hydroxyzine pamoate 25 mg Capsule, 500-count — NDC 0185-0674-05 (Billing 00185-0674-05)
This is a package of 500 capsules of hydroxyzine pamoate 25 mg Capsule from Sandoz Inc, marketed since Dec 1981 and currently FDA-listed; retail pharmacies pay about $0.0636 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003731
- GCN: 13952
- GPI-14 (Medi-Span): 57200040200105
- HICL (First Databank): 001609
- AHFS class code: 04:04.00.00
- RxCUI (RxNorm): 995253
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antihistamine class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Taken by mouth, it's used for anxiety and tension, itching from allergic skin conditions like hives and eczema, and sedation around anesthesia. The injection has additional uses in...
- It can. Drowsiness is the most common effect, though it often fades in a few days or with a lower dose. Don't drive or use dangerous machinery until you know how it affects you.
- It's best not to. Hydroxyzine can strengthen alcohol, narcotics, barbiturates and other sedating drugs. Tell your prescriber about everything you take, since doses of some may need...
- Can I drink alcohol or take other sedating medicines with it?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.064 | $31.80 / 500 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.1922 | $96.10 / 500 capsules |
| Medicare drug plans payPart D · Q2 2026 | $0.1145 | $57.25 / 500 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00185-0674-01 0185-0674-01 | 100 CAPSULE in 1 BOTTLE | $0.0636 / ea | $6.36 | 2014-06-27 | — | Active |
| 00185-0674-05 You're viewing this Main listing | 500 CAPSULE in 1 BOTTLE | $0.0636 / ea | $31.81 | 2014-06-27 | — | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0636 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 56% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00185-0674-01?
What NDC number is used to bill for this package of hydroxyzine pamoate 25 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxyzine Pamoate 25 mg 00115-1803-01 | Amneal | 100 capsules | $0.064 | AB | Availability likely | — |
| hydroxyzine pamoate 25 mgthis 00185-0674-05 | Sandoz | 500 capsules | $0.064 | AB | Availability likely | — |
| Hydroxyzine Pamoate 25 mg 00555-0323-02 | Teva | 100 capsules | $0.064 | AB | Availability likely | — |
| hydroxyzine pamoate 25 mg 00904-7065-61 | Major | 100 capsules | $0.064 | AB | Availability likely | — |
| hydroxyzine pamoate 25 mg 14539-0674-01 | Heritage | 100 capsules | $0.064 | AB | Availability likely | — |
| Hydroxyzine Pamoate 25 mg 50268-0398-50 | AvPAK | 50 capsules | $0.064 | AB | Availability likely | — |
| Hydroxyzine Pamoate 25 mg 60687-0696-01 | American | 100 capsules | $0.064 | AB | Availability likely | — |
| Hydroxyzine pamoate 25 mg 62135-0816-12 | Chartwell | 120 capsules | $0.064 | AB | Availability likely | — |
| Hydroxyzine Pamoate 25 mg 00615-8419-39 | NCS | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 43063-0172-01 | PD-Rx | 100 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 43063-0406-01 | PD-Rx | 100 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 50090-4385-02 | A-S | 20 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 50090-4579-02 | A-S | 20 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 51407-0001-01 | Golden | 100 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 51655-0847-20 | Northwind | 20 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 55154-2337-00 | Cardinal | 10 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 61919-0880-15 | Direct_Rx | 15 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 63629-8874-01 | Bryant | 500 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 63629-9612-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 67046-0281-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 67046-2086-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 68071-2255-02 | NuCare | 20 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 68071-3736-01 | NuCare | 100 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 68071-4915-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 68071-4954-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 68788-7767-01 | Preferred | 100 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 68788-8119-01 | Preferred | 100 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 70518-0209-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 70518-1504-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 71205-0087-15 | Proficient | 15 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 71205-0123-15 | Proficient | 15 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 71205-0433-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 71205-0483-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 71205-0558-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 71335-0998-01 | Bryant | 20 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 71335-1325-01 | Bryant | 20 capsules | — | AB | Discontinued | — |
| hydroxyzine pamoate 25 mg 71335-1714-01 | Bryant | 20 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 71335-2187-01 | Bryant | 20 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 71335-2751-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 71335-3003-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 71610-0217-30 | Aphena | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 71610-0747-30 | Aphena | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 71610-0773-30 | Aphena | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 71610-0883-30 | Aphena | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 72162-1054-03 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 25 mg 72189-0009-30 | Direct_Rx | 30 capsules | — | AB | Discontinued | — |
| Hydroxyzine Pamoate 25 mg 76420-0920-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 82982-0032-30 | Pharmasource | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 87441-0040-01 | Unit | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 51655-0725-52 | Northwind | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 25 mg 87441-0087-01 | Unit | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII 3P3ONR6O1S
A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII U3JF91U133
Hydroxypropyl cellulose is a plant-derived polymer that acts as a binder, thickener, and film-former in medications. It helps hold tablet ingredients together, control how quickly the drug dissolves, and create protective coatings on pills.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
17 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS 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.
⏱️ Dosage and Administration ▾
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 mg to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg 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 t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 mg 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.
⛔ Contraindications ▾
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 ▾
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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧓 Geriatric Use ▾
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.
🆘 Overdosage ▾
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.
🧬 Clinical Pharmacology ▾
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 clinical effects are usually noted within 15 to 30 minutes after oral administration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydroxyzine Pamoate Capsules, USP, for oral administration, are available as 25 mg (equivalent to 25 mg hydroxyzine hydrochloride) are light green/dark green capsules imprinted “E 613” and supplied as: NDC 0185-0674-01 bottles of 100 NDC 0185-0674-05 bottles of 500 NDC 0185-0674-10 bottles of 1000 50 mg (equivalent to 50 mg hydroxyzine hydrochloride) are dark green/white capsules imprinted “E 615” and supplied as: NDC 0185-0676-01 bottles of 100 NDC 0185-0676-05 bottles of 500 NDC 0185-0676-10 bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. KEEP TIGHTLY CLOSED.
KEEP OUT OF THE REACH OF CHILDREN. Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540 46309877 Rev. June 2022
📋 Description ▾
DESCRIPTION Hydroxyzine pamoate is a light yellow, practically 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) [10246-75-0] and can be structurally represented as follows: C 21 H 27 CIN 2 O 2 •C 23 H 16 O 6 M.W. 763.27 Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg.
In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze.
Chemical Structure
⚠️ Precautions ▾
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 post-marketing 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.
🍼 Nursing Mothers ▾
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.
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel NDC 0185-0674-01 hydrOXYzine Pamoate Capsules, USP 25 mg* Rx only 100 Capsules Sandoz 25mg-label
Package/Label Display Panel NDC 0185-0676-01 hydrOXYzine Pamoate Capsules, USP 50 mg* Rx only 100 Capsules Sandoz 50mg-100
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0185-0615-01 HydrOXYzine Pamoate Capsules, USP 50 mg* Rx only 100 Capsules Sandoz 50mg-epic label
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0185-0613-01 HydrOXYzine Pamoate Capsules, USP 25 mg* Contains FD&C Yellow No.6 as a color additive Rx only 100 Capsules Sandoz 25mg-epiclabel