| ATARAX™ |
|Hydroxyzine HCl |
|Anxiolytic - Antihistamine |
|Indications And Clinical Uses: Oral: The management of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. Also used in the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses. Useful in the control of nausea and vomiting, excluding nausea and vomiting of pregnancy (see Contraindications).
I.M.: The treatment of the following types of patients when this route of administration is desirable: the acutely disturbed or hysterical patient; the acute or chronic alcoholic with anxiety, withdrawal symptoms or delirium tremens; as pre and postoperative and pre and postpartum adjunctive medication to allay anxiety and to permit substantial reduction in narcotic dosage and to control emesis, excluding nausea and vomiting of pregnancy (see Contraindications).
Patients may be started on parenteral therapy when indicated by the clinical situation. They should be maintained on oral therapy whenever this route is again practicable.
Contra-Indications: In patients with known hypersensitivity to the drug.
Pregnancy: Hydroxyzine, when administered to the pregnant mouse, rat and rabbit, induced fetal abnormalities in the rat at doses substantially above the human therapeutic range. Clinical data in humans are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.
Manufacturers' Warnings In Clinical States: Lactation: 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.
Precautions: The potentiating effect of hydroxyzine must be considered when the drug is used in conjunction with CNS depressants such as narcotics, non-narcotic analgesics, hypnotics, sedatives, psychotherapeutic agents, barbiturates or alcohol. Therefore, when CNS depressants are administered concomitantly with hydroxyzine, their dosage should be reduced.
Administer hydroxyzine cautiously to epileptic patients.
Occupational Hazards: Since drowsiness may occur with use of this drug, patients should be cautioned against driving a car or operating dangerous machinery while taking hydroxyzine.
Adverse Reactions: Side effects reported with the administration of hydroxyzine are usually mild and transitory in nature.
Anticholinergic: Dry mouth may be encountered at higher dosages.
Involuntary motor activity, including rare instances of tremor and convulsions, has been reported usually with doses considerably higher than those recommended.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Gastric lavage, when necessary. tag_DosageDosage
Dosage And Administration: Oral: Dosage is dependent upon the intensity of the emotional disturbance, rather than upon the weight of the patient.
Adults: 25 to 100 mg 3 or 4 times a day.
Children: under 6 years, 30 to 50 mg daily in divided doses; over 6 years, 50 to 100 mg daily in divided doses.
I.M.: Psychiatric and emotional emergencies, including acute alcoholism: adults, 50 to 100 mg initially, repeated every 4 to 6 hours as needed. Pre and postoperative adjunctive medication: adults, 25 to 100 mg; children, 1 mg/kg body weight. Pre and postpartum adjunctive therapy: 25 to 100 mg. Nausea and vomiting: adults, 25 to 100 mg; children, 1 mg/kg body weight.
When hydroxyzine i.m. is used as preoperative or prepartum adjunctive medication, narcotic requirements may be reduced by as much as 50%. Thus, when 50 mg of hydroxyzine is administered i.m., meperidine dosage may be reduced from 100 mg to 50 mg.
Atarax I.M. is intended only for i.m. administration and should not, under any circumstances, be injected s.c., intra-arterially or i.v.
Atarax I.M. may be administered without further dilution. It should be injected deep into the body of a relatively large muscle such as the upper outer quadrant of the buttock or the lateral thigh.
Adults: The preferred site is the upper outer quadrant of the buttock, (i.e., gluteus maximus) or the mid-lateral thigh.
Children: It is recommended that i.m. injections be given preferably in the mid-lateral muscles of the thigh. In younger children, the periphery of the upper outer quadrant of the gluteal region should be used only when necessary, such as in burn patients, in order to minimize the possibility of damage to the sciatic nerve. The deltoid area should be used only if well developed such as in certain adults and older children, and then only with caution to avoid radial nerve injury. I.M. injections should not be made into the lower and mid-third of the upper arm.
Aspiration and proper anatomical selection of injection sites should be observed as a precaution against inadvertent injection into a blood vessel or major nerve.
Atarax I.M. is physically compatible with parenteral solutions of morphine, atropine, papaverine, codeine, meperidine and scopolamine.
Availability And Storage: Capsules: 10 mg: Each soft orange gelatin capsule contains: hydroxyzine HCl 10 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, lecithin, soybean oil, vegetable shortening and yellow wax; capsule shell: D&C Yellow #10, FD&C Yellow #6, FD&C Red #3, gelatin, glycerin, methylparabens, propylparabens and titanium dioxide. Tartrazine-free. Bottles of 100.
25 mg: Each soft green gelatin capsule contains: hydroxyzine HCl 25 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, lecithin, soybean oil, vegetable shortening and yellow wax; capsule shell: D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin, glycerin, methylparabens, propylparabens and titanium dioxide. Tartrazine-free. Bottles of 100.
50 mg: Each soft red gelatin capsule contains: hydroxyzine HCl 50 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, lecithin, soybean oil, vegetable shortening and yellow wax; capsule shell: FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, methylparabens, propylparabens and titanium dioxide. Tartrazine-free. Bottles of 100.
I.M.: Each mL contains: hydroxyzine HCl 50 mg with benzyl alcohol 0.9%, sodium hydroxide to adjust to optimum pH, and water for injection, q.s. Vials of 10 mL and vials of 1 mL, boxes of 10.
Syrup: Each 5 mL of vanilla-flavored syrup contains: hydroxyzine HCl 10 mg. Nonmedicinal ingredients: alcohol, menthol, sodium benzoate 1.5 mg, sucrose and purified water. Energy: 67 kJ (16 kcal). Tartrazine-free. Bottles of 500 mL.