Amantadine Hydrochloride (Page 5 of 5)

Dosage for Impaired Renal Function

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

CREATININE CLEARANCE

(mL/min/1.73m2)

AMANTADINE

HYDROCHLORIDE

CAPSULES 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

Repackaged by A-S Medication Solutions — Libertyville, IL
See REPACKAGING INFORMATION for available configurations.

A-S Medication Solutions
(click image for full-size original)

Amantadine hydrochloride capsules, USP for oral administration are available as:

100 mg: Red capsules imprinted GG 634 and supplied as:

NDC 0781-2048-01 bottles of 100

NDC 0781-2048-05 bottles of 500

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Dispense in a tight, light-resistant container as defined in the USP.

REFERENCES

1.
W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can Med Assoc J. 129:974-975, 1983.
2.
D.F. Casey, N. Engl. J. Med. 298:516, 1978.
3.
C.D. Berkowitz, J. Pediatr. 95:144, 1979.

06-2009M

7262

Sandoz Inc.

Princeton, NJ 08540

REPACKAGING INFORMATION

Please reference the HOW SUPPLIED section listed above for a description of individual tablets or capsules. This drug product has been received by A-S Medication Solutions — Libertyville, IL in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from A-S Medication Solutions are listed below:

NDC#Count Strength
50090-0020-310100 mg

Repackaged by:

A-S Medication Solutions
(click image for full-size original)

Libertyville, IL 60048

PRINCIPAL DISPLAY PANEL

NDC 50090-0020-3

Packaged by:
A-S Medication Solutions
Libertyville, IL 60048

//medlibrary.org/lib/images-rx/amantadine-hydrochloride-6/50090-0020-3-300x129.jpg
(click image for full-size original)
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0020(NDC:0781-2048)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMANTADINE HYDROCHLORIDE (AMANTADINE) AMANTADINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
ETHYLCELLULOSE (7 MPA.S)
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
METHYLPARABEN
CELLULOSE, MICROCRYSTALLINE
PROPYLPARABEN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code GG634
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0020-3 10 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071293 02/18/1987
Labeler — A-S Medication Solutions LLC (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions LLC 830016429 repack (50090-0020)

Revised: 02/2015 A-S Medication Solutions LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.