Prorex (Injection, Intravenous)

Promethazine injection is used to relieve or prevent certain types of allergies or allergic reactions. It works by blocking a substance called histamine that the body produces. Histamine can cause symptoms like itching, sneezing, a runny nose, and watery eyes. It can sometimes cause the bronchial tubes (the air passages in the lungs) to narrow, making it hard to breathe.

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

Your doctor may also prescribe promethazine for other conditions.

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

It is very important for your doctor to check how you or your child are doing at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine contains sodium metabisulfite. Make sure your doctor knows if you or your child have ever had an allergic reaction to sulfite.

Contact your doctor immediately if you or your child have burning, persistent or worsening pain at the injection site, or any uncontrolled muscle movements after receiving this medicine.

This medicine may affect blood sugar levels. If you or your child notice a change in blood or urine sugar test results, or if you have any questions, consult your doctor.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that cause drowsiness or lessen alertness). Some examples of CNS depressants include antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, antidepressants, or sleeping medicines; prescription pain medicines or narcotics; medicines for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Speak with your doctor or dentist before taking any of these while you or your child are on this medicine.

Contact your doctor immediately if you or your child have pale or blue lips, fingernails, or skin; difficulty or troubled breathing; irregular, fast, slow, or shallow breathing; or shortness of breath. These could be signs of a condition called respiratory depression.

This medicine may cause some individuals to feel dizzy, lightheaded, drowsy, or less alert than usual. Even if taken at bedtime, it may cause some people to feel drowsy or less alert upon waking. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are not alert.

Promethazine can temporarily reduce the number of white blood cells in your blood, increasing the risk of infection. If possible, avoid close contact with people who have infections. Contact your doctor immediately if you or your child suspect an infection, or if you experience fever or chills, cough or hoarseness, pain in the lower back or side, or painful or difficult urination.

Contact your doctor right away if you or your child experience convulsions, difficulty breathing, a fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or extreme tiredness. These could indicate a serious condition called neuroleptic malignant syndrome (NMS).

Contact your doctor immediately if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellowing of the eyes or skin. These could be signs of a liver problem.

Before having any medical tests, inform the doctor in charge that you or your child are taking this medicine. The results of some tests may be influenced by this medicine.

This medicine may cause dry mouth. For temporary relief, try sugarless candy or gum, melting bits of ice in your mouth, or using a saliva substitute. However, if your mouth remains dry for more than 2 weeks, consult your doctor or dentist. Ongoing dry mouth may increase the risk of dental issues, including tooth decay, gum disease, and fungal infections.

This medicine may make your skin more sensitive to sunlight. Use sunscreen when outdoors and avoid sunlamps and tanning beds.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medications. As well inform 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of promethazine injection in the pediatric population. Use of promethazine injection is not advised in children younger than 2 years of age because of the increased risk of respiratory depression. Caution should be used when this drug is given to children 2 years of age and older.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of promethazine injection in the elderly. Nevertheless, elderly patients may be more sensitive to the side effects of this medication than in younger adults, and are more likely to have age-related heart or blood vessel disease or prostate problems, which may require an adjustment in the dose for patients receiving promethazine injection.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances before using this medicine while breastfeeding.

Interactions with Drugs

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are receiving this medication, it is especially critical that your healthcare professional know if you are using any of the medications 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 drugs is not recommended. Your doctor may decide not to treat you with this medication or change some of the other drugs you take.

• Bepridil
• Bromopride
• Calcium Oxybate
• Cisapride
• Dronedarone
• Levoketoconazole
• Magnesium Oxybate
• Mesoridazine
• Pimozide
• Piperaquine
• Potassium Citrate
• Potassium Oxybate
• Saquinavir
• Sodium Oxybate
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tranylcypromine
• Ziprasidone

Using this medication with any of the following medicines is typically not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the medications.

