Adult Dosing
Allergic conditions
- 25 mg IM/IV; may repeat dose within 2 hrs if needed, for continuous therapy use oral route and adjust dosage to lowest effective dose
Nausea and vomiting
- 12.5 - 25 mg IM/IV, q4 hrs PRN
Note: Reduce dosage of analgesics and barbiturates when used for control of postoperative nausea and vomiting
Pre-operative and post-operative medication
- 25 - 50 mg IM/IV combined with appropriately reduced doses of analgesics and atropine-like drugs
Sedation
Obstetrics
- 50 mg IM/IV in early stages of labor; when labor is established, 25 - 75 mg with reduced dose of a narcotic, if necessary repeat with reduce dose of analgesic 1-2 times q4 hrs for normal labor [Max: 100 mg/24 hrs]
Notes:
- Chemical irritation and damage to tissues regardless of the route of administration have occurred
- Prefer deep IM injection
- Intra-arterial injection, SC injection is contraindicated
- Maximum concentration for IV is 25 mg/mL and max rate is 25 mg/min
- Immediately stop the injection if patient complains of pain during IV injection, evaluate for possible arterial injection or perivascular extravasation
- Avoid use if presence of particulate matter and discoloration on visual inspection during administration
- Refer specialized literature before diluting with any injectable solution or combining with any other medication, discard if precipitation or showing any signs of incompatibility
Pediatric Dosing
Allergic conditions
- Do not exceed 50% of the adult dose
Nausea and vomiting
Note: Reduce dosage of analgesics and barbiturates when used for control of postoperative nausea and vomiting
- 0.25-1 mg/Kg IM/IV q4-6 hrs PRN; do not exceed 50% of the adult dose
Pre-operative and post-operative medication
- 1 mg/kg IM/IV; do not exceed 50% of adult dosage
Sedation
- 12.5-25 mg IM/IV X 1. [MAX: 25 mg/dose]
Notes:
- Safety and effectiveness in pediatric patients <2yrs of age have not been established
- Chemical irritation and damage to tissues regardless of the route of administration have occurred
- Prefer deep IM injection
- Intra-arterial injection, SC injection is contraindicated
- Maximum concentration for IV is 25 mg/mL and max rate is 25 mg/min
- Immediately stop the injection if patient complains of pain during IV injection, evaluate for possible arterial injection or perivascular extravasation
- Avoid use if presence of particulate matter and discoloration on visual inspection during administration
- Refer specialized literature before diluting with any injectable solution or combining with any other medication, discard if precipitation or showing any signs of incompatibility
- Administer drug with caution and use lowest effective dose in pediatric patients
2 yrs - Dosage should not exceed half that of the suggested adult dose
- Avoid antiemetics in vomiting of unknown etiology
[Outline]
See Supplemental Patient Information
- Contraindicated in pediatric patients with <2 yrs as fatal respiratory depression has occurred, respiratory depression have occurred due to wide-range of weight based doses in these patients, administer drug with caution in pediatric patients 2 yrs [US Black Box Warning]
- Severe chemical irritation and damage to tissues have occurred irrespective of route of administration; perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration can cause irritation and damage [US Black Box Warning]
- Use lowest effective dose in pediatric patients 2 yrs and avoid concomitant use with other respiratory depressant drugs [US Black Box Warning]
- Avoid use in patients with compromised respiratory function or having risk for respiratory failure as fatal respiratory depression has occurred
- Burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, phlebitis, thrombophlebitis, venous thrombosis, abscesses, tissue necrosis, and gangrene have occurred
- Surgical intervention, including fasciotomy, skin graft or amputation may be required in severe cases (US Black box warning)
- Prefer deep intramuscular injection over intravenous route of administration, prohibit subcutaneous route of administration, severe chemical irritation and damage to tissues have occurred irrespective of route of administration, avoid perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration as pain, severe irritation, damage, severe spasm of distal vessels, and resultant gangrene have occurred [US Black Box Warning]
- Blood is discolored on administration of drug, aspiration of dark blood does not preclude intra-arterial needle placement
- Obscuration of typical arterial backflow have occurred on use of syringes with rigid plungers or small-bore needles
- Immediately stop the injection if patient complains of pain during IV injection, evaluate for possible arterial injection or perivascular extravasation
- Provide appropriate sympathetic block and heparinization for the acute management of unintentional intraarterial injection
- Avoid concurrent use of central-nervous-system depressants such as alcohol, sedative, hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers or reduce doses of such drugs when used with promethazine
- Lowers seizure threshold, avoid concomitant medications, such as narcotics or local anesthetics as they may also affect seizure threshold
- Results in bone marrow depression, leukopenia and agranulocytosis have occurred when used in association with other known marrow-toxic agents
- Avoid use of antiemetic drugs in pediatrics for unknown etiology and reserve only for prolonged vomiting
- Epinephrine should not be used to treat hypotension associated with the drug overdose
- Extrapyramidal symptoms have occurred, avoid use in pediatrics showing signs and symptoms of reye’s syndrome or other hepatic diseases
- Fatal neuroleptic malignant syndrome (NMS) has occurred in association with promethazine alone or in combination with antipsychotic drugs
- Carefully diagnose patients for serious medical illness (e.g. pneumonia, systemic infection, etc.) ,untreated or inadequately treated extrapyramidal signs and symptoms, central anticholinergic toxicity, heart stroke, drug fever, and primary central nervous system pathology
- Immediately discontinue antipsychotic drugs and other drugs not essential for concomitant therapy, provide intensive symptomatic treatment, carefully monitor patients and provide treatment for concomitant serious medical problems for management of NMS
- Carefully consider potential reintroduction of drug therapy in patients recovered from NMS as recurrences of NMS can occur
- Allergic reactions, anaphylactic symptoms and fatal, less severe asthma episodes have occurred in insusceptible patients
- Cholestatic jaundice has occurred on administration
- False-negative or false positive interpretations are possible during diagnosing pregnancy tests based on immunological reactions between HCG and anti-HCG
- Increase in blood glucose has occurred
Cautions: Use cautiously in
- Hepatic impairment
- Cardiovascular disease
- COPD
- Asthma
- Seizure disorders
- Lowered seizure threshold
- Bone-marrow depression
- Narrow angle glaucoma
- Prostatic hypertrophy
- Stenosing peptic ulcer
- Pyloroduodenal obstruction
- GI obstruction
- GU obstruction
- Bladder neck obstruction
- IV administration
- Hypersensitivity to sulfites
- Use of CNS depressant
- Pediatric
- Geriatric
Supplemental Patient Information
- Advise patients to avoid engaging in activities requiring mental alertness such as operating a hazardous machinery or driving an automobile
- Advise patients to immediately report persistent/worsening pain/burning at the injection site
- Avoid prolonged exposure to the sun
- Advise patients to report any involuntary muscle movements
Pregnancy Category:C
Breastfeeding: Possibly unsafe; however occasional short term use of promethazine would pose little risk to the breastfed infant. It may interfere with lactation if given in the early postpartum period. Other less potent antihistamines are preferred. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 November 2010). Manufacturer recommends discontinuation of breastfeeding or treatment taking into account the importance of the drug to the mother.
