Generic Allegra

ALLEGRA tablets are available in 30 mg, 60 mg, and 180 mg strengths. ALLEGRA tablets are coated with a peach colored film coating. Tablets have the following unique shape and identifiers: 30 mg tablets are round, bi-convex and have 03 on one side and a scripted “e” on the other; 60 mg tablets are oval, bi-convex and have 06 on one side and a scripted “e” on the other; and 180 mg tablets are oblong, bi-convex and have 018 on one side and a scripted “e” on the other.

ALLEGRA ODT is available as a 30 mg orally disintegrating tablet and is white, flat-faced, 1/2-inch round shaped with beveled edges and debossed with a scripted “e” on one side and “311AV” on the other side.

ALLEGRA oral suspension is available as 30 mg/ 5 mL (6 mg/mL).

Secondary to the pseudoephedrine component, fexofenadine HCl; pseudoephedrine HCl should be used with caution in patients with the following medical conditions:

• Hypertension
• Diabetes mellitus
• Ischemic heart disease
• Increased intraocular pressure
• Hyperthyroidism
• Prostatic hypertrophy
• Renal impairment (patients with decreased renal function should be given a lower initial dose (one tablet per day) because they have reduced elimination of fexofenadine and pseudoephedrine)

The safety of Allegra has not been established in pregnant women, therefore Allegra should not be used in women who are trying to get pregnant or in women who are pregnant. Women should not take Allegra while breastfeeding their infant because it is not known whether Allegra is excreted in the breast milk.

Allegra D provides effective relief from the symptoms of seasonal allergies including itchy, watery eyes; itchy palate; sneezing and runny nose.

So whether you suffer from allergies secondary to dogs, cats, pets, pollen, ragweed, dander, mildew, dust, mold, feathers, etc. Allegra D will provide relief.

Distinct from the current over-the-counter and many prescription antihistamines, Allegra D, provides relief without causing drowsiness. In fact, regulations require all antihistamines that cause drowsiness to caution users concerning the operation of a motor vehicle or heavy machinery. Allegra does not carry any such label. Therefore, with Allegra D you can continue your normal activities without feeling drowsy or tired.

Allegra D is an antihistamine that works by blocking the action on histamine, when antibodies latch onto mast cells, the mast cells release histamine, a chemical that causes blood vessels in the nose to dilate and leak fluid into surrounding tissue. This results in swelling, itching and nasal discharge. Allegra D blocks the release of histamine so these symptoms of watery eyes, itchy palate, sneezing, stuffiness, runny nose, etc. are significantly decreased.

A common question is what is the difference between Allegra and Allegra D? The difference is Allegra-D combines antihistamine with the nasal decongestant pseudoephedrine. The psuedoephedrine causes a narrowing of the blood vessels in the nose this leads to a clearing of the nasal congestion. This is why so many doctors prefer Allegra D over Allegra.

Fexofenadine hydrochloride, the active ingredient of ALLEGRA, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-(alpha), (alpha)-dimethyl benzeneacetic acid hydrochloride. It has the following chemical structure

ALLEGRA is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

ALLEGRA is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. It significantly reduces pruritus and the number of wheals.

Fexofenadine hydrochloride has a good safety profile in treating allergic rhinitis in children 6-24 months of age, researchers report in the December issue of the Annals of Allergy, Asthma, and Immunology.

“Allergic rhinitis (AR) is a common chronic condition and is estimated to affect up to 40% of children in some countries,” Dr. Frank C. Hampel, of Central Texas Health Research, New Braunfels, Texas, and colleagues write. “Antihistamines are an established first-line treatment for allergic rhinitis and are widely prescribed in infants for allergic symptoms.”

The researchers assessed the safety and tolerability of fexofenadine hydrochloride in children aged 6 months to 2 years in two studies, both multicenter, randomized, placebo-controlled, parallel-group trials. The mean duration of treatment was 8 days.

Altogether, 393 subjects were randomized to twice-daily fexofenadine hydrochloride, 15 or 30 mg, or placebo. All but one received treatment: fexofenadine 15 mg (n = 85); fexofenadine 30 mg (n = 108); and placebo (n = 199). Overall, 265 participants completed the study per protocol.

