Pyril Mal Phenyl HCl

RECOMMENDED DOSES MAY BE ADMINISTERED EVERY 6 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)

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.

Antihistamines may cause excitability, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation.

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

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

Pyril Mal 16 mg/Phenyl HCl 5 mg/5 mL Suspension combines the antihistaminic action of pyrilamine with the sympathomimetic decongestant effect of phenylephrine.

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.

Patients receiving Pyril Mal 16 mg/Phenyl HCl 5 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/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. 02/10 439-10

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.