Amantadine Hydrochloride (Page 5 of 5)

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

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

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

NDC 33261-0773-10 bottles of 10

NDC 33261-0773-30 bottles of 30

NDC 33261-0773-60 bottles of 60

NDC 33261-0773-90 bottles of 90

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

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

100 mg Label

NDC 33261-0773-60

Amantadine

Hydrochloride

Capsules, USP

100 mg

Rx only

60 Capsules

IMAGE LABEL
(click image for full-size original)
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-773(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:33261-773-10 10 CAPSULE (10 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:33261-773-30 30 CAPSULE (30 CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:33261-773-60 60 CAPSULE (60 CAPSULE) in 1 BOTTLE, PLASTIC None
4 NDC:33261-773-90 90 CAPSULE (90 CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071293 02/18/1987
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 11/2013 Aidarex Pharmaceuticals 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 © 2024. All Rights Reserved.