What is hydroxyzine?

Hydroxyzine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of itching, or hives on the skin. Hydroxyzine may be used to treat allergic skin reactions such as hives or contact dermatitis.

Since hydroxyzine also reduces activity in the central nervous system, it can be used as a sedative to treat anxiety and tension. It is also used together with other medications given during and after general anesthesia.

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

Warnings

Hydroxyzine may cause birth defects. Talk to you doctor before using hydroxyzine if pregnant or breastfeeding.

Hydroxyzine can cause a serious heart problem, especially if you use certain medicines at the same time. Tell your doctor about all your current medicines and any you start or stop using.

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

Stop using this medicine 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.

Before taking this medicine

You should not use hydroxyzine if you are allergic to it, or if:

• you have long QT syndrome;
• you are allergic to cetirizine (Zyrtec) or levocetirizine (Xyzal); or

Hydroxyzine could harm the unborn baby or cause birth defects. Talk to you doctor before using hydroxyzine if pregnant.

To make sure this medicine is safe for you, tell your doctor if you have:

• blockage in your digestive tract (stomach or intestines);
• bladder obstruction or other urination problems;
• glaucoma;
• heart disease, slow heartbeats;
• personal or family history of long QT syndrome;
• an electrolyte imbalance (such as high or low levels of potassium in your blood);
• if you have recently had a heart attack.

It is not known whether hydroxyzine passes into breast milk or if it could harm a nursing baby. Talk to your doctor before breastfeeding while using this medicine.

Do not give this medicine to a child without medical advice.

How should I take hydroxyzine?

Take hydroxyzine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Hydroxyzine is for short-term use only.

You should not take this medicine for longer than 4 months. Call your doctor if your anxiety symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

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

Overdose symptoms may include severe drowsiness, nausea, vomiting, uncontrolled muscle movements, or seizure (convulsions).

What to avoid

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

Drinking alcohol with this medicine can cause side effects.

Hydroxyzine side effects

Get emergency medical help if you have signs of an allergic reaction to hydroxyzine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydroxyzine may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have sudden skin redness or a rash that spreads and causes white or yellow pustules, blistering, or peeling.

Stop using hydroxyzine and call your doctor at once if you have:

• fast or pounding heartbeats;
• headache with chest pain;
• severe dizziness, fainting; or
• a seizure (convulsions).

Side effects such as drowsiness and confusion may be more likely in older adults.

Common hydroxyzine side effects may include:

• drowsiness;
• headache;
• dry mouth; or
• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect hydroxyzine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking hydroxyzine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Hydroxyzine can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine.

Other drugs may interact with hydroxyzine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Hydroxyzine Pamoate Description

Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4- [2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy- 3-naphthalene carboxylic acid).

Inert ingredients for the capsule formulations are: hard gelatin capsules (which may contain Yellow 10, Green 3, Yellow 6, Red 33, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.

Hydroxyzine Pamoate – Clinical Pharmacology

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

Hydroxyzine pamoate 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 antihistaminic 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 Hydroxyzine pamoate’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

Indications and Usage for Hydroxyzine Pamoate

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

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 in patients with a prolonged QT interval.

Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

Hydroxyzine is contraindicated in patients with known hypersensitivity to hydroxyzine products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.

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.

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

QT Prolongation/Torsade de Pointes (TdP)

Cases of QT prolongation and Torsade de Pointes have been reported during postmarketing use of hydroxyzine. The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.

Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).

Acute Generalized Exanthematous Pustulosis (AGEP)

Hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema. Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any other sign of hypersensitivity. If signs or symptoms suggest AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity.

Geriatric Use

A determination has not been made whether controlled clinical studies of Hydroxyzine pamoate 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 Hydroxyzine pamoate 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 Hydroxyzine pamoate and observed closely.

Adverse Reactions/Side Effects

Side effects reported with the administration of Hydroxyzine pamoate are usually mild and transitory in nature.

Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

Cardiac System: QT prolongation, Torsade de Pointes.

In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole: allergic reaction, Nervous System: headache, Psychiatric: hallucination, Skin and Appendages: pruritus, rash, urticaria.

Overdosage

The most common manifestation of overdosage of Hydroxyzine pamoate is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. 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 vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action.) Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects.

Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose.

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.

Hydroxyzine Pamoate Dosage and Administration

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 to 100 mg 4 times daily; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 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 3 times daily or 4 times daily; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 to 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.

How is Hydroxyzine Pamoate supplied

Hydroxyzine pamoate capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride)

Store below 30°C (86°F). Dispense in tight, light-resistant containers (USP).

This product’s label may have been updated. For full prescribing information, please visit www.greenstonellc.com.

LAB-1402-1.0
Revised: February 2020

PRINCIPAL DISPLAY PANEL – 100 Capsule Bottle Label (50mg)

NDC 59762-5420-1
100 Capsules

GREENSTONE® BRAND

hydroxyzine
pamoate
Capsules

50 mg*

Rx only

PRINCIPAL DISPLAY PANEL – 100 Capsule Bottle Label (25mg)

NDC 59762-5410-1
100 Capsules

GREENSTONE® BRAND

hydroxyzine
pamoate
Capsules

25 mg*

Rx only