Allegra-D 12 Hour Allergy and Congestion

Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl 180 and pseudoephendrine hcl 240) Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.

Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl 180 and pseudoephendrine hcl 240) should be administered when both the antihistaminic properties of Allegra-D 12 Hour Allergy and Congestion hydrochloride and the nasal decongestant properties of Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride are desired.

Allegra-D 12 Hour Allergy and Congestion contains a combination of Allegra-D 12 Hour Allergy and Congestion and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion). Allegra-D 12 Hour Allergy and Congestion is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) in Allegra-D 12 Hour Allergy and Congestion is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Allegra-D 12 Hour Allergy and Congestion is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Allegra-D 12 Hour Allergy and Congestion may also be used for purposes not listed in this medication guide.

The recommended dose of Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR Extended-Release Tablets is one tablet twice daily administered on an empty stomach with water for adults and children 12 years of age and older. It is recommended that the administration of Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR with food should be avoided. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function.

Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR may be eliminated in the feces in a form that may resemble the original tablet.

How supplied

Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR Extended-Release Tablets contain 60 mg Allegra-D 12 Hour Allergy and Congestion hydrochloride for immediate release and 120 mg Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride for extended release. Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1090-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; HDPE bottles of 500 (NDC 0088-1090-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; and aluminum foil-backed clear blister packs of 100 (NDC 0088-1090-49).

Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR is a two-layer tablet, one white layer and one tan layer with a clear film coating on the tablet. The tablets are engraved with ”06/012D” on the white layer.

Store Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR Extended-Release Tablets at 20-25°C (68-77°F).

Rev. December 2009. sanofi-aventis U.S. LLC Bridgewater, NJ 08807. www.allegra.com

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What is the most important information I should know about Allegra-D 12 Hour Allergy and Congestion?

Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl 180 and pseudoephendrine hcl 240) is contraindicated in patients with known hypersensitivity to any of its ingredients.

Due to its Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) component, Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl 180 and pseudoephendrine hcl 240) is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment. It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias.

Use Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour) by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
• Swallow Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour) whole. Do not break, crush, chew, or dissolve before swallowing.
• Take Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour) with a full glass of water (8 oz/240 mL).
• Do not drink fruit juice at the same time that you take Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour). Certain fruit juices (eg, grapefruit, apple, orange) may decrease Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour)'s effectiveness.
• If you take antacids that contain aluminum or magnesium, do not take them at the same time as Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour). Ask your doctor or pharmacist how to take them with Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour).
• If you miss a dose of Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Allegra-D 12 Hour Allergy and Congestion extended-release tablets (12 hour).

Use: Labeled Indications

Seasonal allergic rhinitis: Relief of symptoms (eg, sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes, nasal congestion) associated with seasonal allergic rhinitis in patients ≥12 years.

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What other drugs will affect Allegra-D 12 Hour Allergy and Congestion?

Allegra-D 12 Hour Allergy and Congestion hydrochloride and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly.

Allegra-D 12 Hour Allergy and Congestion has been shown to exhibit minimal (ca. 5%) metabolism. However, co-administration of Allegra-D 12 Hour Allergy and Congestion hydrochloride with either ketoconazole or erythromycin led to increased plasma concentrations of Allegra-D 12 Hour Allergy and Congestion. Allegra-D 12 Hour Allergy and Congestion had no effect on the pharmacokinetics of either erythromycin or ketoconazole. In 2 separate studies, Allegra-D 12 Hour Allergy and Congestion hydrochloride 120 mg twice daily was co-administered with either erythromycin 500 mg every 8 hours or ketoconazole 400 mg once daily under steady-state conditions to healthy volunteers (n=24, each study). No differences in adverse events or QTc interval were observed when subjects were administered Allegra-D 12 Hour Allergy and Congestion hydrochloride alone or in combination with either erythromycin or ketoconazole. The findings of these studies are summarized in the following table:

Effects on steady-state Allegra-D 12 Hour Allergy and Congestion pharmacokinetics after 7 days of co-administration with Allegra-D 12 Hour Allergy and Congestion hydrochloride 120 mg every 12 hours (two times the recommended twice daily dose) in healthy volunteers (n=24)

The changes in plasma levels were within the range of plasma levels achieved in adequate and well-controlled clinical trials.

The mechanism of these interactions has been evaluated in in vitro, in situ, and in vivo animal models. These studies indicate that ketoconazole or erythromycin co-administration enhances Allegra-D 12 Hour Allergy and Congestion gastrointestinal absorption. This observed increase in the bioavailability of Allegra-D 12 Hour Allergy and Congestion may be due to transport-related effects, such as p-glycoprotein. In vivo animal studies also suggest that in addition to enhancing absorption, ketoconazole decreases Allegra-D 12 Hour Allergy and Congestion gastrointestinal secretion, while erythromycin may also decrease biliary excretion.

