Rx Item-Adcirca 20mg Tab 60 By Lilly Eli & Co Tadalafil

Clinical Information
Gen. Code and Des.
65368 tadalafil ORAL TABLET 20 MG
GCN and Des.
26587 tadalafil ORAL TABLET 20 MG
Strength
20MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24121200 PHOSPHODIESTERASE TYPE 5 INHIBITORS
48480000 VASODILATING AGENTS (RESPIRATORY TRACT)
Active Ingredients
9874 tadalafil 171596295
Inactive Ingredients
2432 lactose 64044515
FDA NDA Approved





1 Item info. These highlights do not include all the info. needed to use ADCIRCA safely and effectively. See full prescribing info. for ADCIRCA ADCIRCA tadalafil t ablets for ral dministration Initial U.S. Approval: 2003 -- RECENT MAJOR CHANGES -- Contraindication s, Concomita nt Guanylate Cyclase (GC) Stimulators 4.2 04/2015 INDICATIONS AND USAGE -- -- ADCIRCA is phosp hodiesterase (PDE5) inhibitor indicated for he treatment of pulmonary arterial hypertension (PAH) WHO Group ) to improve exercise ability Studies establishing effectiveness included predominately patients with NYHA Functional Class II III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue disease ). -- DOSAGE AND ADMINISTRATION -- -- 40 mg once daily, with or without food. Dividing the dose 40 mg) over the course of the day is not recommended Use with ritonavir requires dosage adjustments. -- DOSAGE FORMS AND STRENGTHS Tablets (not scored): 20 mg CONTRAIN DICATIONS Concom itant organic nitrates Concomitant Guanylate Cyclase (GC) Stimulators History of known serious hypersensitivity reaction to ADCIRCA or CIALIS (4. ) -- WARNINGS AND PRECA UTIONS -- - Cardiovascular effects: Carefully consider whether patients with certain underlying conditions (e.g., cardiovascular disease, impaired autonomic control of blood pressure, aortic stenosis) could be adversely affected by vasod ilatory effects of ADCIRCA. Not recommended in patients with pulmona ry veno o cclusive disease. Concomitant alpha blockers or alcohol: Note additive blood ressure lowering effects. Use with Ritonavir: Requires dosage adjustment. (2.3 5.2 ? Other oncomitant potent CYP3A inhibitors: Avoid use with ADCIRCA (5.2 ? Potent Inducers of CYP3A: Avoid use of ADCIRCA in patients chronically taking potent inducers of CYP3A (e.g. rifampin) (5. , 7.2) Effects on the eye: Patients should seek imme diate medical attention if sudden loss of vision occurs, which could be sign of non arteritic ischemic optic neuropathy (NA ION). Hearing impairment: Advise patients to seek immediate medical attention if sudden decrease or loss of hearing occurs. (5.6 ? Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. (5.7 ? Prolonged erection: Advise patients to seek emergency treatment if an erection lasts 4 hours. (5.8 -- - ADVERSE REACTIONS The ost common adverse reaction is headache (6.1 To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at - 800 545 5979 or FDA at - 800 FDA 1088 or www.fda.gov/medwa tch -- -- -- USE IN SPECIFIC POPULAT IONS Renal mpairment (2. , 5. , 8.6 12.3 ? Mild or oderate: Start with 20 mg once daily ( 2.2, 5.3, 8.6 ? Severe: Avoid use of ADCIRCA. (2. 2, 5.3 8.6 Hepatic Impairment (2. , 5. , 8. , 12.3 ? Mild or oderate: Consider ta rting dose of 20 mg once daily (2. 2, 5.4, 8.7 ? Severe: Avoid use of ADCIRCA (2. 2, 5.4 8.7 See 17 for PATIENT COUNSELING info. and FDA approved patient labelin

Rx Item-Adcirca 20mg Tab 60 By Lilly Eli
Item No.:RX520874, Item No. RX520874, 520874, NDC No.: 66302-0467-60, 66302-467-60, 6630246760, 66302046760, 0467-60, 046760 UPC No. 3-66302-46760-7, 366302-467607, 366302467607,

AmericanPharmaWholesale.com
Item No.:RX520874, Item No. RX520874, 520874, NDC No.: 66302-0467-60, 66302-467-60, 6630246760, 66302046760, 0467-60, 046760 UPC No. 3-66302-46760-7, 366302-467607, 366302467607,

TADALAFIL ORAL TABLET 20
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