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See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

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Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction1.2 Benign Prostatic Hyperplasia1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia1.4 Limitation of Use2 DOSAGE AND ADMINISTRATION2.1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction2.2 Tadalafil Tablet for Once Daily Use

17.1 Nitrates

Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates. If you need to use a nitrate medicine, take it at least 48 hours after your last dose of tadalafil. Do not drink excessive amounts of alcohol (eg, 5 or more glasses of wine or 5 or more shots of whiskey) when taking tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or dizziness, increase your heart rate, or lower your blood pressure. If you experience sudden loss of vision in one or both eyes, contact your doctor immediately.

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Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. NDC Code(s): 62332-177-15, 62332-177-30, 62332-177-71, 62332-177-91, view more62332-178-15, 62332-178-30, 62332-178-71, 62332-178-91, 62332-179-30, 62332-179-71, 62332-179-91, 62332-180-30, 62332-180-71, 62332-180-91 If you are a consumer or patient please visit this version.

Stimulation increases blood flow

HIGHLIGHTS OF PRESCRIBING INFORMATION 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 useInitial U.S. Approval: 2003INDICATIONS AND USAGETadalafil tablets USP are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: (1)· erectile dysfunction (ED) (1.1) (1)· the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) (1)· ED and the signs and symptoms of BPH (ED/BPH) (1.3) (1)If tadalafil tablets USP are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4). (1)DOSAGE AND ADMINISTRATION•Tadalafil tablets 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. for Erectile Dysfunction2.3 Tadalafil Tablet for Once Daily Use for Benign Prostatic Hyperplasia2.4 Tadalafil Tablet for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia2.5 Use with Food2.6 Use in Specific Populations2.7 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking Tadalafil Tablet for Once Daily Use5.3 Prolonged Erection5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-blockers and Antihypertensives5.7 Renal Impairment5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of

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Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7

Proper Use

(5)· Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.14). (5)ADVERSE REACTIONSMost 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 Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or INTERACTIONS· Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, antihypertensives or alcohol (7.1). ketoconazole, ritonavir) increase tadalafil tablets exposure (2.7, 5.10, 7.2) requiring dose adjustment: (7)· Tadalafil tablets for use as needed: no more than 10 mg every 72 hours (7)· Tadalafil tablet for once daily use: dose not to exceed 2.5 mg (7)· CYP3A4 inducers (e.g. rifampin) decrease tadalafil tablets exposure (7.2). (7)USE IN SPECIFIC POPULATIONSHepatic Impairment (2.6, 5.8, 8.6): (8)· Mild or Moderate: Dosage adjustment may be needed.

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(8)Renal Impairment (2.6, 5.7, 8.7): (8)· Patients with creatinine clearance 30 mL/min to 50 mL/min: Dosage adjustment may be needed. (8)· Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For cialis order mastercard use as needed: Dose should not exceed 5 mg every 72 hours. (8)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 2/2025 Tadalafil tablets USP are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: (1) · the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) (1) · ED and the signs and symptoms of BPH (ED/BPH) (1.3) (1) If tadalafil tablets USP are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4). Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates (4.1).

Related treatment guides

History of known serious hypersensitivity reaction to tadalafil tablets or Adcirca®(4.2). Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3). · Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status (5.1). · Use of tadalafil tablets with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9). · Tadalafil tablets are not recommended in combination with alpha- blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Tadalafil Tablets7.2 Potential for Other Drugs to Affect Tadalafil Tablets7.3 Potential for Tadalafil Tablets to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic

Brand Name

(2.7, 5.6, 7.1, 12.2) (5) · Patients should seek emergency treatment if an erection lasts >4 hours. · Patients should stop tadalafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). · Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5). · Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.14). Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1).

What is tadalafil used for?

To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or · Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, antihypertensives or alcohol (7.1). ketoconazole, ritonavir) increase tadalafil tablets exposure (2.7, 5.10, 7.2) requiring dose adjustment: (7) · Tadalafil tablets for use as needed: no more than 10 mg every 72 hours (7) · Tadalafil tablet for once daily use: dose not to exceed 2.5 mg (7) rifampin) decrease tadalafil tablets exposure (7.2). Hepatic Impairment (2.6, 5.8, 8.6): (8) · Mild or Moderate: Dosage adjustment may be needed. Renal Impairment (2.6, 5.7, 8.7): (8) · Patients with creatinine clearance 30 mL/min to 50 mL/min: Dosage adjustment may be needed. · Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology

  • Yellow Cialis pills are often taken 30 minutes prior to intimacy for best results.
  • Regular use of yellow Cialis can improve erectile function over time.
  • The yellow pill's profile includes a 36-hour window of effectiveness.
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and/or Pharmacology14 CLINICAL STUDIES14.1 Tadalafil Tablets for Use as Needed for ED14.2 Tadalafil Tablet for Once Daily Use for ED14.3 Tadalafil Tablet

Ingredient Amount per Dose Purpose Notes
Tadalafil 20 mg Active ingredient, vasodilator Main component for ED
Microcrystalline Cellulose - Filler Binds ingredients
Magnesium Stearate - Excipient Improves pill stability
Titanium Dioxide - Coloring agent Provides yellow color

5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)14.4 Tadalafil Tablet 5 mg for Once Daily Use for ED and BPH16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Guanylate Cyclase (GC) Stimulators17.3 Cardiovascular Considerations17.4 Concomitant Use

Pros and cons of Tadalafil (Cialis)

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).•BPH: 5 20mg cialis pill mg, taken at approximately the same time every day (2.3)•ED and BPH: 5 mg, taken at approximately the same time every day (2.3, 2.4)•Tadalafil tablets may be taken without regard to food (2.5). (2)DOSAGE FORMS AND STRENGTHSTablets: 2.5 mg, 5 mg, 10 mg, 20 mg (3). (3)CONTRAINDICATIONSAdministration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates (4.1).History of known serious hypersensitivity reaction to tadalafil tablets or Adcirca®(4.2).Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3).

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WARNINGS AND PRECAUTIONS· Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status (5.1). (5)· Use of tadalafil tablets with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9). (5)· Tadalafil tablets are not recommended in combination with alpha- blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when tadalafil tablets are used as a treatment for ED in men taking alpha-blockers. (2.7, 5.6, 7.1, 12.2) (5)· Patients should seek emergency treatment if an erection lasts >4 hours.

Cialis Dosage Information

Use tadalafil tablets with caution in patients predisposed to priapism (5.3). (5)· Patients should stop tadalafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Tadalafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION (5.4, 6.2). (5)· Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5). with Drugs Which Lower Blood Pressure17.5 Potential for Drug Interactions When Taking Tadalafil Tablet for Once Daily Use17.6 Priapism17.7 Sudden Loss of Vision17.8 Sudden Hearing Loss17.9 Alcohol17.10 Sexually Transmitted Disease17.11 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed.

  • Yellow Cialis pills can be part of a comprehensive ED treatment plan.
  • Discuss potential risks and benefits with your doctor before use.
  • The yellow color aids in quick recognition in a medication regimen.
  • Limit alcohol intake when taking yellow Cialis for optimal results.
  • Cialis (yellow pills) should not be shared with others.
  • The medication acts by increasing blood flow to improve erections.
  • Cialis's effects can last up to 36 hours, offering flexibility.
  • Always verify the pill's authenticity before use to avoid counterfeit.
  • Side effects are usually mild but require attention and medical advice.
  • The yellow Cialis pill is often recommended for its long duration.
  • Men with certain health conditions should avoid yellow Cialis.
  • Cialis, including the yellow formulation, is considered safe when used correctly.