EVOTEX 5 mg Tablets

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EVOTEX 5 mg Tablets

Desription:  

        EVOTEX  Tablets let  is the levo- Isomer of cetirizine (levocetirizine) with twice the affinity for H1- Evolak  labiond rapid and long-lasting antihistaminic action, as compared.

Compositions:

Each film coated tablet contains: Levocetirizine Dihydrochloride……. 5mg. (Product complies with USP Specs.)

Indications:

Mode of action:

Evotex tablet is a potent, selective, peripheral H-1 receptor antagonist with negligible effects on other receptors.

Dosage:

The recommended daily dose on Evotex tablets is 5 mg. In children of age 6-12 years: 5 mg tablet should be given in two divided doses.

In children aged 2 to 6 years:

The recommended daily dose of Evotex tablets is 2.5 mg in children of age 2-6 years, in two divided doses.

In patients with renal Impairment:

The dose of Evotex tablets in renal dysfunction should be titrated as follows.ie, according to creatinine clearance of the patient:

Pharmacokinetics:

The time required for Evotex tabelts to reach peack plasma levels (tmax) is approx. hour.

Evotex tablets achieve steady-state plasma level by the second day.

Volume of distribution of Evotex tablets is 0.4 1/kg.

Evotex tablet has not been found to penetrate into the brain. Evotex tablet is extensively bound to blood components, approx.

1% is the free fraction (which is constant) and the also for in  fraction bound to blood cells and plasma proteins is approx. 28% and 66

%, respectively. Evotex tablet is poorly metabolized (14% of the total oral dose).

After oral administration to healthy individuals, radioactive-Evotex tablets are recovered In urine and faeces, 85% and 135 respectively.

Of the oral dose, approx, 80% of Evotex tablet is eliminated unchanged in urine in 48

hours.

Though intake of Evotex tablets with food does not hamper extent of drug absorption, its speed of absorption might decrease.

Pharmacodynamics:

Same effect as that of cetirizine in only half the dose Evotex tablets 5 mg has the same

clinical effect as that of cetirizine 10 mg) No effect on the QT interval

As compared with desioratadine, Evotex tablet is more effective in treating subjects with rapiconal allergic rhinitis during prolongtablet is mexposure Evotex tablet has a mom rapid (Thour versus 3 hours, respected bollend longer duration of action than

Contra-indications:  Also  for the Known hypersensitivity ingredients of to the active ingredient or any of to medicinesents than sin piperazing derive the hypersensitivity reaction occurs, the for me  patients should stop treatment and immediately

report to the physician

Glucose-galactose malabsorption Lactase deficiency

Hereditary galactose intolerance

Severe renal impairment

Side effects:

Treatment with Evotex tablets might cause the following temporary side effects:

Tiredness

Lack of concentration

Somnolence

Headache

Agitation Dry mouth

Constipation

Hypersensitivity reactions e.g. angioedema, photosensitivity reactions, liver damage, deafness, pruritus, vasculitis etc.

95% of the side effects are mild to moderate.

Warnings: It is better to avoid these

activities during treatment with Evotex tablet since it may cause sedation.

Precautions:

Use during pregnancy:

Overdosing: Overdosage with Evotex tablets can cause somnolence.

Drug Interactions:

Storage:

Store at 25°C. (Excursions permitted between 15°C -30°C), Protect from heat, light & moisture. Improper storage may deteriorate the product. Keep all medicine out of reach of children.

Presentation:

Evotex tablets 5mg: Pack of 10 tablets.

خوراک ڈاکٹر کی ہدایت کے مطابق استعمال کریں۔

جایت ۱۸ ۱۲۵ گری مالی گریڈ درجہ حرارت پر رکھیں۔

(در حرارت کی حد ۱۵ سے ۱۳۰ گری سینٹی گریا ہے )

روشنی میری اور سی سے محفوظ رکھیں۔

تمام ادویات بچوں کی مکئی سے دور رکھیں۔

Manufactured by:

ROTEX PHARMA (PVT) LTD

ROTEX Starts for Quette

Plot No. 206 & 207, Industrial Triangle Kahuta Road, Islamabad Pakistan

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