Amantadine Hydrochloride: Package Insert and Label Information (Page 3 of 3)

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/1.73m2)
AMANTADINE HYDROCHLORIDE DOSAGE
30 to 50 200 mg 1st day and 100 mg each day thereafter
15 to 29 200 mg 1st 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

NDC:17856-0093-3 in a CUP, UNIT-DOSE of 5 SOLUTIONS

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

KEEP TIGHTLY CLOSED

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

Rx Only

REFERENCES

W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can. Med. Assoc. J. 129:974–975, 1983. 1

D.F. Casey, N. Engl. J. Med. 298:516, 1978. 2

C.D. Berkowitz, J. Pediatr. 95:144, 1979. 3

Product No.: 8093

Manufactured for: Wockhardt USA, LLC Parsippany, NJ 07054

Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053

A50-8093-16

REV. 09-11

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

AMANTADINE HYDROCHLORIDE SOLUTION

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AMANTADINE HYDROCHLORIDE
amantadine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0093(NDC:60432-093)
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
Water
Sorbitol
Propylene Glycol
Trisodium Citrate Dihydrate
SACCHARIN SODIUM
Methylparaben
Propylparaben
Anhydrous Citric Acid
Product Characteristics
Color Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0093-3 5 mL in 1 CUP, UNIT-DOSE None
2 NDC:17856-0093-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE
2 10 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-0093-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075060 12/24/1998
Labeler — Atlantic Biologicals Corps (047437707)
Registrant — Atlantic Biologicals Corps (047437707)
Establishment
Name Address ID/FEI Operations
Atlantic Biologicals Corps 047437707 RELABEL (17856-0093), REPACK (17856-0093)

Revised: 05/2020 Atlantic Biologicals Corps

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