Antinaus 50

Name: Antinaus 50

Uses For Antinaus 50

Promethazine injection 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 injection in the pediatric population. Use of promethazine injection is not recommended in children younger than 2 years of age because of the increased risk of respiratory depression. Caution should be used when this medicine is given to children 2 years of age and older.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of promethazine injection in the elderly. 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 or prostate problems, which may require an adjustment in the dose for patients receiving promethazine injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal 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

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 receiving 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.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Bromopride
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Saquinavir
  • Sodium Oxybate
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

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.

  • Alfentanil
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Bromazepam
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Butorphanol
  • Carbinoxamine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Codeine
  • Crizotinib
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dihydrocodeine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxylamine
  • Droperidol
  • Efavirenz
  • Erythromycin
  • Escitalopram
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Isradipine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Levorphanol
  • Lithium
  • Lopinavir
  • Lumefantrine
  • Meclizine
  • Mefloquine
  • Meperidine
  • Methadone
  • Metrizamide
  • Metronidazole
  • Mifepristone
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Nalbuphine
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Panobinostat
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Periciazine
  • Pimavanserin
  • Pitolisant
  • Posaconazole
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinine
  • Ranolazine
  • Remifentanil
  • Ribociclib
  • Salmeterol
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sufentanil
  • Sulpiride
  • Sunitinib
  • Tacrolimus
  • Tapentadol
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tiotropium
  • Toremifene
  • Tramadol
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vinflunine
  • Voriconazole
  • Zolpidem
  • Zuclopenthixol

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.

  • 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 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, 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 (very slow breathing) or
  • Stomach ulcer or
  • Urinary tract blockage or difficult urination—Use with caution. 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.

For the Consumer

Applies to promethazine: oral elixir, oral syrup, oral tablet

Other dosage forms:

  • rectal suppository
  • solution

Along with its needed effects, promethazine (the active ingredient contained in Antinaus 50) 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 promethazine 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 while taking promethazine:

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 of promethazine 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

Usual Adult Dose for Opiate Adjunct

Parenteral:
Pre- or postoperative use: 25 to 50 mg IM or IV once
Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals
-Maximum dose: 100 mg every 24 hours

Comments:
-The average parenteral dose given during established labor is 50 mg.
-Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent.

Uses:
-Administered IV as an adjunct to anesthesia or analgesia with reduced amounts of meperidine of other narcotic analgesics in special surgical situations (e.g., repeated bronchoscopy, ophthalmic surgery, poor-risk patients)
-Therapy adjunctive to meperidine or other analgesics for control of postoperative pain

Usual Pediatric Dose for Motion Sickness

2 years and older:
Treatment:
-Parenteral: 6.25 to 12.5 mg IM or IV every 4 hours a day

Treatment and prevention:
-Oral and Rectal: 12.5 to 25 mg orally or rectally 2 times a day

Comments:
-The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed.
-Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal.

Use:
-Active and prophylactic treatment of motion sickness

Usual Pediatric Dose for Nausea/Vomiting

2 years and older:
Treatment:
Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed
-Maximum dose: 25 mg

Parenteral: 6.25 to 12.5 mg IM or IV every 4 hours as needed

Prophylaxis: Up to 25 mg orally or rectally every 4 to 6 hours as needed

Comments:
-This drug should not be used to treat nausea and vomiting of unknown etiology.
-Doses should be adjusted to the age and severity of the patient.

Uses:
-Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery
-Antiemetic therapy in postoperative patients

Liver Dose Adjustments

Use with caution.

Dialysis

Data not available

Promethazine Pregnancy Warnings

Animal models have failed to reveal evidence of teratogenicity at doses 2.1 to 4.2 times the maximum recommended human dose. When animal models were given intraperitoneal doses, fetal mortality occurred. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Some experts recommend avoiding use 2 weeks prior to delivery due to reports of irritability, excitement, and inhibited platelet aggregation in exposed neonates. -High doses given later in pregnancy have resulted in prolonged neurological/extrapyramidal disturbances in the neonate.

Promethazine Identification

Substance Name

Promethazine

CAS Registry Number

60-87-7

Drug Class

Antiemetics

Phenothiazines

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