• Adagrasib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amantadine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Cannabidiol
• Cannabis
• Carbinoxamine
• Ceritinib
• Cetirizine
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clothiapine
• Clozapine
• Codeine
• Crizotinib
• Dabrafenib
• Daridorexant
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxylamine
• Droperidol
• Duloxetine
• Efavirenz
• Encorafenib
• Entrectinib
• Epinephrine
• Erythromycin
• Escitalopram
• Esketamine
• Etrasimod
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Isradipine
• Ivabradine
• Ivosidenib
• Ketamine
• Ketoconazole
• Lacosamide
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levorphanol
• Lithium
• Lofexidine
• Lopinavir
• Loxapine
• Lumefantrine
• Macimorelin
• Meclizine
• Mefloquine
• Meperidine
• Methacholine
• Methadone
• Metoclopramide
• Metrizamide
• Metronidazole
• Midazolam
• Mifepristone
• Mirtazapine
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Periciazine
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Porfimer
• Posaconazole
• Pregabalin
• Primidone
• Procainamide
• Procarbazine
• Prochlorperazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Revefenacin
• Ribociclib
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secretin Human
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tapentadol
• Telavancin
• Telithromycin
• Tetrabenazine
• Tiotropium
• Topiramate
• Toremifene
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zolpidem
• Zuclopenthixol
• Zuranolone

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

• Aminolevulinic Acid
• Belladonna
• Belladonna Alkaloids
• Betel Nut
• Evening Primrose
• Midodrine
• Phenylalanine

Interactions with Food/Tobacco/Alcohol

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 drugs may additionally 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 medication. Make sure you tell your clinician if you have any other medical issues, especially:

• Brain disease or injury or
• Breathing or lung issues (e.g., asthma, COPD) or
• Comatose state (unconscious) or
• Reye's syndrome or
• Sleep apnea, history of—Should not be used in patients with these conditions.

• Bladder-neck blockage or
• Bone marrow disease (e.g., agranulocytosis, leukopenia) or
• Enlarged prostate or
• Glaucoma, narrow-angle or
• Heart or blood vessel disease or
• Intestinal blockage or
• Liver disease (including jaundice) or
• Neuroleptic malignant syndrome, history of or
• Respiratory depression (extremely slow breathing) or
• Stomach ulcer or
• Urinary tract blockage or difficult urination—Use with caution. May make these conditions worse.

• Seizure disorders—This medication may increase the chance of seizures especially in patients who are also using narcotic or anesthetic medicines.

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

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

Rare

• Convulsions (seizures)
• difficult or unusually fast breathing
• fast heartbeat or irregular pulse
• high fever
• high or low blood pressure
• increased sweating
• loss of bladder control
• severe muscle stiffness
• unusually pale skin
• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain
• black, tarry stools
• blood in the urine
• bloody nose
• blurred vision
• chest pain or discomfort
• chills
• clay-colored stools
• cough or hoarseness
• dark urine
• decreased awareness or responsiveness
• difficulty with speaking
• dizziness
• double vision
• drooling
• fast, pounding, or irregular heartbeat or pulse
• fever with or without chills
• fixed position of the eye
• headache
• heavier menstrual periods
• increases and decreases in blood pressure
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness, dizziness, or fainting
• loss of appetite
• loss of balance control
• lower back or side pain
• mimicry of speech or movements
• muscle trembling, jerking, or stiffness
• mutism
• nausea
• negativism
• noisy breathing
• painful or difficult urination
• peculiar postures or movements, mannerisms, or grimacing
• pinpoint red spots on the skin
• restlessness
• seeing double
• seeing, hearing, or feeling things that are not there
• seizures
• severe sleepiness
• shortness of breath
• shuffling walk
• skin rash
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiffness of the limbs
• swollen glands
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• tightness in the chest
• tremors
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unpleasant breath odor
• unusual bleeding or bruising
• vomiting of blood
• wheezing
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptom of overdose

• Abnormal movements
• confusion as to time, place, or person
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• holding false beliefs that cannot be changed by fact
• hyperexcitability
• irregular, fast or slow, or shallow breathing
• nightmares
• pale or blue lips, fingernails, or skin
• pupils of the eyes, large and not moving or responding to light
• redness of the face, neck, arms, and occasionally, upper chest
• sweating
• troubled breathing
• unusual excitement, nervousness, or restlessness

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. Your healthcare professional may be able to tell you how to prevent or reduce some of these side effects. Check with your healthcare 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, or reddening of the skin
• continuing ringing or buzzing or other unexplained noise in the ears
• discoloration of the skin
• drowsiness
• dry mouth
• excitation
• false or unusual sense of well-being
• hearing loss
• hives or welts
• increased sensitivity of the skin to sunlight
• lack of coordination
• loss of strength or energy
• muscle pain or weakness
• nasal stuffiness
• nervousness
• severe sunburn
• sleeplessness
• trouble sleeping
• 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.

In the U.S.

• Antinaus 50
• Phenergan
• Promacot
• Prorex

Available Dosage Forms:

• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antihistamine

Chemical Class: Aliphatic

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into a muscle or into a vein.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

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