Hydroxyzine Hydrochloride 10 mg/5mL
Hydroxyzine Hydrochloride · SOLUTION · Lannett Company, Inc.
Hydroxyzine Hydrochloride is a solution containing hydroxyzine hydrochloride at 10 mg/5mL, taken oral. Manufactured by Lannett Company, Inc..
Key Facts
- Brand Name
- Hydroxyzine Hydrochloride
- Generic Name
- Hydroxyzine Hydrochloride
- NDC Code (Product)
54838-502- Manufacturer
- Lannett Company, Inc.
- Strength
- 10 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA201674
- Marketing Start
- 08/21/2013
Recall History
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Martin Avenue Pharmacy, Inc.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Advanced Physician Solutions, Inc.
Lack of Assurance of Sterility
Qualitest Pharmaceuticals
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Hi-Tech Pharmacal Co., Inc.
Subpotent; 24 month stability test station
Advanced Physician Solutions, Inc.
Lack of Assurance of Sterility
Hi-Tech Pharmacal Co., Inc.
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Morton Grove Pharmaceuticals, Inc.
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Lannett Company, Inc.
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Akorn, Inc.
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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 & 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: adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children 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: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children 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 for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.
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.
Contraindications
CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. 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 any component of this medication.
Adverse Reactions
ADVERSE REACTIONS Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post marketing reports. Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic : Dry mouth. Central Nervous System : Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. In post-marketing experience, the following additional undesirable effects have been reported: Cardiac System: QT prolongation, Torsade de Pointes. Body as a Whole: Allergic reaction. Nervous System : Headache. Psychiatric : Hallucination. Skin and Appendages : Pruritus, rash, urticaria.
Frequently Asked Questions
What is Hydroxyzine Hydrochloride used for?
Hydroxyzine Hydrochloride contains Hydroxyzine Hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.
Is Hydroxyzine Hydrochloride a controlled substance?
Hydroxyzine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Hydroxyzine Hydrochloride?
The generic name for Hydroxyzine Hydrochloride is Hydroxyzine Hydrochloride. There are 8 other brand versions of Hydroxyzine Hydrochloride.
What is the NDC code for Hydroxyzine Hydrochloride 10 mg/5mL?
The NDC (National Drug Code) for Hydroxyzine Hydrochloride 10 mg/5mL is 54838-502, listed by Lannett Company, Inc..
Other Hydroxyzine Brands
See all →- Hydroxyzine hydrochloride25 mg/176420-882
- Hydroxyzine hydrochloride50 mg/10615-8564
- Hydroxyzine hydrochloride50 mg/10904-7379
- HYDROXYZINE HYDROCHLORIDE10 mg/116571-113
- HYDROXYZINE HYDROCHLORIDE50 mg/116571-115
- Hydroxyzine hydrochloride25 mg/145865-675
- Hydroxyzine hydrochloride25 mg/150090-2648
- HYDROXYZINE HYDROCHLORIDE25 mg/150090-7327
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)