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Promethazine (Oral route)

Pronunciation:

proe-METH-a-zeen

Brand Names:

  • Phenergan
  • Promacot

Dosage Forms:

  • Syrup
  • Elixir
  • Tablet

Warnings:

Oral route(Syrup)

Promethazine hydrochloride plain oral solution should not be used in pediatric patients less than 2 years old because of the potential for fatal respiratory depression. Exercise caution when administering to pediatric patients 2 years or older and use at the lowest effective dose. Avoid concomitant use of other drugs with respiratory depressant effects .

Oral route(Tablet)

Promethazine hydrochloride should not be used in pediatric patients less than 2 years old because of the potential for fatal respiratory depression. Exercise caution when administering to pediatric patients 2 years or older and use at the lowest effective dose. Avoid concomitant use of other drugs with respiratory depressant effects .

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Antihistamine

Chemical—

Aliphatic

Uses of This Medicine:

Promethazine is used to relieve or prevent the symptoms of hay fever, allergic conjunctivitis (inflammation of the eye), and other types of allergy or allergic reactions. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can sometimes close up the bronchial tubes (air passages of the lungs) and make breathing difficult .

Promethazine is also used to prevent and control motion sickness, nausea, vomiting, and dizziness. In addition, it may be used to help people go to sleep and control their pain or anxiety before or after surgery or other procedures .

Promethazine may also be used for other conditions as determined by your doctor .

This medicine is only available with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of promethazine in the pediatric population. Safety and efficacy have not been established in children below 2 years of age. Caution should be used when this medicine is given to children 2 years of age and older .

Older adults—

Insufficient information is available on the relationship of age to the effects of promethazine in geriatric patients. However, elderly patients may be more sensitive to the side effects of this medicine (such as confusion and severe drowsiness) than in younger adults, and are more likely to have age-related heart or blood vessel disease, liver problems, and kidney disease, which may require adjustment of dosage in patients receiving promethazine .

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Cisapride
  • Dronedarone
  • Grepafloxacin
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Sodium Oxybate
  • Sparfloxacin
  • Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acrivastine
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Aripiprazole
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Carbinoxamine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Deslorelin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Erythromycin
  • Escitalopram
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Isradipine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Levorphanol
  • Lithium
  • Lopinavir
  • Lumefantrine
  • Meclizine
  • Mefloquine
  • Methadone
  • Metrizamide
  • Metronidazole
  • Mifepristone
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Posaconazole
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinine
  • Ranolazine
  • Salmeterol
  • Saquinavir
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Suvorexant
  • Tapentadol
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Toremifene
  • Tramadol
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Umeclidinium
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Voriconazole
  • Ziprasidone
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Belladonna
  • Belladonna Alkaloids
  • Betel Nut
  • Evening Primrose
  • Meperidine
  • Midodrine
  • Perampanel
  • Phenylalanine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Brain disease or injury or
  • Breathing or lung problems (e.g., asthma) or
  • Comatose state (unconscious) or
  • Reye's syndrome or
  • Sleep apnea, history of—Promethazine should NOT be used in patients with any of these conditions .
  • Bone marrow disease or
  • Enlarged prostate or
  • Glaucoma or
  • Heart or blood vessel disease or
  • Intestinal tract obstruction or
  • Jaundice or
  • Liver disease or
  • Neuroleptic malignant syndrome, or history of, or
  • Stomach ulcer or
  • Urinary tract blockage or difficult urination—Use with caution. This medicine may make these conditions worse .
  • Seizure disorders—This medicine may increase the chance of seizures especially in patients who are also using narcotic or anesthetic medicines .

Proper Use of This Medicine:

This medicine can be taken with food or a glass of water or milk to lessen stomach irritation if necessary.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For allergy symptoms:
      • Adults and teenagers—12.5 milligrams (mg) before meals and at bedtime; or 25 mg at bedtime as needed.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 6.25 to 12.5 mg three times a day; or 25 mg at bedtime as needed.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    • For prevention of motion sickness:
      • Adults and teenagers—25 mg twice daily; this initial dose should be taken one-half to one hour before traveling. The dose may be repeated eight to twelve hours later if needed. On other days of travel, 25 mg may be taken on arising and again before the evening meal.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 12.5 to 25 mg one-half to one hour before traveling. The dose may be repeated eight to twelve hours later if needed.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    • For nausea and vomiting:
      • Adults and teenagers—25 mg for the first dose, then 12.5 to 25 mg every four to six hours if needed.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 0.5 mg per pound of body weight (1.1 mg per kg) or 12.5 to 25 mg every four to six hours as needed.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    • For sedation:
      • Adults and teenagers—25 to 50 mg.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 12.5 to 25 mg.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    • For control of pain or anxiety before or after surgery:
      • Adults and teenagers—50 mg the night before surgery; 25 to 50 mg after surgery.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 0.5 mg per pound of body weight (1.1 mg per kg) or 12.5 to 25 mg the night before surgery or after the surgery.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not keep outdated medicine or medicine no longer needed.

