Understanding and controlling your respiratory allergies

Allergy DN PE

Generic Name: phenylephrine hydrochloride, methscopolamine nitrate and chlorpheniramine maleate
Dosage Form: tablets

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.

AllergyDN PE™

Day Dose - 40 mg phenylephrine HCl and 2.5 mg methscopolamine nitrate
Night Dose - 10 mg phenylephrine HCl, 8 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate

Allergy DN PE Description

Each Day tablet contains:   Each Night tablet contains:
Phenylephrine HCl 40 mg   Phenylephrine HCl 10 mg
Methscopolamine Nitrate 2.5 mg   Chlorpheniramine Maleate 8 mg
  Methscopolamine Nitrate 2.5 mg

Phenylephrine HCL is a decongestant having the chemical name (-)-m-Hydroxy- α-[(methylamino)methyl] benzyl alcohol hydrochloride; C9H13NO2 • HCl MW = 203.67

Chlorpheniramine maleate is an antihistamine having the chemical name 2-Pyridinepropanamine, γ-(4-chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1); C16H19CIN2•C4H4O4, MW = 390.86.

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)]; C18H24NO4•NO3 MW = 380.40.

Inactive Ingredients:

Day tablets: Each yellow Day tablet contains Croscarmellose Sodium, Dicalcium Phosphate Dihydrate, Hypromellose, 1FD&C Yellow No. 5 (see PRECAUTIONS), Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide.

Night tablets: Each dark green Night tablet contains Croscarmellose Sodium, Dicalcium Phosphate Dihydrate, Hypromellose, 1FD&C Yellow No. 5 (see PRECAUTIONS), FD&C Blue No. 1, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide.

1
Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

Allergy DN PE - Clinical Pharmacology

Chlorpheniramine maleate is an alkylamine-type antihistamine that possesses anticholinergic and sedative effects. Antihistamines competitively antagonize histamine at the H1 receptor site. Thus, activation of H1 receptors by released histamine which results in increased vascular permeability, increased mucus production, pruritus and sneezing is prevented.

Phenylephrine is a sympathomimetic amine, acts directly on adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction that increases peripheral resistance, resulting in an increase in both systolic and diastolic blood pressure. Accompanying the pressor response is a marked reflex bradycardia due to increased vagal activity. It produces vasoconstriction that lasts longer than that produced by ephedrine and epinephrine, and in therapeutic doses, produces little or no central nervous system (CNS) stimulation. Phenylephrine has reduced bioavailability from the gastrointestinal tract because of first pass metabolism by monoamine oxidase in the stomach and liver.

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. It competitively inhibits the action of acetylcholine at muscarinic receptors.

Indications and Usage for Allergy DN PE

For the temporary relief of symptoms associated with allergic rhinitis.

Contraindications

This product is contraindicated in patients with a hypersensitivity or idiosyncratic reaction to chlorpheniramine maleate, methscopolamine nitrate or phenylephrine hydrochloride. This product is also contraindicated in nursing mothers, and in patients with the following conditions: severe hypertension; severe coronary artery disease; narrow-angle glaucoma; urinary retention; hyperthyroidism; peptic ulcer; asthma attack; MAOI therapy (or for 2 weeks after stopping MAOI therapy). Sympathomimetic amines may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetic amines in overdosage may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage.

Antihistamines should be used with considerable caution in pyloroduodenal obstruction; symptomatic prostatic hypertrophy; bladder neck obstruction. 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.

Heat prostration can occur with methscopolamine used where the environmental temperature is high. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, use of methscopolamine would be inappropriate and possibly harmful.

Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate the hypotension effects of nitrates. Co-administration of Allergy DN PE™ and sildenafil citrate has not been studied. Therefore, the use of sildenafil citrate and Allergy DN PE™ together is not recommended.

Precautions

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

General

Use phenylephrine with caution in patients with hypoxia, acidosis, or a history of arteriosclerosis, bradycardia, partial heart block, hypertension, myocardial disease, thrombosis, or ventricular tachycardia. Antihistamines have an atropine-like action and should be used with caution in patients with a history of bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension.

Use methscopolamine with caution in patients with hiatal hernia associated with reflux esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis (especially in the elderly), hyperthyroidism, coronary heart disease, congestive heart failure, and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort.

Drug Interactions

Monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy) and beta-adrenergic blockers increase the effect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, mecamylamine and reserpine. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, antipsychotics, barbiturates and other CNS depressants may have an additive effect. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate.

Information for Patients

Patient consultation should include the following information regarding proper use of this medication:

  • Do not take more medication than the amount recommended.
  • This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke.
  • Do not drive or operate machinery if drowsiness or dizziness occurs.
  • Do not ingest alcoholic beverages, monoamine oxidase inhibitors (MAOI)s, or CNS depression producing medications (hypnotics, sedatives, tranquilizers) while taking this medication.
  • Methscopolamine nitrate may cause blurred vision. Patients should observe caution before driving, using machinery or performing other tasks requiring visual alertness.
  • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose.
  • This medication should be stored in a tight, light-resistant container at temperatures between 59°- 86°F (15°- 30°C).
  • Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Caution patients about the signs of potential side effects, especially:

  • Anticholinergic effects - clumsiness or unsteadiness; severe drowsiness; severe dryness of mouth, nose, or throat; flushing or redness of face; shortness of breath or troubled breathing
  • Blood dyscrasias - sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness
  • Fast or irregular heartbeat
  • Psychotic episodes
  • Tightness in chest

Note: When anticholinergics are given to patients especially children, where the environmental temperature is high there is risk of a rapid increase in body temperature because of suppression of sweat gland activity. Infants, patients with Down's syndrome, and children with spastic paralysis or brain damage may show an increased response to anticholinergics, thus increasing the potential for side effects. Geriatric or debilitated patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion.

