Amantadine Hydrochloride (Page 5 of 5)

Dosage for Parkinsonism

Adult

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

The initial dose of amantadine hydrochloride capsules 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 capsules 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 capsules 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 capsules 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 capsules. When amantadine hydrochloride capsules or anticholinergic antiparkinson drugs are each used with marginal benefit, concomitant use may produce additional benefit.

When amantadine and levodopa are initiated concurrently, the patient can exhibit rapid therapeutic benefits. Amantadine hydrochloride capsules 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 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 capsules.

Dosage for Drug Induced Extrapyramidal Reactions

Adult

The usual dose of amantadine hydrochloride capsules is 100 mg twice a day. Occasionally, patients whose responses are not optimal with amantadine hydrochloride capsules 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

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

Product: 68151-2991

NDC: 68151-2991-0 1 CAPSULE in a PACKAGE

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.

05-2015M

7262

Sandoz Inc.

Princeton, NJ 08540

Amantadine 100 mg CAP

Label ImageLabel Image
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2991(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
AMMONIA
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
ETHYLCELLULOSE (7 MPA.S)
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
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:68151-2991-0 1 CAPSULE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071293 02/18/1987
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-2991)

Revised: 08/2016 Carilion Materials Management

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 © 2022. All Rights Reserved.