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Side effects Allegra in children 6 months to 5 years old were similar to placebo. Side effects varied by age. The most commonly reported side effects were: vomiting, pyrexia, cough, otitis media and diarrhea.
Sanofi-aventis U.S. (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Allegra(R) (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age. This approval makes available a safe and effective seasonal allergy treatment option that is non-impairing to pediatric populations as young as 2 years old.
“Until now, parents had few seasonal antihistamine treatment options that were not associated with cognitively impairing adverse side effects,” says Eli Meltzer, M.D., of the Allergy and Asthma Medical Group and Research Center in San Diego. “However, with Allegra Oral Suspension, which does not cause sedation at any dose and is well-established for its antihistamine activity, a medication is now available in a good tasting, easy-to-swallow formulation that can help reduce the seasonal allergy symptoms of children.”
Seasonal allergic rhinitis is a common chronic condition in children. Symptoms of seasonal allergies include nasal drainage, sneezing, watery eyes and itchy nose, eyes and throat. Studies indicate that seasonal allergy inflammation as well as the impairing side effects of older antihistamines can be disruptive to a child and may affect cognitive skills and function.
Allegra Oral Suspension has also been approved for the treatment of chronic idiopathic urticaria (CIU) in twice-daily 30 mg doses for pediatric patients 2 to 11 years of age and twice-daily 15 mg doses for pediatric patients 6 months to 2 years of age. CIU is a rare and bothersome condition characterized by hives lasting more than 6 weeks from an unknown cause. Its symptoms are caused by a reaction to an unknown trigger in the upper layers of the skin. The condition itself may cause severe itching, but is made worse by scratching.
Allegra Oral Suspension will have a berry flavor* and is expected to be available to consumers in time for the 2007 spring allergy season.
INTRODUCTION: Antihistamines are used for the treatment of allergic rhinitis (AR) symptoms. However, the cognitive effects of some antihistamines can dramatically impair individuals in occupations that require sustained vigilance. METHODS: The cognitive effects of fexofenadine were compared to a placebo (passive control) and cetirizine (active control) in healthy naval flight personnel. All subjects received one dose of each treatment in one of six possible sequences with two washout periods in between, and were assessed for aviation-related cognitive skills using the Aeromedical Vigilance Test (AVT) at both ambient atmospheric conditions and normobaric hypoxic conditions. Drowsiness was self-assessed by participants using a visual analog scale (VAS). RESULTS: There was no significant difference between fexofenadine and placebo over the entire 60-min test period, under ambient atmospheric conditions, or under either hypoxic condition. Compared with placebo, cetirizine significantly increased AVT errors over the entire 60-min test period, at 10,000 ft, and at 15,000 ft. No statistical difference was found between treatments under ambient atmospheric conditions, although cetirizine treatment resulted in a greater change from baseline in adjusted average number of AVT errors (0.2124 +/- 0.06) than fexofenadine treatment (0.1989 +/- 0.07) and placebo (0.0745 +/- 0.07). Furthermore, at 10,000 ft there were significantly more AVT errors with cetirizine than with fexofenadine. There were no significant increases in self-reported drowsiness (VAS) for both cetirizine and fexofenadine compared with placebo. CONCLUSION: Fexofenadine is comparable to placebo in its effect on the cognitive skills important for piloting an aircraft, while cetirizine impairs cognition and may affect piloting ability.
For seasonal allergies the recommended dose for adults and children 12 years or older is 60 mg twice daily or 180 mg once daily. Children 6-11 years of age should be given 30 mg twice daily. For chronic urticaria, adults and children 12 years or older should use 60 mg twice daily, and children 6-11 years of age should use 30 mg twice daily. Take Fexofenadine with water (not fruit juice).[4] Fexofenadine can be taken with or without food.
Treatment Info
Condition / reason: Severe Allergies
Dosage & duration: 180 MG taken once a day as needed for the period of Only as needed
Other conditions: Sinus Congestion & Headaches
Other drugs taken: None
Reported Results
Benefits: Almost immediate relief of allergy symptoms, freer breathing
Side effects: None
Comments: I suffered from severe allergic reactions to almost all allergens. My nasal passages would constrict & I could not breathe through my nose. As a result, my sinuses would clog up & I would experience severe sinus headaches. Taking this medication only as needed — when I began to first experience the severe symptoms — has actually seemed to decrease my symptoms overall. I don’t need to use the medication as often as I did when I first began taking it. In fact, my original prescription was filled 4/8/2007 for a quantity of 30 and I still have four pills left!
Before taking fexofenadine make sure your doctor or pharmacist knows:
Along with their useful effects all medicines can cause unwanted side effects, which usually improve as your body adjusts to the new medicine. Speak with your doctor or pharmacist if any of the following side effects continue or become troublesome.
Side-effects - these occur only rarely with this medicine - What can I do if I experience this
Other side-effects that may occur rarely include tummy upset, being aware of your heart beat, skin rashes, dizziness, mood changes, disturbed sleep or shakiness.
Allegra is now available in an oral suspension that can be given to children between the ages of 2 and 11 years with seasonal allergies and over 6 months with chronic idiopathic urticaria (hives). This can be helpful for older children who can’t yet swallow pills and want an alternative to Claritin, Clarinex, Singulair, and Zyrtec, which are already available in chewable or dissolvable tablets.