Pyril D Suspension
Generic Name: phenylephrine hydrochloride and pyrilamine maleate
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 D Suspension Description
Pyril D Suspension is an antihistamine/ nasal decongestant combination for oral administration as a suspension. Each 5 mL (one teaspoonful) of the grape-flavored, purple-colored suspension for oral administration contains:
|Phenylephrine HCl||5 mg|
|Pyrilamine Maleate||16 mg|
Inactive ingredients: Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sodium saccharin, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate.
Pyril D Suspension - Clinical Pharmacology
Pyril D Suspension combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine.
Phenylephrine 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.
Phenylephrine has a mild central stimulant effect.
Pyrilamine 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.
Indications and Usage for Pyril D Suspension
Pyril D Suspension is indicated for the symptomatic relief of the coryza and nasal congestion associated with the common cold, sinusitis, allergic rhinitis and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.
Pyril D Suspension is contraindicated in patients sensitive to any of the ingredients or related compounds. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.
Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds).
Pyril D Suspension should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see "PRECAUTIONS-DRUG INTERACTIONS").
This product contains an antihistamine that may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck.
Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients and therefore should be used with caution. Antihistamines may cause excitation, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation.
Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or narrow angle glaucoma.
INFORMATION FOR PATIENTS
Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase (MAO) inhibitor (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAO inhibitor drug. If patients are uncertain whether a prescription drug contains an MAO inhibitor, they should be instructed to consult a health professional before taking this product.
MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents. Thus, concomitant administration of Pyril D Suspension and MAO inhibitors should be avoided (see "CONTRAINDICATIONS").
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
No long-term animal studies have been performed with Pyril D Suspension.
Pregnancy Category C
Animal reproduction studies have not been conducted with Pyril D Suspension. It is also not known whether Pyril D Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyril D Suspension should be given to a pregnant woman only if clearly needed.
LABOR AND DELIVERY
Administration of phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Pyril D Suspension should not be administered to a nursing mother.
The most common effects associated with antihistamines have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare.
Other adverse 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.
SIGNS AND SYMPTOMS
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 symptoms may be prominent.
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 D Suspension Dosage and Administration
Pyril D Suspension
Administer the recommended dose every 6 hours. Adults and Children over 12 years of age – 5 to 10 mL (1 to 2 teaspoonfuls); 6 to 12 years of age – 5 mL (1 teaspoonful); 2 to 6 years of age – 2.5 mL (½ teaspoonful); Under 2 years of age – Consult a physician.
NOTE: The maleate salt of pyrilamine and the hydrochloride salt of phenylephrine are provided in a suspension by means of a patented manufacturing process.
How is Pyril D Suspension Supplied
Pyril D Suspension is available in a grape-flavored, purple-colored suspension.
NDC No.: 44183-208-16 – 16 fl. oz. bottles.
Store at controlled room temperature, 20°-25°C (68°-77°F).
Dispense in a tight, lightresistant container (USP/NF) with a child-resistant closure.
Macoven Pharmaceuticals, LLC
Magnolia, TX 77354
PRINCIPAL DISPLAY PANEL - 473mL Bottle Label
Each 5 mL (one teaspoonful) for oral
|Pyrilamine Maleate||16 mg|
|Phenylephrine HCl||5 mg|
16 fl. oz. (473mL)
phenylephrine hydrochloride and pyrilamine maleate suspension
|Labeler - Macoven Pharmaceuticals (832591965)|