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Telfor 120
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Telfor 120





COMPOSITION:

Fexofenadine hydrochloride................ 120 mg

Excipient q.s ...................................... 1 tablet

(Lactose, avicel, PVP, sodium starch glycolate, magnesium stearate,HPMC, PEG 6000, titanium dioxide, talc, red ferric oxide, orange lake color).

DOSAGE FORM: Film coated tablets

PRESENTATION:Box of 2 blisters x 10 tablets.

PHARMACODYNAMICS:

Telfor containing fexofenadine, an antihistamine with selective peripheral H1-receptor antagonist activity, is used to treat the allergy. At the therapeutic dose, it has no sedative or other central nervous system effects. Fexofenadine gives a quick and prolonged action because it slowly binds to H1-receptor, forming a stable complex and slow division.

PHARMACOKINETICS:

Fexofenadine is rapidly absorbed after oral administration with peak plasma concentrations occurring approximately 2 - 3 hrs. Food reduces the plasma peak concentrations by 17%. Fexofenadine is 60 - 70% bound to plasma proteins, primarily to albumin and a1-acid glycoprotein. The mean elimination half-life of fexofenadine is about 14.4 hrs. Approximately 11% of an oral dose of fexofenadine is excreted in the urine, primarily as unchanged drug and 80% is excreted in faeces.

INDICATIONS:

Treatment of symptomsassociated with allergic rhinitise.g sneezing, rhinorrhea, nasal itching, itchy palate and throat, itchy/watery/red eyes.

Treatment of symptomsassociated with chronic idiopathic urticaria: pruritus, skin rash.

CONTRAINDICATIONS:

Hypersensitivity to any components of the drug.

PRECAUTIONS:

The safety and efficacy of fexofenadine in children under 6 years of age have not been studied. Avoid concurrently administrate with other antihistamine.

Caution should be taken in patients with a risk of angiocardiopathy, in individuals with impared renal function.

Pregnant women and breast-feeding mothers.

INTERACTIONS:

Erythromycin and ketoconazole enhance the plasma concentration of fexofenadine due to they increases the absorption and decreases the elimination of fexofenadine. However, the interaction has no meaning of clinical significance.

Antacids containing aluminium hydroxide gel and magnesium hydroxide cause a reductionin the bioavailability of fexofenadine due to binding in the gastrointestinal tract. Therefore,it is advisable to leave 2 hours between administration of fexofenadine hydrochloride and antacids containing aluminium hydroxide gel and magnesium hydroxide.

ADVERSE EFFECTS:

Frequently: Headache, nausea, dyspepsia, dizzinessand fatigue.

Inform your physician about any adverse effects occur during the treatment.

 

OVERDOSAGE:

Information regarding acute overdosage is still limited. However, drowsiness, dizziness, dry mouth have been reported.

Treatment: using normal methods to eliminate the part of drug unabsorbed into gastrointestinal tract. Symptomatic and supportive treatment is recommended.

Dialysis does not significantly reduce drug concentration (1.7%). There is no specific antidote.

 

DOSAGE & ADMINISTRATION:

Adults and children over 12 years: oral dose of 1 tablet o­nce daily.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

This drug is forprescriptions o­nly.

Shelf-life:

24 months from the manufacturing date.

Storage conditions:

Store in dry places, not exceeding 30oC

Specifications : Manufacturer’s.






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