Adult Dosing & Uses
Dosing Forms & Strengths
tablet
- 10mg
- 25mg
- 50mg
- 100mg
- 200mg
syrup
- 10m/5mL
oral concentrate
- 30mg/mL
- 100mg/mL
injectable solution
- 25mg/mL
suppository
- 25mg
Schizophrenia/Psychotic Disorders
PO: Initial 30-75 mg/day divided BID-QID, maintenance usually 200 mg/day (up to 800 mg/day in some patients); some patients may require 1-2 g/day
IV/IM: Initial 25 mg, follow PRN with 25-50 mg after 1 hour, then increase to maximum 400 mg/dose q4-6hr untile patient is controlled; usual dose is 300-800 mg/day
Nausea & Vomiting
PO:10-25 mg q4-6hr PRN
IV/IM: 25-50 mg q4-6hr PRN
PR: 50-100 mg q6-8hr PRN
Preoperative Apprehension
25-50 mg PO 2-3 hours before surgery
12.5-25 mg IM 1-2 hours before surgery
During Surgery
12.5 IM q30min OR 2 mg IV q2min (no more than 25 mg)
Intractable Hiccups
25-50 mg PO TID-QID
Persistent: 25-50 mg IM/IV
Acute Intermittent Porphyria
25-50 mg PO TID-QID
Other Indications & Uses
Tetanus
Off-label: Phencyclidine (PCP) psychosis, migraine HA
Pediatric Dosing & Uses
Dosing Forms & Strengths
tablet
- 10mg
- 25mg
- 50mg
- 100mg
- 200mg
syrup
- 10m/5mL
oral concentrate
- 30mg/mL
- 100mg/mL
injectable solution
- 25mg/mL
suppository
- 25mg
Behavioral Disorders/Hyperactivity
<6 years old: Safety & efficacy not established
>6 years old: 50-100 mg/day PO/IM or 200 mg/day or more may be necessary in older patients in hospitalized patients; if outpatient, may administer 0.55 mg/kg (0.25 mg/lb) q4-6hr PRN
Nausea & Vomiting
<6 years old: Safety & efficacy not established
>6 years old: 0.55 mg/kg (0.25 mg/lb) PO/IM q4-6hr PRN OR 1.1 mg/kg PR q6-8hr PRN
Preoperative Apprehension
<6 years old: Safety & efficacy not established
>6 years old: 0.55 mg/kg (0.25 mg/lb) PO/IM OR 1.1 mg/kg PR 2-3 hours before surgery
Drug Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Frequency Not Defined
Extrapyramidal Symptoms
- Akathisia (60%)
- Dystonia
- Muscle stiffness
- Neuroleptic Malignant Syndrome (infrequent but serious)
- Parkinsonism
- Tardive dyskinesia
Common
- Anticholinergic effects
- Sedation
- Wt gain
- Erectile dysfunction
- Oligomenorrhea/amenorrhea
Less Common
- Cerebral edema, orthostatic hypotension (post-IM inj), tachycardia
- Agitation, anxiety, depression, dizziness, euphoria, headache, insomnia, poikilothermia, restlessness, weakness
- Anorexia, constipation, dyspepsia, ileus
- Lens opacities (prolonged use)
Uncommon
- ECG changes
- Photosensitivity
- Pruritis
- Galactorrhea
- Ejaculatory d/o
- Diarrhea
- Blood dyscrasia
Rare
- Seizure
- Priapism
- Cholestatic jaundice
Contraindications & Cautions
Black Box Warnings
Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials. The deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.
This drug is not approved for the treatment of patients with dementia-related psychosis.
Contraindications
Hypersensitivity to phenothiazines
Coma, severe hypotension, severe CNS depression, concurrency with large amounts of CNS depressants, subcortical brain damage, poorly controlled seizure disorder
Severe cardiovascular disease
Lactation
Cautions
Avoid using in children with suspected Reye's syndrome
Glaucoma, prostatic hypertrophy, stenosing PUD, history of neuroleptic malignant syndrome, Parkinson's disease, hypocalcemia, renal/hepatic impairment, pts who have exhibited a severe reaction to insulin or ECT, history of seizures, asthma, respiratory tract infections, cardiovascular disease, myelosuppression
Risk of extrapyramidal symptoms, neuroleptic malignant syndrome, hypotension
Hypotension may be particularly severe in pts. with pheochromocytoma or mitral insufficiency
Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia
In case of severe hypotension, use norepinephrine or phenylepinephrine, do NOT use epinephrine or dopamine
Antiemetic effect may obscure toxicity of chemotherapeutic drugs
May need anticholinergic antiparkinsonian agent to counter EPS
Strong anticholinergic & alpha blocker
Potential for priapism
FDA Warning regarding off-label use for dementia in elderly
Pregnancy & Lactation
Pregnancy Category: C
Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery
These complications vary in severity; in some cases, symptoms have been self-limited, while in other cases neonates have required intensive care unit support and prolonged hospitalization
Lactation: enters breast milk/not recommended (AAP states "of concern")
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Half-Life: 30 hr
Onset: 30-60 min
Duration: 4-6 hr; 10-12 hr (ext. rel); 3-4 hr (PR)
Bioavailability: extensive 1st-pass metabolism
Protein Bound: 92-97%
Metabolism: hepatic P450 enzyme CYP2D6
Metabolites: 10-12 different compounds
Excretion: urine
Mechanism of Action
Phenothiazine; dopamine D2 receptor antagonist
IV & IM Information
Direct IV Injection Only For
N/V control during surgery to control
Adjunctive treatment of tetanus
IV Administration
Direct IV: dilute with NS to a concentration not exceeding 1 mg/mL and administere at a rate of 1 mg/min in adults and 0.5 mg/min in children. Avoid administration of undiluted drug
Infusion: add appropriate dose to 500-1000 mL of NS and administered slowly
Other Information
IV infusion is only for adjunctive treatment of intractable hiccups in adults
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