TADALAFIL tablet, coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Alembic Pharmaceuticals Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Tadalafil tablets USP are indicated for the treatment of erectile dysfunction (ED). Tadalafil tablets USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tadalafil tablets USP are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). If tadalafil tablets USP are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets USP decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets USP 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 tablets was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)] . Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity t

Каталог на резюме:

  Tadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side. NDC Number          Size 62332-177-30         bottle of 30 Tablets 62332-177-15         30 Tablets (2 blisters of 15 tablets)  Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side. NDC Number         Size 62332-178-30        bottle of 30 Tablets 62332-178-15        30 Tablets (2 blisters of 15 tablets)    Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side. NDC Number    Size 62332-179-30  bottle of 30 Tablets  Tadalafil tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side. NDC Number     Size 62332-180-30    bottle of 30 Tablets 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. 

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

TADALAFIL - TADALAFIL TABLET, COATED
ALEMBIC 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 USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Tadalafil
tablets USP are phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of: (1)
· erectile dysfunction (ED) (1.1) (1)
· the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)
(1)
· ED and the signs and symptoms of BPH (ED/BPH) (1.3) (1)
If tadalafil
tablets USP are used with finasteride to initiate BPH treatment, such
use is recommended for
up to 26 weeks (1.4). (1)
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 tablet 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). (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg (3). (3)
CONTRAINDICATIONS
Administration of tadalafil tablets to patients using any form of
organic nitrate is contraindicated.
Tadalafil tablets were shown to potentiate the hypotensive effect of
nitrates (4.1).
History of known serious hypersensitivity reaction to tadalafil
tablets 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