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fexofenadine hydrochloride and pseudoephedrine hydrochloride
Overview
What is Allegra D-12 Hour?
ALLEGRA-D 12 HOUR (fexofenadine hydrochloride and pseudoephedrine hydrochloride)
Extended-Release Tablets for oral administration contain 60 mg fexofenadine
hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride
for extended release. Tablets also contain as excipients: microcrystalline
cellulose, pregelatinized starch, croscarmellose sodium, magnesium
stearate, carnauba wax, stearic acid, silicon dioxide, hypromellose
and polyethylene glycol.
Fexofenadine hydrochloride, one of the active ingredients of ALLEGRA-D
12 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:
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 12 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. 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-12 Hour look like?
What are the available doses of Allegra D-12 Hour?
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What should I talk to my health care provider before I take Allegra D-12 Hour?
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How should I use Allegra D-12 Hour?
ALLEGRA-D 12 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 12 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 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 with food should be avoided. A dose of one tablet
once daily is recommended as the starting dose in patients with decreased
renal function. (See and .)
ALLEGRA-D 12 HOUR
must be swallowed whole and never crushed or chewed. Occasionally,
the inactive ingredients of ALLEGRA-D 12 HOUR may be eliminated in
the feces in a form that may resemble the original tablet. (See .)
What interacts with Allegra D-12 Hour?
ALLEGRA-D 12 HOUR is contraindicated in patients with known hypersensitivity to any of its ingredients.
Due to its pseudoephedrine component, ALLEGRA-D 12 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 are the warnings of Allegra D-12 Hour?
Array
What are the precautions of Allegra D-12 Hour?
General
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
(see and ).
Information for Patients
Patients taking
ALLEGRA-D 12 HOUR tablets should receive the following information:
ALLEGRA-D 12 HOUR tablets are prescribed for the relief of symptoms
of seasonal allergic rhinitis. Patients should be instructed to take
ALLEGRA-D 12 HOUR tablets only as prescribed. If nervousness, dizziness,
or sleeplessness occur, discontinue use and consult the doctor. Patients
should also be advised against the concurrent use of ALLEGRA-D 12
HOUR tablets with over-the-counter antihistamines and decongestants.
The product should not
be used by patients who are hypersensitive to it or to any of its
ingredients. Due to its pseudoephedrine component, this product should
not be used by patients with narrow-angle glaucoma, urinary retention,
or by patients receiving a monoamine oxidase (MAO) inhibitor or within
14 days of stopping use of MAO inhibitor. It also should not be used
by patients with severe hypertension or severe coronary artery disease.
Patients should be told
that this product should be used in pregnancy or lactation only if
the potential benefit justifies the potential risk to the fetus or
nursing infant. Patients should be advised to take the tablet on an
empty stomach with water. Patients should be directed to swallow the
tablet whole. Patients should be cautioned not to break or chew the
tablet. Patients should also be instructed to store the medication
in a tightly closed container in a cool, dry place, away from children.
Patients should be told
that the inactive ingredients may occasionally be eliminated in the
feces in a form that may resemble the original tablet (see ).
Drug Interactions
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 (twice the recommended dose) was
co-administered with 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 12 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 12 HOUR concomitantly with other sympathomimetic
amines because combined effects on the cardiovascular system may be
harmful to the patient (see ).
| Concomitant Drug | C (Peak plasma concentration) | AUC(0–12h)(Extent of systemic exposure) |
|---|---|---|
| Erythromycin(500 mg every 8 hrs) | +82% | +109% |
| Ketoconazole(400 mg once daily) | +135% | +164% |
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 12 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 data from a bioequivalence study, the bioavailability of fexofenadine was reduced by 36%. Therefore, to maximize the effects of fexofenadine, it is recommended that ALLEGRA-D 12 HOUR should be taken with water (see ).
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no animal or studies on the combination product fexofenadine hydrochloride and pseudoephedrine hydrochloride to evaluate carcinogenesis, mutagenesis, or impairment of fertility.
