TADALAFIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tadalafil tablet is indicated for the treatment of erectile dysfunction (ED). Tadalafil tablet is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tadalafil tablet is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). If tadalafil tablet is 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 tablets was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology ( 12.2)]. Tadalafil tablet is contraindicated in patients with a kn

Product summary:

Tadalafil tablets USP, 5 mg are white color, round shaped, biconvex, film-coated tablets debossed with T17 on one side and H on the other side. NDC 68071-5116-6 BOTTLES OF 60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TADALAFIL- TADALAFIL TABLET, FILM COATED
NUCARE 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 tablet is used with finasteride to initiate BPH
treatment, such use is recommended for up to 26
weeks ( 1.4).
DOSAGE AND ADMINISTRATION
• _Tadalafil tablet 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).
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 tablets 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 i