TADALAFIL tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

Tadalafil (UNII: 742SXX0ICT) (Tadalafil - UNII:742SXX0ICT)

Предлага се от:

Dr.Reddys Laboratories Inc

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични 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 to 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 are contraindicated. tadalafil may potentiate the hypotensive effects of GC stimulators. . Tadalafil tablets are contraindicated in patients with a known serious hypersen

Каталог на резюме:

Tadalafil tablets, USP are supplied as follows: 20 mg, oval shaped, biconvex, yellow colored, film-coated tablet, debossed with on one side and plain on other side. Bottles of 30 NDC 43598-578-30 Bottles of 60 NDC 43598-578-60 Store at 20ºC to 25ºC (68ºF to 77ºF); [See USP Controlled Room Temperature]. Keep out of reach of children.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

TADALAFIL- TADALAFIL TABLET, FILM COATED
DR.REDDYS LABORATORIES 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 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 to 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
tablets or CIALIS (4.3)
WARNINGS AND PRECAUTIONS
Hypotension: Carefully consider whether patients with certain
underlying cardiovascular disease could be adversely
affected by vasodilatory effects of tadalafil. 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 ischemic optic neuropathy (NAION) and may
be permanent. (5.3)
Hearing impairment: Cases of sudden decrease or loss of hearing have
been reported with CIALIS. (5.4)
Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5
inhibitors. (5.5)
Prolonged erection: Advise patients to seek emergency treatment if an
erection lasts >4 hours. (5.6)
ADVERSE REACTIONS
The most common adverse reaction is headache. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CON