The carcinogenic potential and reproductive toxicity of fexofenadine hydrochloride were assessed using terfenadine studies with adequate fexofenadine exposure (area-under-the plasma concentration versus time curve [AUC]). No evidence of carcinogenicity was observed when mice and rats were given daily oral doses up to 150 mg/kg of terfenadine for 18 and 24 months, respectively. In both species, 150 mg/kg of terfenadine produced AUC values of fexofenadine that were approximately 3 times the human AUC at the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR.
Two-year feeding studies in rats and mice conducted under the auspices of the National Toxicology Program (NTP) demonstrated no evidence of carcinogenic potential with ephedrine sulfate, a structurally related drug with pharmacological properties similar to pseudoephedrine, at doses up to 10 and 27 mg/kg, respectively (less than the maximum recommended human daily oral dose of pseudoephedrine hydrochloride on a mg/m basis).
In (Bacterial Reverse Mutation, CHO/HGPRT Forward Mutation, and Rat Lymphocyte Chromosomal Aberration assays) and (Mouse Bone Marrow Micronucleus assay) tests, fexofenadine hydrochloride revealed no evidence of mutagenicity.
Reproduction and fertility studies with terfenadine in rats produced no effect on male or female fertility at oral doses up to 300 mg/kg/day. However, reduced implants and post implantation losses were reported at 300 mg/kg. A reduction in implants was also observed at an oral dose of 150 mg/kg/day. Oral doses of 150 and 300 mg/kg of terfenadine produced AUC values of fexofenadine that were approximately 4 times the AUC at the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR. In mice, fexofenadine produced no effect on male or female fertility at average dietary doses up to 4438 mg/kg (approximately 15 times the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR based on comparison of the AUCs).
Pregnancy
Category C. Terfenadine alone was not teratogenic in rats and rabbits at oral doses up to 300 mg/kg; 300 mg/kg of terfenadine produced fexofenadine AUC values that were approximately 4 and 30 times, respectively, the AUC at the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR.
In mice, no adverse effects and no teratogenic effects during gestation were observed with fexofenadine at dietary doses up to 3730 mg/kg (approximately 15 times the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR based on comparison of the AUCs).
The combination of terfenadine and pseudoephedrine hydrochloride in a ratio of 1:2 by weight was studied in rats and rabbits. In rats, an oral combination dose of 150/300 mg/kg produced reduced fetal weight and delayed ossification with a finding of wavy ribs. The dose of 150 mg/kg of terfenadine in rats produced an AUC value of fexofenadine that was approximately 4 times the AUC at the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR. The dose of 300 mg/kg of pseudoephedrine hydrochloride in rats was approximately 10 times the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR on a mg/m basis. In rabbits, an oral combination dose of 100/200 mg/kg produced decreased fetal weight. By extrapolation, the AUC of fexofenadine for 100 mg/kg orally of terfenadine was approximately 10 times the AUC at the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR. The dose of 200 mg/kg of pseudoephedrine hydrochloride was approximately 15 times the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR on a mg/m basis.
There are no adequate and well-controlled studies in pregnant women. ALLEGRA-D 12 HOUR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Dose-related decreases in pup weight gain and survival were observed in rats exposed to an oral dose of 150 mg/kg of terfenadine; this dose produced an AUC of fexofenadine that was approximately 4 times the AUC at the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR.
Nursing Mothers
It is not known if fexofenadine is excreted in human milk. Because many drugs are excreted in human milk, caution should be used when fexofenadine hydrochloride is administered to a nursing woman. Pseudoephedrine hydrochloride administered alone distributes into breast milk of lactating human females. Pseudoephedrine concentrations in milk are consistently higher than those in plasma. The total amount of drug in milk as judged by AUC is 2 to 3 times greater than the plasma AUC. The fraction of a pseudoephedrine dose excreted in milk is estimated to be 0.4% to 0.7%. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when ALLEGRA-D 12 HOUR is administered to nursing women.
Pediatric Use
Safety and effectiveness of ALLEGRA-D 12 HOUR in children below the age of 12 years have not been established. In addition, the doses of the individual components in ALLEGRA-D 12 HOUR exceed the recommended individual doses for pediatric patients under 12 years of age. ALLEGRA-D 12 HOUR is not recommended for pediatric patients under 12 years of age.
Geriatric Use
Clinical studies of ALLEGRA-D 12 HOUR did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, although the elderly are more likely to have adverse reactions to sympathomimetic amines.
