Nifedipine (Page 5 of 5)

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Nifedipine extended-release tablet is an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7 to14 day period starting with 30 mg once daily. Upward titration should be based on therapeutic efficacy and safety. The usual maintenance dose is 30 mg to 60 mg once daily. Titration to doses above 90 mg daily is not recommended.

If discontinuation of nifedipine extended-release tablets is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

Coadministration of nifedipine with grapefruit juice is to be avoided (see and ). CLINICAL PHARMACOLOGYPRECAUTIONS

Care should be taken when dispensing nifedipine extended-release tablets to assure that the extended-release dosage form has been prescribed.

HOW SUPPLIED

NDC:64725-2057-1 in a BOTTLE of 100 TABLET, EXTENDED RELEASES

The tablets should be protected from light and moisture and stored at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.

Manufactured in Canada by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G1Z7 Canada

Manufactured for: TEVA PHARMACEUTICALS USA Sellersville, PA 18960

LB0008-04

Rev. 3/2012

NIFEDIPINE TABLET, EXTENDED RELEASE

NIFEDIPINE nifedipine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-2057(NDC:0093-2057) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nifedipine (Nifedipine) Nifedipine 30 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE ETHYLCELLULOSES HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE METHYL METHACRYLATE POLYETHYLENE GLYCOLS SILICON DIOXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE

Product Characteristics Color YELLOW (Mustard Yellow) Score no score Shape ROUND Size 9mm Flavor Imprint Code B;30 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64725-2057-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075269 10/18/2012

Labeler — TYA Pharmaceuticals (938389038)

Registrant — TYA Pharmaceuticals (938389038)

Establishment
Name	Address	ID/FEI	Operations
TYA Pharmaceuticals		938389038	RELABEL (64725-2057), REPACK (64725-2057)

Revised: 08/2013 TYA Pharmaceuticals