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Pyrichlor PE

Generic Name: phenylephrine hydrochloride, pyrilamine maleate, and chlorpheniramine maleate
Dosage Form: oral liquid

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Pyrichlor PE™ Liquid
Antihistamine/Decongestant

Sugar Free • Alcohol Free

Pyrichlor PE Description

Pyrichlor PE™ is a grape-flavored antihistamine/decongestant liquid available for oral administration. Each teaspoonful (5 mL) contains:

Phenylephrine HCl 10 mg
Pyrilamine Maleate 10 mg
Chlorpheniramine Maleate 2 mg

INACTIVE INGREDIENTS: Sodium Benzoate, Citric Acid, Saccharin Sodium, Sorbitol Solution, Glycerin, FD&C Red No. 40, FD&C Blue No. 1, Grape Flavor, Purified Water.

Phenylephrine HCl is a nasal decongestant having the chemical name, Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-. Its structure is as follows:

C9H13NO2•HCl     M.W. 203.67

Pyrilamine Maleate is an antihistamine. It's chemical name is 1,2-Ethanediamine, N-[(4-methoxyphenyl)methyl]-N', N'-dimethyl-N-2-pyridinyl-,(Z)-2-butenedioate (1:1). Its structure is as follows:

C17H23N3O•C4H4O4     M.W. 401.47

Chlorpheniramine Maleate is an antihistamine with the chemical name: 2-Pyridinepropanamine,γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1). Its structure is as follows:

C16H19ClN2•C4H4O4     M.W. 390.86

Pyrichlor PE - Clinical Pharmacology

Phenylephrine Hydrochloride

Phenylephrine acts predominantly by a direct action on alpha (α) adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta (β) adrenergic receptors of the heart. Following oral administration, constriction of the blood vessels in the nasal mucosa may relieve nasal congestion. In therapeutic doses the drug causes little, if any, central nervous stimulation.

Pyrilamine Maleate

Pyrilamine is an antihistamine belonging to the ethylenediamine class. Pyrilamine is a highly effective H1 blocker, which possesses local anesthetic activity. Pyrilamine antagonizes most of the smooth muscle stimulating actions of histamine on the H1 receptors of the gastrointestinal tract, blood vessels and bronchial muscle. It also antagonizes the actions of histamines that result in increased capillary permeability and the formation of edema. Pyrilamine has a duration of action of 4 to 6 hours.

Chlorpheniramine Maleate

Chlorpheniramine Maleate is an antihistamine belonging to the alkylamine class. It possesses anticholinergic and sedative effects. It is considered one of the most effective and least toxic of the histamine antagonists. Chlorpheniramine is an H1 receptor antagonist. It antagonizes many of the pharmacological actions of histamine. Chlorpheniramine has a duration of action of 4 to 6 hours.

Indications and Usage for Pyrichlor PE

For the temporary relief of nasal congestion due to the common cold, hay fever or other respiratory allergies.

Contraindications

This product is contraindicated in patients with hypersensitivity to antihistamines, or sympathomimetic amines, and in patients receiving monoamine oxidase (MAO) inhibitor therapy (or for 14 days after stopping MAOI therapy), (see DRUG INTERACTIONS). Sympathomimetic amines are contraindicated in patients with severe hypertension or severe coronary artery disease.

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. Antihistamines should be used with considerable caution in pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder neck obstruction. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.

May cause excitability especially in children.

Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.

Precautions

General

Antihistamines have an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension, hyperactivity to ephedrine.

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

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Information To Patients

Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Patients should be warned accordingly.

Pregnancy

Category C

Animal reproduction studies have not been conducted with this product. It is unknown whether this product can cause fetal harm when administered to a pregnant woman or affect reproduction. This product should be given to a pregnant woman only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers

Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines.

Pediatric Use

This product is not indicated for use in children under 6 years old. Antihistamines may diminish mental alertness; in young children, they may produce paradoxical excitation.

Geriatric Use

The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans.

