Classes
DEA Class; Rx
Common Brand Names; Promethazine DM
- Antitussives, Non-narcotic Combos
Description
Oral non-opioid antitussive and phenothiazine class sedating antihistamine combination
Used to relieve cough and upper respiratory symptoms of allergy or common cold
Boxed warning against use of promethazine in pediatric patients less than 2 years of age due to respiratory depression, including fatalities
Indications
Temporary relief of cough and upper respiratory tract symptoms associated with allergy or the common cold
Contraindications
Promethazine
Hypersensitivity
Newborn/premature infants, <2 years (risk of potentially fatal respiratory depression)
Subcutaneous or intra-arterial administration
BPH
Narrow angle glaucoma
Pyloroduodenal obstruction, stenosing peptic ulcer, bladder neck obstruction
Severe CNS depression
Coma, Severe respiratory depression
Dextromethorphan
Concurrent nonselective MAO inhibitors: serotonin syndrome
Adverse Effects
- Sedation
- Confusion
- Disorientation
- Blurred vision
- Hallucinations
- Dystonias
- Catatonic states
- Euphoria
- Excitation
- Extrapyramidal symptoms
- Tachycardia
- Bradycardia
- Leukopenia (rare)
- Agranulocytosis (rare)
- Obstructive jaundice
- Photosensitivity
- Dry mouth
- Angioneurotic edema
- Tardive dyskinesia
- Urticaria
- Xerostomia
- Impotence
- Urinary retention
Warnings
Promethazine
CVD, asthma, hepatic impairment, peptic ulcer, respiratory impairment
Anaphylaxis in susceptible individuals
May impair ability to drive or perform hazardous tasks
Monitor closely in patients with
-Cardiovascular disease
– Hepatic impairment
– Reye syndrome
– History of sleep apnea
Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia
Antiemetic effect may obscure toxicity of chemotherapeutic drugs
Dextromethorphan
Phenylketonuria: Contains aspartame
Pregnancy and Lactation
Pregnancy category: C
Lactation: Not recommended
Maximum Dosage
Do not exceed 30 mL/day PO (i.e., not to exceed promethazine 37.5 mg in combination with dextromethorphan 90 mg per 24 hours).
Do not exceed 30 mL/day PO (i.e., not to exceed promethazine 37.5 mg in combination with dextromethorphan 90 mg per 24 hours).
Do not exceed 30 mL/day PO (i.e., not to exceed promethazine 37.5 mg in combination with dextromethorphan 90 mg per 24 hours).
12 years: Do not exceed 30 mL/day PO (i.e., not to exceed promethazine 37.5 mg in combination with dextromethorphan 90 mg per 24 hours).
6 to 11 years: Do not exceed 20 mL/day PO (i.e., not to exceed promethazine 25 mg in combination with dextromethorphan 60 mg per 24 hours).
2 to 5 years: Do not exceed 10 mL/day PO (i.e., not to exceed promethazine 12.5 mg in combination with dextromethorphan 30 mg per 24 hours).
Less than 2 years: Contraindicated. Safety and efficacy have not been established.
Contraindicated.
How supplied
Promethazine/dextromethorphan
oral syrup
- (6.25mg/15mg)/5mL
dextromethorphan hydrobromide/promethazine hydrochloride
