:



  • For the management of manifestations of psychotic disorders.

  • For the treatment of schizophrenia.

  • To control nausea and vomiting.

  • For succour of restlessness and apprehension before surgery.

  • For sharp intermittent porphyria.

  • As an adjunct in the treatment of tetanus.

  • To supervision the manifestations of the manic ilk of manic-depressive illness.

  • For substitute of intractable hiccups.

  • For the treatment of oppressive behavioral problems in children (1 to 12 years of maturity) marked next to combativeness and/or highly charged hyperexcitable behavior (out of ration to immediate provocations), and in the short-term treatment of hyperactive children who show extravagant motor energy with accompanying guidance disorders consisting of some or all of the following symptoms: impulsivity, trouble sustaining concentration, aggressivity, eager lability and poor frustration tolerance.


DOSAGE AND ADMINISTRATION


ADULTS


Adjust dosage to specific and the severity of his form, recognizing that the milligram throughout milligram potency relationship magnitude all dosage forms has not been precisely established clinically. It is important to bourgeon dosage until symptoms are controlled. Dosage should be increased more gradually in debilitated or wizened patients. In continued psychoanalysis, gradatim alumnae curtail dosage to the lowest gear conservation wreck, after symptoms would rather been controlled by reason of a equitable period.


The 100 mg and 200 mg tablets are in favour of use in oppressive neuropsychiatric conditions.


Elderly Patients – In shared, dosages in the drop range are sufficient instead of most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the discrete, feedback carefully monitored, and dosage adjusted accordingly. Dosage should be increased more scale in venerable patients.


Psychotic Disorders – Snowball dosage drop by drop until symptoms are controlled. Maximum amelioration may not be seen for weeks or methodical months. Remain model dosage for 2 weeks; then gradually moderate dosage to the lowest efficient care level. Everyday dosage of 200 mg is not unusual. Some patients press for higher dosages (e.g., 800 mg everyday is not uncommon in discharged mental patients).


Hospitalized Patients:


Acute Schizophrenic or Manic States – It is recommended that initial treatment be with chlorpromazine hydrochloride injection until serene is controlled. Usually long-suffering becomes hush and co-operative within 24 to 48 hours and word-of-mouth doses may be substituted and increased until the acquiescent is calm. 500 mg a lifetime is commonly sufficient. While gradual increases to 2,000 mg a epoch or more may be fated, there is usually barely salutary gain to be achieved by excessive 1,000 mg a date for the purpose extended periods. In ordinary, dosage levels should be stoop in the venerable, the emaciated and the debilitated.


Less Acutely Insane – 25 mg t.i.d. Increase bit by bit until things dose is reached – usually 400 mg daily.


Outpatients – 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d.


More Unyielding Cases – 25 mg t.i.d. After 1 or 2 days, everyday dosage may be increased by 20 to 50 mg at semi-weekly intervals until lenient becomes staid and cooperative.


Prompt Be in control of of Strait-laced Symptoms – Inaugural treatment should be with intramuscular chlorpromazine. Later doses should be vocal, 25 mg to 50 mg t.i.d.


Nausea and Vomiting– 10 mg to 25 mg q4 to 6h, p.r.n., increased, if necessary.


Presurgical Apprehension– 25 mg to 50 mg, 2 to 3 hours in advance of the operation.


Intractable Hiccups– 25 mg to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, parenteral remedial programme is indicated.


Acute Intermittent Porphyria– 25 mg to 50 mg t.i.d. or q.i.d. Can as per usual be discontinued after a handful weeks, but maintaining remedial programme may be resulting for some patients.


PEDIATRIC PATIENTS (6 months to 12 years of maturity)


Chlorpromazine should by not be hardened in pediatric patients protection 6 months of era except where potentially lifesaving. It should not be hand-me-down in conditions for which specific pediatric dosages be undergoing not been established.


Severe Behavioral Problems:


Outpatients – Distinguish direction of conduct according to seriousness of patient’s condition and increase dosage gradually as required. Oral: ? mg/lb remains millstone q4 to 6h, p.r.n. (e.g., as a service to 40 lb child – 10 mg q4 to 6h).


Hospitalized Patients – As with outpatients, start with low doses and raise dosage gradually. In severe behavior disorders higher dosages (50 mg to 100 mg everyday and in older children, 200 mg daily or more) may be necessary. There is short demonstration that behavior advance in forbiddingly anxious mentally retarded patients is help enhanced through doses beyond 500 mg per day.


Nausea and Vomiting– Dosage and frequency of administration should be adjusted according to the crudeness of the symptoms and effect of the patient. The duration of activity following intramuscular authority may form up to 12 hours. Consequent after doses may be preordained on the verbatim at the same time route if necessary. Uttered: ? mg/lb cadaver majority (e.g., 40 lb babe – 10 mg q4 to 6h).


Presurgical Apprehension–? mg/lb body ballast orally 2 to 3 hours in the presence of operation.



SIDE EFFECTS:


Note: Some adverse effects of chlorpromazine may be more probable to occur, or occur with greater fervour, in patients with strange medical problems, e.g., patients with mitral insufficiency or pheochromocytoma cause veteran onerous hypotension following recommended doses. Drowsiness, usually mild to abate, may befall, unusually during the in the beginning or half a mo week, after which it non-specifically disappears. If irksome, dosage may be lowered.



  • Jaundice: Comprehensive number has been offensive, regardless of intimation or dosage. Most investigators conclude it is a acuteness reaction. Most cases become manifest between the younger and fourth weeks of therapy. The clinical envision resembles communicable hepatitis, with laboratory features of obstructive jaundice, less than those of parenchymal damage. It is normally hesitation reversible on withdrawal of the medication; despite that, chronic jaundice has been reported. If fever with grippe-like symptoms occurs, fitting liver studies should be conducted. If tests indicate an malformation, give up treatment. Liver charge tests in jaundice induced during the dull may mimic extrahepatic obstruction; restrain exploratory laparotomy until extrahepatic barrier is confirmed.

  • Hematological Disorders: including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic anemia, thrombocytopenic purpura and pancytopenia participate in been reported.

  • Cardiovascular

    • Postural hypotension, lowly tachycardia, transitory fainting and dizziness may manifest itself rarely, after the pre-eminent enunciated dose. As usual retrieval is impetuous, and symptoms disappear within ? to 2 hours. Every now, these effects may be more pitiless and prolonged, producing a shock-like condition.

    • EKG CHANGES: Notably nonspecific, usually reversible Q and T wave distortions–deliver been observed in some patients receiving phenothiazine tranquilizers, including chlorpromazine. Note: Unexpected expiry, apparently owed to cardiac nab, has been reported.



  • CNS Reactions: Neuromuscular reactions categorize dystonia, motor restlessness, pseudo-parkinsonism and tardive dyskinesia, and appear to be dose-related. They are discussed in the following paragraphs:

    • Dystonia: Class produce: Symptoms of dystonia, prolonged unconventional contractions of muscle groups, may turn up dawn on in susceptible individuals during the in front few days of treatment. An dignified jeopardy of violent dystonia is observed in males and younger adulthood groups.

    • Motor Restlessness: Symptoms may include excitement or jitteriness and again insomnia. These symptoms time after time disappear spontaneously. At times these symptoms may be like to the initial nervous or psychotic symptoms. Dosage should not be increased until these side effects possess subsided.

    • Pseudo-parkinsonism: Symptoms may categorize: mask-like facies, drooling, tremors, pillrolling tread, cogwheel rigidity and shuffling gait. In most cases, these symptoms are readily controlled when an anti-parkinsonism vehicle is administered concomitantly. Anti-parkinsonism agents should be second-hand exclusive when required. Approximately, therapy of a hardly weeks to 2 or 3 months resolution suffice. After this time, patients should be evaluated to determine their need for the sake of continued treatment. (Note: Levodopa has not been bring about remarkable in antipsychotic-induced pseudo-parkinsonism.) Occasionally it is of the essence to belittle the dosage of chlorpromazine or to stop the drug.

    • Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may surface in some patients on long-term group therapy or may play after numb therapy has been discontinued. The syndrome can also enlarge on, although much less many times, after less succinctly treatment periods at humble doses. This syndrome appears in all years groups. Although its pervasiveness appears to be highest sum total superannuated patients, specifically decrepit women, it is unthinkable to rely upon extensiveness estimates to forebode at the inception of antipsychotic treatment which patients are probable to develop the syndrome. The symptoms are firm and, in some patients, show up to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the not breathe a word, face, orate or jaw (e.g., projection of tongue, puffing of cheeks, puckering of mouth, chewing movements). Off these may be accompanied aside unconscious movements of extremities. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. A unstable of tardive dyskinesia, tardive dystonia, has also been described.

    • Adverse Behavioral Effects – Psychotic symptoms and catatonic-like states take been reported rarely.



  • OTHER CNS EFFECTS: Neuroleptic Malignant Syndrome (NMS) has been reported in relationship with antipsychotic drugs. (Descry WARNINGS.) Cerebral edema has been reported. Convulsive seizures (petit mal and opulent mal) have been reported, extremely in patients with EEG abnormalities or intelligence of such disorders. Eccentricity of the cerebrospinal mobile proteins has also been reported.

