AMANTADINE HYDROCHLORIDE (Page 5 of 5)

Dosage for Parkinsonism

Adult

The usual dose of amantadine hydrochloride is 100 mg twice a day when used alone. Amantadine hydrochloride has an onset of action usually within 48 hours.

The initial dose of amantadine hydrochloride is 100 mg daily for patients with serious associated medical illnesses or who are receiving high doses of other antiparkinson drugs. After one to several weeks at 100 mg once daily, the dose may be increased to 100 mg twice daily, if necessary.

Occasionally, patients whose responses are not optimal with amantadine hydrochloride at 200 mg daily may benefit from an increase up to 400 mg daily in divided doses. However, such patients should be supervised closely by their physicians.

Patients initially deriving benefit from amantadine hydrochloride not uncommonly experience a fall-off of effectiveness after a few months. Benefit may be regained by increasing the dose to 300 mg daily. Alternatively, temporary discontinuation of amantadine hydrochloride for several weeks, followed by reinitiation of the drug, may result in regaining benefit in some patients. A decision to use other antiparkinson drugs may be necessary.

Dosage for Concomitant Therapy

Some patients who do not respond to anticholinergic antiparkinson drugs may respond to amantadine hydrochloride. When amantadine hydrochloride or anticholinergic antiparkinson drugs are each used with marginal benefit, concomitant use may produce additional benefit.

When amantadine hydrochloride and levodopa are initiated concurrently, the patient can exhibit rapid therapeutic benefits. Amantadine hydrochloride should be held constant at 100 mg daily or twice daily while the daily dose of levodopa is gradually increased to optimal benefit.

When amantadine hydrochloride is added to optimal well-tolerated doses of levodopa, additional benefit may result, including smoothing out the fluctuations in improvement which sometimes occur in patients on levodopa alone. Patients who require a reduction in their usual dose of levodopa because of development of side effects may possibly regain lost benefit with the addition of amantadine hydrochloride.

Dosage for Drug-induced Extrapyramidal Reactions

Adult

The usual dose of amantadine hydrochloride is 100 mg twice a day. Occasionally, patients whose responses are not optimal with amantadine hydrochloride at 200 mg daily may benefit from an increase up to 300 mg daily in divided doses.

Dosage for Impaired Renal Function

Depending upon creatinine clearance, the following dosage adjustments are recommended:

CREATININE CLEARANCE (mL/min/1.73m 2)	AMANTADINE HYDROCHLORIDE DOSAGE
30 to 50	200 mg 1 st day and 100 mg each day thereafter
15 to 29	200 mg 1 st day followed by 100 mg on alternate days
<15	200 mg every 7 days

The recommended dosage for patients on hemodialysis is 200 mg every 7 days.

HOW SUPPLIED

Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL is colorless with a raspberry flavor and is supplied in the following oral dosage forms:

NDC 0121-0646-10 (Unit dose cups of 100 mg/10 mL, 10 unit dose cups per tray, 10 trays per case) and NDC 0121-0646-16 (16 fl oz or 473 mL bottles).

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

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

REFERENCES

• W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction. Can. Med. Assoc. J. 129:974-975, 1983.
• D.F. Casey, N. Engl. J. Med. 298: 516, 1978.
• C.D. Berkowitz, J. Pediatr. 95: 144, 1979.

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R10/11

PRINCIPAL DISPLAY PANEL — 473 bottle

NDC 0121-0646-16

NSN 6505-01-130-1945

Amantadine Hydrochloride Oral Solution USP

50 mg/5 mL

Each 5 mL (1 teaspoonful) contains

Amantadine Hydrochloride 50 mg

Usage Dosage: See Package Insert

Dispense in a tight container as defined in the USP.

KEEP TIGHTLY CLOSED

Store at 20° to 25°C (68° — 77°F) [See USP Controlled Room Temperature].

Rx Only
16 fl oz (473 mL)

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

PRINCIPAL DISPLAY PANEL — 10 mL Cup Label

Delivers 10 mL

NDC 0121-0646-10

A MANTADINE H YDROCHLORIDE
O RAL S OLUTION USP

Each 10 mL contains: Amantadine Hydrochloride
100 mg

Usage Dosage: See Insert

Package Not Child-Resistant

Rx ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

AMANTADINE HYDROCHLORIDE amantadine hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0646 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANTADINE HYDROCHLORIDE (AMANTADINE) AMANTADINE HYDROCHLORIDE 50 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SORBITOL SODIUM HYDROXIDE

Product Characteristics Color Score Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0121-0646-16 473 mL in 1 BOTTLE None 2 NDC:0121-0646-10 10 TRAY in 1 CASE contains a TRAY 2 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-0646-10) and contains a CUP, UNIT-DOSE 2 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0646-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074509 07/17/1995

Labeler — Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Operations
Pharmaceutical Associates, Inc.		097630693	manufacture (0121-0646)

Revised: 06/2022 Pharmaceutical Associates, Inc.