Urtizin Tablet

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.

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.

Urtizin 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. Urtizin 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 Urtizin with monoamine oxidase inhibitors should be avoided.

Hydroxyzine is contraindicated in patients with a known hypersensitivity to Hydroxyzine or any of its ingredients.

Side effects reported with the administration of Urtizin 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.

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.

The potentiating action of Urtizin 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 Urtizin, their dosage should be reduced. Since drowsiness may occur with the use of Urtizin, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Urtizin. 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 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.

The most common manifestation of Urtizin overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and Levarterenol or Metaraminol. Epinephrine should not be used as Urtizin counteracts its pressor action.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with Urtizin. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate Urtizin in body fluids or tissue after its ingestion or administration.

Sedating Anti-histamine

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