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Promethazine Hydrochloride Oral solution

It is used to treat allergic reactions and to treat or prevent nausea and vomiting from illness or m... more

Generic Name: promethazine  |  Brand Name: Promacot

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

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.

What is this medicine?

PROMETHAZINE (proe METH a zeen) is an antihistamine. It is used to treat allergic reactions and to treat or prevent nausea and vomiting from illness or motion sickness. It is also used to make you sleep before surgery, and to help treat pain or nausea after surgery.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • glaucoma
  • high blood pressure or heart disease
  • kidney disease
  • liver disease
  • lung or breathing disease, like asthma
  • prostate trouble
  • pain or difficulty passing urine
  • seizures
  • an unusual or allergic reaction to promethazine or phenothiazines, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine should not be given to infants and children younger than 2 years old.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
  • other phenothiazines like trimethobenzamide

This medicine may also interact with the following medications:

  • barbiturates like phenobarbital
  • bromocriptine
  • certain antidepressants
  • certain antihistamines used in allergy or cold medicines
  • epinephrine
  • levodopa
  • medicines for sleep
  • medicines for mental problems and psychotic disturbances
  • medicines for movement abnormalities as in Parkinson's disease, or for gastrointestinal problems
  • muscle relaxants
  • prescription pain medicines

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better in 1 to 2 days.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce the risk of dizzy or fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you are diabetic, check your blood-sugar levels regularly.


Last Updated: July 16, 2009
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