Prescription drugs info

Teratogenic Effects
Category C. There was no evidence of teratogenicity in rats or rabbits at oral doses of terfenadine up to 300 mg/kg (which led to fexofenadine exposures that were approximately 4 and 30 times, respectively, the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on comparison of AUCs).

In mice, no adverse effects and no teratogenic effects during gestation were observed with fexofenadine hydrochloride at oral doses up to 3730 mg/kg (which led to fexofenadine exposures that were approximately 15 times the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on comparison of AUCs).

There are no adequate and well controlled studies in pregnant women. Fexofenadine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects. Dose-related decreases in pup weight gain and survival were observed in rats exposed to an oral dose of 150 mg/kg of terfenadine (which led to fexofenadine exposures that were approximately 3 times the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on comparison of AUCs).

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Allegra ODT contains phenylalanine, a component of aspartame. Each 30 mg Allegra ODT contains 5.3 mg phenylalanine. Allegra products other than Allegra ODT do not contain phenylalanine.

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Allegra tablets, Allegra ODT and Allegra oral suspension are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of Allegra. Rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

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Allegra tablets dosage and administration
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Adults and Children 12 Years and Older. The recommended dose of Allegra tablets is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.

Children 6 to 11 Years. The recommended dose of Allegra tablets is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Allegra ODT dosage and administration
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Children 6 to 11 Years. Allegra ODT is intended for use only in children 6 to 11 years of age. The recommended dose of Allegra ODT is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Allegra ODT is designed to disintegrate on the tongue, followed by swallowing with or without water. Allegra ODT should be taken on an empty stomach. Allegra ODT is not intended to be chewed.

Allegra ODT should not be removed from the original blister package until the time of administration.

Allegra oral suspension dosage and administration
Seasonal Allergic Rhinitis

Children 2 to 11 Years : The recommended dose of Allegra oral suspension is 30 mg twice daily. A dose of 30 mg (5 mL) once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Shake bottle well before each use.

Chronic Idiopathic Urticaria

Children 6 Months to 11 years: The recommended dose of Allegra oral suspension is 30 mg (5 mL) twice daily for patients 2 to 11 years of age and 15 mg (2.5 mL) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of Allegra oral suspension are 30 mg (5 mL) once daily for patients 2 to 11 years of age and 15 mg (2.5 mL), once daily for patients 6 months to less than 2 years of age.

Shake bottle well, before each use.

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-Allegra Tablets: 30 mg, 60 mg, and 180 mg
-Allegra ODT: 30 mg
- Allegra oral suspension: 30 mg/5mL (6mg/mL)

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, ½-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)

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Allegra is an H1-receptor antagonist indicated for the following:

- Relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age
- Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients ≥ 6 months of age.

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Before you have any skin tests for allergies, tell the doctor in charge that you are taking Allegra. The results of the test may be affected by Allegra.

When taking Allegra on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by the Allegra.

Allegra will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using Allegra .

Allegra may cause some people to become drowsy or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to Allegra before you drive, use machines, or do anything else that could be dangerous if you are not alert .

Allegra may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

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An excessive dose of any medicine can have serious consequences. Seek medical attention whenever an overdose is suspected.

Symptoms of Allegra overdose may include:
- Dizziness, drowsiness, dry mouth

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ALLEGRA

Adults and Children 12 Years and Older
For hay fever, the usual dosage is 60 milligrams twice a day or 180 milligrams once a day. For hives, it’s 60 milligrams twice a day. If you have kidney problems, your doctor may have you take only one 60-milligram dose daily.

Children 6 through 11 years old
For hay fever or hives, the usual dosage is 30 milligrams twice a day. Children with kidney problems may be prescribed only one 30-milligram dose each day.

ALLEGRA-D

Adults and Children 12 Years and Older

12-Hour Tablets: Take 1 tablet twice a day. People with kidney problems should take only 1 tablet daily.

24-Hour Tablets: Take 1 tablet once a day. Allegra-D 24-hour tablets should generally not be taken by people with kidney problems.

Allegra-D is not recommended for children less than 12 years old.

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The effects of Allegra during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known whether Allegra appears in breast milk. If the drug is essential to your health, your doctor may advise you to stop nursing until your treatment is finished.

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