Deconsal CT

DESCRIPTION

Deconsal®CT(phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are an antihistamine/nasal decongestantcombination for oral administration as a chewable tablet.

Each Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablet in agrape-flavored, dye-free, mottled brown-colored, scored tablet for oral administration contains:

Phenylephrine HCl.............10 mg
Pyrilamine Maleate.............16 mg

Inactive ingredients: Calcium phosphate dibasic, compressible sugar, corn starch, grape flavor, hypromellose, magnesium aluminum silicate, magnesium stearate, microcrystalline cellulose, saccharin sodium, talc, tannic acid, and xanthan gum.

SeeDOSAGE AND ADMINISTRATIONsection for further descriptive composition.

INDICATIONS

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are indicated for the symptomatic relief of thecoryzaandnasalcongestionassociated with thecommon cold,sinusitis,allergic rhinitisand other upper respiratory tract infections. Appropriate therapy should be provided for the primary disease.

DOSAGE AND ADMINISTRATION

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets are available as grape-flavored, dye-free, mottled brown-colored, round, scored tablet imprinted with CC on one side and the score line on the other

NDCNo.: 10122-202-10 - Bottles of 100 Chewable Tablets andNDCNo.: 10122-202-02 single tablet sample pouches.

Store at controlled room temperature, 20o-25o C (68o -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

SIDE EFFECTS

The most common effects associated withantihistamineshave been drowsiness sedation, dryness ofmucousmembranes, andgastrointestinaleffects. 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 Systems (CNS)- disturbed coordination,tremor, irritability, insomnia, visual disturbances, weakness, nervousness,convulsion, headache,euphoria, anddysphoria.

Genitourinary- urinary frequency,difficult urination.

Gastrointestinal- epigastric discomfort,anorexia, nausea, vomiting, diarrhea, constipation. Respiratory - tightness of the chest andwheezing, shortness of breath. Hematologic -hemolytic anemia,thrombocytopenia,agranulocytosis.

DRUG INTERACTIONS

MAO inhibitors may prolong and intensify theanticholinergiceffects of sympathomimetic agents. Thus, concomitant administration of Deconsal® CT Tannate Chewable Tablets and MAO inhibitors should be avoided (see"CONTRAINDICATIONS").

警告

This product contains an antihistamine that may cause drowsiness and may have additivecentral nervous system(CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines should be used with caution in patients with stenosingpeptic ulcer, pyloroduodenal obstruction, and urinarybladderobstruction due to symptomatic prostatichypertrophyand narrowing of the bladder neck.

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 angleglaucoma.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term animal studies have been performed with Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets.

Pregnancy

Teratogenic Effects- Pregnancy Category C

Animal reproduction studies have not been conducted with Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets. It is also not known whether Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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 fetalanoxiaorbradycardiaby increasing contractility of theuterusand 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® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Tablets should not be administered to a nursing mother.

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.

Treatment

Induce vomiting if it has not occurred spontaneously. Precautions must be taken againstaspirationespecially in infants, children, and comatose patients. Ifgastriclavage is indicated, isotonic or half-isotonicsalinesolution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.

CONTRAINDICATIONS

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) 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, includingasthma. Phenylephrine is contraindicated in patients with hypertension or with peripheralvascularinsufficiency (ischemiamay result with risk ofgangreneorthrombosisof compromised vascular beds).

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets should not be used in patients receiving amonoamine oxidase inhibitor(MAOI) (see "PRECAUTIONS-DRUG INTERACTIONS").

CLINICAL PHARMACOLOGY

Deconsal® CT (phenylephrine hcl and pyrilamine maleate tannate chewable tablets) Tannate Chewable Tablets combines the sympathomimeticdecongestanteffect of phenylephrine with the antihistaminic effect of pyrilamine.

Phenylephrine

Phenylephrine is a decongestant which is a potent postsynaptic a-receptoragonistwith 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 thebronchior 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 ofhistamineonsmooth muscle,capillarypermeability, and can both stimulate and depress the central nervous system. Pyrilamine also possesses anticholinergic andsedativeproperties.

PATIENT INFORMATION

警告患者不要喝酒精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, orParkinson's disease), or for 2 weeks after stopping theMAO inhibitordrug. If patients are uncertain whether aprescription drugcontains an MAO inhibitor, they should be instructed to consult a health professional before taking this product.