The pseudoephedrine component of ALLEGRA-D 12 HOUR is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
What are the side effects of Allegra D-12 Hour?
ALLEGRA-D 12 HOUR
In one clinical
trial (n=651) in which 215 subjects with seasonal allergic rhinitis
received the 60 mg fexofenadine hydrochloride/120 mg pseudoephedrine
hydrochloride combination tablet twice daily for up to 2 weeks, adverse
events were similar to those reported either in subjects receiving
fexofenadine hydrochloride 60 mg alone (n=218 subjects) or in subjects
receiving pseudoephedrine 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 fexofenadine hydrochloride/pseudoephedrine
hydrochloride combination group, 0.5% for the fexofenadine hydrochloride
group, and 4.1% for the pseudoephedrine hydrochloride group. All adverse
events that were reported by greater than 1% of subjects who received
the recommended daily dose of the fexofenadine hydrochloride/pseudoephedrine
hydrochloride combination are listed in the following table.
Many of the adverse
events occurring in the fexofenadine hydrochloride/pseudoephedrine
hydrochloride combination group were adverse events also reported
predominately in the pseudoephedrine hydrochloride group, such as
insomnia, headache, nausea, dry mouth, dizziness, agitation, nervousness,
anxiety, and palpitation.
| Adverse Experience | 60 mg FexofenadineHydrochloride/120 mgPseudoephedrineHydrochlorideCombination TabletTwice Daily(n=215) | FexofenadineHydrochloride60 mg Twice Daily(n=218) | PseudoephedrineHydrochloride120 mg Twice Daily(n=218) |
|---|---|---|---|
| Headache | 13.0% | 11.5% | 17.4% |
| Insomnia | 12.6% | 3.2% | 13.3% |
| Nausea | 7.4% | 0.5% | 5.0% |
| Dry Mouth | 2.8% | 0.5% | 5.5% |
| Dyspepsia | 2.8% | 0.5% | 0.9% |
| Throat Irritation | 2.3% | 1.8% | 0.5% |
| Dizziness | 1.9% | 0.0% | 3.2% |
| Agitation | 1.9% | 0.0% | 1.4% |
| Back Pain | 1.9% | 0.5% | 0.5% |
| Palpitation | 1.9% | 0.0% | 0.9% |
| Nervousness | 1.4% | 0.5% | 1.8% |
| Anxiety | 1.4% | 0.0% | 1.4% |
| Upper Respiratory Infection | 1.4% | 0.9% | 0.9% |
| Abdominal Pain | 1.4% | 0.5% | 0.5% |
What should I look out for while using Allegra D-12 Hour?
ALLEGRA-D 12 HOUR is contraindicated
in patients with known hypersensitivity to any of its ingredients.
Due to its pseudoephedrine component,
ALLEGRA-D 12 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.
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.
What might happen if I take too much Allegra D-12 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 12 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 170 and 340 times, respectively,
the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR
on a mg/m basis.) The median oral lethal dose in newborn
rats was 438 mg/kg (approximately 30 times the maximum recommended
human daily oral dose of ALLEGRA-D 12 HOUR on a mg/m basis).
In dogs, no evidence of toxicity was observed at oral doses up to
2000 mg/kg (approximately 450 times the maximum recommended human
daily oral dose 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
12 HOUR on a mg/m basis).
How should I store and handle Allegra D-12 Hour?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. ALLEGRA-D 12 HOUR Extended-Release Tablets contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 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 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 Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.)ALLEGRA-D 12 HOUR Extended-Release Tablets contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 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 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 Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.)ALLEGRA-D 12 HOUR Extended-Release Tablets contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. ALLEGRA-D 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 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 Extended-Release Tablets at 20–25°C (68–77°F). (See USP Controlled Room Temperature.)
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. At the recommended oral dose, it has little or no pressor
effect in normotensive adults.
Non-Clinical Toxicology
ALLEGRA-D 12 HOUR is contraindicated in patients with known hypersensitivity to any of its ingredients.Due to its pseudoephedrine component, ALLEGRA-D 12 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.
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.
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 (twice the recommended dose) was co-administered with 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.
Array
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 12 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 12 HOUR concomitantly with other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient (see ).
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 (see and ).
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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