Prescription Drug Information: ANTARA (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
Antara (fenofibrate) Capsules, are available in two strengths:
- 43 mg capsules, imprinted with “43” and a segmented band, on the light green cap and “ANTARA” and “LUPIN” on the white to off-white body, available in bottles of 30 (NDC # 27437-109-06).
- 130 mg capsules, imprinted with “130” and a segmented band, on the dark green cap and “ANTARA” and “LUPIN” on the white body, available in bottles of 30 (NDC # 27437-110-06) and 100 (NDC # 27437-110-01).
Storage: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature] in a tightly closed container.
17 PATIENT COUNSELING INFORMATION
- of the potential benefits and risks of Antara.
- not to use Antara if there is a known hypersensitivity to fenofibrate capsules or fenofibric acid.
- that if they are taking coumarin anticoagulants, Antara may increase their anticoagulant effect, and increased monitoring may be necessary.
- of medications that should not be taken in combination with Antara.
- to continue to follow an appropriate lipid-modifying diet while taking Antara.
- to take Antara once daily, without regard to food, at the prescribed dose, swallowing each capsule whole.
- to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking Antara.
- to inform their physician of symptoms of liver injury (e.g., jaundice, abnormal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms .
- to return to their physician’s office for routine monitoring.
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States
Lupin Pharmaceuticals Inc.
111 South Calvert Street, 21st Floor
Baltimore, MD 21202
or Call: 1-800-399-2561
June 2021
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ANTARA®
(fenofibrate) capsules
43 mg
Rx only
30 capsules
Lupin Pharmaceuticals Inc.
ANTARA®
(fenofibrate) capsules
130 mg
Rx only
30 capsules
Lupin Pharmaceuticals Inc.
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Labeler — Lupin Pharmaceuticals, Inc. (089153071) |
Registrant — LUPIN LIMITED (675923163) |
Establishment | |||
Name | Address | ID/FEI | Operations |
EthyPharm Industries | 278800789 | MANUFACTURE (27437-109), MANUFACTURE (27437-110) |
Establishment | |||
Name | Address | ID/FEI | Operations |
AndersonBrecon, Inc. | 053217022 | PACK (27437-109), PACK (27437-110) |
Revised: 12/2023 Lupin Pharmaceuticals, Inc.
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