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Drugs reference index «Antinaus 50»

Antinaus 50

Generic Name: promethazine (Injection route, Intravenous route)

proe-METH-a-zeen

Injection routeSolution

Promethazine hydrochloride injection, USP should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression.

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride injection, USP in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride injection, USP have resulted in respiratory depression in these patients.

Caution should be exercised when administering promethazine hydrochloride injection to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine hydrochloride injection be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided .

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

Oral routeSyrup

Promethazine hydrochloride plain oral solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression.

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.

Caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided .

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

Oral routeTablet

Promethazine hydrochloride should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression.

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.

Caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided .

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

Rectal routeSuppository

Promethazine hydrochloride should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression.

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.

Caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided .

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

Commonly used brand name(s):

In the U.S.

  • Antinaus 50
  • Phenergan
  • Promacot
  • Prorex

Available Dosage Forms:

  • Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antihistamine

Chemical Class: Aliphatic

Uses For Antinaus 50

Promethazine is used to relieve or prevent some 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 Antinaus 50

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.

Pediatric

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 .

Geriatric

No 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 than in younger adults, and are more likely to have age-related heart or blood vessel disease and/or prostate problems, 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.

Interactions with Medicines

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
  • Grepafloxacin
  • Sparfloxacin

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.

  • Fentanyl
  • Gatifloxacin
  • Isradipine
  • Levorphanol
  • Lithium
  • Methadone
  • Metrizamide
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Octreotide
  • Oxycodone
  • Pentamidine
  • Procarbazine
  • Tapentadol
  • Tramadol
  • 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
  • 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 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
  • 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 promethazine

This section provides information on the proper use of a number of products that contain promethazine. It may not be specific to Antinaus 50. Please read with care.

A nurse or other trained health professional will give you this medicine .

Precautions While Using Antinaus 50

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 contains sodium metabisulfite. Make sure your doctor knows if you have had an allergic reaction to sulfite in the past .

While being treated with this medicine, tell your doctor if you experience persistent or worsening pain or burning at the injection site or any involuntary muscle movements .

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 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 .

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 .

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 .

Antinaus 50 Side Effects

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 or nurse immediately if any of the following side effects occur:

Incidence not known
  • Abdominal or stomach pain
  • black, tarry stools
  • blood in urine
  • bloody nose
  • blurred vision
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • cough or hoarseness
  • dark urine
  • decreased awareness or responsiveness
  • difficulty breathing
  • difficulty in speaking
  • dizziness
  • double vision
  • drooling
  • fast, pounding, or irregular heartbeat or pulse
  • fever with or without chills
  • fixed position of eye
  • headache
  • heavier menstrual periods
  • increases and decreases in blood pressure
  • 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 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 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 lips or in mouth
  • stiffness of limbs
  • swollen glands
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
  • tightness in chest
  • tremors
  • twisting movements of body
  • uncontrolled movements, especially of face, neck, and back
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • wheezing
  • yellow eyes or skin
Symptom of overdose
  • Abnormal movements
  • confusion as to time, place, or person
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • 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 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. 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, or reddening of skin
  • continuing ringing or buzzing or other unexplained noise in ears
  • discoloration of skin
  • drowsiness
  • dry mouth
  • 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
  • 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.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

  • Promethazine Prescribing Information (FDA)
  • Phenadoz Prescribing Information (FDA)
  • Phenergan MedFacts Consumer Leaflet (Wolters Kluwer)
  • Phenergan Detailed Consumer Information (PDR)
  • Phenergan Prescribing Information (FDA)
  • Phenergan Consumer Overview
  • Promethegan Prescribing Information (FDA)

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