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Dallergy PE Tablets

Generic Name: chlorpheniramine maleate, methscopolamine nitrate and phenylephrine hydrochloride
Dosage Form: tablet, extended release

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Dallergy PE Caplets

Dallergy PE Tablets Description

Each Dallergy PE Caplet (capsule shaped caplet) contains:

Chlorpheniramine Maleate . . . . . . . . . . . 8 mg

Methscopolamine Nitrate . . . . . . . . . . . 2.5 mg

Phenylephrine Hydrochloride . . . . . . . . 20 mg

in a specially prepared base to provide a prolonged therapeutic effect.

Chlorpheniramine Maleate is an antihistamine having the chemical name 2-pyridinepropanamine, γ-(4 chlorophenyl)- N,N-dimethyl, (Z)-2- butenedioate (1:1), having the following structural formula:

C16H19ClN2 • C4H4O4                   M.W. 390.86

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Methscopolamine Nitrate is an anticholinergic having the chemical name 3-Oxa-9-azoniatricyclo [3.3.1.02,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)- 9, 9- dimethyl-, nitrate, [7(S)-(1α, 2β, 4β, 5α, 7β)]-, having the following structural formula:

C18H24NO4• NO3                            M.W. 380.4

Phenylephrine Hydrochloride is a decongestant having the chemical name Benzenemethanol, 3-hydroxy-α- [(methylamino)methyl]-, hydrochloride (R)-, having the following structural formula:

C9H13NO2 • HCl                           M.W. 203.67[/IC]

Dallergy PE Caplets contain ingredients of the following therapeutic classes: antihistamine, antisecretory agent, and nasal decongestant.

INACTIVE INGREDIENTS

Inactive ingredients include: calcium phosphate, magnesium stearate, methylcellulose, povidone, and stearic acid.

Dallergy PE Tablets - Clinical Pharmacology

Chlorpheniramine Maleate is an alkylamine type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use; but a significant proportion of patients do experience this effect.

Methscopolamine Nitrate is a quaternary ammonium derivative of 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. In this formulation, it is used because of its antisecretory effects on the respiratory system.

Phenylephrine Hydrochloride is a sympathomimetic amine which acts predominantly on alpha receptors and has little action on beta receptors. It, therefore, functions as an oral nasal decongestant with minimal CNS stimulation.

Indications and Usage for Dallergy PE Tablets

This product is indicated for the relief of upper respiratory symptoms due to seasonal and perennial allergic and non-allergic rhinitis, such as: nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, post-nasal drip, and hay fever.

Contraindications

Dallergy PE Caplets are contraindicated in patients with hypersensitivity to any of the ingredients. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, patients on monoamine oxidase inhibitor (MAOI) therapy, patients with narrow angle glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack.

Warnings

Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly (60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed recommended dosage.

Precautions

General

Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol.

Information for Patients

Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.

Drug Interactions

MAOIs and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Dallergy PE Caplets. It is also not known whether Dallergy PE Caplets can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Dallergy PE Caplets should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dallergy PE Caplets are administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients under 6 years of age have not been established. Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions, and death. A paradoxical reaction characterized by hyperexcitability may occur in older children taking antihistamines. Use is not recommended for children under six (6) years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients, and dosage adjustments are often required.

When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of the suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics. Appropriate studies with phenylephrine have not been performed in the pediatric population; however, no pediatric- specific problems have been documented to date.

Geriatric Use

Confusion, hallucinations, seizures, and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function.

Adverse Reactions

Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children).

Overdosage

In all cases of suspected overdose, immediately call your regional poison control center, and/or contact a physician immediately. The stomach should be emptied promptly by lavage or by induction of emesis with Syrup of Ipecac. The installation of activated charcoal into the stomach also should be considered. The treatment of overdose is essentially symptomatic and supportive. If respiratory depression is present, treat promptly with oxygen and/or mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine type drugs should be used.

Dallergy PE Tablets Dosage and Administration

Dallergy PE Caplets: Adults and children 12 years of age and older: 1 caplet every 12 hours, not to exceed 2 caplets a day. Children 6 to under 12 years: As prescribed by a physician.

Not recommended for children under 6 years of age.

Caplets should not be crushed or chewed prior to swallowing.

How is Dallergy PE Tablets Supplied

Dallergy PE Caplets are white, capsule shaped caplets with “LAS 154” debossed on one side. The opposite side is plain. Available in bottles of 100 caplets (NDC 68134-154-01).

Storage and Handling

Store at 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°-86°F). See USP Controlled Room Temperature.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Rx Only

Manufactured for:
Palmetto Pharmaceuticals, Inc.
Greenville, SC 29615

500396   Rev. 04/2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1 Container Label

DALLERGY  PE
chlorpheniramine maleate / methscopolamine nitrate / phenylephrine hcl tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68134-154
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 8 mg
METHSCOPOLAMINE NITRATE (METHSCOPOLAMINE) METHSCOPOLAMINE NITRATE 2.5 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
MAGNESIUM STEARATE  
HYPROMELLOSE 2208 (4000 CPS)  
POVIDONE K30  
STEARIC ACID  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LAS154
Contains         
Packaging
# Item Code Package Description
1 NDC:68134-154-01 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 07/08/2010
Labeler - Palmetto Pharmaceuticals, Inc. (963291864)
Registrant - Palmetto Pharmaceuticals, Inc. (963291864)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE
Revised: 05/2010
 
Palmetto Pharmaceuticals, Inc.
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