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Cialis

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Cialis

Indications
Dosage
How Supplied

INDICATIONS

Erectile Dysfunction

CIALIS® is indicated for the treatment of erectile dysfunction (ED).

Benign Prostatic Hyperplasia

CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Erectile Dysfunction And Benign Prostatic Hyperplasia

CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

Limitation Of Use

If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown [see Clinical Studies].

DOSAGE AND ADMINISTRATION

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

CIALIS For Use As Needed For Erectile Dysfunction

  • The recommended starting dose of CIALIS 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.
  • CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.

CIALIS For Once Daily Use For Erectile Dysfunction

  • The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
  • The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

CIALIS For Once Daily Use For Benign Prostatic Hyperplasia

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

CIALIS For Once Daily Use For Erectile Dysfunction And Benign Prostatic Hyperplasia

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

Use With Food

CIALIS may be taken without regard to food.

HOW SUPPLIED

Dosage Forms And Strengths

Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow:

2.5 mg tablets debossed with “C 2½”
5 mg tablets debossed with “C 5”
10 mg tablets debossed with “C 10”
20 mg tablets debossed with “C 20”

Storage And Handling

CIALIS (tadalafil) is supplied as follows:

Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes:

2.5 mg tablets debossed with “C 2 ½”

Blisters of 2 x 15 NDC 0002-4465-34

5 mg tablets debossed with “C 5”

Bottles of 30 NDC 0002-4462-30
Blisters of 2 x 15 NDC 0002-4462-34

10 mg tablets debossed with “C 10”

Bottles of 30 NDC 0002-4463-30

20 mg tablets debossed with “C 20”

Bottles of 30 NDC 0002-4464-30

Storage

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.

Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA. Revision Date 04/2014

Last reviewed on RxList: 5/19/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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