Drug Notebook

FDA Alerts

    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
  • 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.

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promethazine
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(pro METH a zeen)

Uses

Nasal Allergies and the Common Cold

Management of seasonal allergic rhinitis (e.g., hay fever) and perennial (nonseasonal) allergic rhinitis.

Management of seasonal nonallergic (vasomotor) rhinitis.

Symptomatic relief of rhinorrhea and sneezing associated with the common cold.

Other Allergic Conditions

Adjunct to epinephrine and other standard measures in the treatment of anaphylactic reactions after the acute manifestations have been controlled.

Used IM for management of other uncomplicated allergic reactions of the immediate type when oral therapy is impossible or contraindicated.

Prevention and treatment of mild, uncomplicated skin manifestations of urticaria and angioedema.

Management of allergic conjunctivitis caused by foods or inhaled allergens.

Treatment of mild transfusion reactions not caused by ABO incompatibility or pyrogens.

Treatment of dermatographism.

Sedation

Treatment to produce sedation in surgery and obstetrics (during labor); reduces preoperative tension and anxiety, facilitates sleep.

Routine sedation.

Pain

Adjunct to analgesics (e.g., opiates) for management of pain (e.g., postoperative).

Used IV as adjunct to analgesics (e.g., opiates) and anesthesia during surgery (e.g., bronchoscopy, ophthalmic surgery) and in poor-risk patients.

Motion Sickness

Prevention and treatment of nausea, vomiting, and/or vertigo associated with motion sickness.

Nausea and Vomiting

Prevention and management of nausea and vomiting of various etiologies (e.g., anesthesia, surgery, postoperative).

Hemolytic Disease of the Newborn

May ameliorate hemolytic disease of the newborn† (erythroblastosis fetalis) when administered during pregnancy in Rh-sensitized women.†

Dosage and Administration

Administration

Administer orally or rectally, or by IV or deep IM injection.

Do not administer subcutaneously or intra-arterially. (See Precautions Associated with Parenteral Administration under Cautions.)

IV Administration

Administer preferably through the tubing of a freely flowing IV infusion set.

Concentration of the injection should not exceed 25 mg/mL.

Rate of administration should not exceed 25 mg/minute. (See Cardiovascular Effects under Cautions.)

Dosage

Dosages of promethazine hydrochloride by the various routes of administration are identical.

Parenteral and rectal routes are used when oral administration is not feasible; institute oral therapy as soon as possible.

When used for management of common cold, administer only for short-term due to toxic potential of long-term therapy.

When used for allergic conditions, administer at bedtime because of pronounced sedative effects; adjust dosage to the smallest amount adequate to relieve symptoms.

Pediatric Patients

Common Cold

Oral

Children 2 to <6 years of age (as directed by a clinician): 1.56 mg every 4–6 hours.

Children 6 to <12 years of age: 3.125 mg every 4–6 hours.

Children ≥12 years of age: 6.25 mg every 4–6 hours.

Allergic Conditions

Oral

Children ≥2 years of age: up to 25 mg at bedtime or up to 12.5 mg 3 times daily (should be adjusted to age and weight). Alternatively, 0.5 mg/kg at bedtime or 0.125 mg/kg as needed.

Rectal , IM, or IV

May be administered rectally, by deep IM, or IV in dosages identical to oral dosages.

Sedation

Preoperative or Postoperative Sedation
Oral, Rectal, IM, or IV

Children ≥2 years of age: 12.5–25 mg or 0.5–1.1 mg/kg.

Routine Sedation
Oral or Rectal

Children ≥2 years of age: 12.5–25 mg or 0.5–1.1 mg/kg.

Pain

Adjunct to Analgesics
Oral, Rectal, IM, or IV

Children ≥2 years of age: 12.5–25 mg or 0.5–1.1 mg/kg; reduce analgesic dosage accordingly.

Motion Sickness

Oral or Rectal

Children ≥2 years of age: 12.5–25 mg or 0.5 mg/kg administered at least 30–60 minutes prior to departure. Administer a second dose 8–12 hours later if necessary; additional doses may be given on arising in the morning and before the evening meal for the duration of the journey.

Nausea and Vomiting

Oral or Rectal

Children ≥2 years of age: Usually, 1.1 mg/kg; should be adjusted to age, weight, and severity of condition. Alternatively, 0.25–0.5 mg/kg or 7.5–15 mg/m2 4–6 times daily.

IM or IV

Children ≥2 years of age: 0.25–0.5 mg/kg or 7.5–15 mg/m2 4–6 times daily.

Adults

Common Cold

Oral

6.25 mg every 4–6 hours.

Allergic Conditions

Oral

25 mg before retiring. Alternatively, 12.5 mg administered before meals and on retiring.

Rectal, IM, or IV

25 mg; dose may be repeated within 2 hours if necessary.

Transfusion Reactions

25 mg administered prior to or during a blood transfusion.

Sedation

Preoperative or Postoperative Sedation
Oral or Rectal

For preoperative sedation, a 50-mg dose may be administered the night before surgery and 50 mg usually is given before surgery.

For postoperative sedation, 25–50 mg is used.

IM or IV

25–50 mg.

Routine Sedation
Oral, Rectal, IM, or IV

25–50 mg.

Sedation in Obstetric Patients
IM or IV

50 mg administered during the early stage of labor. When labor is established, 25–75 mg is given with a reduced dose of an opiate agonist. 25–50 mg doses may be repeated once or twice at 4-hour intervals if necessary.

Pain

Adjunct to Analgesics
Oral, Rectal, IM or IV

25–50 mg; reduce analgesic dosage accordingly.

Motion Sickness

Oral

25 mg administered at least 30–60 minutes prior to departure. Administer 25 mg 8–12 hours later if necessary; additional doses may be given on arising in the morning and before the evening meal for the duration of the journey.

Nausea and Vomiting

Oral, Rectal, IM, or IV

12.5–25 mg; administer additional doses of 12.5–25 mg every 4–6 hours if necessary; reduce dosage of analgesics and barbiturates accordingly.

Hemolytic Disease of the Newborn

Oral

3.7–5 mg/kg daily (given to the nearest 25-mg multiple) has been given initially in 4 divided doses after the first trimester or the 16th week of gestation in Rh-sensitized pregnant women. In extremely severe cases, maintenance dosage as high as 6.5 mg/kg daily has been used.†

Prescribing Limits

Pediatric Patients

Common Cold

Oral

Maximum 9.36 mg in 24 hours for children 2 to <6 years of age.

Maximum 18.75 mg in 24 hour for children 6 to <12 years of age.

Maximum 37.5 mg in 24 hours for children ≥12 years of age.

Adults

Common Cold

Oral

Maximum 37.5 mg in 24 hours.

Sedation

Sedation in Obstetric Patients
IM or IV

Maximum 100 mg during a 24-hour period of labor.

Special Populations

Geriatric Patients

Use caution in dosage selection. Parenteral dosage should be reduced.

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