Tadalafil 5 MG Tablets — Generic for Cialis — Camber Pharma

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:

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

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).

Dosage Forms And Strengths

Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg (3).

Contraindications

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).

• (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).

Adverse Reactions

Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug Interactions

Use In Specific Populations

Hepatic Impairment (2.6, 5.8, 8.6):

Renal Impairment (2.6, 5.7,8.7):

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2019