Atarax

Name: Atarax

Is hydroxyzine (Vistaril) safe to use during pregnancy or while breastfeeding?

  • A limited number of studies of hydroxyzine in pregnant women suggests that there may be a relationship between its use in the first trimester of pregnancy and congenital abnormalities in the fetus. Therefore, hydroxyzine should be avoided during the first trimester of pregnancy.
  • It is not known if hydroxyzine is excreted into breast milk. In general, antihistamines are not recommended for use during breastfeeding because they can cause stimulation or seizures in newborns.

Before Using Atarax

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydroxyzine in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydroxyzine in the elderly. However, elderly patients are more likely to have unwanted side effects (such as confusion, drowsiness) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydroxyzine.

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 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.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • 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
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Butorphanol
  • Carbinoxamine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dihydrocodeine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxepin
  • Doxylamine
  • Droperidol
  • Ebastine
  • Efavirenz
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Hydroquinidine
  • Hydroxychloroquine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Levorphanol
  • Lumefantrine
  • Meclizine
  • Mefloquine
  • Meperidine
  • Methadone
  • Metronidazole
  • Mifepristone
  • Mizolastine
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Nalbuphine
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Periciazine
  • Perphenazine
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Posaconazole
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Remifentanil
  • Ribociclib
  • Risperidone
  • Ritonavir
  • Sertindole
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sufentanil
  • Sulpiride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tiotropium
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Zolpidem
  • Zuclopenthixol

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:

  • Electrolyte imbalance or
  • Heart attack or
  • Heart disease or
  • Heart failure, uncompensated or
  • Heart rhythm problems (eg, long QT syndrome, slow heartbeat), or family history of—Use with caution. May cause side effects to become worse.
  • Heart rhythm problem (eg, prolonged QT interval)—Should not be used in patients with this condition.
  • Skin problems—Use with caution. May make these conditions worse.

Important information

You should not use Atarax if you are allergic to hydroxyzine, or if you are pregnant.

Before you take Atarax, tell your doctor if you have a seizure disorder, liver disease, or kidney disease.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Stop using Atarax and call your doctor at once if you have a serious side effect such as tremors, confusion, seizures, or restless muscle movements in your eyes, tongue, jaw, or neck.

Drinking alcohol can increase certain side effects of hydroxyzine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, nausea, vomiting, feeling like you might pass out.

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of Atarax.

For Healthcare Professionals

Applies to hydroxyzine: compounding powder, intramuscular solution, oral capsule, oral suspension, oral syrup, oral tablet

Nervous system

Very common (10% or more): Drowsiness/somnolence
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness, attention disturbance
Rare (less than 0.1%): Tremor, convulsions
Frequency not reported: Psychomotor impairment, paresthesia, extrapyramidal effects, seizure, coma, ataxia, slurred speech, bitter taste in mouth, faintness, vertigo
Postmarketing reports: Sedation, dyskinesia/involuntary motor activity[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth
Uncommon (0.1% to 1%): Constipation, nausea
Frequency not reported: Increased gastric reflux, diarrhea, epigastric pain, increased GI peristalsis
Postmarketing reports: Vomiting[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Asthenia
Frequency not reported: Lassitude, weakness, tinnitus, labyrinthitis, chills
Postmarketing reports: Malaise, pyrexia[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia
Frequency not reported: Sleep disturbances, depression, increased anxiety, nightmares, irritability
Postmarketing reports: Agitation, confusion, disorientation, hallucinations[Ref]

Cardiovascular

Frequency not reported: Palpitations, flushing, chest tightness
Postmarketing reports: QT interval prolongation, Torsade de Pointes and other ventricular arrhythmias, tachycardia, hypotension[Ref]

Dermatologic

Frequency not reported: Hair loss, eczema
Postmarketing reports: Pruritus, rash (erythematous, maculo-papular), urticaria, dermatitis, angioneurotic edema, increased sweating, fixed drug eruption, acute generalized exanthematous pustulosis, erythema multiforme, Stevens-Johnson syndrome[Ref]

Genitourinary

Frequency not reported: Dysuria
Postmarketing reports: Urinary retention[Ref]

Endocrine

Frequency not reported: Priapism, impotence, early menses[Ref]

Hematologic

Frequency not reported: Blood disorders (agranulocytosis, leucopenia, hemolytic anemia, thrombocytopenia)[Ref]

Hepatic

Frequency not reported: Liver dysfunction
Postmarketing reports: Abnormal liver function tests[Ref]

Metabolic

Frequency not reported: Prophyria, anorexia[Ref]

Hypersensitivity

Frequency not reported: Angioedema
Postmarketing reports: Allergic reaction, hypersensitivity reaction, anaphylactic shock[Ref]

Musculoskeletal

Frequency not reported: Myalgia[Ref]

Ocular

Postmarketing reports: Accommodation disorder, blurred vision[Ref]

Respiratory

Frequency not reported: Thickened respiratory tract secretions, wheezing, nasal stuffiness, throat dryness
Postmarketing reports: Bronchospasm[Ref]

Some side effects of Atarax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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