TADALAFIL tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [see Clinical Studies ( 14.3)] . Administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology ( 12.2)] . Tadalafil tablets are con

Ürün özeti:

Tadalafil tablets, USP are supplied as follows: Tadalafil tablets, USP, 20 mg: Yellow coloured, capsule shaped, biconvex film coated tablet with "Cipla" debossed on one side and '376' on other side. NDC 70934-473-06 Bottles of 06 with child resistant closure NDC 70934-473-15 Bottles of 15 with child resistant closure Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

TADALAFIL- TADALAFIL TABLET, FILM COATED
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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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 USE
INITIAL U.S. APPROVAL:2003
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.4) 05/2017
INDICATIONS AND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of:
erectile dysfunction (ED) ( 1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2)
ED and the signs and symptoms of BPH (ED/BPH) ( 1.3)
If tadalafil is used with finasteride to initiate BPH treatment, such
use is recommended for up to 26 weeks ( 1.4).
DOSAGE AND ADMINISTRATION
_Tadalafil tablets for use as needed:_
ED: Starting dose: 10 mg as needed prior to sexual activity. Increase
to 20 mg or decrease to 5 mg based upon
efficacy/tolerability. Improves erectile function compared to placebo
up to 36 hours post dose. Not to be taken more
than once per day ( 2.1).
_Tadalafil tablets for once daily use:_
ED: 2.5 mg taken once daily, without regard to timing of sexual
activity. May increase to 5 mg based upon efficacy and
tolerability ( 2.2).
BPH: 5 mg, taken at approximately the same time every day ( 2.3)
ED and BPH: 5 mg, taken at approximately the same time every day (
2.3, 2.4)
Tadalafil tablets may be taken without regard to food ( 2.5).
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg ( 3).
CONTRAINDICATIONS
Administration of tadalafil tablets to patients using any form of
organic nitrate is contraindicated. Tadalafil was shown to
potentiate the hypotensive effect of nitrates ( 4.1).
History of known serious hypersensitivity reaction to tadalafil or
ADCIRCA
( 4.2).
Administration with guanylate cyclase (GC) stimulators, such as
riociguat ( 4.3).
WARNINGS AND PRECAUTIONS
Patients should not use tadalafil tablets if sex is inadvisable due to
cardiovascular stat