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Extendryl SR Jr capsules

Description

Each dose contains:
Phenylephrine
HCl
Chlorpheniramine
Maleate
Methscopolamine
Nitrate
Extendryl SR Capsule
20 mg 8 mg 2.50 mg
Extendryl JR Capsule
10 mg 4 mg 1.25 mg
Extendryl Chewable Tablet
(Root beer flavored)
10 mg 2 mg 1.25 mg
Extendryl Syrup (5 mL)
(Root beer flavored)
10 mg 2 mg 1.25 mg

Clinical Pharmacology

Chlorpheniramine maleate is an alkylamine antihistamine which possesses anticholinergic and sedative effects. Phenylephrine HCl is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors, with a mild central stimulant effect. Methscopolamine nitrate is a derivative of scopolamine, which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its inability to cross the blood-brain barrier.

Indications and Usage

Relief of respiratory congestion, allergic rhinitis, vasomotor rhinitis, and allergic skin reactions of urticaria and angioedema.

Contraindications

Contraindicated in patients receiving MAO inhibitors, in patients with a known hypersensitivity to any of the ingredients, and in patients with glaucoma, hypertension, cardiac disease, or hyperthyroidism.

Precautions

General:   Use cautiously, if at all, in the presence of pyloric obstruction. Use with caution in those over 40 years of age, in the presence of diabetes mellitus or urinary retention, and in men with prostatic hypertrophy or a history of bladder difficulty. If disturbances in urination occur, medication should be discontinued for 1 or 2 days and then resumed at a lower dosage. Antihistamines may cause excitability, especially in children. Information for patients: Because this product may cause blurring of vision or drowsiness, patients should be cautioned against driving or operating machinery.

Drug interactions:   MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol or other CNS depressants may have an additive effect. Pregnancy: Pregnancy Category C. It is also not known whether the product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The product should be given to a pregnant woman only if clearly needed. Nursing mothers: It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Pediatric use: Safety and effectiveness in children below the age of 6 have not been established.

Geriatric use:   Anticholinergic and CNS stimulant effects more likely to occur in older patients; danger of precipitating undiagnosed glaucoma; possible impairment of memory.

Adverse Reactions

Side effects include xerostomia, blurred vision, bradycardia, mydriasis, flushing, palpitation, dizziness, constipation, urinary retention, drowsiness, increased irritability or excitability, nausea or dysphagia.

Overdosage

The stomach should be emptied promptly by lavage or by induction of emesis (syrup of ipecac recommended). The installation of activated charcoal into the stomach also should be considered. If respiratory depression is present, treat promptly with oxygen and/or mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type drugs should be used.

Dosage and Administration

Extended-Release Capsules:   Adults and children 12 years of age and older: One SR. capsule every 12 hours. Children 6 to under 12 years of age: One JR. capsule every 12 hours. Syrup: Adults and children 12 years of age and older: 1 or 2 teaspoonfuls every 3 or 4 hours. Children 6 to under 12 years of age: 1 / 2 to 1 teaspoonful depending on age and body weight, may be repeated every 4 hours. Tablets: Adults and children 12 years of age and older: 1 or 2 tablets every 4 hours. Children 6 to under 12 years of age: 1 tablet every 4 hours. Do not exceed 4 doses in 24 hours.

How Supplied

Capsules and tablets in bottles of 100, syrup in pints.

Supplied as green/red Extendryl Extended-Release Sr/Jr capsules in bottles of 100: "SR," NDC 0256-0111-01; "JR," NDC 0256-0177-01.

Extendryl Syrup as root beer flavored syrup in pints, NDC 0256-0127-01.

Extendryl Chewable Tablets: convex, tan colored, scored on one side in bottles of 100, NDC 0256-0133-01.

Rev. 8/99

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