Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets)

Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets)
© The Swiss Pharmacy

Atarax (Generic Hydroxyzine Hydrochloride Tablets) is used
to assist in the management of anxiety and tension states in
adults, psychomotor agitation and acute stress situations
such as, for example, those accompanying minor surgical
procedures or allergic states.
Atarax tablets are also used in the management of pruritus
due to allergic conditions such as chronic urticaria and
atopic and contact dermatitis, and in histamine-mediated
pruritus.

Atarax Tablets are
manufactured by Dr.
Reddy's Laboratories
Limited, India in the
strengths of 10 mg and 25
mg.

Chemical Structure

The active ingredient contained in Atarax tablets
is Hydroxyzine Hydrochloride.
Each Atarax tablet contains Hydroxyzine
Hydrochloride equivalent to 10 mg or 25 mg of
Hydroxyzine.

Uses of Atarax 10 mg and 25 mg Tablets:
Atarax (Hydroxyzine Hydrochloride Tablets) is used for symptomatic
relief of anxiety and tension associated with psychoneurosis and as
an adjunct in organic disease states in which anxiety is manifested.
It is also useful in the management of pruritus due to allergic
conditions such as chronic urticaria and atopic and contact
dermatoses and in histamine-mediated pruritus.
As a sedative when used as a premedication and following general
anesthesia, Hydroxyzine Hydrochloride may potentiate Meperidine
and Barbiturates, so their use in pre-anesthetic adjunctive therapy
must be modified on an individual basis.
Hydroxyzine is an antihistamine. It works by preventing the effects of
a substance called histamine, which is produced by the body.
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Recommended Adult Dosage
The dose of Atarax Tablets (Hydroxyzine Hydrochloride Tablets)
for various indications is given below:
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 to 100 mg four times a day; 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.

Recommended Adult Dosage
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 three times a day or four times a day.
Children under 6 years, 50 mg daily in divided doses.
Children over 6 years, 50 to 100 mg daily in divided doses.
As with all medications, the dosage should be adjusted
according to the patient's response to therapy.

Contraindications
➔
Atarax is contraindicated in patients with a known hypersensitivity to
Hydroxyzine Hydrochloride, to Cetirizine, to other piperazine derivatives, to
Aminophylline, or to Ethylenediamine or any component of the tablet.
➔
Pregnancy and lactation.
➔
Severe hepatic or renal failure
➔
Prostate adenoma with urinary retention
➔
Narrow angle glaucoma
➔
Patients with porphyria
➔
Children below 12 months

Contraindications
➔
Concomitant therapy with monoamine oxidase inhibitors
➔
Patients with known acquired or congenital QT interval prolongation.
➔
Patients with a known risk factor to QT interval prolongation including a
known cardiovascular disease, significant electrolytes imbalance
(hypokalaemia, hypomagnesaemia), family history of sudden cardiac
death, significant bradycardia, concomitant use with drugs known to
prolong the QT interval and/or induce Torsade de Pointes.
➔
Atarax tablets include lactose. Patients with rare hereditary problems
of galactose intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.

Storage Instructions
Atarax Tablets (Generic Hydroxyzine Hydrochloride
Tablets) have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
It is not known whether this drug is excreted in human milk. Since many
medicines are so excreted, Hydroxyzine (Atarax tablets) should not be
given to nursing mothers.
Hydroxyzine (Atarax tablets) has been associated with prolongation of the QT
interval on the electrocardiogram. During post-marketing surveillance, there
have been cases of QT interval prolongation and Torsade de Pointes in
patients taking hydroxyzine. Most of these patients had other risk factors,
electrolyte abnormalities or concomitant treatment that may have been
contributory.
Caution is needed in patients who have a known predisposing factor to
cardiac arrhythmia, including electrolyte imbalance (hypokalaemia,
hypomagnesaemia), who have pre-existing heart disease, or who are
concomitantly treated with a potentially arrhythmogenic drug. In those
patients, use of alternative treatments is to be considered.

Warnings
Atarax tablets should be used at the lowest effective dose and for the
shortest possible duration. Treatment with Atarax should be stopped if
signs or symptoms occur that may be associated with cardiac arrhythmia,
and the patients seek immediate medical attention. Patients should be
advised to promptly report any cardiac symptoms.
Atarax tablets should be administered cautiously in patients with
increased potential for convulsions.
Young children are more susceptible to develop adverse events related
to the central nervous system. In children, convulsions have been more
frequently reported than in adults. The recommended doses should be
strictly followed in children (possibility of central nervous system
stimulation).

