Promethazine/Codeine

DEA Class; Rx

Common Brand Names; 

Combination of an opiate agonist with antitussive activity (codeine) and a phenothiazine-structure antihistamine (promethazine)
Used together to relieve cough and upper respiratory symptoms due to conditions such as the common cold
Not indicated in pediatric patients under 18 years of age; contraindicated for cough and cold in neonates, infants and children less than 12 years of age; contraindicated in adolescent pediatric patients 12 to 18 years after tonsillectomy or adenoidectomy

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

Promethazine

• Hypersensitivity
• Children <12 years (risk of potentially fatal respiratory depression)
• Subcutaneous or intra-arterially administration
• Benign prostatic hypertrophy
• Narrow angle glaucoma
• Pyloroduodenal obstruction, stenosing peptic ulcer, bladder neck obstruction
• Severe CNS depression
• Coma, severe respiratory depression

Codeine

• Absolute: acute abdominal condition, diarrhea associated w/ toxins, pseudomembranous colitis, respiratory depression
• Relative: asthma (acute), inflammatory bowel disease, respiratory impairment
• Children <12 years
• Postoperative management in children <18 years following tonsillectomy and/or adenoidectomy
• 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

• Sedation (common)
• Confusion (common)
• Disorientation (common)
• Adverse anticholinergic effects (dry mouth, blurred vision)
• Photosensitivity
• EPS
• Tachycardia
• Bradycardia
• Leukopenia (rare)
• Agranulocytosis (rare)
• Obstructive jaundice
• Confusion
• Dizziness
• False feeling of well being
• Headache
• Lightheadedness
• Malaise
• Paradoxical CNS stimulation
• Restlessness
• Seizure (with excessive doses)
• Weakness
• Blurred vision
• Hypotension (especially with IV use)
• Tachycardia
• Bradycardia
• Dyspnea
• Respiratory depression
• Anorexia
• Nausea
• Vomiting
• Xerostomia

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

There is no information on effects of codeine milk production; because of potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, breastfeeding is not recommended during treatment