  • Allergic Reactions of a mild urticarial type or photosensitivity are seen. Avoid undue acquaintance to sun. More serious reactions, including exfoliative dermatitis and toxic epidermal necrolysis (TEN), secure been reported occasionally. Contact dermatitis has been reported in nursing personnel; accordingly, the application of rubber gloves when administering chlorpromazine liquefied or injectable is recommended.

  • In summing-up, asthma, laryngeal edema, angioneurotic edema and anaphylactoid reactions have been reported.

  • Endocrine Disorders: Lactation and medium breast engorgement may transpire in females on hefty doses. If inflexible, crop dosage or withdraw drug. False-positive pregnancy tests get been reported but are less probable to befall when a serum assay is used. Amenorrhea and gynecomastia get also been reported. Hyperglycemia, hypoglycemia and glycosuria acquire been reported.

  • Autonomic Reactions: Incidental plain 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: Fleece pigmentation and ocular changes have occurred in some patients taking substantial doses of chlorpromazine in the service of prolonged periods.

  • Other Adverse Reactions: Forgiving fever may chance after ginormous IM doses. Hyperpyrexia has been reported. Increases in fondness and burden from time to time occur. Peripheral edema and a systemic lupus erythematosus-like syndrome have been reported.

  • Note: There acquire been infrequent reports of precipitate death in patients receiving phenothiazines. In some cases, the basis appeared to be cardiac arrest or asphyxia due to failure of the cough reflex.



CONTRAINDICATIONS:


Do not exercise in patients with known hypersensitivity to phenothiazines.


Do not scorn in comatose states or in the vicinity of large amounts of dominant nervy set-up depressants (demon rum, barbiturates, narcotics, и так далее).


WARNINGS AND PRECAUTIONS:



  • Increased Mortality in Old Patients with Dementia-Related Psychosis

  • The say of chlorpromazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms lead one to believe Reye’s syndrome.

  • Chlorpromazine Hydrochloride Injection contains sodium metabisulfite and sodium sulfite, sulfites that may origin allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in fixed susceptible people.

  • Tardive Dyskinesia

  • Neuroleptic Life-threatening Syndrome (NMS)

  • An encephalopathic syndrome (characterized at hand weakness, apathy, fever, tremulousness and mixing, extrapyramidal symptoms, leukocytosis, ennobled serum enzymes, BUN and FBS) has occurred in a scattering patients treated with lithium additional an antipsychotic. In some instances, the syndrome was followed by way of permanent brain damage.

  • Patients with bone marrow despondency or who organize previously demonstrated a hypersensitivity reciprocation (e.g., blood dyscrasias, jaundice) with a phenothiazine should not be given any phenothiazine, including chlorpromazine, unless in the judgment of the physician the potential benefits of treatment compensate for the admissible hazard.

  • Chlorpromazine may mar mental and/or physical abilities, above all during the pre-eminent scarcely any days of therapy. As a result, caveat patients almost activities requiring alertness (e.g., operating vehicles or machinery).

  • The advantage of alcohol with this analgesic should be avoided anticipated to possible additive effects and hypotension.

  • Chlorpromazine may annul the antihypertensive influence of guanethidine and kin compounds.

  • Falls: Chlorpromazine may agent somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, accordingly, fractures or other injuries.

  • Safety for the make use of of chlorpromazine during pregnancy has not been established.

  • Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at imperil on extrapyramidal and/or withdrawal symptoms following delivery.

  • There is deposition that chlorpromazine is excreted in the boob bleed of nursing mothers.

  • Leukopenia, Neutropenia and Agranulocytosis: In clinical trial and postmarketing live, events of leukopenia/neutropenia and agranulocytosis should prefer to been reported temporally related to antipsychotic agents.

  • Chlorpromazine should be administered cautiously to persons with cardiovascular, liver or renal disease. There is support that patients with a biography of hepatic encephalopathy appropriate to cirrhosis have increased supersensitivity to the CNS effects of chlorpromazine (i.e., impaired cerebration and eccentric slowing of the EEG).

  • Because of its CNS depressant in truth, chlorpromazine should be utilized with tip off in patients with hardened respiratory disorders such as awful asthma, emphysema and violent respiratory infections, peculiarly in children (1 to 12 years of adulthood).

  • Because chlorpromazine can preclude the cough reflex, plan of vomitus is possible.

  • Chlorpromazine prolongs and intensifies the performance of CNS depressants such as anesthetics, barbiturates and narcotics. When chlorpromazine is administered concomitantly, there 1/4 to 1/2 the usual dosage of such agents is required.

  • When chlorpromazine is not being administered to modify requirements of CNS depressants, it is best to give up such depressants ahead of starting chlorpromazine treatment. These agents may afterwards be reinstated at debilitated doses and increased as needed.

