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Sneez 180 Tablets (Fexofenadine 180mg Film Coated Tablets)Sneez D Tablets (Fexofenadine HCL 60mg + Levofloxacin 250mg Film

Sneez 60 Tablets (Fexofenadine 60mg Film Coated Tablets)
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Sneez 60 Tablets (Fexofenadine 60mg Film Coated Tablets)

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Composition:

SNEEZ 60 Tablets
Each tablet contains 60mg Fexofenadine Hydrochloride as active ingredient.
SNEEZ 120 Tablet:
Each tablet contains 120mg Fexofenadine Hydrochloride as active ingredient.
SNEEZ 180 Tablets:
Each tablet contains 180mg Fexofenadine Hydrochloride as active ingredient.
Clinical Pharmacology:
Mechanism of Action:

Fexofenadine, a metabolite of terfenadine, is an antihistamine with selective peripheral H1 receptor antagonistic activity.

Pharmacokinetics:

Fexofenadine Hydrochloride was rapidly absorbed following oral administration of a single dose to 60mg tablets by healthy male volunteers with a mean time to maximum plasma concentration occurring at 2.6 hours postdose. After administration of a single 60mg dose as an oral solution to healthy subjects, the mean plasma concentration was 209ug/ml. Mean steady-state peak plasma concentration of 286ug/ml were observed when healthy volunteers were administered multiple doses of Fexofenadine Hydrochloride (60mg oral solution every 12 hours for 10 doses) Fexofenadine pharmacokinetics were linear for oral dose up to 120mg twice daily. Although the absolute bio availability of Fexofenadine hydrochloride tablets is unknown, the tablets are bioequivalent to an oral solution. The mean elimination half life of Fexofenadine was 14.4 hours following administration of 60 mg, twice daily, to steady-state in normal volunteers, Human mass balance studies documented a recovery of approximately 80% and 11% (‚ÄĚC) Fexofenadine Hydrochloride dose in the faeces and urine, respectively. Approximately 5% of the total dose was metabolized beacause the absolute bio availability of Fexofenadine Hydrochloride has not been established, it is unknown if the faecal components represents unabsorbed drug or the result of biliary excretion. The Pharmacokinetics of Fexofenadine Hydrochloride in allergic rhinitis patients were similar to those in healthy subjects. Peak Fexofenadine plasma concentrations weje similar between adolescent (12-16 years of age) and adult patients. Fexofenadine Hydrochloride is 60% to 70% bound to plasma protiens, primarily albumin and 4-1-acid glycoprotein. Effects of age: In older subjects (65 years old), peak plasma levels of Fexofenadine hydrochloride were 99% greater than those observed in normal volunteers ( trolled studies in pregnant women. Fexofenadine Hydrochloride should be used during pregnancy only if the potential benefits justifies the potential risk of the fetus.

Nursing Mothers

There are no adequate and well-controlled studies in women during lactation. Because many drugs are excreted in human milk, caution should be exercised when Fexofenadine Hydrochloride is administered to nursing woman.

Pediatric Use:
safety and effectiveness of SNEEZ in pediatric under the age of 6 years have not been established.

Geriatric Use:
In placebo-controlled trials, 42 patients, age 60 to 68 years, received doses of 20mg to 240mg of Fexofenadine Hydrochloride twice daily for up to two weeks Adverse events were similar in this group compared to patients under age 60 years

Adverse reactions:

In placebo- controlled clinical trials, which included 2461 patients receiving Fexofenadine Hydrochloride at doses of 20mg to 240 mg twice daily, adverse events, including drowsiness, was not dose related and was similar across subgroups defined by age, gender and race. The percent of patients, who withdrew prematurely because of adverse events was 22% with Fexofenadine Hydrochloride vs 3% with placebo. All adverse events were reported by greater than 1% of patients who received the recommended dose of Fexofenadine Hydrochloride (60mg twice-daily), and that were more common with Fexofenadine than placebo.
Adverse events occurring in greater than 1% of Fexofenadine Hydrochloride-treated patients (60mg twice daily), but that were more common in the placebo-treated group, include, headache and throat irritation. The frequency and magnitude of laboratory abnormalities were similar in Fexofenadine Hydrochloride and placebo-treated patients.

Overdosage:

Clinical Features: Information regarding acute overdosage is limited to experience from clinical trails conducted during the development of SNEEZ single dose of Fexofenadine Hydrochloride up to 800mg (6 normal volunteers at this dose level), and doses up to 690mg twice daily for one month (3 normal volunteers at this level), were administered without the development of clinically significant adverse events.
Treatment of Overdosage: In the events of overdose, consider standard measure to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Hemodialysis did not effectively remove Fexofenadine from blood(up to 1.7% removed) following terfenadine administration.

Dosage and Administration:

SNEEZ 60Tablets:
The recommended dose of SNEEZ 60mg for adults & children aged 6 years or older is twice daily.

SNEEZ 120Tablets:

The recommended dose of SNEEZ 120mg for adults & children aged 12 years or older is once daily.

SNEEZ 180 Tablets:

The recommended dose of SNEEZ 180mg for adults & children aged 12 years or older is once daily.

Storage:

Store in a cool & dry place away from sunlight. Keep out of reach of children.

Presentation:

SNEEZ 60: Packet contains one strip of 10 tablets.
SNEEZ 120: Packet contains one strip of 10 tablets.
SNEEZ 180: Packet contains one strip of 10 tablets.