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

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