Prescription Drugs

CLINICAL PHARMACOLOGY Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine and the antitussive effect of dextromethorphan. Phenylephrine Phenylephrine is a decongestant which is a potent post synaptic a-receptor agonist with little effect on p receptors of the heart. A direct action at the 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 p-adrenergic receptors of the bronchi or peripheral blood vessels. Phenylephrine has a mild stimulant effect. Pyrilamine Pyrilamine is an antihistamine, Hi receptor blocking agent belonging to the ethylenediamine class of antihistamines. Hi-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. Dextromethorphan Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity.

Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan HBr) Tannate Chewable Tablets DESCRIPTION Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets are an antihistamine/nasal decongestant/antitussive combination for oral administration as a chewable tablet. Each Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablet in a grape-flavored, dye-free, mottled brown-colored, scored tablet for oral administration contains: Phenylephrine HCl.................10 mg Pyrilamine Maleate................16 mg Dextromethorphan HBr...........15 mg Inactive ingredients: Citric acid, calcium phosphate dibasic, hypromellose, grape flavor, magnesium aluminum silicate, magnesium stearate, compressible sugar, corn starch, mannitol, sucralose, talc, tannic acid, and xanthan gum. See DOSAGE AND ADMINISTRATION section for further descriptive composition.

INDICATIONS Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets are indicated for the symptomatic relief of coryza, nasal congestion, and cough associated with the common cold, sinusitis, allergic rhinitis, and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease. DOSAGE AND ADMINISTRATION Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets: Administer the recommended dose every 12 hours. 12 years and older - 1 to 2 tablets; 6 to 12 years of age - !4 to 1 tablet. HOW SUPPLIED Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets are available as grape-flavored, dye-free, mottled brown-colored, scored tablet imprinted with CT on one side and the score line on the other NDC No.: 10122-203-10 - Bottles of 100 Chewable Tablets and NDC No.: 10122-203-02 single tablet sample pouches. Store at controlled room temperature, 20°-25° C (68° -77° F). Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure. Protect from moisture. Manufactured for: Cornerstone BioPharma, Inc. Cary, NC 27518.

PATIENT INFORMATION 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.

OVERDOSE 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. Dextromethorphan may produce central excitement and mental confusion. Very high doses of dextromethorphan may produce respiratory depression. 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. CONTRAINDICATIONS Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets are 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). Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see "PRECAUTIONS-DRUG INTERACTIONS").

SIDE EFFECTS The most common effects associated with antihistamines have been drowsiness sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines, sympathomimetics, and antitussives have been rare. Other adverse reactions may include: Dermatologic - urticaria, drug rash, photosensitivity, pruritus. Cardiovascular - hypotension, hypertension, cardiac arrhythmias, palpitations. Central Nervous Systems (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 the chest and wheezing, shortness of breath. Hematologic - hemolytic anemia, thrombocytopenia, agranulocytosis. DRUG INTERACTIONS MAO inhibitors may prolong and intensify the anticholinergic effects of sympathomimetic agents. Patients may develop hyperpyrexia, hypotension, nausea, myoclonic leg jerks, and coma following coadministration of MAO inhibitors and dextromethorphan. Thus, concomitant administration of Deconsal® DM Tannate Chewable Tablets and MAO inhibitors should be avoided (see "CONTRAINDICATIONS").

WARNINGS 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. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. PRECAUTIONS General 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. Dextromethorphan should be used with caution in sedated patients, and in patients confined to the supine position. Carcinogenesis, Mutagenesis, Impairment Of Fertility No long-term animal studies have been performed with Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets. Pregnancy Teratogenic Effects- Pregnancy Category C Animal reproduction studies have not been conducted with Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets. It is also not known whether Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets 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. Nursing Mothers Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Tablets should not be administered to a nursing mother.