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Pyril Mal Phenyl HCl Dex HBr

Generic Name: pyrilamine maleate, phenylephrine hydrochloride and dextromethorphan hydrobromide
Dosage Form: oral suspension

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.

Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension

Indications and Usage for Pyril Mal Phenyl HCl Dex HBr

Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension is indicated for temporary relief of the inflammation, nasal congestion, and cough associated with the common cold, sinusitis, allergic rhinitis, and other upper respiratory conditions. Appropriate therapy should be provided for the primary disease.

Pyril Mal Phenyl HCl Dex HBr Dosage and Administration

RECOMMENDED DOSES MAY BE ADMINISTERED EVERY 8 HOURS.
Adults and children 12 years of age and older:
5-10 mL (1-2 teaspoonfuls). (2)
Children 6-12 years of age: 5 mL (1 teaspoonful). (2)
Children 2-6 years of age: 2.5 mL (1/2 teaspoonful). (2)
Under 2 years of age: Consult a physician. (2)

DOSAGE FORM AND STRENGTH

Oral suspension, pyrilamine maleate 16 mg, phenylephrine hydrochloride 5 mg, dextromethorphan hydrobromide 15 mg per 5 mL

Contraindications

Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension is contraindicated in patients with a known sensitivity to any of its components. It is also contraindicated in patients with severe hypertension or peripheral vascular insufficiency, as ischemia may result, with the risk of gangrene or thrombosis of compromised vascular beds.

Antihistamines are contraindicated for use in the treatment of lower respiratory tract conditions, including asthma.

Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension
should not be used in patients receiving a monoamine oxidase (MAO) inhibitor. (See 5 WARNINGS AND PRECAUTIONS and 7 DRUG INTERACTIONS)

Warnings and Precautions

5.1 General
Antihistamines may cause drowsiness and may have additive CNS effects with alcohol or other CNS depressants such as hypnotics, sedatives, and tranquilizers.

5.2 Special Risk Patients
Use with caution in patients with diabetes, hypertension, or cardiovascular disease, hyperthyroidism, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck.

Dextromethorphan should be used with caution in sedated patients, and in patients confined to the supine position.

Antihistamines may cause excitability, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients and should be prescribed with caution.

Adverse Reactions

The most common side effects associated with antihistamines include drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines, sympathomimetics, and antitussives have been rare.

Other reactions may include:

Dermatologic: urticaria, drug rash, photosensitivity, pruritus

Cardiovascular: hypotension, hypertension, cardiac arrhythmias, palpitations

Central Nervous System (CNS): disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria

Genitourinary: urinary frequency, difficult urination

Gastrointestinal: epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation

Respiratory: tightness of chest and wheezing, shortness of breath

Hematologic: hemolytic anemia, thrombocytopenia, agranulocytosis

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents. Patients may develop hyperpyrexia, hypotension, nausea, myoclonic leg jerks, and coma following coadministration of MAO inhibitors and dextromethorphan. Therefore, concomitant administration of Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension and MAO inhibitors should be avoided (see 4 CONTRAINDICATIONS).

USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C:
Animal reproduction studies have not been conducted with Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension. It is not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension should be given to a pregnant woman only if clearly needed.

8.2 Labor and Delivery
Administration of phenylephrine in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

8.3 Nursing Mothers
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension should not be administered to a nursing mother.

OVERDOSAGE:

10.1 Signs and Symptoms
These may vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and signs and symptoms may be prominent. Dextromethorphan may produce central excitement and mental confusion. Very high doses of dextromethorphan may produce respiratory depression.

10.2 Treatment
Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration, especially in infants, children, and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.

Pyril Mal Phenyl HCl Dex HBr Description

Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension is a grape-flavored, dye-free, combination antihistamine/nasal decongestant/antitussive suspension.
Each 5 mL (one teaspoonful) for oral administration contains:
Pyrilamine maleate......................................16 mg
Phenylephrine hydrochloride .........................5 mg
Dextromethorphan hydrobromide…………15 mg

Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension also contains: citric acid, glycerin, grape flavor, methylparaben, purified water, benzoic acid, sodium citrate, propylene glycol, propylparaben, and sodium saccharin.

