Drug Name

Atarax (Hydroxyzine)

Generic Name

Hydroxyzine (hye-DROX-i-zeen)

Looks like

• Atarax 10 mg-orange, tablets
• Atarax 25 mg-green, tablets
• Atarax 50 mg-yellow, tablets
• Atarax 100 mg-red, tablets

Dosage Form

Tablets

Route Of Administration

ORAL

Imprint Code

Atarax;10 / Atarax;25 / Atarax;50 / Atarax;100

Size

7mm / 7mm / 9mm / 12mm

Alternatives

Pain
Ultram (Tramadol), Tramadol, Vicodin, Aleve (Naproxen), Percocet
Anxiety
Xanax, Lexapro (Escitalopram), Valium, Cymbalta (Duloxetine), Ativan
Nausea/ Vomiting
Ativan, Phenergan (Promethazine), Reglan (Metoclopramide), Zofran
Sedation
Ativan, Desyrel (Trazodone), Phenergan (Promethazine)

Drug Uses

Treating anxiety, for sedation before and after general anesthesia, and to treat itching due to certain allergic conditions, including hives and contact dermatitis (eg, poison ivy). It also may be used for other conditions as determined by your doctor.

Drug class

Atarax is an antihistamine. It works by affecting the brain to reduce anxiety. It also has other activities, including opening breathing tubes, relieving pain or allergy symptoms, and preventing or treating nausea and vomiting caused by motion sickness.

Contains

Inert ingredients for the tablets are: acacia; carnauba wax; dibasic calcium phosphate; gelatin; lactose; magnesium stearate; precipitated calcium carbonate; shellac; sucrose; talc; white wax. The 10 mg tablets also contain: sodium hydroxide; starch; titanium dioxide; Yellow 6 Lake. The 25 mg tablets also contain: starch; velo dark green. The 50 mg tablets also contain: starch; velo yellow. The 100 mg tablets also contain: alginic acid; Blue 1; polyethylene glycol; Red 3. The inert ingredients for the syrup are: alcohol; menthol; peppermint oil; sodium benzoate; spearmint oil; sucrose; water.

Chemical formula

Hydroxyzine hydrochloride is designated chemically as 1 - (p - chlorobenzhydryl) 4 - [2 - (2 - hydroxyethoxy) - ethyl] piperazine dihydrochloride.

Mechanism of Action

Atarax is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines.

Atarax is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity, and anti- histaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and Atarax's clinical effects are usually noted within 15 to 30 minutes after oral administration.

How Taken

Take sildenafil exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Sildenafil is usually taken when needed. It can be taken anywhere from 4 hours to one-half hour before sexual activity. Generally, it is taken 1 hour before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.
Taking sildenafil after eating a high-fat meal (such as a cheeseburger and french fries) may cause the medication to take a little longer to start working.
Do not take sildenafil more than once a day.
If you develop dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw) during sexual activity, refrain from further sexual activity and notify your doctor.
Contact your doctor or seek emergency medical attention for any erection that lasts longer than 4 hours. A sustained erection can damage the penis.
Grapefruit and grapefruit juice may interact with sildenafil. The interaction could lead to potentially adverse effects. You should discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Store this medication at room temperature away from moisture and heat.

Dosage

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50-100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50-100 mg daily in divided doses.

For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50-100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50-100 mg in adults, and 0.6 mg/kg in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient's response to therapy.

Overdose

The most common manifestation of Atarax overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and Levophed (levarterenol), or Aramine (metaraminol). Do not use epinephrine as Atarax counteracts its pressor action.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

Storage

Store Atarax at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light in a tightly closed container. Do not store in the bathroom. Keep Atarax out of the reach of children and away from pets.

How Supplied

Atarax Tablets

10 mg-orange tablets:
100's (NDC 0049-5600-66)

25 mg-green tablets:
100's (NDC 0049 - 5610 - 66),
500's (NDC 0049-5610-73)

50 mg-yellow tablets:
100's (NDC 0049-5620-66)

Atarax 100 Tablets

100 mg-red tablets:
100's (NDC 0049-5630-66)

What is the most important information I should know about Atarax (Hydroxyzine)?

Use Atarax as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Atarax by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Atarax and you are using it regularly, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Atarax.

What should I discuss with my doctor before taking Atarax (Hydroxyzine)?

Some medical conditions may interact with Atarax . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have asthma, glaucoma, difficulty urinating, urinary or intestinal blockage, a prostate disease, or a blood disease
• if you drink alcoholic beverages

Some MEDICINES MAY INTERACT with Atarax . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Sodium oxybate (GHB) because side effects such as an increase in sleep duration and slowed breathing may occur.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Atarax may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

No information about product pharmacokinetics.

Possible side effects

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); involuntary movements.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

What should I avoid while taking Atarax (Hydroxyzine)?

Atarax may increase the effects of alcohol. Avoid alcohol while taking Atarax.

If Atarax is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Atarax with the following:

Barbiturates such as Seconal and Phenobarbital
Narcotics such as Demerol and Percocet
Non-narcotic analgesics such as Motrin and Tylenol

Contraindications

Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to it.

Warnings

Nursing Mothers
It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

For Tablets Only
This product is manufactured with 1,1,1-trichloroethane, a substance which harms public health and the environment by destroying ozone in the upper atmosphere.

Precautions

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore when central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced.

Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Atarax. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

Geriatric Use
A determination has not been made whether controlled clinical studies of Atarax included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The extent of renal excretion of Atarax has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of Atarax and observed closely.

Most important fact about Atarax

Atarax is not intended for long-term use (more than 4 months). Your doctor should re-evaluate the prescription periodically.

Special warnings about Atarax

Atarax increases the effects of drugs that depress the activity of the central nervous system. If you are taking narcotics, non-narcotic analgesics, or barbiturates in combination with Atarax, their dosage should be reduced.

This medication can cause drowsiness. Driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended until you know how you react to Atarax.

Special information if you are pregnant or breastfeeding

Although the effects of Atarax during pregnancy have not been adequately studied in humans, birth defects have appeared in animal studies with Atarax. You should not take Atarax in early pregnancy. If you are pregnant or plan to become pregnant, inform your doctor immediately. Atarax may appear in breast milk and could affect a nursing infant. If Atarax is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished.

References

References and complaints