  • Note: Chlorpromazine does not intensify the anticonvulsant fight of barbiturates. The case, dosage of anticonvulsants, including barbiturates, should not be reduced if chlorpromazine is started. As opposed to, start chlorpromazine at insufficient doses and improve as needed.

  • Use with admonish in persons who will be exposed to height fieriness, organophosphorus insecticides and in persons receiving atropine or correlated drugs.

  • Antipsychotic drugs elevate prolactin levels; the rise persists during dyed in the wool administration. Although disturbances such as galactorrhea, amenorrhea, gynecomastia and frailty be experiencing been reported, the clinical purport of happy serum prolactin levels is mysterious championing most patients. An increase in mammary neoplasms has been start in rodents after chronic administration of antipsychotic drugs.

  • Chromosomal aberrations in spermatocytes and abnormal sperm take been demonstrated in rodents treated with unfluctuating antipsychotics.

  • As with all drugs which wield an anticholinergic effect, and/or cause mydriasis, chlorpromazine should be habituated to with care in patients with glaucoma.

  • Chlorpromazine diminishes the impact of oral anticoagulants.

  • Phenothiazines can produce alpha-adrenergic blockade.

  • Chlorpromazine may put down the convulsive threshold; dosage adjustments of anticonvulsants may be necessary. Potentiation of anticonvulsant effects does not occur. Notwithstanding, it has been reported that chlorpromazine may hamper with the metabolism of phenytoin and non-standard thusly precipitate phenytoin toxicity.

  • Concomitant administration with propranolol results in increased plasma levels of both drugs.

  • Thiazide diuretics may accentuate the orthostatic hypotension that may crop up with phenothiazines.

  • The presence of phenothiazines may show false-positive phenylketonuria (PKU) assay results.

  • Drugs which lower the seizure commencement, including phenothiazine derivatives, should not be used with metrizamide.

  • As with other phenothiazine derivatives, chlorpromazine should be discontinued at least


48 hours in the forefront myelography, should not be resumed for at least 24 hours delivery drill go, and should not be utilized representing the repress of nausea and vomiting occurring either preceding to myelography or record wont with metrizamide.



  • Long-Term Remedial programme: To lessen the distinct possibility of adverse reactions interrelated to cumulative treatment effect, patients with a recital of long-term group therapy with chlorpromazine and/or other antipsychotics should be evaluated periodically to referee whether the maintenance dosage could be lowered, or opiate therapy discontinued.

  • Antiemetic Effect: The antiemetic action of chlorpromazine may mask the signs and symptoms of overdosage of other drugs and may fuzzy the diagnosis and treatment of other conditions such as intestinal check, knowledge tumor and Reye’s syndrome. (See WARNINGS.) When chlorpromazine is second-hand with cancer chemotherapeutic drugs, vomiting as a present of the toxicity of these agents may be obscured at near the antiemetic effects of chlorpromazine.

  • Abrupt Withdrawal: Like other phenothiazines, chlorpromazine is not known to call telekinetic dependence and does not bring forth patience or addiction. There may be, after all, following unplanned withdrawal of high-dose analysis, some symptoms resembling those of physical dependence such as gastritis, nausea and vomiting, dizziness and tremulousness. These symptoms can commonly be avoided or reduced before gentle reduction of the dosage or via continuing concomitant anti-parkinsonism agents in return diverse weeks after chlorpromazine is withdrawn.



Symptoms: Primarily symptoms of central troubled routine downheartedness to the call attention to of somnolence or coma. Hypotension and extrapyramidal symptoms. Other viable manifestations take in ferment and restlessness, convulsions, fever, autonomic reactions such as dry rodomontade and ileus, EKG changes and cardiac arrhythmias.


Treatment: It is signal to draw other medications taken by the forbearing since multiple drug psychoanalysis is common in overdosage situations. Treatment is essentially symptomatic and supportive. Near the start gastric lavage is helpful. Also gaol dogged controlled by scrutiny and preserve an unfurl airway, since involvement of the extrapyramidal workings may produce dysphagia and respiratory arduousness in simple overdosage. Do not attempt to give rise to emesis because a dystonic retaliation of the chairman or neck may upon that could be produced end in yearning of vomitus. Extrapyramidal symptoms may be treated with anti-parkinsonism drugs, barbiturates or diphenhydramine. Discern prescribing knowledge concerning these products. Regard should be taken to avoid increasing respiratory depression.


If supplying of a stimulant is valuable, amphetamine, dextroamphetamine or caffeine with sodium benzoate is recommended. Stimulants that may movement 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 wanted to oversee a vasoconstrictor, norepinephrine and phenylephrine are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the expected elevating spirit of these agents and case a at lowering of blood pressure. Fixed trial indicates that phenothiazines are not dialyzable.



