Roxyzin 10 mg/5 ml

INDICATIONS

Hydroxyzine Hydrochloride is indicated-

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and histamine-mediated pruritus. ... Read moreHydroxyzine Hydrochloride is indicated-

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and histamine-mediated pruritus.
As a sedative when used as premedication and following general anesthesia.

The effectiveness of Hydroxyzine as an antianxiety agent for long-term use (>4 months) has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

PHARMACOLOGY

Hydroxyzine Hydrochloride is an anxiolytic antihistamine of the piperazine class which is a H1 receptor antagonist. Hydroxyzine 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. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and clinical effects are usually noted within 15 to 30 minutes after oral administration.

DOSAGE & ADMINISTRATION

For symptomatic relief of anxiety and tension-

Adults: 50-100 mg 4 times daily.
Children (>6 years): 50-100 mg (5-10 teaspoonfuls) daily in divided doses.
Children (<6 years): 50 mg (5 teaspoonfuls) daily in divided doses.

Pruritus due to allergic conditions-

Adults: 25 mg 3 to 4 times daily.
Children ( 6 years): 50-100 mg (5-10 teaspoonfuls) daily in divided doses.
Children (<6 years): 50 mg (5 teaspoonfuls) daily in divided doses.

As a sedative (premedication and following general anesthesia)-

Adults: 50-100 mg.
Children: 0.6 mg/kg of body weight.

INTERACTION

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. Simultaneous administration of Hydroxyzine with monoamine oxidase inhibitors should be avoided.

SIDE EFFECTS

Side effects reported with the administration of Hydroxyzine Hhydrochloride are usually mild and transitory in nature. More common side effects include drowsiness, headache, psychomotor impairment, and antimuscarinic effects such as urinary retention, dry mouth, blurred vision, and gastrointestinal disturbances. Other rare side-effects of antihistamines include hypotension, palpitation, arrhythmias, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis, rashes, and photosensitivity reactions), blood disorders, liver dysfunction, and angle-closure glaucoma.

PREGNANCY & LACTATION

Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, Hydroxyzine is contraindicated in early pregnancy. 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 & WARNINGS

The potentiating action of Hydroxyzine must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, non-narcotic analgesics, and barbiturates. Therefore, when central nervous system depressants are administered concomitantly with Hydroxyzine, their dosage should be reduced. Since drowsiness may occur with the use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Hydroxyzine. Patients should be advised against the simultaneous use of other CNS depressant drugs and cautioned that the effect of alcohol may be increased.

USE IN SPECIAL POPULATIONS

Use in renal impairment patient: In case of renal impairment, half of the normal dose should be given.Use in the elderly patient: In the elderly, it is advised to start with half the recommended dose due to the prolonged action.

THERAPEUTIC CLASS

Sedating Anti-histamine

STORAGE CONDITIONS

Store in a cool & dry place. Protect from light. Keep out of the reach of children.