From the Guidelines
Contraindications for Phenergan (Promethazine)
Phenergan (promethazine) is contraindicated in pediatric patients under 2 years of age due to the risk of fatal respiratory depression 1.
- Other contraindications include:
- Known hypersensitivity to promethazine or other phenothiazines
- Concomitant use of monoamine oxidase inhibitors (MAOIs)
- History of sleep apnea or severe respiratory impairment
- Known prolonged QT interval or taking other medications that prolong the QT interval
Important Considerations
The "black box warning" regarding fatal respiratory depression in children younger than 2 years is a critical consideration when evaluating the use of Phenergan 1.
- Additionally, the use of Phenergan requires careful consideration of the patient's overall health status, including any history of respiratory impairment or sleep disorders.
- The potential for unpredictable responses and prolonged recovery associated with the use of phenothiazines, such as Phenergan, should also be taken into account 1.
From the FDA Drug Label
Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. PROMETHAZINE HYDROCHLORIDE TABLETS USP ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE
The contraindications for Phenergan (promethazine) are:
- Use in pediatric patients less than two years of age
- Comatose states
- Known hypersensitivity or idiosyncratic reaction to promethazine or other phenothiazines
- Treatment of lower respiratory tract symptoms, including asthma 2 2
From the Research
Contraindications for Phenergan (Promethazine)
There are several contraindications for Phenergan (promethazine) that have been identified in various studies, including:
- Concomitant use of monoamine oxidase inhibitors (MAOIs) due to the risk of serotonin syndrome 3, 4
- Use in patients with a history of thrombophlebitis or other blood clotting disorders, as promethazine can cause thrombophlebitis 5
- Use in patients with severe cardiovascular disease, as promethazine can cause hypotension and other cardiovascular effects
- Use in patients with epilepsy, as promethazine can lower the seizure threshold
- Use in patients with glaucoma, as promethazine can cause mydriasis
Warnings and Precautions
In addition to the contraindications listed above, there are several warnings and precautions that should be considered when using Phenergan (promethazine), including:
- Risk of photosensitivity reactions, particularly when used topically 6
- Risk of cytotoxicity, particularly with high doses or prolonged use 7
- Risk of metabolic bioactivation, which can increase the risk of adverse effects 7
- Risk of enantioselective effects, which can affect the toxicity and efficacy of the drug 7
Special Populations
Phenergan (promethazine) should be used with caution in certain special populations, including:
- Pediatric patients, as the risk of adverse effects may be increased 5
- Geriatric patients, as the risk of adverse effects may be increased due to age-related changes in physiology
- Pregnant or breastfeeding women, as the risk of adverse effects to the fetus or infant may be increased