TADALAFIL tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

AvPAK

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil 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 contraindicated in patients with a known serious hypersensitivi

Povzetek izdelek:

Tadalafil tablets, USP are supplied as follows: Four strengths of oval shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes: 2.5 mg tablets: Oval shaped, biconvex, light yellow to yellow colored, film coated tablet, debossed with ‘RDY’ on one side and '2.5' on the other side. 5 mg tablets: Oval shaped, biconvex, light yellow to yellow colored, film coated tablet, debossed with, ‘RDY' on one side and '5' on the other side. NDC 50268-738-13 (10 tablets per card, 3 cards per carton) 10 mg tablets: Oval shaped, biconvex, yellow colored, film coated tablet, debossed with on one side and plain on the other side. 20 mg tablets: Oval shaped, biconvex, yellow colored, film coated tablet, debossed with on one side and plain on the other side. NDC 50268-739-13 (10 tablets per card, 3 cards per carton). Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature].   Keep out of reach of children.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

TADALAFIL- TADALAFIL TABLET, FILM COATED
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
TADALAFIL
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TADALAFIL TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FORTADALAFIL
TABLETS.
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 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 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 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
tablets or ADCIRCA
( 4.2).
• Administration with guanylate cyclase (GC) stimulators, such as
riociguat ( 4.3).
WARNINGS AND PRECAUTIONS
• Patients should not use tadalafil if sex is inadvisable due to
cardiovascular status ( 5.1).
• Use of t