Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets)

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

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

3. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) Atarax Tablets are manufactured by Dr. Reddy's Laboratories Limited, India in the strengths of 10 mg and 25 mg. © The Swiss Pharmacy

4. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) Chemical Structure © The Swiss Pharmacy

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

6. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

7. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) Recommended Adult Dosage The dose of Atarax Tablets 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

8. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

9. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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 URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

10. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

11. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

12. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

13. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

14. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

15. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

16. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

17. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

18. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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 URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

19. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

20. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

21. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy

22. Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) Atarax Tablets Atarax Tablets (Generic Hydroxyzine Hydrochloride Tablets) are manufactured by Dr. Reddy's Laboratories Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9866_Atarax-Tablets.html © The Swiss Pharmacy