GENERIC NAME: promethazine

BRAND NAME: Phenergan, Phenadoz, Promethegan

DRUG CLASS AND MECHANISM: Promethazine is a phenothiazine in the same drug class

as chlorpromazine (Thorazine) and trifluoperazine (Stelazine). However, unlike the other drugs in this
class, promethazine is not used as an anti-psychotic. It used as an anti-histamine, sedative,
and antiemetic (anti-nausea). The body releases histamine during several types of allergic reactions.
When histamine binds to its receptors on cells, it stimulates changes within the cells that lead to
sneezing, itching, and increased mucus production. Antihistamines such as promethazine compete with
histamine for one of the receptors for histamine (the H1 receptor) on cells. However, when the
antihistamines bind to the receptors they do not stimulate the cells. Instead, they prevent histamine from
binding and stimulating the cells. Promethazine also blocks the action of acetylcholine (anticholinergic
effect), and this may explain its benefit in reducing the nausea of motion sickness. It is used as a sedative
because it causes drowsiness as a side effect. The FDA approved promethazine in 1951

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Tablets: 12.5, 25, and 50 mg; Suppositories: 12.5, 25, and 50 mg; Syrup: 6.25 mg/5
ml; Injection: 25 and 50 mg/ml.

STORAGE: Tablets, syrup and injection should be stored at room temperature between 15-25 C (68-77
F). Suppositories should be stored at 2-8 C (36-46 F).

PRESCRIBED FOR: Promethazine is prescribed for treating nausea or vomiting, motion sickness, and
allergic reactions and for sedation.

DOSING:

 Allergic reactions are treated with 6.25-25 mg 3 times daily. A single 25 mg dose administered at
bedtime also may suffice. 

 Nausea and vomiting may be managed with 12.5-25 mg administered every 4-6 hours as
needed. 

 Doses of 12.5-50 mg at bedtime are used for sedation. 

 For prevention of motion sickness, 25 mg is used 30 to 60 minutes before the motion begins and
then every 8 to 12 hours as needed. Oral, rectal and injectable doses are similar. 

 Promethazine injections are used when the oral route is not possible (for example, with severe
vomiting). 

 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 may be chilled in the refrigerator for 20 to
30 minutes or placed in cold water before the wrapper is removed.
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), andprocarbazine (Matulane), because of the increased risk of extrapyramidal
symptoms (EPS)--uncontrollable movement disorders.

Excessive anti-cholinergic effects (described below) can occur when promethazine is used with other
antihistamines, for example, diphenhydramine (Benadryl); some phenothiazines, for
example, thioridazine (Mellaril); some tricyclic antidepressants, for
example, amitriptyline (Elavil); clozapine (Clozaril), cyclobenzaprine (Flexeril),
and disopyramide (Norpace).

promethazine, Phenergan (cont.)

Excessive sedation may occur when promethazine is combined with other medications that depress the
central nervous system (brain) and cause sedation. 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
(EPS, see below) when promethazine is combined with medicines that also cause EPS. Such drugs
include antipsychotics,metoclopramide (Reglan), and amoxapine (Asendin).

Promethazine should not be used with propylthiouracil (PTU) due to the increased risk of low white blood
cell counts and increased 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. Administration of

promethazine within 2 weeks of delivery may affect platelet function in the newborn.

NURSING MOTHERS: It is not known whether promethazine is excreted in breast-milk.

SIDE EFFECTS: Promethazine often causes sedation. In children less than two it can depress respiration
and lead to death. Therefore, it 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 palpitationsor even seizures. Promethazine also
causes anticholinergic side effects such as blurred vision, dry mouth, dilated pupils, nausea, urinary
retention (inability to urinate), impotence, and constipation.

EPS may occur. EPS are categorized as dystonic reactions (alterations in muscle tone), sharp,
involuntary muscle movements (often limited to one muscle or muscle group), akathisia (subjective
restlessness), and Parkinsonism. Parkinsonian symptoms are more common in older persons whereas
children more often develop involuntary muscle movement reactions. Dystonic reactions are most
commonly seen during the first week of treatment. Restlessness and Parkinsonian symptoms usually
develop days to weeks after starting therapy.

A complex called neuroleptic malignant syndrome (NMS) can occur in patients receiving phenothiazines.
NMS consists of high body temperature, severe EPS, changes in consciousness and mental status, and
increased heart rate with low orhigh blood pressure. NMS occurs more frequently in young men and in
persons who are dehydrated.
Rarely, blood cell disorders can occur; low white cell counts can lead to severe infections.

Phenothiazines such as promethazine can cause skin hyperpigmentation (darkening) but usually only
after prolonged use. The effect usually is restricted to areas of the body exposed to sunlight. Thus, people
who need long-term treatment with promethazine should either keep out of the sun or use effective
sunscreens.

Phenothiazines can cause blurred vision, difficulty with nighttime vision, or changes in color vision.

Liver damage has been reported rarely with phenothiazines. Jaundice is possible. Jaundice also may
occur in newborns of mothers who receive phenothiazines during pregnancy.

Phenothiazines such as promethazine block dopamine receptors. This effect can lead to increases in
blood levels of prolactin, a hormone involved in lactation (formation of breast milk). As a result,
phenothiazines can cause the breast to produce fluid ("milk") even when a woman is not pregnant.
Additionally, phenothiazines can cause missed menstrual periods, breast enlargement or tenderness, loss
of sexual drive, impotence, inability to ejaculate, and priapism.Weight gain also may occur.

WARNING: Promethazine should not be used in children younger than 2 years since it might cause
serious (possibly fatal) slow/shallow breathing. This problem has occurred even with normal doses in this
age group. The lowest effective dosage should be used, and other drugs that affect breathing should be
avoided. Seek immediate medical attention in the unlikely event that slow/shallow breathing occurs.
In children, drugs for nausea should only be used in cases of prolonged vomiting when the cause is
known. Avoid use of promethazine in children with liver disease(including possible Reye's syndrome).
USES: Promethazine is used to prevent and treat nausea and vomiting related to certain conditions
(e.g., motion sickness, before/after surgery). It is also used to treat allergic symptoms such
as rash, itching, and runny nose. It may be used for a short time to treat a runny nose due to the common
cold. It may also be used to help you feel calmer before/after surgery or to help certain narcotic pain
relievers (e.g., meperidine) work better.Promethazine is an antihistamine. It works by blocking a certain
natural substance (histamine) that your body makes during an allergic reaction. Its other effects (e.g.,
anti-nausea, calming, pain relief) may work by affecting other natural substances (e.g., acetylcholine) and
by acting directly on certain parts of the brain.Cough-and-cold products have not been shown to be safe
or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in
children younger than 6 years unless specifically directed by the doctor. Some products (such as long-
acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor
or pharmacist for more details about using your product safely.These products do not cure or shorten the
length of the common cold and may cause serious side effects. To decrease the risk for serious side
effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give
other cough-and-cold medication that might contain the same or similar ingredients (see also Drug
Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms
(such as drinking enough fluids, using a humidifier or saline nose drops/spray).