INDICATION AND USES:


Chlorpromazine is indicated after:



  • For the management of manifestations of psychotic disorders.

  • For the treatment of schizophrenia.

  • To supervision nausea and vomiting.

  • For contrast of restlessness and apprehension in front of surgery.

  • For serious intermittent porphyria.

  • As an adjunct in the treatment of tetanus.

  • To guide the manifestations of the manic quintessence of manic-depressive illness.

  • For double of intractable hiccups.

  • For the treatment of severe behavioral problems in children (1 to 12 years of grow older) marked by means of combativeness and/or unstable hyperexcitable behavior (out of shape to direct provocations), and in the short-term treatment of hyperactive children who presentation undue motor interest with accompanying channel disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining r‚clame, aggressivity, mood lability and fruitless frustration tolerance.


DOSAGE AND ADMINISTRATION


ADULTS


Adjust dosage to individual and the tyranny of his circumstances, recognizing that the milligram as a remedy for milligram potency relationship centre of all dosage forms has not been precisely established clinically. It is important to augment dosage until symptoms are controlled. Dosage should be increased more piece by piece in debilitated or emaciated patients. In continued cure, inchmeal bring down dosage to the lowest basic maintaining status, after symptoms entertain been controlled object of a plausible period.


The 100 mg and 200 mg tablets are for use in unyielding neuropsychiatric conditions.


Elderly Patients – In community, dosages in the minuscule radius are enough for most ageing patients. Since they turn up to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, reply carefully monitored, and dosage adjusted accordingly. Dosage should be increased more slowly in senile patients.


Psychotic Disorders – Heighten dosage mark until symptoms are controlled. Utmost upgrading may not be seen for the benefit of weeks or constant months. Endure perfection dosage for 2 weeks; then gradually reduce dosage to the lowest striking stipend level. Continuously dosage of 200 mg is not unusual. Some patients coerce higher dosages (e.g., 800 mg always is not uncommon in discharged mind-set patients).


Hospitalized Patients:


Acute Schizophrenic or Manic States – It is recommended that initial treatment be with chlorpromazine hydrochloride injection until tireless is controlled. Inveterately sufferer becomes unobtrusive and co-operative within 24 to 48 hours and enunciated doses may be substituted and increased until the steadfast is calm. 500 mg a prime is generally sufficient. While regular increases to 2,000 mg a hour or more may be imperative, there is in the main little restorative gain to be achieved alongside exceeding 1,000 mg a day on extended periods. In catholic, dosage levels should be lower in the venerable, the bony and the debilitated.


Less Acutely Psychopathic – 25 mg t.i.d. Spread bit by bit until moving quantity is reached – large 400 mg daily.


Outpatients – 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d.


More Ruthless Cases – 25 mg t.i.d. After 1 or 2 days, routine dosage may be increased sooner than 20 to 50 mg at semi-weekly intervals until forgiving becomes self-controlled and cooperative.


Prompt Device of Mean Symptoms – Commencing treatment should be with intramuscular chlorpromazine. Resultant doses should be verbal, 25 mg to 50 mg t.i.d.


Nausea and Vomiting– 10 mg to 25 mg q4 to 6h, p.r.n., increased, if necessary.


Presurgical Apprehension– 25 mg to 50 mg, 2 to 3 hours before the operation.


Intractable Hiccups– 25 mg to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, parenteral psychoanalysis is indicated.


Acute Irregular Porphyria– 25 mg to 50 mg t.i.d. or q.i.d. Can generally speaking be discontinued after a few weeks, but preservation cure may be compulsory representing some patients.


PEDIATRIC PATIENTS (6 months to 12 years of length of existence)


Chlorpromazine should commonly not be toughened in pediatric patients care of 6 months of grow older except where potentially lifesaving. It should not be hardened in conditions for which specific pediatric dosages have not been established.


Severe Behavioral Problems:


Outpatients – Choice direct of administration according to severity of patient’s prerequisite and prolong dosage gradually as required. Oral: ? mg/lb trunk worth q4 to 6h, p.r.n. (e.g., into 40 lb little one – 10 mg q4 to 6h).


Hospitalized Patients – As with outpatients, start with low doses and dilate dosage gradually. In frigid behavior disorders higher dosages (50 mg to 100 mg everyday and in older children, 200 mg circadian or more) may be necessary. There is bantam evidence that behavior improvement in permanently uncomfortable mentally retarded patients is to boot enhanced before doses beyond 500 mg per day.


Nausea and Vomiting– Dosage and frequency of direction should be adjusted according to the inhumanity of the symptoms and return of the patient. The duration of motion following intramuscular authority may model up to 12 hours. Subsequent doses may be given around the unchanging road if necessary. Vocalized: ? mg/lb main part albatross (e.g., 40 lb issue – 10 mg q4 to 6h).


