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ALLEGRA-D 24 HOUR
Overview
What is ALLEGRA-D 24 HOUR?
ALLEGRA-D 24 HOUR (fexofenadine
hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets for
oral administration contain 180 mg fexofenadine hydrochloride for immediate
release and 240 mg pseudoephedrine hydrochloride for extended release. Tablets
also contain as excipients: microcrystalline cellulose, sodium chloride,
cellulose acetate, polyethylene glycol, opadry white, povidone, talc,
hypromellose, croscarmellose sodium, copovidone, titanium dioxide, magnesium
stearate, colloidal silicon dioxide, brilliant blue aluminum lake, acetone,
isopropyl alcohol, methyl alcohol, methylene chloride, water, and black ink.
Fexofenadine hydrochloride, one of the active ingredients of ALLEGRA-D 24
HOUR, is a histamine H-receptor antagonist with the
chemical name
(±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α,
α-dimethyl benzeneacetic acid hydrochloride and the following chemical
structure:
Fexofenadine Hydrochloride Structure Image
The molecular weight is 538.13 and the empirical formula is CHNO•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.
Pseudoephedrine hydrochloride, the other active ingredient of ALLEGRA-D 24
HOUR, is an adrenergic (vasoconstrictor) agent with the chemical name
[S-(R*,R*)]-α-[1-(methylamino)ethyl]-benzenemethanol hydrochloride and the
following chemical structure:
The molecular weight is 201.70 and the molecular formula is CHNO•HCl. Pseudoephedrine
hydrochloride occurs as fine, white to off-white crystals or powder, having a
faint characteristic odor. It is very soluble in water, freely soluble in
alcohol, and sparingly soluble in chloroform.
What does ALLEGRA-D 24 HOUR look like?
What are the available doses of ALLEGRA-D 24 HOUR?
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What should I talk to my health care provider before I take ALLEGRA-D 24 HOUR?
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How should I use ALLEGRA-D 24 HOUR?
ALLEGRA-D 24 HOUR 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 24 HOUR should be administered when both the antihistaminic
properties of fexofenadine hydrochloride and the nasal decongestant properties
of pseudoephedrine hydrochloride are desired (see ).
The recommended dose of ALLEGRA-D 24 HOUR Extended-Release
Tablets is one tablet once daily administered on an empty stomach with water for
adults and children 12 years of age and older. ALLEGRA-D 24 HOUR tablets should
generally be avoided in patients with renal insufficiency. ALLEGRA-D 24 HOUR
must be swallowed whole and never crushed or chewed.
What interacts with ALLEGRA-D 24 HOUR?
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What are the warnings of ALLEGRA-D 24 HOUR?
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What are the precautions of ALLEGRA-D 24 HOUR?
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What are the side effects of ALLEGRA-D 24 HOUR?
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What should I look out for while using ALLEGRA-D 24 HOUR?
ALLEGRA-D 24 HOUR is contraindicated in patients with known
hypersensitivity to any of its ingredients.
Due to its pseudoephedrine component, ALLEGRA-D 24 HOUR 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 (see section). 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.
What might happen if I take too much ALLEGRA-D 24 HOUR?
Most reports of fexofenadine hydrochloride overdose contain
limited information. However, dizziness, drowsiness, and dry mouth have been
reported. For the pseudoephedrine hydrochloride component of ALLEGRA-D 24 HOUR,
information on acute overdose is limited to the marketing history of
pseudoephedrine hydrochloride. Single doses of fexofenadine hydrochloride up to
800 mg (6 healthy volunteers at this dose level), and doses up to 690 mg twice
daily for one month (3 healthy volunteers at this dose level), were administered
without the development of clinically significant adverse events.
In large doses, sympathomimetics may give rise to giddiness, headache,
nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations,
difficulty in micturition, muscular weakness and tenseness, anxiety,
restlessness, and insomnia. Many patients can present a toxic psychosis with
delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory
collapse, convulsions, coma, and respiratory failure.
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). The effect of hemodialysis on the removal of pseudoephedrine is
unknown.
No deaths occurred in mature mice and rats at oral doses of fexofenadine
hydrochloride up to 5000 mg/kg (approximately 110 and 230 times, respectively,
the maximum recommended human daily oral dose of ALLEGRA-D 24 HOUR on a
mg/m basis.) The median oral lethal dose in newborn rats
was 438 mg/kg (approximately 20 times the maximum recommended human daily oral
dose of ALLEGRA-D 24 HOUR on a mg/m basis). In dogs, no
evidence of toxicity was observed at oral doses up to 2000 mg/kg (approximately
300 times the maximum recommended human daily oral dose of ALLEGRA-D 24 HOUR on
a mg/m basis). The oral median lethal dose of
pseudoephedrine hydrochloride in rats was 1674 mg/kg (approximately 55 times the
maximum recommended human daily oral dose of ALLEGRA-D 24 HOUR on a mg/m basis).
How should I store and handle ALLEGRA-D 24 HOUR?
