Vifas

VIFAS (60 MG TABLET): A peach-colored, oval, biconvex film-coated tablet, a score with "VF" and "60" on one side and "
Click on icon to see table/diagram/image
" logo on the others.
Each film-coated tablet contains Fexofenadine HCl 60 mg.
VIFAS (180 MG TABLET): A peach-colored, oblong, biconvex film-coated tablet, scored with "VF" and "180" on one side and "
Click on icon to see table/diagram/image
" logo on the others.
Each film-coated tablet contains Fexofenadine HCl 180 mg.

Pharmacology: Pharmacodynamics: Fexofenadine, a second-generation antihistamine, is the active metabolite of terfenadine. Fexofenadine is a specific, selective, histamine H₁-receptor antagonist. Unlike terfenadine, Fexofenadine does not block the potassium channel involved in repolarization of cardiac cells. Fexofenadine also does not possess appreciable anticholinergic, antidopaminergic, or α- or β-adrenergic blocking effects at usual antihistaminic doses. Fexofenadine does not cross the blood-brain barrier at usual doses therefore the incidence of CNS effects or sedative effect are less than those of other antihistamines.
Pharmacokinetics: Fexofenadine is rapidly absorbed from the GI tract following oral administration, peak plasma concentrations are achieved in about 2.6 hours. Fexofenadine distributes more extensively into plasma than into blood or saliva. The drug does not appear to cross the blood-brain barrier. It is not known if Fexofenadine cross the placenta or is distributed into breast milk. Fexofenadine is 60-70% bound to plasma proteins, principally albumin and α1-acid glycoprotein. About 5% of a single oral dose of Fexofenadine is metabolized. Negligible amount are metabolized in the liver by the cytochrome P-450 microsomal enzyme system. About 80% of Fexofenadine is principally eliminated in feces and 11-12% is excreted in urine.

Symptomatic relief of seasonal allergic rhinitis e.g., sneezing, rhinorrhea, oronasopharyngeal itching, watery eyes, red eyes and symptomatic relief of chronic idiopathic urticaria in adults and children 6 years of age and older.

The usual dosage for adult and children 12 years of age and older: Patients with normal renal function: 60 mg twice daily or 180 mg once daily.
Patients with impaired renal function: 60 mg once daily.
The usual dosage for children 6-11 years of age: Patients with normal renal function: 30 mg twice daily.
Patients with impaired renal function: 30 mg once daily.

Overdosage symptoms of the drug are dizziness, drowsiness, dry mouth.
If any overdosage symptoms occur, symptomatic and supportive treatment should be initiated. Fexofenadine is not effectively removed by hemodialysis.

The drug is contraindicated in patient with known hypersensitivity to Fexofenadine and any components in the formulation.

Fexofenadine may cause drowsiness in some patients. Those who drive or operate dangerous machinery or other tasks associated with the risk of falling from a height should be tested to ensure that this drug does not cause drowsiness.
Should not be used in the first trimesters of pregnancy, breast feeding women and children younger than 6 months of age.
If arrhythmia occurs, discontinue the drug and consult physicians.
Use with caution in patients with renal impairment.
Concomitant administration of Fexofenadine with macrolides antibiotics such as erythromycin, or imidazole antifungals such as ketoconazole may cause increases of the drug plasma level.

Should not be taken closely in time with antacids containing aluminum and magnesium because plasma concentration of Fexofenadine might be decreased.
Although Fexofenadine does not share the cardiotoxic potential of its parent drug, terfenadine, however, use with caution in patient with cardiovascular risk.
Caution, precaution, contraindication of pseudoephedrine should be considered if Fexofenadine is used in combination with pseudoephedrine.
Use in patients with hepatic impairment: The dose adjustment is not necessary in mild to moderate hepatic impairment patients.
Use in the elderly: Should be used with caution in patients 65 years of age and older because the drug is excreted by kidneys and geriatric patients may have decreased renal function.

There are no well adequate controlled studies on the use of the drug in pregnancy; therefore, it should be given only if the potential benefit outweighs the potential risk for the fetus.
It is not known whether the drug distributed into human milk or not, therefore the drug should be avoided. If the drug has to be used, the decision should be made whether to discontinue the drug or stop breast feeding.

The common adverse reactions reported are drowsiness, fatigue, headache, viral infection (e.g., cold, influenza), nausea, dry mouth, dizziness, agitation, upper respiratory tract infection, back pain, coughing, fever, otitis media, sinusitis.
In addition insomnia, anxiety, palpitation, sleep disorder, paroniria, rash, urticaria, pruritus, hypersensitivity reaction including angioedema, chest, dyspnea, flushing, anaphylaxis have been reported.

Ketoconazole and erythromycin increased the plasma concentration of Fexofenadine.
Antacids containing aluminum and magnesium decreased the plasma concentration of Fexofenadine.
Fruit juices (grapefruit, orange, apple) may reduce bioavailability of Fexofenadine.
Laboratory test interferences: Fexofenadine should be discontinued at least 24-48 hours before skin testing procedure because Fexofenadine may interfere or decrease positive result of skin reaction indicator.

Store below 30°C.

Antihistamines & Antiallergics

R06AX26 - fexofenadine ; Belongs to the class of other antihistamines for systemic use.

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