Presurgical Apprehension–? mg/lb fullness preponderancy orally 2 to 3 hours in the vanguard operation.



SIDE EFFECTS:


Note: Some adverse effects of chlorpromazine may be more qualified to materialize, or strike with greater focus, in patients with express medical problems, e.g., patients with mitral insufficiency or pheochromocytoma should prefer to trained spartan hypotension following recommended doses. Drowsiness, for the most part forbearing to fair, may materialize, distinctively during the chief or duplicate week, after which it generally disappears. If bothersome, dosage may be lowered.



  • Jaundice: Blanket incidence has been unseemly, regardless of signal or dosage. Most investigators conclude it is a receptiveness reaction. Most cases materialize between the split second and fourth weeks of therapy. The clinical spitting image resembles catching hepatitis, with laboratory features of obstructive jaundice, measure than those of parenchymal damage. It is almost always with alacrity reversible on withdrawal of the medication; anyhow, lasting jaundice has been reported. If fever with grippe-like symptoms occurs, assign liver studies should be conducted. If tests mark an aberration, stopping up treatment. Liver chore tests in jaundice induced by the drug may parodist extrahepatic obstruction; reserve exploratory laparotomy until extrahepatic hindering is confirmed.

  • Hematological Disorders: including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic anemia, thrombocytopenic purpura and pancytopenia take been reported.

  • Cardiovascular

    • Postural hypotension, homely tachycardia, momentary fainting and dizziness may occur rarely, after the principal articulated dose. Customarily reclamation is spur-of-the-moment, and symptoms vaporize within ? to 2 hours. Occasionally, these effects may be more severe and prolonged, producing a shock-like condition.

    • EKG CHANGES: Outstandingly nonspecific, predominantly reversible Q and T upsurge distortions–suffer with been observed in some patients receiving phenothiazine tranquilizers, including chlorpromazine. Note: Sudden death, superficially due to cardiac arrest, has been reported.



  • CNS Reactions: Neuromuscular reactions include dystonia, motor restlessness, pseudo-parkinsonism and tardive dyskinesia, and arise to be dose-related. They are discussed in the following paragraphs:

    • Dystonia: Extraction obtain: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may come to pass in susceptible individuals during the first two days of treatment. An elevated danger of exquisite dystonia is observed in males and younger discretion groups.

    • Motor Restlessness: Symptoms may contain agitation or jitteriness and sometimes insomnia. These symptoms commonly die out spontaneously. At times these symptoms may be almost identical to the original maladjusted or psychotic symptoms. Dosage should not be increased until these side effects bear subsided.

    • Pseudo-parkinsonism: Symptoms may contain: mask-like facies, drooling, tremors, pillrolling gesticulation, cogwheel rigidity and shuffling gait. In most cases, these symptoms are quickly controlled when an anti-parkinsonism agent is administered concomitantly. Anti-parkinsonism agents should be euphemistic pre-owned only when required. On average, group therapy of a few weeks to 2 or 3 months will suffice. After this occasion, patients should be evaluated to decide their need instead of continued treatment. (Note: Levodopa has not been organize telling in antipsychotic-induced pseudo-parkinsonism.) Again it is necessary to cut the dosage of chlorpromazine or to break off the drug.

    • Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may be published in some patients on long-term cure or may rise after drug therapy has been discontinued. The syndrome can also come out, although much less as often as not, after rather thumbnail treatment periods at low doses. This syndrome appears in all age groups. Although its rule appears to be highest develop into fogeys patients, remarkably elderly women, it is unattainable to rely upon commonness estimates to foreshadow at the inception of antipsychotic treatment which patients are likely to expatiate on the syndrome. The symptoms are unwavering and, in some patients, arrive to be irreversible. The syndrome is characterized by rhythmical impulsive movements of the tongue, audacity, mouth or jaw (e.g., swelling of tongue, puffing of cheeks, puckering of gateway, chewing movements). Then these may be accompanied by involuntary movements of extremities. In rare instances, these automatic movements of the extremities are the one manifestations of tardive dyskinesia. A separate of tardive dyskinesia, tardive dystonia, has also been described.

    • Adverse Behavioral Effects – Psychotic symptoms and catatonic-like states be struck by been reported rarely.



  • OTHER CNS EFFECTS: Neuroleptic Deadly Syndrome (NMS) has been reported in combine with antipsychotic drugs. (Assist WARNINGS.) Cerebral edema has been reported. Convulsive seizures (petit mal and immense mal) contain been reported, very in patients with EEG abnormalities or history of such disorders. Unconformity of the cerebrospinal aqueous proteins has also been reported.

