RVP

Drug Catalog - Product Detail

TADALAFIL 10MG TB 30CT

NDC Mfr Size Str Form
66993-0702-30 PRASCO LABORATORIES 30 10MG TABLET
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Generic Name
TADALAFIL
Substance Name
TADALAFIL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA021368
Description
11 DESCRIPTION Tadalafil 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)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil 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. Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 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 1/2” Bottles of 30 NDC 66993-700-30 5 mg tablets debossed with “C 5” Bottles of 30 NDC 66993-701-30 Blisters of 2 x 15 NDC 66993-701-38 10 mg tablets debossed with “C 10” Bottles of 30 NDC 66993-702-30 20 mg tablets debossed with “C 20” Bottles of 30 NDC 66993-703-30 16.2 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.
Indications & Usage
1 INDICATIONS AND USAGE 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 is indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies ( 14.3 )] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Do not split tadalafil tablets; entire dose should be taken. Tadalafil 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 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 may be taken without regard to food ( 2.5 ). 2.1 Tadalafil for Use as Needed for Erectile Dysfunction The recommended starting dose of tadalafil 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 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 tadalafil, this should be taken into consideration. 2.2 Tadalafil for Once Daily Use for Erectile Dysfunction The recommended starting dose of tadalafil for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The tadalafil dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. 2.3 Tadalafil for Once Daily Use for Benign Prostatic Hyperplasia The recommended dose of tadalafil for once daily use is 5 mg, taken at approximately the same time every day. When therapy for BPH is initiated with tadalafil and finasteride, the recommended dose of tadalafil for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks. 2.4 Tadalafil for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia The recommended dose of tadalafil for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. 2.5 Use with Food Tadalafil may be taken without regard to food. 2.6 Use in Specific Populations Renal Impairment 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 ( 5.7 ) and Use in Specific Populations ( 8.7 )] . Tadalafil for Once Daily Use Erectile Dysfunction Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil for once daily use is not recommended [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.7 )] . 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: Tadalafil for once daily use is not recommended [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.7 )] . Hepatic Impairment 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 tadalafil 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 tadalafil is not recommended [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.6 )] . Tadalafil for Once Daily Use Mild or moderate (Child Pugh Class A or B): Tadalafil for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if tadalafil for once daily use is prescribed to these patients. Severe (Child Pugh Class C): The use of tadalafil is not recommended [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.6 )] . 2.7 Concomitant Medications Nitrates Concomitant use of nitrates in any form is contraindicated [see Contraindications ( 4.1 )] . Alpha-Blockers ED — When 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 tadalafil should be initiated at the lowest recommended dose [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.2 )] . BPH — Tadalafil is not recommended for use in combination with alpha-blockers for the treatment of BPH [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.2 )] . CYP3A4 Inhibitors Tadalafil for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of tadalafil is 10 mg, not to exceed once every 72 hours [see Warnings and Precautions ( 5.10 ) and Drug Interactions ( 7.2 )] . Tadalafil 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 ( 5.10 ) and Drug Interactions ( 7.2 )] .