Promethazine w/Codeine(codeine phosphate, promethazine hcl) – Various
Contraindicated in pediatrics <6 yrs of age. Concomitant administration of promethazine products with other respiratory depressants is associated with respiratory depression, and sometimes death, in pediatrics. Respiratory depression, including fatalities, have been reported with use of promethazine in pediatrics <2 yrs.
OTHER BRAND NAMES
Prometh w/ Codeine (Actavis)
Temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold.
Adults: 5mL q4-6h. Max: 30mL/24hr. Elderly: Start at lower end of dosing range.
Pediatrics: ≥12 yrs: 5mL q4-6h. Max: 30mL/24hr. 6-<12 yrs: 2.5-5mL q4-6h. Max: 30mL/24hr.
Syrup: (Codeine Phosphate-Promethazine Hydrochloride) 10mg-6.25mg/5mL [118mL, 273mL, 473mL]
Comatose states, treatment of lower respiratory tract symptoms (eg, asthma), pediatric patients <6 yrs.
Should only be given to a pregnant woman if clearly needed. Caution in elderly. Codeine: Do not increase dose if cough fails to respond to treatment. May cause/aggravate constipation. Caution in atopic children. Capacity to elevate CSF pressure and respiratory depressant effects may be markedly exaggerated in head injury, intracranial lesions, or with preexisting increase in intracranial pressure. May obscure clinical course in patients with head injuries. Avoid with acute febrile illness with productive cough or in chronic respiratory disease. May produce orthostatic hypotension in ambulatory patients. Give with caution and reduce initial dose with acute abdominal conditions, convulsive disorders, significant hepatic/renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, recent GI or urinary tract surgery, and in the very young, elderly, or debilitated. Use lowest effective dose for the shortest period of time. Potential for abuse and dependence. Promethazine: May impair mental/physical abilities. May lead to potentially fatal respiratory depression; avoid with compromised respiratory function (eg, chronic obstructive pulmonary disease, sleep apnea). May lower seizure threshold; caution with seizure disorders. Leukopenia and agranulocytosis reported, especially when given with other marrow toxic agents; caution with bone marrow depression. Neuroleptic malignant syndrome (NMS) reported; d/c immediately if NMS occurs. Hallucinations and convulsions may occur in pediatrics. Acutely ill pediatric patients who are dehydrated may have increased susceptibility to dystonias. Cholestatic jaundice reported. Caution with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal/bladder-neck obstruction, cardiovascular disease, or with impaired liver function. May increase blood glucose.
Drowsiness, dizziness, sedation, blurred vision, dry mouth, increased or decreased BP, N/V, constipation, urinary retention, leukopenia, agranulocytosis, respiratory depression, NMS.
See Boxed Warning. Possible interaction with MAOIs (eg, increased incidence of extrapyramidal effects); consider initial small test dose. Promethazine: May increase, prolong, or intensify the sedative action of other CNS depressants, such as alcohol, sedative/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, TCAs, and tranquilizers; avoid such agents or administer in reduced doses. Reduce dose of barbiturate by at least 1/2 and narcotic analgesic by 1/4-1/2. May reverse vasopressor effect of epinephrine. Caution with other agents with anticholinergic properties and drugs that also affect seizure threshold (eg, narcotics, local anesthetics).
Category C, caution in nursing.
MECHANISM OF ACTION
Codeine: Narcotic analgesic/antitussive; primary effects are on CNS and GI tract. Promethazine: Phenothiazine derivative; blocks H1 receptor and provides sedative and antiemetic effects.
Absorption: Well-absorbed. Distribution: Codeine: Crosses placenta; found in breast milk. Metabolism: Codeine: Liver via O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. Promethazine: Liver; sulfoxides and N-demethylpromethazine (metabolites). Elimination: Codeine: Urine (primary; inactive metabolites and free/conjugated morphine), feces (negligible amount; parent compound and metabolites). Promethazine: Urine (metabolites).
Assess for drug hypersensitivity or idiosyncracy, history of drug abuse/dependence, or any other conditions where treatment is contraindicated or cautioned. Assess BP, pregnancy/nursing status, and for possible drug interactions.
Monitor for signs/symptoms of CNS and respiratory depression, constipation, leukopenia, agranulocytosis, cholestatic jaundice, seizures, NMS, orthostatic hypotension, and abuse and dependence. Monitor pediatric patients for hallucinations, convulsions, and dystonias. Monitor glucose levels. Reevaluate 5 days or sooner if cough is unresponsive to treatment.
Instruct to measure medication with an accurate measuring device. Inform that therapy may cause drowsiness and may impair mental and/or physical abilities required for performing potentially hazardous tasks (eg, driving, operating machinery); advise to avoid such activities until it is known that they do not become drowsy or dizzy with the therapy. Avoid the use of alcohol and other CNS depressants while on therapy. Report any involuntary muscle movements. Avoid prolonged sun exposure. Inform that therapy may produce orthostatic hypotension. Inform about risks and the signs of morphine overdose (extreme sleepiness, confusion, shallow breathing). Instruct nursing mothers to watch for signs of morphine toxicity in their infants (eg, increased sleepiness more than usual, difficulty breastfeeding, breathing difficulties, or limpness); notify pediatrician immediately if these signs are noticed or get emergency medical attention.
Administration: Oral route. Storage: 20-25°C (68-77°F).