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].ALLEGRA-D 24 HOUR Extended-Release Tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 24 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1095-47), with an activated charcoal pouch. All bottles have a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA-D 24 HOUR Extended-Release Tablet is a white, round, film coated tablet. The tablet has 308AV printed on one side in black ink.Store ALLEGRA-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Rev. December 2009sanofi-aventis U.S. LLCBridgewater, NJ 08807©2009 sanofi-aventis U.S. LLC ALLEGRA-D 24 HOUR Extended-Release Tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 24 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1095-47), with an activated charcoal pouch. All bottles have a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA-D 24 HOUR Extended-Release Tablet is a white, round, film coated tablet. The tablet has 308AV printed on one side in black ink.Store ALLEGRA-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Rev. December 2009sanofi-aventis U.S. LLCBridgewater, NJ 08807©2009 sanofi-aventis U.S. LLC ALLEGRA-D 24 HOUR Extended-Release Tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 24 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1095-47), with an activated charcoal pouch. All bottles have a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA-D 24 HOUR Extended-Release Tablet is a white, round, film coated tablet. The tablet has 308AV printed on one side in black ink.Store ALLEGRA-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Rev. December 2009sanofi-aventis U.S. LLCBridgewater, NJ 08807©2009 sanofi-aventis U.S. LLC ALLEGRA-D 24 HOUR Extended-Release Tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 24 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1095-47), with an activated charcoal pouch. All bottles have a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA-D 24 HOUR Extended-Release Tablet is a white, round, film coated tablet. The tablet has 308AV printed on one side in black ink.Store ALLEGRA-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Rev. December 2009sanofi-aventis U.S. LLCBridgewater, NJ 08807©2009 sanofi-aventis U.S. LLC ALLEGRA-D 24 HOUR Extended-Release Tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 24 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1095-47), with an activated charcoal pouch. All bottles have a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA-D 24 HOUR Extended-Release Tablet is a white, round, film coated tablet. The tablet has 308AV printed on one side in black ink.Store ALLEGRA-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Rev. December 2009sanofi-aventis U.S. LLCBridgewater, NJ 08807©2009 sanofi-aventis U.S. LLC ALLEGRA-D 24 HOUR Extended-Release Tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 24 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1095-47), with an activated charcoal pouch. All bottles have a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal. ALLEGRA-D 24 HOUR Extended-Release Tablet is a white, round, film coated tablet. The tablet has 308AV printed on one side in black ink.Store ALLEGRA-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.) Rev. December 2009sanofi-aventis U.S. LLCBridgewater, NJ 08807©2009 sanofi-aventis U.S. LLC
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Fexofenadine hydrochloride, the major active metabolite of
terfenadine, is an antihistamine with selective peripheral H-receptor antagonist activity. Fexofenadine hydrochloride
inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine
release from peritoneal mast cells in rats. In laboratory animals, no
anticholinergic or alpha-adrenergic-receptor blocking
effects were observed. Moreover, no sedative or other central nervous system
effects were observed. Radiolabeled tissue distribution studies in rats
indicated that fexofenadine does not cross the blood-brain barrier.
Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and
exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride
is recognized as an effective agent for the relief of nasal congestion due to
allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those
of ephedrine and central effects similar to, but less intense than,
amphetamines. It has the potential for excitatory side effects.
Non-Clinical Toxicology
ALLEGRA-D 24 HOUR is contraindicated in patients with known hypersensitivity to any of its ingredients.Due to its pseudoephedrine component, ALLEGRA-D 24 HOUR 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 (see section). 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.
Fexofenadine hydrochloride and pseudoephedrine hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly.
Fexofenadine has been shown to exhibit minimal (ca. 5%) metabolism. However, co-administration of fexofenadine hydrochloride with either ketoconazole or erythromycin led to increased plasma concentrations of fexofenadine. Fexofenadine had no effect on the pharmacokinetics of either erythromycin or ketoconazole. In 2 separate studies, fexofenadine 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 QT interval were observed when subjects were administered fexofenadine hydrochloride alone or in combination with either erythromycin or ketoconazole. The findings of these studies are summarized in the following table:
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 , and animal models. These studies indicate that ketoconazole or erythromycin co-administration enhances fexofenadine gastrointestinal absorption. This observed increase in the bioavailability of fexofenadine may be due to transport-related effects, such as p-glycoprotein. animal studies also suggest that in addition to enhancing absorption, ketoconazole decreases fexofenadine gastrointestinal secretion, while erythromycin may also decrease biliary excretion.
Due to the pseudoephedrine component, ALLEGRA-D 24 HOUR 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 is used concomitantly with digitalis. Care should be taken in the administration of ALLEGRA-D 24 HOUR concomitantly with other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient (see ).
Administration of 120 mg of fexofenadine hydrochloride (2 × 60 mg capsule) within 15 minutes of an aluminum and magnesium containing antacid (Maalox) decreased fexofenadine AUC by 41% and C by 43%. ALLEGRA-D 24 HOUR should not be taken closely in time with aluminum and magnesium containing antacids.
Fruit juices such as grapefruit, orange and apple may reduce the bioavailability and exposure of fexofenadine. 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 fexofenadine 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 fexofenadine was reduced by 36%. Therefore, to maximize the effects of fexofenadine, it is recommended that ALLEGRA-D 24 HOUR should be taken with water (see ).
Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy (see ). Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.
Because ALLEGRA-D 24 HOUR is a once-daily, fixed-dose combination that cannot be titrated and renal insufficiency increases the bioavailability and prolongs the half-life of fexofenadine hydrochloride and pseudoephedrine hydrochloride, ALLEGRA-D 24 HOUR tablets should generally be avoided in patients with renal insufficiency (see , and ).
In a placebo-controlled clinical study in the United States, which included 570 subjects with seasonal allergic rhinitis aged 12 years and older receiving fexofenadine hydrochloride tablets at doses of 120 or 180 mg once daily, adverse events were similar in fexofenadine hydrochloride and placebo-treated subjects. The following table lists adverse experiences that were reported by greater than 2% of subjects treated with fexofenadine hydrochloride tablets at doses of 180 mg once daily and that were more common with fexofenadine hydrochloride than placebo.
Events that have been reported during controlled clinical trials involving subjects with seasonal allergic rhinitis 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 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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