Due to the Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) component, Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl 180 and pseudoephendrine hcl 240) is contraindicated in patients taking monoamine oxidase inhibitors and for 14 days after stopping use of an MAO inhibitor. Concomitant use with antihypertensive drugs which interfere with sympathetic activity (e.g., methyldopa, mecamylamine, and reserpine) may reduce their antihypertensive effects. Increased ectopic pacemaker activity can occur when Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) is used concomitantly with digitalis. Care should be taken in the administration of Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl 180 and pseudoephendrine hcl 240) concomitantly with other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient.

Drug Interactions with Antacids

Administration of 120 mg of Allegra-D 12 Hour Allergy and Congestion hydrochloride (2 x 60 mg capsule) within 15 minutes of an aluminum and magnesium containing antacid (Maalox®) decreased Allegra-D 12 Hour Allergy and Congestion AUC by 41% and Cmax by 43%. Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl 180 and pseudoephendrine hcl 240) should not be taken closely in time with aluminum and magnesium containing antacids.

Interactions with Fruit Juices

Fruit juices such as grapefruit, orange and apple may reduce the bioavailability and exposure of Allegra-D 12 Hour Allergy and Congestion. This is based on the results from 3 clinical studies using histamine induced skin wheals and flares coupled with population pharmacokinetic analysis. The size of wheal and flare were significantly larger when Allegra-D 12 Hour Allergy and Congestion hydrochloride was administered with either grapefruit or orange juices compared to water. Based on the literature reports, the same effects may be extrapolated to other fruit juices such as apple juice. The clinical significance of these observations is unknown. In addition, based on the population pharmacokinetics analysis of the combined data from grapefruit and orange juices studies with the bioequivalence study data, the bioavailability of Allegra-D 12 Hour Allergy and Congestion was reduced by 36%. Therefore, to maximize the effects of Allegra-D 12 Hour Allergy and Congestion, it is recommended that Allegra-D 12 Hour Allergy and Congestion should be taken with water.

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What are the possible side effects of Allegra-D 12 Hour Allergy and Congestion?

Allegra-D 12 Hour Allergy and Congestion (Allegra-D 12 Hour Allergy and Congestion hcl and Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hcl) 12 HOUR

In one clinical trial (n=651) in which 215 subjects with seasonal allergic rhinitis received the 60 mg Allegra-D 12 Hour Allergy and Congestion hydrochloride/120 mg Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride combination tablet twice daily for up to 2 weeks, adverse events were similar to those reported either in subjects receiving Allegra-D 12 Hour Allergy and Congestion hydrochloride 60 mg alone (n=218 subjects) or in subjects receiving Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride 120 mg alone (n=218). A placebo group was not included in this study.

The percent of subjects who withdrew prematurely because of adverse events was 3.7% for the Allegra-D 12 Hour Allergy and Congestion hydrochloride/Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride combination group, 0.5% for the Allegra-D 12 Hour Allergy and Congestion hydrochloride group, and 4.1% for the Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride group. All adverse events that were reported by greater than 1% of subjects who received the recommended daily dose of the Allegra-D 12 Hour Allergy and Congestion hydrochloride/Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride combination are listed in the following table.

Adverse Experiences Reported in One Active-Controlled Seasonal Allergic Rhinitis Clinical Trial at Rates of Greater than 1%

Many of the adverse events occurring in the Allegra-D 12 Hour Allergy and Congestion hydrochloride/Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride combination group were adverse events also reported predominately in the Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride group, such as insomnia, headache, nausea, dry mouth, dizziness, agitation, nervousness, anxiety, and palpitation.

Allegra-D 12 Hour Allergy and Congestion Hydrochloride

In placebo-controlled clinical trials, which included 2461 subjects receiving Allegra-D 12 Hour Allergy and Congestion hydrochloride at doses of 20 mg to 240 mg twice daily, adverse events were similar in Allegra-D 12 Hour Allergy and Congestion hydrochloride and placebo-treated subjects. The incidence of adverse events, including drowsiness, was not dose related and was similar across subgroups defined by age, gender, and race. The percent of subjects who withdrew prematurely because of adverse events was 2.2% with Allegra-D 12 Hour Allergy and Congestion hydrochloride vs 3.3% with placebo.

Events that have been reported during controlled clinical trials involving subjects with seasonal allergic rhinitis and chronic idiopathic urticaria at incidences less than 1% and similar to placebo and have been rarely reported during postmarketing surveillance include: insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) Hydrochloride

Pseudoephedrine (Allegra-D 12 Hour Allergy and Congestion 12 Hour Allergy and Congestion) hydrochloride may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, drowsiness, tachycardia, palpitation, pressor activity, cardiac arrhythmias and ischemic colitis have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.