Allergy DN PE

For the temporary relief of symptoms associated with allergic rhinitis.

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.

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.

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™ 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

Applies to chlorpheniramine / methscopolamine / phenylephrine: oral capsule extended release, oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet chewable extended release, oral tablet extended release

Nervous system

Nervous system side effects of phenylephrine have included headache, dizziness, nervousness, restlessness, tremor, insomnia, convulsions, and central nervous system depression. Antihistamines such as chlorpheniramine and anticholinergics such as methscopolamine may cause drowsiness and dizziness.[Ref]

Cardiovascular

Cardiovascular side effects of phenylephrine have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]

Psychiatric

Psychiatric side effects of phenylephrine have included hallucinations, fear, and anxiety.[Ref]

Gastrointestinal

Gastrointestinal side effects of phenylephrine have included nausea. Antihistamines such as chlorpheniramine and anticholinergics such as methscopolamine may cause excessive dryness of the nose, throat, and mouth.[Ref]

Respiratory

Respiratory side effects of phenylephrine have included respiratory difficulty.[Ref]

Genitourinary

Genitourinary side effects of phenylephrine have included dysuria.[Ref]

General

General side effects of phenylephrine have included pallor and weakness.[Ref]

Ocular

Ocular side effects including blurred vision may be caused by antihistamines such as chlorpheniramine and anticholinergics such as methscopolamine.[Ref]

Some side effects of Allergy DN PE may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.