Amantadine Hydrochloride (Page 5 of 5)

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

NDC: 71335-0469-1: 20 Capsules in a BOTTLE

NDC: 71335-0469-2: 30 Capsules in a BOTTLE

NDC: 71335-0469-3: 10 Capsules in a BOTTLE

NDC: 71335-0469-4: 14 Capsules in a BOTTLE

NDC: 71335-0469-5: 60 Capsules in a BOTTLE

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Cadila Healthcare Ltd.

Matoda, Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 12/16

Revision Date: 23/12/2016

Amantadine Hcl 100mg Capsule

Label
(click image for full-size original)
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0469(NDC:68382-512)
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
ETHYLCELLULOSE (4 MPA.S)
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color RED (red opaque colored cap) , RED (red opaque colored body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 652
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-0469-1 20 CAPSULE in 1 BOTTLE None
2 NDC:71335-0469-2 30 CAPSULE in 1 BOTTLE None
3 NDC:71335-0469-3 10 CAPSULE in 1 BOTTLE None
4 NDC:71335-0469-4 14 CAPSULE in 1 BOTTLE None
5 NDC:71335-0469-5 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208278 08/04/2016
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-0469), RELABEL (71335-0469)

Revised: 12/2021 Bryant Ranch Prepack

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