TADALAFIL tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

REMEDYREPACK INC.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 tablet is 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 tablet. Tadalafil tablet potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and tadalafil tablet on the nitric oxide/cGMP pathway [see Clinical Pharmacology ( 12.2)]. Coadministration of GC stimulators such as riociguat with tadalafil tablet is contraindicated. Tadalafil tablet may potentiate the hypotensive effects of GC stimulators. Tadalafil tablet is contraindicat

leaflet_short:

Tadalafil tablets USP is supplied as follows: 20 mg yellow colored, almond shaped, biconvex film coated tablets having ‘L 64’ debossed on one side and plain on other side NDC: 70518-3529-00 NDC: 70518-3529-01 PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 12 in 1 BOTTLE PLASTIC Store at room temperature 20°C to 25°C (68°F to 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TADALAFIL- TADALAFIL TABLET, FILM COATED
REMEDYREPACK 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
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)
(2)
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
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 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, CONTACT MACLEO