Adult Dosing
Temporary relief of cough and upper respiratory symptoms associated with allergy or common cold
- 5 mL PO q4 - 6 hrs PRN
- Max: 30 mL/day
Pediatric Dosing
Temporary relief of coughs and upper respiratory symptoms associated with allergy or common cold
- Children < 6 years: Contraindicated
- Children 6-12 years: 2.5 mL - 5 mL PO q4 - 6 hrs PRN
- Max: 30 mL/day
[Outline]
See Supplemental Patient Information
- Contraindicated in pediatric patients less than 6 yrs of age. Concurrent administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have occurred with use of promethazine hydrochloride in pediatric patients <2 yrs of age; a wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression (US Black Box Warning)
- Avoid increasing dosage of codeine if cough fails to respond; reevaluate in 5 days or sooner for possible underlying pathology
- Aggravation of constipation may occur
- Respiratory depression leading to arrest, coma and death has occurred with the use of codeine antitussives in young children, particularly in <1 yr infants whose ability to deactivate the drug is not fully developed
- Administration of codeine is accompanied by histamine release; use cautiously in atopic children
- Respiratory depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure is markedly exaggerated in the presence of head injury, intracranial lesions, or a preexisting increase in intracranial pressure
- Avoid use of narcotic analgesics or cough suppressants, including codeine, in asthmatic patients, acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient’s respiratory function
- Orthostatic hypotension has occurred in ambulatory patients with use of codeine
- Avoid concomitant use or reduce dosages of alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers
- Potentially fatal respiratory depression has occurred with use of promethazine
- Avoid use in patients with compromised respiratory function
- Avoid concomitant use with drugs lowering seizure threshold
- Avoid use in association with known marrow-toxic agents as leukopenia and agranulocytosis have occurred
- Neuroleptic Malignant Syndrome (NMS) has occurred with use of promethazine; properly manage NMS by immediate discontinuation of therapy, providing intensive symptomatic treatment and medical monitoring and provide treatment for any concomitant serious medical problems
- Sudden death has occurred on excessively large dosages of antihistamines including promethazine in pediatric patients
- Hallucinations and convulsions have occurred with therapeutic doses and overdoses with promethazine component
- Promethazine has been associated with reports of cholestatic jaundice
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Diabetes mellitus
- Cardiovascular disease
- Convulsive disorders
- Fever
- Hypothyroidism
- Addison disease
- Ulcerative colitis
- Prostatic hypertrophy
- Patients with recent GI or urinary tract surgery
- Stenosing peptic ulcer
- Pyloroduodenal obstruction
- Bladder-neck obstruction
- Patients with bone-marrow depression
- Patients with initially poor cerebral or coronary circulation
- Atopic children
- Patients receiving tricyclic antidepressants
- Narrow-angle glaucoma
- Debilitated patients
- Very young patients
- Geriatrics
- Pregnancy
Supplemental Patient Information
- Advise patients to avoid engaging in activities requiring mental alertness such as operating hazardous machinery or driving an automobile
- Advise patients to avoid prolonged exposure to the sun
- Patients should be advised to report any involuntary muscle movements
Pregnancy Category:NR
Breastfeeding: It is not known whether this drug is excreted in human milk. According to manufacturer’s data a decision should be made whether to discontinue nursing or discontinue the drug, by analyzing risk and benefit ratio in nursing mothers; caution advised.
US Trade Name(s)
US Availability
codeine/promethazine (generic)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]