Pyrilamine Maleate is an antihistamine having the chemical name, 1,2-Ethanediamine, N-[(4-methoxyphenyl)methyl]-N', N'-dimethyl-N-2-pyridinyl-, (Z)-2-butenedioate (1:1).

Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is (–)-m-Hydroxy-_- [(methylamino)methyl]benzyl alcohol hydrochloride.

Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. Chemically, it is 3-methoxy-17-9_, 13_, 14_-morphinan hydrobromide monohydrate.

Pyril Mal Phenyl HCl Dex HBr - Clinical Pharmacology

Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension combines the antihistaminic action of pyrilamine with the sympathomimetic decongestant effect of phenylephrine and the antitussive effect of dextromethorphan.

12.1 Mechanism of Action
Pyrilamine maleate
Pyrilamine maleate is an antihistamine, H1 receptor blocking agent belonging to the ethylenediamine class of antihistamines. H1-blocking drugs inhibit the actions of histamine on smooth muscle, capillary permeability, and can both stimulate and depress the central nervous system. Pyrilamine also possesses anticholinergic and sedative properties.

Phenylephrine HCl
Phenylephrine hydrochloride is a decongestant which is a potent postsynaptic α-receptor agonist with little effect on β receptors of the heart. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Phenylephrine has no effect on β-adrenergic receptors of the bronchi or peripheral blood vessels.

Dextromethorphan hydrobromide

Dextromethorphan is an antitussive agent and, unlike the isomeric levorphenol, it has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is approximately equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity.

Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed with Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension.

How Supplied/Storage and Handling

16.1 How Supplied
Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension is a grape-flavored, dye-free suspension supplied in 16 oz. (473 mL) bottles, NDC 68032-440-16.

16.2 Storage and Handling
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.
Store at controlled room temperature 20°-25°C (68°-77°F)

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

Patient Counseling Information

Patients receiving Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension should be given the following information:
1. Do not drink alcoholic beverages or engage in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using this drug.
2. Do not take this product if currently taking a prescription MAO inhibitor (for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAO inhibitor. Instruct patients to consult a health professional if they are unsure whether a prescription drug contains an MAO inhibitor before taking Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension.

*Sections or subsections omitted from the full prescribing information are not listed.

Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 02/10 440-10

PACKAGING

NDC 68032-440-16

Pyril Mal 16mg/Phenyleph HCl 5 mg/DM HBr 15mg/5mL Suspension

Rx Only


Pyrlamine maleate 16 mg/5 mL
Phenylephrine hydrochloride 5 mg/5 mL
Dextromethorphan hydrobromide 15 mg/5 mL

Grape Flavor

EACH TEASPOONFUL (5 mL) CONTAINS:
Pyrlamine maleate .................. 16 mg
Phenylephrine HCl ..................... 5 mg
Dextromethorphan HBr ........... 15 mg


16 fl oz (473 mL)

Indications: Pyril Mal 16 mg/Phenyl HCl 5 mg/Dex HBr 15 mg/5 mL Suspension is indicated for temporary relief of the swelling and nasal congestion associated with the common cold, sinusitis, allergic rhinitis, and other upper respiratory conditions.

RECOMMENDED DOSES MAY BE ADMINISTERED EVERY 8 HOURS.
Adults and children 12 years of age and older:
5-10 mL (1-2 teaspoonfuls).
Children 6-12 years of age: 5 mL (1 teaspoonful).
Children 2-6 years of age: 2.5 mL (1/2 teaspoonful).
Under 2 years of age: Consult a physician.

See package insert for dosing information and directions for use.
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.

Store at controlled room temperature 20°-25°C (68°-77°F)
PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 02/10 440-20


Pyril Mal Phenyl HCl Dex HBr 
pyrilamine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-440
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 16 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
GLYCERIN  
METHYLPARABEN  
WATER  
SACCHARIN SODIUM  
BENZOIC ACID  
SODIUM CITRATE  
PROPYLENE GLYCOL  
PROPYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-440-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/15/2010 02/28/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010
 
River's Edge Pharmaceuticals, LLC
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