Edsave 20 Tablet_

Tadalafil is a 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 is 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). …

• 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
• 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
• BPH: 5 mg, taken at approximately the same time every day ED and BPH: 5 mg, taken at approximately the same time every day Tadalafil tablets may be taken without regard to food
• Tadalafil Tablets for Use as Needed for Erectile Dysfunction The recommended starting dose of tadalafil tablets 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
• Tadalafil tablets for use as needed were shown to improve erectile function compared to placebo up to 36 hours following dosing
• Therefore, when advising patients on optimal use of tadalafil tablets, this should be taken into consideration. …

Four strengths of yellow colored, oval-shaped, film coated tablets, debossed on both side as below: 2.5 mg tablets debossed with “2.5” on one side and “V” on other side 5 mg tablets debossed with “5” on one side and “V” on other side 10 mg tablets debossed with “10” on one side and “V” on other side 20 mg tablets debossed with “20” on one side and “V” on other side Tablets: 2.5 mg, 5 mg, 10 mg, 20 …

• Tadalafil tablets are not indicated for use
• In pediatric patients
• Safety and efficacy in patients below the age of 18 years have not been established
• A randomized, double-blind, placebo-controlled trial
• In pediatric patients (7 to 14 years of age) with Duchenne muscular dystrophy, who received tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate any benefit of treatment with tadalafil on a range of assessments of muscle strength and performance. …

Of the total number of subjects in ED clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. Of the total number of subjects in BPH clinical studies of tadalafil (including the ED/BPH study), approximately 40 percent were over 65, while approximately 10 percent were 75 and over. …

• ?See FDA-approved patient labeling ( Patient Information )” Nitrates Physicians should discuss with patients the contraindication of tadalafil tablets with regular and/or intermittent use of organic nitrates
• Patients should be counseled that concomitant use of tadalafil with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke
• Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. …

• Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated
• Tadalafil was shown to potentiate the hypotensive effect of nitrates
• History of known serious hypersensitivity reaction to tadalafil or ADCIRCA ®
• Administration with guanylate cyclase (GC) stimulators, such as riociguat . …

Tadalafil tablets 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: Tadalafil tablets for use as needed: no more than 10 mg every 72 hours Tadalafil tablets 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 Tablets Nitrates — Administration of tadalafil tablets to patients who are using any form of organic nitrate, is contraindicated. …

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 tablets, it is important to note the following: 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 ). …

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 VKT Pharma Pvt. Ltd at 1 844-387-1231 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. …

8.1 Pregnancy Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 11 times the maximum recommended human dose …

Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

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