TADALAFIL tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)

Sẵn có từ:

Cipla USA Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). Tadalafil tablets are contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Do not use nitrates within 48 hours of the last dose of tadalafil tablets. Tadalafil potentiates the hypotensive effect of nitrates.This potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)] . Coadministration of GC stimulators such as riociguat with tadalafil tablets is contraindicated. Tadalafil may potentiate the hypotensive effects of GC stimulators. Tadalafil tablet is contraindicated in patients with a known serious hypersensitivi

Tóm tắt sản phẩm:

Tadalafil tablets, USP are supplied as follows: Brown colored, capsule shaped, biconvex film coated tablet with 'Cipla' debossed on one side and 526 on other side.                                                                                                 Carton of 4 Tablets (1 x 4 Unit-dose) with child-resistant blister         NDC 69097-526-16 Bottles of 60 with child-resistant closure                                                      NDC 69097-526-03                   Store at 25°C (77°F): excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature.] Keep out of reach of children.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

TADALAFIL- TADALAFIL TABLET, FILM COATED
CIPLA USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TADALAFIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TADALAFIL TABLETS.
TADALAFIL TABLETS, FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Contraindications (4.1, 4.2) 09/2020
Warnings and Precautions-Cardiovascular Effects Removed
(5.1) 09/2020
Warnings and Precautions-Use with Potent Removed
CYP3A Inhibitors or Inducers (5.2) 09/2020
Warnings and Precautions-Use in Renal Removed
Impairment (5.3) 09/2020
Warnings and Precautions-Use in Hepatic Removed
Impairment (5.4) 09/2020
Warnings and Precautions-Effects on Bleeding Removed
(5.9) 09/2020
Warnings and Precautions-Hypotension (5.1) 09/2020
Warnings and Precautions-Worsening Pulmonary 09/2020
Vascular Occlusive Disease (5.2)
Warnings and Precautions-Visual Loss (5.3) 09/2020
Warnings and Precautions-Hearing Impairment (5.4) 09/2020
Warnings and Precautions-Combination with 09/2020
Other PDE5 Inhibitors (5.5)
INDICATIONS AND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of pulmonary arterial hypertension (PAH)
(WHO Group 1) to improve exercise ability. Studies establishing
effectiveness included predominately patients with NYHA
Functional Class II – III symptoms and etiologies of idiopathic or
heritable PAH (61%) or PAH associated with connective
tissue diseases (23%). (1.1)
DOSAGE AND ADMINISTRATION
40 mg once daily, with or without food. (2.1)
Dividing the dose (40 mg) over the course of the day is not
recommended. (2.1)
Use with ritonavir requires dosage adjustments. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 20 mg (3)
CONTRAINDICATIONS
Concomitant organic nitrates (4.1)
Concomitant Guanylate Cyclase (GC) Stimulators (4.2)
History of known serious hypersensitivity reaction to tadalafil or
CIALIS (4.3)
WARNINGS AND PRECAUTIONS
Hypotension: Carefully consider whether patients with certain
u