Fexofast-180

Fexofenadine hydrochloride.

Each tablet of FEXOFAST-180 contains 180 mg of Fexofenadine HCl.

Pharmacology: Fexofenadine HCl is a third generation non-sedating H₁-antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine.
Human histamine wheal and flare studies following single and twice-daily doses of Fexofenadine HCl demonstrate that the drug exhibits an antihistaminic effect beginning within 1 hr, achieving maximum at 6 hrs and lasting 24 hrs. There was no evidence of tolerance to these effects after 28 days of dosing. A positive dose-response relationship between doses of 10-130 mg taken orally was found to exist. In this model of antihistaminic activity, it was found that doses of at least 130 mg were required to achieve a consistent effect that was maintained over a 24 hr period. Maximum inhibition in skin wheal and flares areas were >80%.
Fexofenadine at concentrations 32 times greater than the therapeutic concentration in man had no effect on the delayed rectifier K⁺ channel cloned from human heart. Fexofenadine HCl (5-10 mg/kg orally) inhibited antigen-induced bronchospasm in sensitised guinea pigs and inhibited histamine release at supratherapeutic concentrations (10-100 micromolar) from peritoneal mast cells.
Pharmacokinetics: Fexofenadine HCl is rapidly absorbed into the body following oral administration, with t_max occurring at approximately 1-3 hrs post-dose. The mean C_max value was approximately 494 ng/ml following the administration of a 180 mg dose, once daily.
Fexofenadine is 60-70% plasma-protein bound. Fexofenadine undergoes negligible metabolism (hepatic or non-hepatic), as it was the only major compound identified in urine and feces of animals and man. The plasma concentration profiles of Fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11-15 hrs after multiple dosing.
The major route of elimination is believed to be via biliary excretion while up to 10% of ingested dose is excreted unchanged through the urine.

For the relief of symptoms associated with allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.
For the relief of symptoms associated with chronic idiopathic urticaria in adults and children 12 years of age and older.

The recommended dose for adults and children aged 12 years and older is one tablet once daily.
Special Risk groups: Studies in special risk groups (elderly or patients with renal or hepatic impairment) indicate that it is not necessary to adjust the dose of Fexofenadine HCl in these patients.

There have been no reported cases of acute overdosage with Fexofenadine. However, in the event of overdose, use standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove Fexofenadine HCl from the blood.

Patients with known hypersensitivity to any of the ingredients of FEXOFAST.

Fexofenadine HCl should be administered with care in patients with renal or hepatic impairment.
Effect on the ability to drive or operate machinery: Based on the pharmacodynamic profile and reported adverse events, Fexofenadine is unlikely to effect the ability to drive or operate machinery. However, it is advisable to check the individual response before driving or operating machinery.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.

There are no adequate and well controlled studies in pregnant women. As with any other medication, Fexofenadine HCl should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
There are· no adequate and well controlled studies with Fexofenadine in women during lactation. Since Fexofenadine was found in human milk when terfenadine was administered to lactating mothers, Fexofenadine is not recommended in nursing mothers.

In controlled clinical trials, the most commonly reported adverse effects were headache, drowsiness, nausea, dizziness and fatigue. The incidence of these events observed with Fexofenadine was similar to that observed with placebo.
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate) - not necessarily inclusive: Those indicating need for medical attention: Incidence rare - Observed during clinical practice: Anaphylaxis and hypersensitivity reactions (chest tightness; feeling of warmth redness of the face, neck, arms and occasionally, upper chest; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; shortness of breath, difficult or labored breathing).
Those indicating need for medical attention only if they continue or are bothersome: Incidence less frequent: Back pain; dizziness, drowsiness; dysmenorrhea (painful menstrual bleeding); dyspepsia (stomach upset); fatigue (unusual feeling of tiredness); headache; nausea; sinusitis (headache; pain or tenderness around eyes or cheekbones; runny or stuffy nose); viral infections such as cold, flu.
Incidence rare - Observed during clinical practice: Nervousness; rash - urticarial and pruritic; sleep disorders (sleeplessness; terrifying dreams; trouble sleeping).

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other drugs through hepatic mechanisms. Co-administration of Fexofenadine HCl with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of Fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse events compared to the drugs given singly.
No interaction between Fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 min prior to Fexofenadine HCl caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave two hrs between administration of Fexofenadine HCl and aluminium- and magnesium- hydroxide containing antacids.

Store in a cool and dry place below 25°C.

Antihistamines & Antiallergics

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

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