Tadalafil
Generic Name: tadalafil
Brand Names:
Tadalafil
11 DESCRIPTION Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: 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)-.
Overview
11 DESCRIPTION Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: 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)-.
Uses
1 INDICATIONS AND USAGE Tadalafil Tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: • erectile dysfunction (ED) ( 1.1 ) • the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) • ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If Tadalafil Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil Tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Dosage
2 DOSAGE AND ADMINISTRATION Do not split Tadalafil Tablets; entire dose should be taken. • 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. Not to be taken more than once per day ( 2.1 ). • Tadalafil Tablets 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 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 ).
Side Effects
6 ADVERSE REACTIONS Most 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 Unichem Pharmaceuticals (USA), Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to over 9000 men during clinical trials worldwide.
Interactions
7 DRUG INTERACTIONS • Tadalafil can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ( 7.1 ). • CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase Tadalafil exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: o Tadalafil for use as needed: no more than 10 mg every 72 hours o Tadalafil for once daily use: dose not to exceed 2.5 mg • CYP3A4 inducers (e.g. rifampin) decrease Tadalafil exposure ( 7.2 ). 7.1 Potential for Pharmacodynamic Interactions with Tadalafil Nitrates - Administration of Tadalafil to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, Tadalafil was shown to potentiate the hypotensive effect of nitrates.
Warnings
5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing Tadalafil, it is important to note the following: • Patients should not use Tadalafil if sex is inadvisable due to cardiovascular status ( 5.1 ). • Use of Tadalafil with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.6 , 5.9 ). • Tadalafil is 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. 4 CONTRAINDICATIONS • Administration of Tadalafil Tablets to patients using any form of organic nitrate is contraindicated. Tadalafil Tablets was 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 ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tadalafil Tablets USP are supplied as follows: Tadalafil Tablets USP, 20 mg Yellow color, almond shaped tablets film coated tablets debossed with "289" on one side of the tablet and "U" on other side of tablet.
Frequently Asked Questions
What is Tadalafil used for?▼
1 INDICATIONS AND USAGE Tadalafil Tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: • erectile dysfunction (ED) ( 1.1 ) • the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) • ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If Tadalafil Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil Tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
What are the side effects of Tadalafil?▼
6 ADVERSE REACTIONS Most 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 Unichem Pharmaceuticals (USA), Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to over 9000 men during clinical trials worldwide.
What are the important warnings for Tadalafil?▼
5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing Tadalafil, it is important to note the following: • Patients should not use Tadalafil if sex is inadvisable due to cardiovascular status ( 5.1 ). • Use of Tadalafil with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.6 , 5.9 ). • Tadalafil is 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. 4 CONTRAINDICATIONS • Administration of Tadalafil Tablets to patients using any form of organic nitrate is contraindicated. Tadalafil Tablets was 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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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.