TADALAFIL- tadalafil tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Camber Pharmaceuticals, Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Tadalafil tablet is 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 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. 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 is contraindicated. Tadalafil may potentiate the hypotensive effects of GC stimulators.   Tadalafil tablet is contraindicated in patients with a known serious hypersensitivity to tadalaf

Rezumat produs:

Tadalafil tablets USP, 20 mg are white color, capsule shaped, biconvex, film-coated tablets debossed with ‘T15’ on one side and ‘H’ on the other side. They are supplied as follows: Bottles of 30 tablets NDC 31722-647-30 Bottles of 60 tablets NDC 31722-647-60 Carton of 100 (10x10) unit-dose tablets NDC 31722-647-31 Store at 20 o C to 25°C (68 o F to 77°F); [see USP Controlled Room Temperature]. Keep out of reach of children.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TADALAFIL - TADALAFIL TABLET
CAMBER 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 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 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, CONTACT HETERO LABS LIMITED AT