Mechanism of action :

Chlorpromazine improves psychotic conditions by blocking postsynaptic dopamine receptors in the mesolimbic area of the brain and producing alpha-adrenergic blockade and antihistaminic effects.

Pharmacokinetics :

Chlorpromazine is affected by first-pass metabolism (some metabolites are active).Protein binding is very high and excretes mainly into the urine and bile.

Contraindications :

Hypersensitivity to chlorpromazine, CNS depression, comatose states, hypothyroidism, pheochromocytoma.

Precautions to Consider :

Before using this medication , check with your doctor about the following cases :

If you have:

• You are allergic to Chlorpromazine Hydrochloride or any other phenothiazine.
• With some dental procedure,Chlorpromazine Hydrochloride induced blood dyscrasias may result in infections , delayed healing and bleeding . 
• Children especially those with acute illnesses ,are more prone to extrapyramidal symptoms 
• Elderly patients are more likely to develop extrapyramidal, anticholinergic , hypotensive and sedative effects ; reduced dosage recommended 

-Cardiovascular disease, severe hypertension or hypotension, Angina pectoris

-CNS depression 

-Comatose states

-Congenital long QT syndrome

-History of cardiac arrhythmias 

-known genetic defect leading to reduced levels of activity of P450 2D6 isozyme activity 

-Cardiac reserve deficiency, such as mitral insufficiency 

-Pheochromocytoma 

-Renal insufficiency 

-Conditions for which vomiting is a sign , such as : Brain tumor , Drug overdose , Intestinal obstruction 

-Reye’s syndrome 

-Glaucoma 

-Parkinson’s disease 

-Peptic ulcer 

-Urinary retention 

-Prostatic hypertrophy 

-Respiratory disorders,chronic , especially in children

-Seizure disorders,or history of 

-Hepatic function impairment

-Breast cancer

-Alcoholism active 

Pregnancy and breast feeding :

Class: C

Pregnancy :phenothiazines are not recommended for use during pregnancy. Phenothiazines cross the placenta. Although adequate and well-controlled studies in human have not been done ,there have been reports of prolonged jaundice, hyporeflexia or hyperreflexia،and extrapyramidal effects in the neonates of mothers who received phenothiazines during pregnancy.

Breast- feeding:

Phenothiazines are distributed into breast milk and may cause drowsiness or movement disorders in the nursing infant .Breast –feeding while receiving phenothiazines is not recommended during therapy with chlorpromazine.

Adverse effects :

The following side/adverse effect have been selected in the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate) –not necessarily inclusive .

Those indicating need for medical attention :

Incidence more frequent

Akathisia (restlessness or need to keep moving ) ;blurred vision associated with anticholinergic effect;dystonic extrapyramidal effects (muscle spasms of face,neck,body, arms or legs, causingunusual postures or expression on face; sticking out of tongue; tic-like or twitching movements ;trouble in breathing, speaking or swallowing; twisting movements of body; inability to move eyes); hypotension (fainting) ; ocular changes ; including deposition of opaque material in lens and cornea ; epithelial keratopathy ; or pigmentary retinopathy (blurred vision ;defective color vision ;difficulty seeing at night);Parkinsonian extrapyramidal effects (difficulty in speaking or swallowing ;loss of balance control ; mask-like face ;shuffling walk ; stiffness of arms or legs ;trembling and shaking of hands and fingers); tardive dyskinesia (lip smacking or puckering ; puffing of cheeks ; rapid or worm-like movements of tongue ; uncontrolled chewing movements;uncontrolled movements of arms or legs) ; or tardive dystonia(unusual facial expression or body position ; increased blinking or spasms of eyelid ; uncontrolled twisting movements of neck ,trunk ,arms or legs .

Incidence less frequent 

Difficulty in urinating : photosensitivity (skin rash ; severe sunburn); cholestatic jaundice 

Incidence rare 

Blood dyscrasias; including agranulocytosis ;leukocytopenia ; or thrombocytopenia (sore throat ;fever ;unusual bleeding or bruising ;unusual tiredness or weakness);cholestatic jaundice (abdominal or stomach pains; aching muscles and joints; fever and chills; severe skin itching ;yellow eyes or skin ; fatigue ; nausea ,vomiting or diarrhea ); dark urine; fever melanosis ( tanning or blue-gray discoloration of skin) ;neuroleptic malignant syndrome ( NMS) (difficult or fast breathing ; drooling ; fast heartbeat  ; fever;high or low [irregular] blood pressure ; impaired consciousness , ranging from confusion to coma ; increased sweating ; loss of bladder control ; severe muscle stiffness ; trembling or shaking; trouble in speaking or swallowing ) ; obstipation or paralytic ileus (severe constipation) ;paradoxical effects ; including aggravation of psychosis / agitation; bizarre dreams ; excitement ; and insomnia ( trouble in sleeping ) ;pneumonia (chest pain ; shortness of breath) –may be asymptomatic ;priapism (prolonged ,painful , inappropriate penile erection);QT prolongation  and torsades de pointes (irregular or slow heart rate ; recurrent fainting sudden death )–appears to be dose related ;seizures –more common in patients with a family history of seizures or febrile convulsions ; systemic lupus erythematosus –like syndrome ( fever ; hair loss , headache ; increasedsensitivity of skin to sunlight ;joint pain ; redness of hands ; skin rash ; sores in mouth  ; unusual tiredness or weakness ); temperature regulation dysfunction ; including heatstroke ( hot dry skin ; inability to sweat ; muscle weakness; confusion ); or hypothermia (clumsiness; confusion ; drowsiness ; muscle weakness ; shivering )

Drug interaction:

• Alcohol, CNSdepressant such as anesthetics, antidepressants, Fluoxetine, Fluvoxamine, Paroxetine, Maprotiline, antithyroid agents, extrapyramidal reaction–causing medications such as Succinylcholin, Amantadine ,hypotension–producing medication, Levodopa, Litium, Metrizamide, Astemizole , Cisapride, Disopyramide, Erythromycin, Pimozide, Probucol, Procainamide, Quinidine, Anticholinergic medications , Amphetamines , Antacids , Anticoagulants, Anticonvulsants including barbiturates, Bromocriptine, Diuretics 

including thiazide, Opioid (narcotic ) analgesics ,Epinephrine.

