Promethazine/Codeine/Phenylephrine

DEA Class; Rx

Common Brand Names; Prometh VC with Codeine Syrup

Oral opioid antitussive (codeine), decongestant (phenylephrine), and phenothiazine-related antihistamine (promethazine) combination
Used for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in adults
Not indicated in pediatric patients under 18 years of age; contraindicated in neonates, infants and children less than 12 years of age; contraindicated in adolescents 12 to 18 years after tonsillectomy or adenoidectomy

Promethazine

• Hypersensitivity

• Children <12 years (risk of potentially fatal respiratory depression)

• Subcutaneous or intra-arterially administration

• BPH

• Narrow angle glaucoma

• Pyloroduodenal obstruction, stenosing peptic ulcer, bladder neck obstruction

• Severe CNS depression

• Coma

• Severe respiratory depression

Codeine

• Children <12 years

• Absolute: acute abdominal condition, diarrhea associated w/ toxins, pseudomembranous colitis, respiratory depression

• Postoperative use in children (<18 years) following tonsillectomy and/or adenoidectomy (see Black Box Warnings)

• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

• Significant respiratory depression

• Porphyria

• Treatment of lower respiratory tract symptoms, including asthma

• Known or suspected gastrointestinal obstruction, including paralytic ileus

Phenylephrine

• Hypersensitivity to phenylephrine or sulfites

• Severe hypertension

• Ventricular tachycardia

• Closed angle glaucoma

• Do not use within 14 days of MAO inhibitors

• Risk of hypertension

Concomitant use of opioids, including promethazine HCl and codeine phosphate oral solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome; available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

Codeine and its active metabolite, morphine, are present in human milk; there are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk