Each tablet contains:
Pseudoephedrine HCL…... ……120 mg
Methscopolamine Nitrate………..2.5 mg
Pseudoephedrine hydrochloride is a nasal decongestant. Chemically it is [S-(R*,R*)]-α-
[1(methylamino) ethyl]-benzenemethanol hydrochloride; C10H15NO•HCl, MW = 201.7.
Pseudoephedrine HCL
Methscopolamine nitrate is an anticholinergic having the chemical name 3-oxa-9-azoniatricyclo
[3.3.1.0 2, 4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate, [7(S)-(1α, 2β,
4β, 5α, 7β)]; C17H21NO4•CH3NO3, MW = 80.4.
Methscopolamine Nitrate
Inactive Ingredients: Dibasic Calcium Phosphate, D & C Yellow #10 (aluminum lake) Dye,
Magnesium Stearate, Methylcellulose, Povidone and Stearic Acid.
CLINICAL PHARMACOLOGY
Pseudoephedrine HCl is an indirect-acting sympathomimetic amine that exerts a decongestant
action on the nasal mucosa. It does this by vasoconstriction, which results in reduction of
tissue hyperemia, edema, nasal congestion, and an increase in nasal airway patency. In the
usual dose it has minimal vasopressor effects. Pseudoephedrine HCl is rapidly and almost
completely absorbed from the gastrointestinal tract. It has a plasma half-life of 6 to 8 hours.
Alkaline urine is associated with slower elimination of the drug. The drug is distributed to the
body tissues and fluids, including the central nervous system (CNS). Approximately 50% to
75% of the administered dose is excreted unchanged in the urine; the remainder is apparently
metabolized in the liver to inactive compounds by N-demethylation, parahydroxylation, and
oxidative deamination.
Methscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic
scopolamine which possesses the peripheral actions of the belladonna alkaloids, but does not
exhibit the central actions because of its lack of ability to cross the blood-brain barrier. Its
antimuscarinic effect causes inhibition of salivary secretions, reduction in volume and total acid
content of gastric secretion, and inhibition of gastrointestinal motility. It is poorly and unreliably
absorbed. Drug effects appear in about one hour and persist for about 4 to 6 hours. It is
excreted primarily in the urine and bile, or as unabsorbed drug in feces.
INDICATIONS AND USAGE
For the temporary relief of symptoms associated with allergic rhinitis.
CONTRAINDICATIONS
This product is contraindicated in patients with hypersensitivity to pseudoephedrine HCL and
methscopolamine nitrate. AlleRx™-D is contraindicated in patients with severe hypertension,
severe coronary artery disease, patients on monoamine oxidase inhibitor (MAOI) therapy or
within 14 days of stopping monoamine oxidase inhibitor (MAOI) therapy. AlleRx™-D is also
contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and
during an asthmatic attack.
WARNINGS
Sympathomimetic amines should be used cautiously in patients with hypertension, diabetes
mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and
prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation
with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60
years or older) are more likely to exhibit adverse reactions. At dosages higher than the
recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed
recommended dosage.
Hypertensive crisis can occur with concurrent use of pseudoephedrine HCl and MAOI, and for
14 days after stopping MAOI therapy. Methscopolamine nitrate may produce drowsiness or
blurred vision. The patient should be cautioned regarding activities requiring mental alertness
such as operating a motor vehicle or performing hazardous work while taking AlleRx™-D.
Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate
the hypotensive effects of nitrates. Co-administration of AlleRx™-D and sildenafil citrate has
not been studied. Therefore, the use of sildenafil citrate and AlleRx™-D together is not
recommended.
PRECAUTIONS
General
AlleRx™-D should be used with caution in patients with diabetes mellitus,
hypertension, cardiovascular disease, and hyperactivity to sympathomimetic amines.
Methscopolamine nitrate should be used with caution in the elderly and all patients with
autonomic neuropathy, hepatic or renal disease, or ulcerative colitis.
Drug Interactions
Do not prescribe AlleRx™-D for use in patients that are now taking prescription MAOIs
(certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease),
or for 14 days after stopping MAOI drug therapy. Beta-adrenergic blockers and MAOIs
may potentiate the pressor effect of pseudoephedrine HCl. Concurrent use of digitalis
glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may
reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and
veratrum alkaloids. Concurrent use of pseudoephedrine HCl with other sympathomimetic amines
may increase pressor or cardiovascular effects of either medication.
The use of pseudoephedrine HCl may result in additive CNS depressant effects when
coadministered with alcohol, antihistamines, psychotropics, or other drugs which produce CNS
depression. Concurrent use of tricyclic antidepressants may antagonize the effects of
pseudoephedrine HCl.
Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic
antidepressants, and other drugs with anticholinergic effects. Concomitant administration with
antacids may interfere with the absorption of methscopolamine nitrate.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies to assess the longterm carcinogenic and mutagenic potential or the effect on
fertility in animals or humans have not been performed.
Pregnancy Category C
It is not known whether AlleRx™-D can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. AlleRx™-D should be given to a pregnant
woman only if clearly needed.
Nursing Mothers
It is not known whether this combination drug is excreted in human milk. However, pseudoephedrine
HCl administered alone distributes into the breast milk of lactating human females; therefore, 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.
Pediatric Use
The safety and effectiveness in children under 12 years of age have not been established.
Geriatric Use
The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics.
Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions,
CNS depression, and/or death. Pseudoephedrine HCl is known to be substantially excreted by the
kidneys, 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.
ADVERSE REACTIONS
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred
vision, cardiac palpitations, flushing, and increased irritability or excitement (especially in
children). Some individuals may display sympathomimetic amine effects such as tachycardia,
palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with
certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor,
weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS
depression, arrhythmias, and cardiovascular collapse with hypotension. Urinary retention may
occur in patients with prostatic hypertrophy.
DRUG ABUSE AND DEPENDENCE
Rebound congestion may occur after vasoconstriction subsides when pseudoephedrine HCl is
discontinued. Patients may increase the amount of drug and frequency of use, producing
toxicity and perpetuating the rebound congestion. Excessive use may cause systemic effects
which are more likely in the elderly. Habituation and toxic psychosis have followed long-term
high-dose therapy.
OVERDOSAGE AND TREATMENT OF OVERDOSAGE
The treatment of overdosage should provide symptomatic and supportive care. Induction of
emesis and gastric lavage may be performed if the patient is alert and seen within early hours
after ingestion. Drug remaining in the stomach may be absorbed by the administration of
activated charcoal. Stimulants should not be used because they may precipitate convulsions. If
convulsions or marked CNS excitement occurs, treatment with appropriate measures is
indicated. Since the effects of AlleRx™-D last up to 12 hours, the patient should be monitored
for at least that length of time and treated as necessary.
DOSAGE AND ADMINISTRATION
Adults and adolescents 12 years of age and over: One tablet every 12 hours, not to exceed
2 tablets in 24 hours. AlleRx™-D is not recommended for children under 12 years of age.
HOW SUPPLIED
Bottles of 60 Tablets (NDC 10122-702-60), yellow, capsule-shaped and scored debossed with
“CBP” on one side and "01" to the right of the score on the other side, each containing 120 mg
of pseudoephedrine HCl and 2.5 mg of methscopolamine nitrate.
Keep out of reach of pediatric population.
Store at controlled room temperature between 20° and 25°C (68° and 77°F), see Controlled
Room Temperature.
Distributed by Cornerstone Biopharma, Inc., Cary, NC 27518.
500353
CBA749B1107
Rev. 11/07
AlleRx-D label
| AlleRx-D pseudoephedrine hydrochloride methscopolamine nitrate tablet | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 07/01/2008 | ||
| Labeler - Cornerstone Therapeutics Inc. (153886994) |
| Registrant - Cornerstone Therapeutics Inc. (153886994) |
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