Indications :

Chlorpromazine include treatment of psychotic disorders such as schizophrenia, nausea & vomiting, , nausea & vomiting during surgery, hiccups, porphyria, tetanus, migrains & headache

Dosage and administration:

Only for deep IM injection

Adult :

Psychotic disorders ( severe): Intramuscular, 25 to 50 mg, the dose being repeated in one hour if needed & every three to twelve hours thereafter as needed & tolerated. The dosage may be increased gradually over several days as needed & tolerated.

Nausea and vomiting ; Intramuscular, initially 25 mg in single dose, if the dose is well tolerated, 25 to 50 mg may be administered every three to four hours as needed & tolerated until vomiting stops.

Nausea and vomiting during surgery: Intramuscular,12.5 mg in a single dose, if no hypotension occurs, the dose may be repeated in 30 minutes as needed & tolerated.

Apprehension and restlessness , presurgical: Intramuscular, 12.5 to 25mg one to two hours before surgery. Hiccups, intractable: If hiccup persist after oral treatment, intramuscular 25 to 50 mg three or four times per day.

Porphyria , acute , intermittent: Intramuscular, 25mg every 6 to 8 hours until  patient can take oral therapy.

Tetanus: intramuscular, 25 to 50 mg three or four times per day, dose and frequency of administration may be increase gradually based on patient response.

Migraine headache (treatment): Intramuscular, 25 to 50 mg ( maximum 100 mg).

• Geriatric, emaciated, or debilitated patients usually require a lower initial dose & more gradual dosage titration than do younger & healthier patients.

Usual adults prescribing limits:

1 gram per day.

Although sometimes doses are increased gradually to 2 grams or more oer day for short periods, 1gram or less usually is sufficient for extended therapy. 

Pediatric dose:

Psychotic disorders or Nausea and vomiting ;

Children up to 6 months of age: dosage has not been established.

Children 6 months to 12 years of age: Intramuscular, 550 mcg/kg or 15mg per square meter of body surface area every 6 to 8 hours as needed.

Nausea and vomiting during surgery:

Children up to 6 months of age: dosage has not been established.

Children 6 months to 12 years of age: Intramuscular, 275 mcg/ kg body weight, the dose being repeated in 30 minutes as needed & tolerated

Apprehension and restlessness , presurgical

Children up to 6 months of age: dosage has not been established.

Children 6 months to 12 years of age: Intramuscular, 550 mcg / kg one to two hours before surgery.

Tetanus :

Children up to 6 months of age: dosage has not been established.

Children 6 months to 12 years of age: Intramuscular, 550 mcg / kg every 6 to 8 hours as needed.

Usual pediatric prescribing limits:

children 6 months to 5 years of age( up to 23 kg) 40 mg per day.

Children 5 to 12 years of age ( 23 to 46 kg) 75 mg per day, except in unmanageable cases.

Warnings : 

• Compliance with therapy; not taking more or less in the dose & duration than prescribed
• Possible drowsiness or blurred vision; caution when driving, using machines or doing other things requiring alertness or accurate vision
• Several weeks of therapy may be required to produce desired effects in treatment of mental or emotional conditions 
• Caution if any kind of surgery, dental treatment or emergency treatment is required; telling physician or dentist in charge about chlorpromazine because of possible drug interactions or hypotension 
• Avoiding use of alcoholic beverages or other CNS depressant during therapy 
• Possible dizziness or lightheadedness ( orthostatic hypotension ) ; caution when getting up suddenly from a lying or sitting position 
• Possible heatstroke: Caution during exercise ,hot weather or when taking hot baths 
• Possible hypothermia: Caution during prolonged exposure to cold
• Caution if any laboratory tests required; possible changes in ECG readings and interference with gonadorelin, metyrapone, phenylketonuria, and urine bilirubin test results
• Avoiding the use of over–the-counter medications for colds or allergies to prevent increased anticholinergic effects and risk of developing heatstroke
• Possible eye photosensitivity; wearing sunglasses that block ultraviolet light 
• Possible dryness of mouth; using sugarless gum or candy, ice or saliva substitute for relief ; checking with physician or dentist if dry mouth continues for more than 2 weeks 
• Possible skin photosensitivity ;avoiding unprotected exposure to sun ; using protective clothing; using a sunblock product that includes protection against both  UVA-caused photosensitivity reactions and UVB- caused sunburn reactions; avoiding use of sunlamps, tanning bed or tanning booth; checking with physician if sever reaction occurs.
• Avoid skin contact with liquid forms of this medication; contact dermatitis has resulted.
• Medications containing sulfites. Patients sensitive to sulfites may be sensitive to chlorpromazine hydrochloride injection products because of the sulfites preservatives present.
• Do not use if markedly discolored or if a precipitate is present.

Storage conditions :

Store below 30°C in original package. Protect from light & freezing .

Keep out of reach of children 

Package sizes :

Each box contains: 10 * 2 mL ampoules in 2 randos & leaflet

MAH: Oxin Darou Vesht Company

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