Adult Dosing
Coughs and upper respiratory symptoms
- 1 teaspoonful (5 mL) q 4-6 hrs
- Max dose: 30 mL in 24 hrs
Pediatric Dosing
- Contraindicated in pediatric patients <6 yrs of age
[Outline]
See Supplemental Patient Information
- Respiratory depression and death have been reported in children receiving codeine after tonsillectomy and/or adenoidectomy. These patients had an evidence of being ultra-rapid metabolizers of codeine resulting from a CYP2D6 polymorphism (US Black Box warning)
- Contraindicated in pediatric patients 16 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
- 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
- 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
- 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; 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 in pediatric patients
- Hallucinations and convulsions have occurred with therapeutic doses and overdoses with phenylephrine component
- Urinary retention has occurred in patients with symptomatic, benign prostatic hypertrophy
- False-negative or false-positive interpretations may result on diagnosing pregnancy tests based on immunological reactions between HCG and anti-HCG
- An increase in blood glucose may occur
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Diabetes mellitus
- Cardiovascular disease
- Heart diseases
- Patients with arteriosclerosis
- Ulcerative colitis
- Prostatic hypertrophy
- Patients with recent GI or urinary tract surgery
- Stenosing peptic ulcer
- Pyloroduodenal obstruction
- Bladder-neck obstruction
- Acute abdominal conditions
- Patients with bone-marrow depression
- Patients with initially poor cerebral or coronary circulation
- Patients taking diet preparations, such as amphetamines or phenylpropanolamine
- Atopic children
- Persons with seizure disorders
- Patients receiving tricyclic antidepressants
- Thyroid diseases
- Hypothyroidism
- Narrow-angle glaucoma
- Fever
- COPD
- Sleep apnea
- Addison disease
- Debilitated patients
- Very young patients
- Geriatrics
Supplemental Patient Information
- Advise patients to avoid engaging in activities requiring mental alertness such as operating hazardous machinery or driving an automobile
- Patients should be advised to report any involuntary muscle movements
- Advise patients to avoid prolonged exposure to the sun
Pregnancy Category:C
Breastfeeding: 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.Higher dosages of oral narcotics in mothers while breastfeeding can cause infant drowsiness. Newborn infants are particularly sensitive to the effects of even small dosages of narcotic analgesics, particularly in the first week of life. Newborn's dosage is limited by the small volumes of colostrum in the first 2-3 days postpartum. Once the mother's milk comes in, it is best to use a nonnarcotic analgesic and limit the maternal dosage and duration of treatment with codeine and combinations to 4 days. Mothers with ultrarapid CYP2D6 metabolism may excrete unexpectedly higher amounts of morphine into their milk after use of codeine and increase the risk of adverse effects in infant. Phenylephrine is unlikely to reach the infant in large amounts. Intravenous or oral administration of phenylephrine decreases milk production. Literature unavailable on the use of oral phenylephrine during breastfeeding, prefer an alternative drug, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7 January 2011). Manufacturer advises caution.
US Trade Name(s)
US Availability
codeine/phenylephrine/promethazine (generic)
- SYRUP: [10 mg/5 mg/6.25 mg]/5 mL
Prometh vc with codeine (codeine/phenylephrine/promethazine)
- SYRUP: [10 mg/5 mg/6.25 mg]/5 mL
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]