Tadalafil

TADALAFIL — tadalafil tablet, coated
Alembic Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

1.1 Erectile Dysfunction

Tadalafil tablets USP are indicated for the treatment of erectile dysfunction (ED).

1.2 Benign Prostatic Hyperplasia

Tadalafil tablets USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia

Tadalafil tablets USP are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

1.4 Limitation of Use

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)].

2 DOSAGE AND ADMINISTRATION

Do not split tadalafil tablets; entire dose should be taken.

2.1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction

· The recommended starting dose of tadalafil tablets for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.

· The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.

· Tadalafil tablets for use as needed were shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of tadalafil tablets, this should be taken into consideration.

2.2 Tadalafil Tablet for Once Daily Use for Erectile Dysfunction

· The recommended starting dose of tadalafil tablet for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

· The tadalafil tablet dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

2.3 Tadalafil Tablet for Once Daily Use for Benign Prostatic Hyperplasia

· The recommended dose of tadalafil tablet for once daily use is 5 mg, taken at approximately the same time every day.

· When therapy for BPH is initiated with tadalafil tablet and finasteride, the recommended dose of tadalafil tablet for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

2.4 Tadalafil Tablet for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia

The recommended dose of tadalafil tablet for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

2.5 Use with Food

Tadalafil tablets may be taken without regard to food.

2.6 Use in Specific Populations

Renal Impairment

Tadalafil Tablets for Use as Needed

· Creatinine clearance 30 mL/min to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.

· Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Tadalafil Tablet for Once Daily Use

Erectile Dysfunction

· Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablet for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

· Creatinine clearance 30 mL/min to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.

· Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablet for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Hepatic Impairment

Tadalafil Tablets for Use as Needed

· Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of tadalafil tablet once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.

· Severe (Child Pugh Class C): The use of tadalafil tablets are not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].

Tadalafil Tablet for Once Daily Use

· Mild or moderate (Child Pugh Class A or B): Tadalafil tablet for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if tadalafil tablet for once daily use is prescribed to these patients.

· Severe (Child Pugh Class C): The use of tadalafil tablet is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].

2.7 Concomitant Medications

Nitrates

Concomitant use of nitrates in any form is contraindicated [see Contraindications (4.1)].

Alpha-Blockers

ED — When tadalafil tablets are coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and tadalafil tablets should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

BPH — Tadalafil tablets are not recommended for use in combination with alpha-blockers for the treatment of BPH [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

CYP3A4 Inhibitors

Tadalafil Tablets for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of tadalafil tablet is 10 mg, not to exceed once every 72 hours [see Warnings and Precautions (5.10) and Drug Interactions (7.2)].

Tadalafil Tablet for Once Daily Use — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose is 2.5 mg [see Warnings and Precautions (5.10) and Drug Interactions (7.2)].

3 DOSAGE FORMS AND STRENGTHS

Tadalafil tablets 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.

Tadalafil tablets 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side.

Tadalafil tablets 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side.

Tadalafil tablets 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side.

4 CONTRAINDICATIONS

4.1 Nitrates

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)].

4.2 Hypersensitivity Reactions

Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil or Adcirca®. Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)].

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

Do not use tadalafil tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including tadalafil tablets, may potentiate the hypotensive effects of GC stimulators.

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