Hydroxyzine label

Hydroxyzine

Hydroxyzine Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.

Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Tablets. However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information.

Limitations of Use

  • Rizatriptan benzoate tablets  should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablet is administered to treat any subsequent attacks.
  • Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
  • Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
  • Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
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History

There is currently no drug history available for this drug.

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Other Information

Rizatriptan benzoate tablets contains rizatriptan benzoate USP, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.

Rizatriptan benzoate USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:

Structure

Its molecular formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate USP is a white to almost white, crystalline powder that is soluble in water and methanol, slightly soluble in isopropyl alcohol.

Rizatriptan benzoate tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, ferric oxide (red), and magnesium stearate.

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Hydroxyzine Manufacturers

  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Hydroxyzine | Jubilant Cadista Pharmaceuticals Inc.
    No Recall

    Hydroxyzine | Jubilant Cadista Pharmaceuticals Inc.

    Hydroxyzine | Jubilant Cadista Pharmaceuticals Inc.
    2.1 Dosing Information in Adults

    The recommended starting dose of rizatriptan benzoate tablets is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10 mg dose may provide a greater effect than the 5 mg dose, but may have a greater risk of adverse reactions [see Clinical Studies (14.1)].

    Redosing in Adults

    Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.

    2.2 Dosing Information in Pediatric Patients (Age 6 to 17 Years)

    Information related to dosage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Tablets.  However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that dosage information.

    2.4 Dosage Adjustment for Patients on Propranolol

    Adult Patients

    In adult patients taking propranolol, only the 5 mg dose of rizatriptan benzoate tablet is recommended, up to a maximum of 3 doses in any 24-hour period (15 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

    Pediatric Patients

    Dosage adjustment information of rizatriptan benzoate for pediatric patients (6 to 17 years old) taking  propranolol is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Tablets.  However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that dosage adjustment information.

  • General Injectables & Vaccines, Inc
    Hydroxyzine | General Injectables & Vaccines, Inc
    No Recall

    Hydroxyzine | General Injectables & Vaccines, Inc

    Hydroxyzine | General Injectables & Vaccines, Inc

    The recommended dosages for hydroxyzine hydrochloride intramuscular solution are:

    For adult psychiatric and emotional emergencies, including acute alcoholism
    IM: 50-100 mg stat., and q. 4-6h., p.r.n.
    Nausea and vomiting excluding nausea and vomiting of pregnancy
    Adults: 25-100 mg IM
    Children: 0.5mg/lb body weight IM
    Pre- and postoperative adjunctive medication.
    Adults: 25-100 mg IM
    Children: 0.5mg/lb body weight IM Pre- and postpartum adjunctive therapy
    25-100 mg IM
    As with all potent medications, the dosage should be adjusted according to the patient's response to therapy.

    FOR ADDITIONAL INFORMATION OF THE ADMINISTRATION AND SITE OF SELECTION SEE PRECAUTIONS SECTION. NOTE: Hydroxyzine hydrochloride intramuscular solution may be administered without further dilution. Patients may be started on intramuscular therapy when indicated. They should be maintained on oral therapy whenever this route is practicable.
    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • General Injectables & Vaccines, Inc
    Hydroxyzine | General Injectables & Vaccines, Inc
    No Recall

    Hydroxyzine | General Injectables & Vaccines, Inc

    Hydroxyzine | General Injectables & Vaccines, Inc

    The recommended dosages for hydroxyzine hydrochloride intramuscular solution are:

    For adult psychiatric and emotional emergencies, including acute alcholism
    IM: 50-100 mg stat., and q. 4-6h., p.r.n.
    Nausea and vomiting excluding nausea and vomiting of pregnancy
    Adults:25-200 mg IM
    Children: 0.5 mg/lb body weight IM
    Pre- and postoperative adjunctive medication
    Adults:25-200 mg IM
    Children: 0.5 mg/lb body weight IM Pre-and postpartum adjunctive therapy
    25-100 mg IM
    As with all potent medications, the dosage should be adjusted according to the patient's response to therapy.