Warnings
Hydroxyzine (Atarax tablets) is not recommended in elderly patients
because of a decrease of hydroxyzine elimination in this population as
compared to adults and greater risk of adverse reactions (e.g.
anticholinergic effects)
Because of its potential anticholinergic effects, Atarax tablets should be
used cautiously in patients suffering from obstructive respiratory disorders
(e.g. asthma), hyperthyroidism, hypotension, hepatic insufficiency,
glaucoma, bladder outflow obstruction, decreased gastro-intestinal
motility, myasthenia gravis, dementia and in patients with a history of
seizures.
Caution should be exercised in patients with pheochromocytoma because
the administration of antihistamines may lead to catecholamine release.

Warnings
Co-administration with CNS depressants: Dosage adjustments may be
required if Atarax tablets are used simultaneously with other central
nervous system depressant drugs or with drugs having anticholinergic
properties.
The concomitant use of alcohol or other sedating drugs and Atarax
tablets should be avoided.
Atarax dosage should be reduced in patients with hepatic dysfunction
and in patients with moderate or severe renal impairment.
The treatment with Atarax tablets should be stopped at least 5 days
before allergy testing or metacholine bronchial challenge, to avoid
effects on the test results.

Atarax Tablets and Alcohol
Alcohol can increase the nervous system side effects of Atarax
Tablets (Hydroxyzine Hydrochloride Tablets) such as dizziness,
drowsiness, and difficulty concentrating. Some people may also
experience impairment in thinking and judgment. You should
avoid or limit the use of alcohol while being treated with
Hydroxyzine.

Possible Side Effects
Most common Hydrochloride (Atarax Tablets) side effects are given below:
Skin and Appendages: Oral Hydroxyzine Hydrochloride is associated with fixed
drug eruptions in postmarketing reports. Side effects reported with the
administration of Hydroxyzine tablets are usually mild and transitory in nature.
Anticholinergic: Dry mouth.
Central Nervous System: Drowsiness is usually transitory and may disappear
in a few days of continued therapy or upon reduction of dose. Involuntary
motor activity including rare instances of tremor and convulsions have been
reported, usually with doses considerably higher than those recommended.
Clinically significant respiratory depression has not been reported at
recommended doses.

Possible Side Effects
In postmarketing experience with Hydroxyzine Hydrochloride
(Atarax Tablets), the following additional undesirable effects have
been reported:
Body as a Whole: Allergic reaction.
Nervous System: Headache.
Psychiatric: Hallucination.
Skin and Appendages: Pruritus, rash, urticaria

Atarax Tablets Overdosage
The most common manifestation of Hydroxyzine Hydrochloride (Atarax
Tablets) 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.

Atarax Tablets Overdosage
Hypotension, though unlikely, may be controlled withintravenous fluids
and Levarterenol, or Metaraminol. Do not use Epinephrineas as Atarax
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 Hydroxyzine.
However, if other agents such as barbiturates have been ingested
concomitantly, hemodialysis may be indicated.
There is no practical method to quantitate Hydroxyzine in body fluids
or tissue after its ingestion or administration.

Atarax Tablets During Pregnancy
Hydroxyzine Hydrochloride (Atarax Tablets) has been classified by the
US FDA as Pregnancy Category C.
Hydroxyzine is contraindicated during pregnancy. Animal studies have
shown reproductive toxicity. Hydroxyzine crosses the placental barrier
leading to higher foetal than maternal concentrations.
To date, no relevant epidemiological data are available relating to
exposure to Hydroxyzine during pregnancy.
In neonates whose mothers received Hydroxyzine during late
pregnancy and/or labour, the following events were observed
immediately or only a few hours after birth: hypotonia, movement
disorders including extrapyramidal disorders, clonic movements, CNS
depression, neonatal hypoxic conditions, or urinary retention.

Atarax Tablets (Generic Hydroxyzine
Hydrochloride Tablets) are manufactured by Dr.
Reddy's Laboratories Limited, India.

Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets)

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