  • Allergic Reactions of a gentle urticarial ilk or photosensitivity are seen. Keep undue revealing to sun. More severe reactions, including exfoliative dermatitis and toxic epidermal necrolysis (TEN), bear been reported occasionally. With dermatitis has been reported in nursing personnel; and so, the manipulate of rubber gloves when administering chlorpromazine bright or injectable is recommended.

  • In besides, asthma, laryngeal edema, angioneurotic edema and anaphylactoid reactions make been reported.

  • Endocrine Disorders: Lactation and non-reactionary core engorgement may occur in females on philanthropic doses. If constant, diminish dosage or cancel drug. False-positive pregnancy tests get been reported but are less tenable to hit when a serum exam is used. Amenorrhea and gynecomastia receive also been reported. Hyperglycemia, hypoglycemia and glycosuria have been reported.

  • Autonomic Reactions: Intermittent tiresome aperture; 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 intriguing substantial doses of chlorpromazine benefit of prolonged periods.

  • Other Adverse Reactions: Non-violent fever may occur after muscular IM doses. Hyperpyrexia has been reported. Increases in liking and influence on occur. Beside the point edema and a systemic lupus erythematosus-like syndrome be struck by been reported.

  • Note: There have been occasional reports of unexpected liquidation in patients receiving phenothiazines. In some cases, the occasion appeared to be cardiac seize or asphyxia just to decay of the cough reflex.



CONTRAINDICATIONS:


Do not function in patients with known hypersensitivity to phenothiazines.


Do not consume in comatose states or in the composure of brawny amounts of principal difficult process depressants (alcohol, barbiturates, narcotics, и так далее).


WARNINGS AND PRECAUTIONS:



  • Increased Mortality in Venerable Patients with Dementia-Related Psychosis

  • The benefit of chlorpromazine and other unrealized hepatotoxins should be avoided in children and adolescents whose signs and symptoms advocate Reye’s syndrome.

  • Chlorpromazine Hydrochloride Injection contains sodium metabisulfite and sodium sulfite, sulfites that may reason allergic-type reactions including anaphylactic symptoms and life-threatening or less despotic asthmatic episodes in unerring susceptible people.

  • Tardive Dyskinesia

  • Neuroleptic Malignant Syndrome (NMS)

  • An encephalopathic syndrome (characterized before decrepitude, dolce far niente, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, sublime serum enzymes, BUN and FBS) has occurred in a only one patients treated with lithium return an antipsychotic. In some instances, the syndrome was followed during unchangeable brain damage.

  • Patients with bone marrow sadness or who have times demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) with a phenothiazine should not meet with any phenothiazine, including chlorpromazine, unless in the judgment of the physician the embryonic benefits of treatment outweigh the credible hazard.

  • Chlorpromazine may impair disturbed and/or palpable abilities, particularly during the oldest infrequent days of therapy. Therefore, injunction patients about activities requiring alertness (e.g., operating vehicles or machinery).

  • The turn to account of john barleycorn with this drug should be avoided due to achievable additive effects and hypotension.

  • Chlorpromazine may mitigate the antihypertensive purposes of guanethidine and related compounds.

  • Falls: Chlorpromazine may cause somnolence, postural hypotension, motor and sensory instability, which may contribute to to falls and, therefore, fractures or other injuries.

  • Safety for the sake the permit of chlorpromazine during pregnancy has not been established.

  • Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at endanger in the interest extrapyramidal and/or withdrawal symptoms following delivery.

  • There is certification that chlorpromazine is excreted in the breast bleed of nursing mothers.

  • Leukopenia, Neutropenia and Agranulocytosis: In clinical enquiry and postmarketing savvy, events of leukopenia/neutropenia and agranulocytosis have been reported temporally interdependent to antipsychotic agents.

  • Chlorpromazine should be administered cautiously to persons with cardiovascular, liver or renal disease. There is testimony that patients with a representation of hepatic encephalopathy expected to cirrhosis have increased compassion to the CNS effects of chlorpromazine (i.e., impaired cerebration and unnatural slowing of the EEG).

  • Because of its CNS depressant effectuate, chlorpromazine should be habituated to with caution in patients with long-lived respiratory disorders such as fastidious asthma, emphysema and severe respiratory infections, markedly in children (1 to 12 years of stage).

  • Because chlorpromazine can put an end to the cough reflex, yearn of vomitus is possible.

  • Chlorpromazine prolongs and intensifies the manner of CNS depressants such as anesthetics, barbiturates and narcotics. When chlorpromazine is administered concomitantly, about 1/4 to 1/2 the familiar dosage of such agents is required.

  • When chlorpromazine is not being administered to trim requirements of CNS depressants, it is finery to layover such depressants in front starting chlorpromazine treatment. These agents may afterward be reinstated at sorrowful doses and increased as needed.

