TADALAFIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

PD-RX Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Tadalafil tablets, USP are supplied as follows: Four strengths of yellow coloured, oval-shaped tablets are available in different sizes and supplied in the following package sizes: Tadalafil tablets, USP, 5 mg: 5 mg tablets debossed with ‘5’ on one side and “V” on the other side. Bottles of 90 NDC 72789-324-90 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                TADALAFIL- TADALAFIL TABLET, FILM COATED
PD-RX 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
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 status ( 5.1).
Use of tad
                                
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