    FOR ADDITIONAL INFORMATION OF THE ADMINISTRATION AND SITE OF SELECTION SEE PRECAUTIONS SECTION. NOTE: Hydroxyzine hydrochloride intramuscular solution may be administered without further dilution. Patients may be started on intramuscular therapy when indicated. They should be maintained on oral therapy whenever this route is practicable.
    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • General Injectables & Vaccines, Inc
    Hydroxyzine | General Injectables & Vaccines, Inc
    No Recall

    Hydroxyzine | General Injectables & Vaccines, Inc

    Hydroxyzine | General Injectables & Vaccines, Inc

    The recommended dosages for hydroxyzine hydrochloride intramuscular solution are:

    For adult psychiatric and emotional emergencies, including acute alcoholism
    IM: 50-100 mg stat., and q. 4-6 hy., p.r.n.
    Nausea and vomiting excluding nausea and vomiting of pregnancey
    Adults: 25-100 mg IM
    Children: 0.5 mg/lb body weight IM
    Pre-and postoperative adjunctive medication
    Adults: 25-100 mg IM
    Children: 0.5 mg/lb body weight IM Pre-and postpartum adjunctive therapy
    25-100 mg IM
    As with all potent medications, the dosage should be adjusted according to the patient's response to therapy.

    FOR ADDITIONAL INFORMATION OF THE ADMINISTRATION AND SITE OF SELECTION SEE PRECAUTIONS SECTION. NOTE: Hydroxyzine hydrochloride intramuscular solution may be administered without further dilution. Patients may be started on intramuscular therapy when indicated. They should be maintained on oral therapy whenever this route is practicable. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • General Injectables & Vaccines, Inc
    Hydroxyzine | General Injectables & Vaccines, Inc
    No Recall

    Hydroxyzine | General Injectables & Vaccines, Inc

    Hydroxyzine | General Injectables & Vaccines, Inc

    The recommended dosages for hydroxyzine hydrochloride intramuscular solution are:

    For adult psychiatric and emotional emergencies, including acute alcoholism:
    IM: 50-100 mg sta., and q. 406h., p.r.n.
    Nausea and vomiting excluding nausea and vomiting of pregnancy
    Adults: 25-100 mg IM
    Children:0.5 mg/lb body weight IM
    Pre- and postoperative adjunctive medication
    Adults: 25-100 mg IM
    Children:0.5 mg/lb body weight IM Pre- and postpartum adjunctive therapy
    25-100 mg IM
    As with all potent medications, the dosage should be adjusted according to the patient's response to therapy.


    FOR ADDITIONAL INFORMATION OF THE ADMINISTRATION AND SITE OF SELECTION SEE PRECAUTIONS SECTION. NOTE: Hydroxyzine hydrochloride intramuscular solution may be administered without further dilution. Patients may be started on intramuscular therapy when indicated. They should be maintained on oral therapy whenever this route is practicable.
    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.


  • Major Pharmaceuticals
    Hydroxyzine | Major Pharmaceuticals
    No Recall

    Hydroxyzine | Major Pharmaceuticals

    Hydroxyzine | Major Pharmaceuticals

    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 to100 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.

  • Silarx Pharmaceuticals, Inc
    Hydroxyzine | Silarx Pharmaceuticals, Inc
    No Recall

    Hydroxyzine | Silarx Pharmaceuticals, Inc

    Hydroxyzine | Silarx Pharmaceuticals, Inc

    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 daily.: 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: in adults, 25 mg three times to four times daily.; children under 6 years, 50 mg daily in divided doses and 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 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.

  • Preferred Pharmaceuticals, Inc.
    Hydroxyzine | Preferred Pharmaceuticals, Inc.
    No Recall

    Hydroxyzine | Preferred Pharmaceuticals, Inc.

    Hydroxyzine | Preferred Pharmaceuticals, Inc.

    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 daily.: 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: in adults, 25 mg three times to four times daily.; children under 6 years, 50 mg daily in divided doses and 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 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.

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