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Product Name
:
MULTIRAXIN
Chemical Name
:
Hydroxyzinc-Hcl
Therapeutic Category
:
Respiratory tract drugs
Pharmacologic Category
:
Antiemetic; - Histamine H1; Antagonist - Histamine H1; Antagonist, First Generation - Piperazine Derivative
Pharmaceutical Form
:
Syrup
Composition
:
Hydroxyzinc-Hcl 10mg/5ml
Monitoring Parameters
Dosing
 
Dosing: Adult
Note: Adjust dose based on patient response.
Anxiety:
Oral: 50-100 mg 4 times/day
Preoperative sedation:
Oral: 50-100 mg
Pruritus: Oral: 25 mg 3-4 times/day

Dosing: Pediatric

Note: Adjust dose based on patient response.
Preoperative sedation:
Oral: 0.6 mg/kg/dose
Pruritus, anxiety: Oral:
<6 years: 50 mg daily in divided doses
≥6 years: 50-100 mg daily in divided dose

Dosing: Geriatric

Initiate dosing using the lower end of the recommended dosage range due to an increased potential for anticholinergic side effects. Refer to adult dosing.

Dosing: Hepatic Impairment

Change dosing interval to every 24 hours in patients with primary biliary cirrhosis (Simons F, 1989)
Use
 
Treatment of anxiety/agitation (including adjunctive therapy in alcoholism); adjunct to pre- and postoperative analgesia and anesthesia; antipruritic; antiemetic
Adverse Reactions
 
Frequency not defined.
Central nervous system: Dizziness, drowsiness, fatigue, hallucination, headache, nervousness, seizure
Dermatologic: Pruritus, rash, urticaria
Gastrointestinal: Xerostomia
Neuromuscular & skeletal: Involuntary movements, paresthesia, tremor
Ocular: Blurred vision
Respiratory: Respiratory depression (at higher than recommended doses)
Miscellaneous: Allergic reaction
Contraindications
 
Hypersensitivity to hydroxyzine or any component of the formulation; early pregnancy; SubQ, intra-arterial, or I.V. injection
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns:
• Glaucoma: Use with caution in patients with narrow-angle glaucoma; condition may be exacerbated by cholinergic blockade. Screening is recommended.
• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.
• Respiratory disease: Use with caution in patients with asthma or COPD.
Concurrent drug therapy issues:
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations:
• Elderly: May be inappropriate in this age group due to potent anticholinergic effects; nonanticholinergic antihistamines preferred for treating allergic reactions (Beers Criteria).
Other warnings/precautions:
• Appropriate administration: I.V., SubQ, and intra-arterial administration are contraindicated since tissue damage, intravascular hemolysis, thrombosis, and digital gangrene can occur.
Metabolism/Transport Effects
Inhibits CYP2D6 (weak)
Interactions
 
Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Amphetamines: May diminish the sedative effect of Antihistamines. Risk C: Monitor therapy
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy
Barbiturates: HydrOXYzine may enhance the CNS depressant effect of Barbiturates. Management: Consider a decrease in the barbiturate dose, as appropriate, when used together with hydroxyzine. With concurrent use, monitor patients closely for excessive response to the combination. Risk D: Consider therapy modification
Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modification
Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy
CNS Depressants: HydrOXYzine may enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification
Meperidine: HydrOXYzine may enhance the CNS depressant effect of Meperidine. Management: Consider a decrease in meperidine dose, as appropriate, when used together with hydroxyzine. With concurrent use, monitor patients closely for excessive response to the combination. Risk D: Consider therapy modification
Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: May increase CNS depression; monitor for increased effects with coadministration. Caution patients about effects.
Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).
Pregnancy
 
Pregnancy Implications
Hydroxyzine-induced fetal abnormalities were observed at high dosages in animal studies. Neonatal withdrawal symptoms have been reported following long-term maternal use or the use of large doses near term. Use in early pregnancy is contraindicated by the manufacturer.
Lactation
 
Excretion in breast milk unknown/not recommended
Mechanism of Action
 
Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. Possesses skeletal muscle relaxing, bronchodilator, antihistamine, antiemetic, and analgesic properties.
Pharmacodynamics / Kinetics
 
Onset of action: Oral: 15-30 minutes; Injection: Rapid
Duration: Decreased histamine-induced wheal and flare areas: 2 to ≥36 hours; Suppression of pruritus: 1-12 hours (Simons, 1984)
Absorption: Oral: Rapid
Distribution: Adults: Vd ~16 L/kg (Simons, 1984); Elderly: ~23 L/kg (Simons K, 1989); Hepatic dysfunction: ~23 L/kg (Simons F, 1989)
Metabolism: Hepatic to multiple metabolites, including cetirizine (active) (Simons F, 1989)
Half-life elimination: Adults: ~20 hours (Simons, 1984); Elderly: ~29 hours (Simons K, 1989); Hepatic dysfunction: ~37 hours (Simons F, 1989)
Time to peak: Oral administration: Serum: ~2 hours; Peak suppression of antihistamine-induced wheal and flare: 4-12 hours (Simons, 1984)
Excretion: Urine
 
   
 
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