Atax-Mediotic

 

 

Composition:                                     

Each coated tablet contains: Hydroxyzine HCl 25 mg.

Each 5 ml contains: Hydroxyzine HCl 10 mg.

 

Clinical Pharmacology:

  -  Atax Mediotic 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, bronchodilator activity, antihistaminic, analgesic and antiemetic effects have been demonstrated experimentally and confirmed clinically.

  -  Clinical studies indicate that Hydroxyzine in therapeutic dosage does not increase gastric secretion nor acidity, and in most cases has mild antisecretory activity.

  -  Hydroxyzine is rapidly absorbed from the gastrointestinal tract and Atax Mediotic’s clinical effects are usually noted within 15 – 30 minutes after oral administration.

 

Indications:

-  For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

-  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 premedication and following general anesthesia.

 

Contra-Indications:

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

-  Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to it.

 

Warnings:

Nursing Mothers: It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, this medication should not be given to nursing mothers.

 

Precautions:

-  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 use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking this medication.

-  Patients should be advised against the simultaneous use of other CNS depressant drug, and cautioned that the effect of alcohol may be increased.

 

Adverse reactions:

Side effects reported with the administration of this medication are usually mild and transitory in nature

-  The most common side effects: dry mouth and drowsiness.

-  Respiratory depression, involuntary motor activity including tremor and convulsions have been reported, usually with doses considerably higher than those recommended.

 

Overdosage:

 -  The most common manifestation of this medication overdosage is hypersedation.

 -  If vomiting has not occurred spontaneously, it should be induced. Immediate gastric Iavage is

also recommended.

 -  General supportive care, including frequent monitoring of the vital signs

and close observation of the patient, is indicated.

 

Dosage & Adminstration:

    -  For symptomatic relief of anxiety and tension in:

   Children under 6 years: 50 mg daily in divided doses.

   Childern over 6 years: 50 – 100 mg in divided doses.

  Adults: 50 - 100 mg (4 times daily).

    -  For use in the management of pruritus due to allergic conditions:

     Children under 6 years: 50 mg in divided doses.

   Children over 6 years: 50 – 100 mg daily in divided doses.

   Adults: 25 mg (3 or 4 times daily).

-  As a sedative when used as a premedication and following general anesthesia: 50 – 100 mg in adults, and 0.6 mg / kg in children.

-  As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

 

Storage:

 -  Store below 25 °C.

 -  Do not despense with out a medical prescription.

 

Presentation:

  -  Each box contains 20 cotated tablets.

  -  Each Bottle contains 100 ml syrup.