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Cialis

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Cialis

Cialis

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.

Use In Specific Populations

Renal Impairment

CIALIS for Use as Needed

  • Creatinine clearance 30 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 and Use In Specific Populations].

CIALIS for Once Daily Use

Erectile Dysfunction

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

  • Creatinine clearance 30 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: CIALIS for once daily use is not recommended [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
Hepatic Impairment

CIALIS 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 CIALIS 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 CIALIS is not recommended [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

CIALIS for Once Daily Use

  • Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients.
  • Severe (Child Pugh Class C): The use of CIALIS is not recommended [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Concomitant Medications

Nitrates

Concomitant use of nitrates in any form is contraindicated [see CONTRAINDICATIONS].

Alpha-Blockers

ED — When CIALIS is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and CIALIS should be initiated at the lowest recommended dose [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

BPH — CIALIS is not recommended for use in combination with alpha-blockers for the treatment of BPH [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

CYP3A4 Inhibitors

CIALIS for Use as Needed For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CIALIS is 10 mg, not to exceed once every 72 hours [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

CIALIS 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 and DRUG INTERACTIONS].

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. Revised: 10/2013

Last reviewed on RxList: 10/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.



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