Keep out of the reach of children.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects .

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor .

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, antidepressants, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

Check with your doctor right away if you have symptoms of pale or blue lips, fingernails, or skin; difficult or troubled breathing; irregular, fast, slow, or shallow breathing; or shortness of breath. These could be signs of a condition called respiratory depression .

Check with your doctor right away and stop taking your medicine (if directed by your doctor) if you have muscle stiffness, fever, difficult or fast breathing, seizures, fast heartbeat, increased sweating, loss of bladder control, unusually pale skin, or tiredness or weakness. These may be symptoms of a serious condition called neuroleptic malignant syndrome (NMS) .

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine .

This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections .

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .

This medicine controls nausea and vomiting. For this reason, it may cover up some of the signs of overdose caused by other medicines or the symptoms of encephalopathy or Reye's syndrome. This will make it difficult for your doctor to diagnose these conditions. Make sure your doctor knows that you are taking this medicine .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare
(Symptoms of neuroleptic malignant syndrome; two or more occur together; most of these effects do not require emergency medical attention if they occur alone )
Convulsions (seizures)
difficult or unusually fast breathing
fast heartbeat or irregular pulse
high fever
high or low (irregular) blood pressure
increased sweating
loss of bladder control
severe muscle stiffness
unusually pale skin
unusual tiredness or weakness

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
Abdominal or stomach pain
black, tarry stools
bleeding gums
blood in urine or stools
bloody nose
blurred vision
chest pain or discomfort
chills
clay-colored stools
confusion as to time, place, or person
cough or hoarseness
dark urine
decreased awareness or responsiveness
difficulty or troubled breathing
double vision
fast, pounding, or irregular heartbeat or pulse
fever with or without chills
fixed position of eye
headache
heavier menstrual periods
high fever
holding false beliefs that cannot be changed by fact
hyperexcitability
increased or decreased blood pressure
increased sweating
irregular, fast or slow, or shallow breathing
itching
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lightheadedness, dizziness, or fainting
loss of appetite
loss of bladder control
lower back or side pain
mimicry of speech or movements
mutism
nasal stuffiness
nausea
negativism
nightmares
noisy breathing
not breathing
painful or difficult urination
pale or blue lips, fingernails, or skin
peculiar postures or movements, mannerisms or grimacing
pinpoint red spots on skin
seeing double
seeing, hearing, or feeling things that are not there
seizures
severe muscle stiffness
severe sleepiness
shortness of breath
skin rash
slow or irregular heartbeat
sore throat
sores, ulcers, or white spots on lips or in mouth
sticking out of tongue
swollen glands
tightness in chest
tremors
uncontrolled twisting movements of neck
unpleasant breath odor
unusual bleeding or bruising
unusual excitement, nervousness, or restlessness
unusual tiredness or weakness
vomiting of blood
wheezing
yellow eyes or skin
Symptoms of overdose
Discouragement
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
dry mouth
excessive muscle tone
feeling of warmth
feeling sad or empty
irritability
lack of appetite
loss of interest or pleasure
muscle tension or tightness
overactive reflexes
pupils of eyes large and not moving or responding to light
redness of the face, neck, arms and occasionally, upper chest
shakiness and unsteady walk
sudden death
trouble concentrating
trouble sleeping
unconsciousness
unsteadiness, trembling, or other problems with muscle control or coordination
unusual paleness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
blistering, crusting, irritation, itching, or reddening of skin
continuing ringing or buzzing or other unexplained noise in ears
cracked, dry, scaly skin
dizziness
drowsiness
excitation
false or unusual sense of well-being
hearing loss
hives or welts
increased sensitivity of skin to sunlight
lack of coordination
loss of strength or energy
muscle pain or weakness
redness or other discoloration of skin
relaxed and calm
sunburn
swelling
unable to sleep
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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