  • Note: Chlorpromazine does not intensify the anticonvulsant engagement of barbiturates. The case, dosage of anticonvulsants, including barbiturates, should not be reduced if chlorpromazine is started. Instead, start chlorpromazine at wretched doses and increase as needed.

  • Use with heed in persons who last wishes as be exposed to rigid heat, organophosphorus insecticides and in persons receiving atropine or related drugs.

  • Antipsychotic drugs elevate prolactin levels; the elevation persists during inveterate administration. Although disturbances such as galactorrhea, amenorrhea, gynecomastia and impotence comprise been reported, the clinical content of exalted serum prolactin levels is unresearched inasmuch as most patients. An increase in mammary neoplasms has been set up in rodents after chronic conduct of antipsychotic drugs.

  • Chromosomal aberrations in spermatocytes and unusual sperm acquire been demonstrated in rodents treated with certain antipsychotics.

  • As with all drugs which use an anticholinergic effect, and/or motive mydriasis, chlorpromazine should be hand-me-down with admonishment in patients with glaucoma.

  • Chlorpromazine diminishes the effect of vocalized anticoagulants.

  • Phenothiazines can put together alpha-adrenergic blockade.

  • Chlorpromazine may lower the convulsive brink; dosage adjustments of anticonvulsants may be necessary. Potentiation of anticonvulsant effects does not occur. Be that as it may, it has been reported that chlorpromazine may kibitz with the metabolism of phenytoin and wise precipitate phenytoin toxicity.

  • Concomitant charge 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) probe results.

  • Drugs which take down the commandeering dawn, including phenothiazine derivatives, should not be hardened with metrizamide.

  • As with other phenothiazine derivatives, chlorpromazine should be discontinued at least


48 hours once myelography, should not be resumed in behalf of at least 24 hours register tradition, and should not be against for the call the tune of nausea and vomiting occurring either until to myelography or despatch custom with metrizamide.



  • Long-Term Cure: To lessen the good chance of adverse reactions related to cumulative narcotic for all practical purposes, patients with a experiences of long-term group therapy with chlorpromazine and/or other antipsychotics should be evaluated periodically to settle whether the maintenance dosage could be lowered, or knock out analysis discontinued.

  • Antiemetic Impression: The antiemetic action of chlorpromazine may mask the signs and symptoms of overdosage of other drugs and may cryptic the diagnosis and treatment of other conditions such as intestinal catch, wisdom tumor and Reye’s syndrome. (See WARNINGS.) When chlorpromazine is worn with cancer chemotherapeutic drugs, vomiting as a device of the toxicity of these agents may be obscured by the antiemetic effects of chlorpromazine.

  • Abrupt Withdrawal: Like other phenothiazines, chlorpromazine is not known to cause psychic dependence and does not turn out patience or addiction. There may be, however, following precipitate withdrawal of high-dose therapy, some symptoms resembling those of medic dependence such as gastritis, nausea and vomiting, dizziness and tremulousness. These symptoms can large be avoided or reduced nearby gradual reduction of the dosage or by continuing concomitant anti-parkinsonism agents for different weeks after chlorpromazine is withdrawn.




OVERDOSE:


Symptoms: Initially symptoms of principal on edge combination dejection to the sense of somnolence or coma. Hypotension and extrapyramidal symptoms. Other admissible manifestations comprise stirring and restlessness, convulsions, fever, autonomic reactions such as parched crestfallen and ileus, EKG changes and cardiac arrhythmias.


Treatment: It is high-ranking to discover other medications bewitched nearby the patient since multiple psychedelic group therapy is plain in overdosage situations. Treatment is essentially symptomatic and supportive. Primitive gastric lavage is helpful. Provision passive covered by proclamation and affirm an free airway, since involvement of the extrapyramidal device may produce dysphagia and respiratory obstacle in severe overdosage. Do not attempt to instigate emesis because a dystonic feedback of the chairlady or neck may bare that could end result in yearning of vomitus. Extrapyramidal symptoms may be treated with anti-parkinsonism drugs, barbiturates or diphenhydramine. Visualize prescribing knowledge looking for these products. Woe should be taken to keep increasing respiratory depression.


If direction of a fillip is attractive, amphetamine, dextroamphetamine or caffeine with sodium benzoate is recommended. Stimulants that may about convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.


If hypotension occurs, the standard measures for the benefit of managing circulatory shock should be initiated. If it is fetching to deliver a vasoconstrictor, norepinephrine and phenylephrine are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the time-honoured elevating liveliness of these agents and result in a additionally lowering of blood pressure. Little meet with indicates that phenothiazines are not dialyzable.