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promethazine Images

Generic Name: promethazine

Brand Names: Phenergan, Pentazine, Phenergan Fortis, Promacot, Phenadoz, Promethazine Hydrochloride, Prorex, Promethegan

There is an FDA Alert for this drug. Click here to view it.

    Children <2 Years of Age
  • Promethazine is contraindicated in pediatric patients <2 years of age, because of risk of developing potentially fatal respiratory depression.
    Respiratory Depression in Children <2 Years of Age
  • Postmarketing reports of respiratory depression, including fatalities, in pediatric patients <2 years of age receiving a wide range of weight-adjusted doses.
    Children ≥2 Years of Age
  • Administer with caution.
  • Use the lowest effective dose.
  • Avoid concomitant use with other respiratory depressant drugs.

    Warnings Regarding Parenteral Administration
  • Because of risk of severe tissue injury, including gangrene requiring amputation, following IV administration of promethazine, FDA states that the preferred route of administration is deep IM injection.

    Perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration of promethazine may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury, including burning or pain at the site of injection, phlebitis, swelling, and blistering. (See IV Administration under Dosage and Administration and see Precautions Associated with Parenteral Administration under Cautions.)

  • FDA has notified healthcare professionals that a Boxed Warning describing these risks is being added to the prescribing information for promethazine hydrochloride.

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