Hydroxyzine Pamoate


Remedyrepack Inc.
Human Prescription Drug
NDC 70518-2769
Hydroxyzine Pamoate is a human prescription drug labeled by 'Remedyrepack Inc.'. National Drug Code (NDC) number for Hydroxyzine Pamoate is 70518-2769. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Hydroxyzine Pamoate drug includes Hydroxyzine Pamoate - 100 mg/1 . The currest status of Hydroxyzine Pamoate drug is Active.

Drug Information:

Drug NDC: 70518-2769
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Hydroxyzine Pamoate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Hydroxyzine Pamoate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Remedyrepack Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Capsule
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:HYDROXYZINE PAMOATE - 100 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 08 Jun, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA088488
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:REMEDYREPACK INC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:995232
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UNII:M20215MUFR
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Antihistamine [EPC]
Histamine Receptor Antagonists [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
70518-2769-030 CAPSULE in 1 BLISTER PACK (70518-2769-0)08 Jun, 2020N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Hydroxyzine pamoate hydroxyzine pamoate croscarmellose sodium magnesium stearate starch, corn lactose monohydrate d&c red no. 28 d&c red no. 33 d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 gelatin titanium dioxide ferrosoferric oxide fd&c blue no. 2 indigotindisulfonate sodium propylene glycol shellac hydroxyzine pamoate hydroxyzine hydroxyzine dihydrochloride light yellow barr;324;100

Indications and Usage:

Indications and usage 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 dr
ug for the individual patient.

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.

Dosage and Administration:

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 four times a day; 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 three times a day or four times a day.; 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.

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.

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 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.
to report suspected adverse reactions, contact teva at 1-888-838-2872 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.

Description:

Description hydroxyzine pamoate, usp 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). it has the following structural formula: c 21 h 27 cln 2 o 2 •c 23 h 16 o 6 m.w. 763.27 hydroxyzine pamoate capsules, usp are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. in addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. the 25 mg also contains anhydrous lactose. the 50 mg and 100 mg also contain lactose monohydrate. the capsule shell ingredients for the 25 mg capsule are d&c red no. 28, d&c yellow no. 10, fd&c blue no. 1, fd&c red no. 40, fd&c yellow no. 6, gelatin, and titanium dioxide. the 50 mg capsule shell contains d&c red no. 33, d&c yellow no. 10, fd&c yellow no. 6, gelatin, and titanium dioxide. the 100 mg capsule shell contains d&c red no. 28, d&c red no. 33, d&c yellow no. 10, fd&c blue no. 1, fd&c red no. 40, gelatin, and titanium dioxide. the edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, d&c yellow no. 10 aluminum lake, fd&c blue no. 1 aluminum lake, fd&c blue no. 2 aluminum lake, fd&c red no. 40 aluminum lake, propylene glycol, and shellac glaze. structural formula

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's clinical effects are usually noted within 15 to 30 minutes after oral administration.

How Supplied:

How supplied hydroxyzine pamoate capsules, usp (hydroxyzine pamoate, usp equivalent to hydroxyzine hydrochloride), 100 mg are available as light yellow opaque cap and pink opaque body filled with yellow powder, imprinted in black ink stylized “barr” over “324” on one piece and “100” on the other piece, packaged in ndc: 70518-2769-00 packaging: 30 in 1 blister pack dispense in a tight, light-resistant container as defined in the usp, with a child-resistant closure (as required). store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. keep this and all medications out of the reach of children. repackaged and distributed by: remedy repack, inc. 625 kolter dr. suite #4 indiana, pa 1-724-465-8762

Package Label Principal Display Panel:

Drug: hydroxyzine pamoate generic: hydroxyzine pamoate dosage: capsule adminstration: oral ndc: 70518-2769-0 color: yellow shape: capsule score: no score size: 19 mm imprint: barr;324;100 packaging: 30 in 1 blister pack active ingredient(s): hydroxyzine pamoate 100mg in 1 inactive ingredient(s): croscarmellose sodium magnesium stearate starch, corn lactose monohydrate d&c red no. 28 d&c red no. 33 d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 gelatin titanium dioxide ferrosoferric oxide fd&c blue no. 2 indigotindisulfonate sodium propylene glycol shellac remedy_label


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