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|Chlorpromazine Hydrochloride

Chlorpromazine Hydrochloride

Trade Names:
Chlorpromazine Hydrochloride
- Tablets 10 mg
- Tablets 25 mg
- Tablets 50 mg
- Tablets 100 mg
- Injection 25 mg/mL

Trade Names:
Thorazine
- Tablets 200 mg
- Suppositories 100 mg (as base)

Mechanism of Action

Pharmacology

Effects apparently caused by dopamine receptor blockade in CNS.

Indications and Usage

Management of manic phase of manic-depressive disorder; treatment of schizophrenia; relief of anxiety and restlessness prior to surgery; adjunct in treatment of tetanus; management of acute intermittent porphyria and severe behavioral and conduct disorders in children 1 to 12 years of age; control of nausea and vomiting; relief of intractable hiccoughs.

Unlabeled Uses

Treatment of migraine headaches (IM or IV forms).

Contraindications

Comatose or severely depressed states; allergy to product or other phenothiazines; presence of large amounts of other CNS depressants.

Dosage and Administration

IM 25 mg for prompt control; may repeat in 1 hr. PO 25 to 50 mg tid after initial regimen. May initiate oral dosing with 10 mg tid to qid or 25 mg bid or tid.

PO 0.5 mg/kg q 4 to 6 hr as needed; PR 1 mg/kg q 6 to 8 hr as needed; IM 0.5 mg/kg q 6 to 8 hr as needed.

PO 25 mg tid; increase as needed; usually 400 mg/day. IM 25 mg initially; may give additional 25 to 50 mg in 1 hr. Increase gradually until controlled. Up to 2,000 mg/day may be needed but generally not for extended periods.

PO Start low and increase gradually; 50 to 100 mg/day may be needed in severe cases or 200 mg/day or more in older children. IM Up to 5 yr of age: Do not exceed 40 mg/day. 5 to 12 yr of age: Do not exceed 75 mg/day if possible.

PO 25 to 50 mg tid or qid; IM 25 mg tid to qid.

IM 25 to 50 mg tid to qid usually in conjunction with barbiturates; IV 25 to 50 mg diluted to greater than or equal to 1 mg/mL and administered at rate of 1 mg/min.

IM/IV 0.5 mg/kg q 6 to 8 hr. When giving IV, dilute to at least 1 mg/mL and administer at rate of 1 mg per 2 min. In children 23 kg or under, do not exceed 40 mg/day; 23 to 45 kg, do not exceed 75 mg/day if possible.

PO 10 to 25 mg q 4 to 6 hr as needed. PR 100 mg q 6 to 8 hr as needed. IM 25 mg. If no hypotension, may give 25 to 50 mg q 4 to 6 hr as needed.

IM 12.5 mg; repeat in 0.5 hr if necessary and if no hypotension. IV 2 mg per fractional injection, at 2-min intervals (max, 25 mg). Dilute to 1 mg/mL (1 mL [25 mg]) mixed with 24 mL of saline.

PO 0.55 mg/kg q 4 to 6 hr. PR 1.1 mg/kg q 6 to 8 hr as needed. IM 0.55 mg/kg q 6 to 8 hr as needed. Do not exceed 40 mg/day if younger than 5 yr of age (or 20 kg) or 75 mg/day if 5 to 12 yr of age (or 20 to 40 kg).

IM 0.25 mg/kg. Repeat in 0.5 hr if necessary and no hypotension occurs. IV 1 mg per fractional injection at 2 minute intervals and not exceeding recommended IM dosage.

PO 25 to 50 mg 2 to 3 hr prior to surgery. IM 12.5 to 25 mg 1 to 2 hr before surgery.

PO 0.55 mg/kg 2 to 3 hr before surgery. IM 0.55 mg/kg 1 to 2 hr before surgery.

PO 25 to 50 mg tid to qid. IM May give 25 to 50 mg if symptoms persist 2 to 3 days. IV May use slow infusion if hiccoughs persist.

General Advice

• Administer tablets as prescribed, without regard to meals. Administer with food if GI upset occurs.
• Undiluted injection is for IM administration only. Inject prescribed dose slowly, deep into outer quadrant of buttock.
• Injection must be diluted, following manufacturer"s guidelines, before administering IV.
• Do not administer injection if particulate matter or marked discoloration noted. A slight yellowish discoloration is normal and will not alter potency.
• If injection is spilled on skin or clothing, rinse area immediately with water to prevent contact dermatitis.

Storage/Stability

Store tablets, suppositories, and injection at controlled room temperature (59° to 86°F). Protect injection from light. Refrigeration is not required.

Drug Interactions

May cause increased CNS depression and may precipitate extrapyramidal reaction.

May reduce therapeutic effects of and increase anticholinergic effects of chlorpromazine; may lead to tardive dyskinesia.

May increase frequency and severity of neuromuscular excitation and hypotension.

May result in increased plasma levels of beta-blocker and chlorpromazine.

The risk of life-threatening cardiac arrhythmias, including torsades de pointes, may be increased.

Actions of these drugs may be decreased or reversed.

The hypotensive effect of guanethidine may be inhibited.

May cause disorienting unconsciousness and extrapyramidal effects.

May result in excessive sedation and hypotension.

Risk of seizure may increase.

Plasma levels of chlorpromazine may be elevated, increasing the risk of side effects.

Laboratory Test Interactions

Chlorpromazine may discolor urine (pink to red-brown). False-positive pregnancy test results may occur (less likely with a serum test). Increases in protein-bound iodine have been reported. False-positive phenylketonuria test results may occur.

