Each capsule contains 60mg Fexofenadine Hydrochloride as active ingredient. Each tablet contains 120mg Fexofenadine Hydrochloride as active ingredient. Each tablet contains 180mg Fexofenadine Hydrochloride as active ingredient.

Fexofenadine, a metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine inhibits antigen-induced bronchospasm and histamine release. No anti cholinergic or alpha 1-adrenergic receptor blocking effects has been observed. Moreover, no sedative or other central nervous system effects were observed. Fexofenadine does not cross the blood-brain barrier.

Fexofenadine Hydrochloride is rapidly absorbed following oral administration with maximum plasma concentration occuring at 2.6 hours. The mean elimination half-life of Fexofenadine Hydrochloride is 14.4 hours following administration of 60mg, twice daily. Fexofenadine Hydrochloride excreted in the faeces and urine, approximately 80% and 11% respectively. Approximately 5% of the total dose were metabolized. The pharmacokinetics of Fexofenadine Hydrochloride in allergic rhinitis patients is found to be similar to those in healthy subjects. Peak Fexofenadine plasma concentrations were similar between adolescent (12-16 years of age) and adult patients. Fexofenadine Hydrochloride is 60% to 70% bound to plasma proteins, primarily albumin and a1-acid glycoprotein.

Special population pharmacokinetics (for age and renal and hepatic impairment), obtained after a single dose of 80mg Fexofenadine Hydrochloride subjects in a separate study of similar design.

In older subjects ( > 65 years old), peak plasma levels of Fexofenadine Hydrochloride were 99% greater than those observed in normal volunteers (< 65 years old). Mean elimination half-lives were similar to those observed in normal volunteers.

In patients with mild (creatinine clearance 41-80 ml/min) to severe (creatinine clearance 11-40 ml/min) renal impairment, peak plasma levels of Fexofenadine were 87% and 111% greater, respectively and mean elimination half-lives were 59% and 72% longer, respectively. Peak plasma levels in patients on dialysis were 82% greater and half-life was 31% longer than observed in normal volunteers.

The pharmacokinetics of Fexofenadine Hydrochloride in patients with hepatic disease did not differ substantially from those observed in healthy subjects.

Following single and twice Fexofenadine Hydrochloride doses, demonstrated that the drug exhibits anti histamine effects by 1 hour, achieves maximum effect at 2-3 hours, and an effect is still seen at 12 hours. There was no evidence of tolerance to these effects after 28 days of dosing.

Fexofenadine did not prolong QTc at plasma concentrations in laboratory animals. No effect was observed on calcium channels current, delayed K+ channel current or action potential duration in guinea pigs. No statistically significant increase in mean QTc intervals compared to placebo was observed in 714 allergic rhinitis patients given Fexofenadine Hydrochloride capsules in doses of 60mg to 240mg twice daily for two weeks

In three, 2-weeks multi-centre, randomized double-blind, placebo controlled trials in patients 12-68 years of age with allergic rhinitis, Fexofenadine Hydrochloride 60mg twice daily significantly reduced total symptom scores (the sum of the individual scores for sneezing, rhinorrhea itchy nose/palate/throat, itchy/watery/red eyes) compared to placebo.

FEXINOL 60mg and FEXINOL 120mg FEXINOL 60mg Capsules / FEXINOL 120mg Tablets is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children of 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/throat/itchy/watery/red eyes. FEXINOL 180mg tablets: FEXINOL 180mg Tablets is indicated for the relief of symptoms associated with chronic idiopathic urticaria.

FEXINOL is contraindicated in patients with known hypersensitivity to any of its ingredients.

In two separate studies, Fexofenadine Hydrochloride 120mg twice daily (twice the recommended dose) was co-administered with erythromycin 500mg every 8 hours or ketoconazole 400mg once daily under steady state conditions to normal, healthy volunteers (n=24, each study). No differences in adverse events or QTc interval were observed when subjects were administered Fexofenadine Hydrochloride alone or in combination with erythromycin or ketoconazole.

The carcinogenic potential and reproductive toxicity of Fexofenadine Hydrochloride were assessed using terfenadine. No evidence of carcinogenicity was observed when mice and rats were given daily oral doses of 50 and 150mg/kg of terfenadine for 18 and 4 months, respectively

There are no adequate & well-controlled studies in pregnant women. Fexofenadine HCl should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

There are no adequate and well-controlled studies in women during lactation

Safety and effectiveness of Fexofenadine Hydrochloride in pediatric patients under the age of 12 years have not been established.

Fexofenadine twice daily for up to two weeks Adverse events were similar in this group compared to patients under age of 60 years.

In placebo-controlled clinical trials, which included 2461 patients receiving Fexofenadine Hydrochloride at doses of 20mg to 240mg twice daily, adverse events were similar in Fexofenadine Hydrochloride and placebo-treated patients. The incidence of adverse events, including drowsiness, was not dose related and was similar across subgroups defined by age, gender, and race. Adverse experience reported in Placebo-Controlled Allergic Rhinitis Clinical Trials Fexofenadine60mg Twice daily PlaceboTwice daily Viral infection 2.5% 1.5% Nausea 1.6% 1.5% Dysmenorrhea 1.5% 0.3% Drowsiness 1.3% 0.9% Dyspepsia 1.3% 0.6% Fatigue 1.3% 0.9% The frequency and magnitude of laboratory abnormalities were similar in Fexofenadine Hydrochloride and placebo-treated patients.

Information regarding acute overdosage is limited to experience from clinical trials conducted during the development of FEXINOL. Single doses of Fexofenadine Hydrochloride upto 800mg (6 normal volunteers at this dose level), and doses up to 690 mg twice daily for one month (3 normal volunteers at this dose level), were administered without the development of clinically significant adverse events. In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Additionally, no clinical signs of toxicity or gross pathological findings were observed. In dogs, no evidence of toxicity was observed at oral doses up to 2000mg/kg (450 times the maximum recommended human daily oral dose based on mg/m2).

FEXINOL 60mg Capsules: The recommended dose of FEXINOL 60mg for adults and Children aged 12 years or older is 60mg twice daily. FEXINOL 120mg Tablets: The recommended dose of FEXINOL 120mg for adults and Children aged 12 years or older is 120mg once daily. FEXINOL 180mg Tablets: The recommended dose of FEXINOL 180mg for adults and Children aged 12 years or older is 180mg once daily. A dose of 60mg once daily is recommended as the starting dose in patients with decreased renal function.

Store FEXINOL capsules and tablets at controlled room temperature (15-30C)

Do not use later than the date of Expiry

FEXINOL 60mg capsules: Packet contains one blister of 10 capsules. FEXINOL 120mg tablets: Packet contains one blister of 10 tablets. FEXINOL 180mg tablets: Packet contains one blister of 10 tablets.

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