Adverse Reactions

Hyperactive individuals may display ephedrine-like reactions 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. Possible side effects of antihistamines are drowsiness, dry mouth, anorexia, nausea, vomiting, headache and nervousness, blurred vision, polyuria, heartburn, dysuria, and very rarely, dermatitis.

Drug Interactions

MAO inhibitors (or for 14 days after stopping MAOI therapy), and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines. Beta-adrenergic blockers and MAO inhibitors (or for 14 days after stopping MAOI therapy), may potentiate the pressor effect of sympathomimetics. 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 tricyclic antidepressants may antagonize the effects of sympathomimetics. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect.

Overdosage

Manifestations of antihistamine overdosage may vary from CNS depression (sedation, apnea, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors, or convulsions). Other signs and symptoms may be dizziness, tinnitus, blurred vision and hypertension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms. Overdosage with sympathomimetics may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness and insomnia. Other effects may include tachycardia, hypertension, pallor, mydriasis, hypernea, hallucinations, but in some individuals there may be CNS depression with somnolence, stupor or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to a compartmental shift rather than a depletion of potassium.

Treatment

In the event of overdosage, emergency treatment should be started immediately. Since the action of a sustained release product may continue for as long as 12 hours, treatment of overdosage should be directed toward reducing further absorption and supporting the patient for at least that length of time. Gastric emptying (syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion, even if patient has vomited spontaneously. 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. Saline cathartics, such as Milk of Magnesia, are useful for hastening the evacuation of unreleased medication. In severe cases of overdose, it is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes, and to give intravenous potassium as indicated. Vasopressors may be used to treat hypotension. Excessive CNS stimulation may be counteracted with parenteral diazepam. Stimulants should not be used. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or hypothermic blanket. Apnea is treated with ventilatory support.

Pyrichlor PE Dosage and Administration

Adults: 1-2 Teaspoonfuls every 4-6 hours, or as directed by your physician or health-care provider. Do not exceed 8 teaspoonfuls in a 24 hour period. Children 6-12 years of age: 1 Teaspoonful every 4-6 hours, or as directed by your physician or health-care provider. Do not exceed 4 teaspoonfuls in a 24 hour period. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How is Pyrichlor PE Supplied

Pyrichlor PE™ Liquid is a grape-flavored, sugar-free, alcohol-free, liquid supplied in 16 fl. oz. bottles, NDC 51991-624-16.

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

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

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.

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

Rx Only

Manufactured by: Tri-Med Laboratories, Inc., Somerset, NJ 08873
Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Iss. 8/09

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Breckenridge
Pharmaceuticals, Inc.

NDC 51991-624-16

Pyrichlor PE
Liquid

Antihistamine/Decongestant

  • Sugar Free
  • Alcohol Free

Description: Each 5 mL (one teaspoonful) for oral
administration contains:

Phenylephrine HCl 10 mg
Pyrilamine Maleate 10 mg
Chlorpheniramine Maleate 2 mg

INACTIVE INGREDIENTS: Sodium Benzoate,
Citric Acid, Saccharin Sodium, Sorbitol Solution,
Glycerin, FD&C Red No. 40, FD&C Blue No. 1
Grape Flavor, Purified Water.

Rx Only

Net Contents:
16 fl. oz. (One Pint) 473 mL

Pyrichlor PE 
phenylephrine hydrochloride, pyrilamine maleate, and chlorpheniramine maleate liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-624
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Pyrilamine Maleate (Pyrilamine) Pyrilamine Maleate 10 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Benzoate  
Citric Acid Monohydrate  
Saccharin Sodium  
Sorbitol  
Glycerin  
FD&C Red No. 40  
FD&C Blue No. 1  
Water  
Product Characteristics
Color PURPLE (Clear) Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-624-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/06/2009 09/30/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Trimed 182050567 MANUFACTURE
Revised: 10/2010
 
Breckenridge Pharmaceutical, Inc.

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