Adverse Reactions

Cardiovascular

Orthostatic hypotension; hypertension; tachycardia; bradycardia; syncope; cardiac arrest; circulatory collapse; ECG changes.

CNS

Faintness; drowsiness; dystonias; dizziness; extrapyramidal side effects (eg, pseudoparkinsonism, tardive dyskinesia); muscle spasms; motor restlessness; headache; weakness; tremor; fatigue; slurring; insomnia; vertigo; seizures; sedation; NMS; cerebral edema.

Dermatologic

Photosensitivity; skin pigmentation; dry skin; exfoliative dermatitis; urticarial rash; maculopapular hypersensitivity reaction; seborrhea; eczema; contact dermatitis.

EENT

Pigmentary retinopathy; glaucoma; photophobia; blurred vision; increased IOP; mydriasis; nasal congestion; miosis.

GI

Dry mouth; dyspepsia; constipation; adynamic ileus (with possible complications resulting in death); nausea; atonic colon; obstipation.

Genitourinary

Urinary retention and hesitancy; impotence; sexual dysfunction; menstrual irregularities; lactation; moderate breast engorgement; priapism; breast enlargement; galactorrhea.

Hematologic

Agranulocytosis; eosinophilia; leukopenia; hemolytic anemia; thrombocytopenic purpura; pancytopenia.

Hepatic

Jaundice.

Metabolic

Altered cholesterol levels.

Respiratory

Laryngospasm; bronchospasm; dyspnea, aspiration pneumonia; asthma; laryngeal edema.

Miscellaneous

Increased appetite and weight; polydipsia; heat stroke/hyperpyrexia; sudden death; angioneurotic edema; anaphylactoid reactions; systemic lupus erythematosus-like syndrome; increased prolactin levels.

Precautions

Pregnancy

Safety not established.

Lactation

Excreted in breast milk.

Children

Do not use in children younger than 6 mo of age unless considered life-saving. Do not use in conditions for which specific children"s dosage is not established.

Elderly

More susceptible to enhanced effects; consider lower dose.

Special Risk Patients

Use caution in patients with CV disease or mitral insufficiency, history of glaucoma, EEG abnormalities or seizure disorders, prior brain damage, or hepatic or renal impairment, or who will be exposed to extreme heat.

Abrupt withdrawal

Abrupt withdrawal of high-dose therapy may cause symptoms resembling physical dependence such as gastritis, nausea, vomiting, dizziness, and tremulousness. Avoid sudden discontinuation of therapy if possible. Attempt to gradually reduce dose if decision to discontinue medication is made.

Antiemetic effect

May mask the signs and symptoms of overdosage of other drugs and obscure the diagnosis and treatment of other conditions such as intestinal obstruction, brain tumor, or Reye syndrome.

Aspiration

As result of suppression of cough reflex, aspiration of vomitus possible.

Bedfast patient

Administer IM dose to patient who is bedfast. Keep patient lying down for at least 30 min after injection to minimize hypotensive effects.

Bone marrow suppression

Patients with bone marrow depression or who have previously demonstrated a hypersensitivity reaction with a phenothiazine should not receive chlorpromazine unless, in the judgment of the physician, the potential benefits outweigh the possible risks.

CNS effects

May impair mental or physical abilities, especially during the first few days of therapy. May lower convulsive threshold; dosage adjustments of anticonvulsants may be necessary.

Hepatic effects

Jaundice usually occurs between second and fourth weeks of treatment; considered hypersensitivity reaction. Usually reversible.

Hyperprolactinemia

Patients treated with antipsychotic agents often have elevation in prolactin levels; however, there is no evidence of increased breast tumor risk.

NMS

Has occurred with agents of this class; is potentially fatal. Signs and symptoms are hyperpyrexia, muscle rigidity, altered mental status, irregular pulse, irregular BP, tachycardia, and diaphoresis.

Tardive dyskinesia

Syndrome of potentially irreversible involuntary body and facial movements may develop. Prevalence highest in the elderly, especially women. Use smallest effective dose.

Overdosage

Symptoms

CNS depression, hypotension, extrapyramidal symptoms, agitation, restlessness, convulsions, fever, hypothermia, hyperthermia, coma, autonomic reactions, ECG changes, cardiac arrhythmias.

Patient Information

• Explain name, dose, action, and potential side effects of drug, including risk of developing tardive dyskinesia.
• Advise patient, family, or caregiver that dose will be adjusted periodically until max benefit has been obtained.
• Advise patient, family, or caregiver not to change the dose or stop taking unless advised by health care provider.
• Instruct patient not to stop taking chlorpromazine when feeling better.
• Instruct patient, family, or caregiver to immediately report fainting or loss of consciousness, palpitations, dizziness, high fever, muscle rigidity or unusual muscle movements, altered mental status, irregular pulse, sore throat or other signs of infection, bleeding or unusual bruising, or yellowing of the skin or eyes.
• Advise patient, family, or caregiver to notify health care provider of any of the following: excessive drowsiness, increased agitation or anxiety, involuntary body or facial movements.
• Advise patient to avoid strenuous activity during periods of high temperature or humidity.
• Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
• Instruct patient to get up slowly from lying or sitting position and to avoid sudden position changes to prevent postural hypotension. Advise patient to report dizziness with position changes to health care provider. Caution patient that hot tubs and hot showers or baths may make dizziness worse.
• Advise patient to take sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Advise patient that drug may cause drowsiness, impaired judgment or thinking skills, and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Caution patient that medication may cause sensitivity to sunlight and to avoid unnecessary exposure to UV light (sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light until tolerance is determined.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Instruct patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
• Advise patient that follow-up visits and lab tests may be required to monitor therapy and to keep appointments.