Laboratory Tests

The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on conditions):

  • Blood pressure determination - recommended at frequent intervals during therapy
  • Electrocardiogram (ECG) - monitoring may be required
  • Intraocular pressure determination - recommended at periodic intervals, as these medications may increase the intraocular pressure

Laboratory Test Interactions

Antihistamines may interfere with diagnostic test results for skin tests using allergen extracts. Anticholinergics may interfere with diagnostic test results for gastric acid secretion by antagonizing the effect of pentagastrin and histamine, and for radionucleotide gastric emptying studies by delaying gastric emptying.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. This product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

Use of phenylephrine during labor may cause fetal anoxia and bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

Nursing Mothers

It is not known whether this combination drug is excreted in human milk. However, phenylephrine 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. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation.

Adverse Reactions

The following adverse reactions have been observed with the use of phenylephrine, chlorpheniramine and methscopolamine: Increased irritability or excitement (especially in children), arrhythmias, palpitations, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness dryness of mouth, hallucinations, hypotension, hypertension, increased sensitivity of skin to sun, increased sweating, flushing, loss of appetite, paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands or feet, trembling, troubled breathing, unusual tiredness or weakness, nausea or vomiting. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, convulsions, and cardiovascular collapse with accompanying hypotension.

Note: Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose or throat are more likely to occur in the elderly. Nightmares, unusual excitement, nervousness, restlessness, or irritability are more likely to occur in children and the elderly. When anticholinergics are given to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in body temperature.

Drug Abuse and Dependence

Central nervous system stimulants such as phenylephrine have been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal.

Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

OVERDOSAGE AND TREATMENT OF OVERDOSAGE

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. Either isotonic or half-isotonic saline may be used for lavage. Administration of an activated charcoal slurry is beneficial after lavage and/or emesis if less than 4 hours have passed since ingestion. Stimulants should not be used, because they may precipitate convulsions. Use of a short-acting barbiturate is recommended if convulsions or marked CNS excitement occur. Since the effects of this product may last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary. Cardiovascular and renal effects include difficulty in urination, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, anorexia, nausea, vomiting, diarrhea and abdominal cramps.

Allergy DN PE Dosage and Administration

Adults and adolescents 12 years of age and over

One yellow Day tablet in the morning and one dark green Night tablet in the evening. Allergy DN PE™ is not recommended for children under 12 years of age.

How is Allergy DN PE Supplied

Allergy DN PE™ is supplied in boxes of 20 tablets NDC #51991-558-20, one blister card of 10 Day Tablets NDC # 51991-556-17, and one blister card of 10 Night tablets NDC #51991-557-17.

Day tablets are yellow, oval-shaped and scored, debossed with B 556.

Night tablets are dark green, oval-shaped and scored, debossed with B 557.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

PHARMACIST: Dispense in original container.

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

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Provident Pharmaceuticals, Colorado Springs, CO 80919
Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487

Rx Only

360672501 ISS. 4/08

PRINCIPAL DISPLAY PANEL - 20 tablet carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-558-20

AllergyDN PE

Day Dose - 40 mg phenylephrine HCl and 2.5 mg methscopolamine nitrate
Night Dose - 10 mg phenylephrine HCl, 8 mg chlorpheniramine maleate and
2.5 mg methscopolamine nitrate

Day Dose - 40 mg phenylephrine HCl and 2.5 mg methscopolamine nitrate
Night Dose - 10 mg phenylephrine HCl, 8 mg chlorpheniramine maleate and
2.5 mg methscopolamine nitrate

20 Tablets containing the Following:

10 Yellow Day Tablets each contain:   10 Dark Green Night Tablets each contain:
Phenylephrine HCl................ 40 mg    Phenylephrine HCl.................. 10 mg
Methscopolamine Nitrate......2.5 mg    Chlorpheniramine Maleate......8 mg
                                                           Methscopolamine Nitrate......2.5 mg

20 Tablets (2 blister cards of 10 tablets)

Rx Only

Allergy DN PE 
phenylephrine hydrochloride, methscopolamine nitrate and chlorpheniramine maleate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-558
Packaging
# Item Code Package Description
1 NDC:51991-558-20 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK 10 
Part 2 1 BLISTER PACK 10 
Part 1 of 2
DAY DOSE 
phenylephrine hydrochloride, methscopolamine nitrate tablet
Product Information
Item Code (Source) NDC:51991-556    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 40 mg
Methscopolamine Nitrate (Methscopolamine) Methscopolamine Nitrate 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Dibasic Calcium Phosphate Dihydrate  
Cellulose, Microcrystalline  
FD&C Yellow no. 5  
Hypromellose  
Silicon Dioxide  
Croscarmellose Sodium  
Magnesium Stearate  
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code B;556
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-556-17 10 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/01/2008
Part 2 of 2
NIGHT DOSE 
phenylephrine hydrochloride, methscopolamine nitrate and chlorpheniramine maleate tablet
Product Information
Item Code (Source) NDC:51991-557    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
Methscopolamine Nitrate (Methscopolamine) Methscopolamine Nitrate 2.5 mg
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 8 mg
Inactive Ingredients
Ingredient Name Strength
Dibasic Calcium Phosphate Dihydrate  
Cellulose, Microcrystalline  
FD&C Yellow no. 5  
FD&C Blue no. 1  
Hypromellose  
Silicon Dioxide  
Croscarmellose Sodium  
Magnesium Stearate  
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code B;557
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-557-17 10 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/01/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/01/2008
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Provident Pharmaceuticals, LLC 171901445 MANUFACTURE
Revised: 10/2009
 
Breckenridge Pharmaceutical, Inc.

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