Cialis Indications, Dosage, Storage, Stability - Tadalafil

Cialis Indications, Dosage, Storage, Stability - Tadalafil

INDICATIONS AND USAGE

CIALIS is indicated for the treatment of erectile dysfunction.

The recommended starting dose of CIALIS 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. CIALIS was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration. CIALIS may be taken without regard to food.

Renal Insufficiency — No dose adjustment is required in patients with mild renal insufficiency. For patients with moderate (creatinine clearance 31 to 50 mL/min) renal insufficiency, a starting dose of 5 mg not more than once daily is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. For patients with severe (creatinine clearance <30 mL/min) renal insufficiency on hemodialysis, the maximum recommended dose is 5 mg (see General and Patients with Renal Insufficiency under PRECAUTIONS and Pharmacokinetics in Special Populations under CLINICAL PHARMACOLOGY).

Hepatic Impairment — For patients with mild or moderate degrees of hepatic impairment (Child-Pugh Class A or B), the dose of CIALIS should not exceed 10 mg once daily. In patients with severe hepatic impairment (Child-Pugh Class C), the use of CIALIS is not recommended (see Patients with Hepatic Impairment under PRECAUTIONS and Pharmacokinetics in Special Populations under CLINICAL PHARMACOLOGY).

Concomitant Medications — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CIALIS is 10 mg, not to exceed once every 72 hours (see General and Drug Interactions under PRECAUTIONS).

Concomitant use of nitrates in any form and alpha-adrenergic blockers (other than 0.4 mg once-daily tamsulosin) is contraindicated (see CONTRAINDICATIONS and Drug Interactions under PRECAUTIONS).

Geriatrics — No dose adjustment is required in patients >65 years of age.

CIALISâ (tadalafil) is supplied as follows:

Three strengths of film-coated, almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes:

5-mg tablets debossed with "C 5"

Bottles of 30 NDC 0002-4462-30

10-mg tablets debossed with "C 10"

Bottles of 30 NDC 0002-4463-30

20-mg tablets debossed with "C 20"

Bottles of 30 NDC 0002-4464-30

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.

Literature issued November, 2003

Manufactured for Lilly ICOS LLC by Eli Lilly and Company Indianapolis, IN 46285, USA NL 3534 AMP PRINTED IN USA Copyright ã 2003, Lilly ICOS LLC. All rights reserved.