The incidence of treatment-emergent adverse events (TEAEs) was comparable between groups in the combined population — 48.2% in the placebo group, 40.0% in the fexofenadine 15 mg group, and 35.2% in the fexofenadine 30 mg group.

The most common TEAE was vomiting. Most TEAEs were unrelated to study medication. The TEAEs that were possibly related to study medication were mild to moderate in intensity.

“No clinical differences were observed between the fexofenadine treatment groups and placebo for any vital sign or any ECG variable,” Dr. Hampel and colleagues found. “No clinically meaningful differences were observed between the fexofenadine treatment groups and placebo for any of the physical examination results.”

They add: “To our knowledge, this is the first report to establish the safety and tolerability of fexofenadine at clinically relevant doses in children between 6 months and 2 years.”

Seldane, an antihistamine related to Allegra, has been implicated in dangerous interactions with the common antibiotic erythromycin, the antifungal medication ketoconazole (Nizoral), and several similar drugs. Allegra poses no such risks. It is also safe for people with liver disease.

Fexofenadine hydrochloride, the active ingredient of Allegra tablets, Allegra ODT and Allegra oral suspension, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α,α-dimethyl benzeneacetic acid hydrochloride. It has the following chemical structure

The molecular weight is 538.13 and the empirical formula is C32H39NO4•HCl.

Fexofenadine hydrochloride is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine hydrochloride is a racemate and exists as a zwitterion in aqueous media at physiological pH.

Allegra is formulated as a tablet for oral administration. Each tablet contains 30, 60, or 180 mg fexofenadine hydrochloride (depending on the dosage strength) and the following excipients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The aqueous tablet film coating is made from hypromellose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide.

Allegra ODT is formulated for disintegration in the mouth immediately following administration. Each orally disintegrating tablet contains 30 mg fexofenadine hydrochloride and the following excipients: citric acid anhydrous, crospovidone, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium starch glycolate, aspartame, natural and artificial orange flavor, artificial cream flavor, and alcohol anhydrous; the alcohol is predominantly removed during the manufacturing process.

Allegra oral suspension, a white uniform suspension, contains 6 mg fexofenadine hydrochloride per mL and the following excipients: propylene glycol, edetate disodium, propylparaben, butylparaben, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, artificial raspberry cream flavor, sucrose, xylitol and purified water.

Dizziness, drowsiness, and dry mouth have been reported with fexofenadine hydrochloride overdose. Single doses of fexofenadine hydrochloride up to 800 mg (6 healthy subjects at this dose level), and doses up to 690 mg twice daily for 1 month (3 healthy subjects at this dose level) or 240 mg once daily for 1 year (234 healthy subjects at this dose level) were administered without the development of clinically significant adverse events as compared to placebo.

In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Following administration of terfenadine, hemodialysis did not effectively remove fexofenadine, the major active metabolite of terfenadine, from blood (up to 1.7% removed).

No deaths occurred at oral doses of fexofenadine hydrochloride up to 5000 mg/kg in mice (110 times the maximum recommended daily oral dose in adults and children based on mg/m2) and up to 5000 mg/kg in rats (230 timesthe maximum recommended daily oral dose in adults and 210 times the maximum recommended daily oral dose in children based on mg/m2). 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 2000 mg/kg (300 times the maximum recommended daily oral dose in adults and 280 times the maximum recommended daily oral dose in children based on mg/m2).

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to fexofenadine hydrochloride in 5083 patients in trials for allergic rhinitis and chronic idiopathic urticaria. In these trials, 3010 patients 12 years of age and older with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 20 to 240 mg twice daily or 120 to 180 mg once daily. A total of 646 patients 6 to 11 years of age with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 15 to 60 mg twice daily. The duration of treatment in these trials was 2 weeks. A total of 534 patients 6 months to 5 years of age with allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 15 to 30 mg twice daily. The duration of treatment in these trials ranged from 1 day to 2 weeks. There were 893 patients 12 years of age and older with chronic idiopathic urticaria exposed to fexofenadine hydrochloride at doses of 20 to 240 mg twice daily or 180 mg once daily. The duration of treatment in these trials was 4 weeks.