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Medication Written by Pharmacists Reviewed by Doctors

GENERIC NAME: promethazine

BRAND NAME: Phenergan

DRUG CLASS AND MECHANISM: Promethazine is a phenothiazine in the same class of drugs as chlorpromazine (Thorazine) and trifluoperazine (Stelazine); however, unlike the other drugs in this class, promethazine is not used clinically as an anti-psychotic. It acts as an anti-histamine, a sedative, and an anti-emetic (anti-nausea). Promethazine is used principally as an anti-emetic, to prevent motion sickness or as an anti-histamine in combination with other medications in cough and cold preparations. Promethazine was approved by the FDA in 1951.

PRESCRIPTION: yes

GENERIC AVAILABLE: yes

PREPARATIONS: Tablets: 12.5, 25, and 50 mg.  Suppositories: 25mg. It also is available as an injectable medication.

STORAGE: Tablets and suppositories should be stored between 2° (36°F) and 30°C (86°F).

PRESCRIBED FOR: Promethazine is used to prevent motion sickness, nausea or vomiting, itching associated with allergies or for sedation.

DOSING: Tablets may be taken with or without food. Suppositories are unwrapped and moistened with water before insertion into the rectum. If the suppository is too soft from being stored in a warm place, it can be hardened by chilling in the refrigerator for 20 to 30 minutes or placing in cold water before the wrapper is removed.

For prevention of motion sickness, a tablet or suppository should be used 30 to 60 minutes before the motion begins and then every 8 to 12 hours as needed. For sedation, it is given at bedtime. For other problems, for example, itching, it can be given every 4 to 8 hours.

Promethazine should not be used in children less than two years of age because it can depress respiration and has caused fatalities in children under two.  It should be used cautiously in children older than two.

DRUG INTERACTIONS: Promethazine should not be taken with any of the MAO (mono-amine oxidase) inhibitor-class of antidepressants, for example, isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and procarbazine (Matulane), since the effects of both drugs add to each other and lead to complications.

Excessive anti-cholinergic effects (described below) can occur when promethazine is used with any of the following: some antihistamines, e.g., carbinoxamine (Rondec), clemastine (Tavist), diphenhydramine (Benadryl); some phenothiazines, e.g., thioridazine (Mellaril), triflupromazine (Stelazine); some tricyclic antidepressants, e.g., amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), protriptyline (Vivactil); clozapine (Clozaril), cyclobenzaprine (Flexeril), and disopyramide (Norpace). Anticholinergic side effects are listed under SIDE EFFECTS below.

Excessive sedation may occur when promethazine is combined with other medications that depress the central nervous system (brain). Such drugs include ethanol, barbiturates, anti-anxiety medications, sedatives, other phenothiazines, and narcotic pain medications.

There may be an increase in the risk of certain neurologic reactions that affect movement of muscles, called extrapyramidal symptoms (EPS), when promethazine is used together with other medicines which also cause these reactions. Such drugs include antipsychotics, metoclopramide (Reglan), and amoxapine (Asendin).

Promethazine should not be used with propylthiouracil (PTU) due to the increased risk of dangerous drops in the white blood cell count which can increase the risk of infections. The reason for this interaction is not known.

Concurrent use of promethazine with the dye used for myelography (x-rays of the spinal cord) can lower the threshold for seizures and thus increase the risk of seizures. Promethazine should be stopped at least 48 hours before myelography and not restarted until at least 24 hours after myelography.

PREGNANCY: There are no adequate studies of promethazine in pregnant women. However, studies in animals suggest no important effects on the fetus. Promethazine therefore can be used in pregnancy if the physician feels that it is needed. Anti-histamines in general are not recommended for use in pregnancy, especially during the third trimester, because they increase the risk for a seizure in the fetus.

NURSING MOTHERS: Anti-histamines are not recommended for use during breast-feeding because they can stimulate newborns or cause seizures in premature infants. Anti-histamines also inhibit lactation (production of breast milk).

SIDE EFFECTS: Promethazine often causes sedation and tiredness. In children less than two it can depress respiration and lead to death and, therefore, should not be used in children less than two years old.  Dizziness may also occur. Ironically, promethazine sometimes stimulates patients, particularly children. Such stimulation may be manifest by restlessness, inability to sleep, heart palpitations or even seizures.






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Last Editorial Review: 10/16/2005





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