Atarax

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Common side effects of hydroxyzine are:

• Sedation
• Tiredness
• Sleepiness
• Dizziness
• Disturbed coordination
• Drying and thickening of oral and other respiratory secretions
• Stomach distress

Other important side effects include:

• Confusion
• Dry mouth
• Nervousness
• Irritability
• Blurred vision
• Double vision
• Tremor
• Seizure
• Loss of appetite
• Nausea

Hydroxyzine should be used with caution (if at all) in persons with narrow-angle glaucoma, prostatic hypertrophy (enlarged prostate gland), hyperthyroidism, cardiovascular disease, hypertension, and asthma.

• Track Cold and Flu Symptoms Near You
• How Colds and Allergies Can Lead to Tinnitus
• Allergies and Chronic Inflammation

• 13 Best Quit-Smoking Tips Ever
• What Stress Does to Your Mouth
• Healthy Home: To Buy or Not to Buy Organic?

• Frequent Constipation?
• Greater Food Accessibility

• Cheshire Pharm. Systems

• Pfizer U.S. Pharmaceuticals Group

• Roerig

In the U.S.

• Atarax
• Vistaril

Available Dosage Forms:

• Tablet
• Syrup
• Capsule
• Suspension

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Antihistamine

Chemical Class: Piperazine (class)

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.

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

• Chest pain or discomfort
• cough
• difficulty with swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, or skin rash
• irregular or slow heart rate
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• tightness in the chest
• unusual tiredness or weakness

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

• Decreased awareness or responsiveness
• drowsiness
• nausea
• seizures
• severe sleepiness
• vomiting

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:

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Dry mouth
• headache
• seeing, hearing, or feeling things that are not there

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.

Available on request.

Rx only

LAB-0122-2.0
June 2006

Atarax (hydroxyzine) reduces activity in the central nervous system. It also acts as an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing and runny nose, or hives on the skin.

Atarax is used as a sedative to treat anxiety and tension. It is also used together with other medications given for anesthesia.

Atarax is also used to treat allergic skin reactions such as hives or contact dermatitis.

Atarax may also be used for purposes not listed in this medication guide.

Take Atarax exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Measure Atarax syrup with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

Summary of Use during Lactation

Small occasional doses of hydroxyzine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Other agents are preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

In one telephone follow-up study, mothers reported irritability and colicky symptoms 10% of infants exposed to various antihistamines and drowsiness was reported in 1.6% of infants. None of the reactions required medical attention.[1]

All adverse reactions in breastfed infants reported in France between January 1985 and June 2011 were compiled by a French pharmacovigilance center. Of 174 reports, hydroxyzine was reported to cause adverse reactions in 8 infants and to be one of the drugs most often suspected in serious adverse reactions, primarily sedation.[2]

Effects on Lactation and Breastmilk

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women.[3][4] However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers.[3] Whether lower oral doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Desloratadine, Fexofenadine, Loratadine

References

1. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

2. Soussan C, Gouraud A, Portolan G et al. Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014;70:1361-6. PMID: 25183382

3. Messinis IE, Souvatzoglou A, Fais N et al. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985;8:143-6. PMID: 3928731

4. Pontiroli AE, De Castro e Silva E, Mazzoleni F et al. The effect of histamine and H1 and H2 receptors on prolactin and luteinizing hormone release in humans: sex differences and the role of stress. J Clin Endocrinol Metab. 1981;52:924-8. PMID: 7228996