TADALAFIL tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Mylan Pharmaceuticals Inc.

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 tablets potentiate the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and tadalafil tablets on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)] . Co-administration of GC stimulators such as riociguat with tadalafil tablets is contraindicated. Tadalafil tablets may potentiate the hypotensive effects of GC stimulators. Tadalafil tablets are contraindicated in patients with a k

Обзор продуктов:

Tadalafil Tablets, USP are available containing 20 mg of tadalafil, USP. The 20 mg tablets are yellow, film-coated, round, unscored tablets debossed with T9DI over 20 on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-6976-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep out of reach of children.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

TADALAFIL- TADALAFIL TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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
INDICATIONS AND USAGE
Tadalafil tablets are 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
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DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 20 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reaction is headache. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Renal Impairment (2.2, 8.6, 12.3)
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Hepatic Impairment (2.2, 8.7, 12.3)
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2021
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)
Concomitant organic nitrates (4.1)
Concomitant Guanylate Cyclase (GC) stimulators (4.2)
History of known serious hypersensitivity reaction to tadalafil
tablets or CIALIS
(4.3)
®
Hypotension: Carefully consider whether patients with certain
underlying cardiovascular disease could
be adversely affected by vasodilatory effects of tadalafil tablets.
Not recommended in patients with
pulmonary veno-occlusive disease. (5.1, 5.2)
Effects on the eye: Sudden loss of vision could be a sign of
non-arteritic isc