Get your patient on Hydroxyzine Pamoate - Hydroxyzine Pamoate capsule (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.

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.

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 post-marketing 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 post-marketing 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.

To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Hydroxyzine pamoate is a light yellow odorless powder, practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1- piperazinyl]ethoxy]ethanol 4,4 -methylenebis[3-hydroxy-2-naphthoate] (1:1) and can be structurally represented as follows:

Chemical Formula:

C ₂₁ H ₂₇ ClN ₂ O ₂ .C ₂₃ H ₁₆ O ₆

Molecular Weight: 763.29

Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, D&C Yellow #10), printing ink which contains shellac glaze ~45% (20% esterified) in Ethanol, iron oxide black, n-butyl alcohol, isopropyl alcohol, propylene glycol and ammonium hydroxide 28%); magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate.

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.

Hydroxyzine Pamoate Capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) are available as:

25 mg capsules: Hard gelatin capsules, green opaque cap, green opaque body, cap and body imprinted EP136 in black ink. They are supplied as follows:

Bottles of 120 Capsules: NDC 62135-816-12

50 mg capsules: Hard gelatin capsules, white opaque cap, green opaque body, cap and body imprinted EP112 in black ink. They are supplied as follows:

Bottles of 120 Capsules: NDC 62135-817-12

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light resistant containers (USP).

Manufactured for:

Chartwell RX, LLC.

Congers, NY 10920

L71907

Rev 01/2024