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SYMMETREL (AMANTADINE HCL) TABLETS AND SYRUP: PRESCRIBING INFORMATION

DESCRIPTION

Symmetrel (Amantadine Hydrochloride) is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride.

Amantadine Hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform.

Amantadine Hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug.

Symmetrel is available in tablets and syrup.

Each tablet intended for oral administration contains 100 mg amantadine hydrochloride and has the following inactive ingredients: magnesium stearate, hydroxypropyl methylcellulose, microcrystalline cellulose, sodium starch glycolate, FD&C Yellow No. 6.

Symmetrel syrup contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: citric acid, artificial raspberry flavor, propylparaben, methylparaben, and sorbitol solution.


CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

Symmetrel pharmacodynamics


PHARMACOKINETICS

Symmetrel pharmacokinetics


INDICATIONS AND USAGE

Symmetrel indications and usage


CONTRAINDICATIONS

Amantadine Hydrochloride (Symmetrel) tablets and syrup are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in Symmetrel.


WARNINGS

Symmetrel warnings


PRECAUTIONS

Symmetrel precautions


DRUG INTERACTIONS

Symmetrel drug interactions


NONCLINICAL TOXICOLOGY

Symmetrel nonclinical toxicology


USE IN SPECIAL POPULATIONS

Symmetrel use in special populations


ADVERSE REACTIONS

Symmetrel adverse reactions


OVERDOSAGE

Symmetrel overdosage


DOSAGE AND ADMINISTRATION

Symmetrel dosage and administration


HOW SUPPLIED

Symmetrel (Amantadine Hydrochloride, USP) is available in light orange, convex curved, triangular shaped 100 mg tablets with "SYMMETREL" debossed on one side and plain on the other side as bottles of 100.

As a clear, colorless syrup [each 5 mL (1 teaspoonful) contains 50 mg amantadine hydrochloride] in: 16 oz. (480 mL) bottles.

Storage

Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Manufactured and distributed by Novartis, Endo Pharmaceuticals companies and their divisions.

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