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What is Cialis (Tadalafil)and how is it used?

Cialis (Tadalafil) is a prescription medicine used to treat the symptoms of erectile dysfunction. Cialis may be used alone or with other medications.

Cialis belongs to a class of drugs called Phosphodiesterase-5 Enzyme Inhibitors.

It is not known if Cialis is safe and effective in children.

What are the possible side effects of Cialis?

Cialis may cause serious side effects including:

  • chest pain,
  • pain spreading to the jaw or shoulder,
  • nausea,
  • sweating,
  • vision changes,
  • sudden vision loss,
  • ringing in your ears,
  • sudden hearing loss, and
  • an erection that is painful or lasts longer than 4 hours

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Cialis include:

  • headache,
  • flushing (warmth, redness or tingly feeling),
  • nausea,
  • upset stomach,
  • runny or stuffy nose,
  • muscle pain,
  • back pain, and
  • pain in your arms or legs

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Cialis. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

CIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:

 

 

CIALIS (tadalafil) Structural Formula - Illustration

 

The chemical designation is pyrazino[1′;,2′;:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.

CIALIS is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

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 (Tadalafil) 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 (Tadalafil) 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 (Tadalafil)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 (Tadalafil) may be taken without regard to food.

Use In Specific Populations

Renal Impairment

Cialis (Tadalafil) 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 (Tadalafil) For Once Daily Use

Erectile Dysfunction
  • 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].
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 (Tadalafil) 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 (Tadalafil) 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 (Tadalafil) 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 PRECAUTIONSDRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

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

CYP3A4 Inhibitors

Cialis (Tadalafil) 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.

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