TADALAFIL tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Solco Healthcare US, LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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)] . Coadministration of GC stimulators such as riociguat with tadalafil tablets are contraindicated. Tadalafil tablets may potentiate the hypotensive effects of GC stimulators. Tadalafil tablets are contraindicated in patients with a k

製品概要:

Tadalafil Tablets,USP are supplied as follows: 20 mg pale orange, film-coated, almond-shaped tablets (not scored), debossed with “990” Store at 20o C to 25o C (68o F to 77o F); excursions permitted to 15o C to 30o C (59o F to 86o F) [see USP Controlled Room Temperature]. Keep out of reach of children.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

TADALAFIL- TADALAFIL TABLET
Solco Healthcare US, LLC
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PATIENT INFORMATION
Tadalafil Tablets, USP
(ta DAL a fil)
Read this patient information before you start taking tadalafil
tablets and each time you get a refill. There
may be new information. This information does not take the place of
talking with your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about tadalafil
tablets?
Never take tadalafil tablets with any nitrate or guanylate cyclase
stimulator medicines:
•
Your blood pressure could drop quickly to an unsafe level
•
You could get dizzy, faint and even have a heart attack or stroke.
Nitrates include:
•
Medicines that treat chest pain (angina)
•
Nitroglycerin in any form including tablets, patches, sprays, and
ointments
•
Other nitrate medicines (isosorbide mononitrate or dinitrate)
•
Street drugs that are inhaled, called “poppers” (amyl nitrate,
butyl nitrate or nitrite)
Guanylate cyclase stimulators include:
•
Riociguat (Adempas®) a medicine that treats pulmonary arterial
hypertension and chronic-
thromboembolic pulmonary hypertension
Ask your healthcare provider or pharmacist if you are not sure if you
take a nitrate or guanylate cyclase
stimulator medicine.
What are tadalafil tablets?
Tadalafil tablets are a prescription medicine used to treat pulmonary
arterial hypertension (PAH, high blood
pressure in your lungs) to improve your ability to exercise.
It is not known if tadalafil tablets are safe or effective in
children.
Who should not take tadalafil tablets?
Do not take tadalafil tablets if you
•
take any medicines called nitrates.
•
use recreational drugs called “poppers” like amyl nitrate, butyl
nitrate or nitrite.
•
take any medicines called guanylate cyclase stimulators
•
are allergic to tadalafil or any other ingredient in tadalafil
tablets. See “What are the ingredients in
tadalafil tablets?” at the end of this leaflet.
See “What is the most important information I should know abo

製品の特徴

TADALAFIL- TADALAFIL TABLET
SOLCO HEALTHCARE US, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TADALAFIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TADALAFIL.
TADALAFIL (TADALAFIL) TABLET FOR ORAL USE.
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
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 20 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reaction is headache. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US,
LLC. AT 1-866-257-
2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Renal Impairment (2.2, 8.6, 12.3)
•
•
Hepatic Impairment (2.2, 8.7, 12.3)
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 8/2022
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 ischemic optic neuropathy
(NAION) and may be pe