CIALIS- tadalafil tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)

थमां उपलब्ध:

PD-Rx Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

Tadalafil

रचना:

Tadalafil 20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

CIALIS ® is indicated for the treatment of erectile dysfunction (ED). CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown [see Clinical Studies ( 14.3)] . Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology ( 12.2)] . CIALIS is contraindicated in patients with a known serious hypersensitivity to tadalafil (CI

उत्पाद समीक्षा:

CIALIS (tadalafil) is supplied as follows: 20 mg: yellow, almond-shaped tablets debossed with "C 20" available in bottles of 5, NDC 43063-236-05 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.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

CIALIS- TADALAFIL TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIALIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIALIS.
CIALIS (TADALAFIL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.4)
05/2017
INDICATIONS AND USAGE
CIALIS
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 CIALIS is used with finasteride to initiate BPH treatment, such use
is recommended for up to 26 weeks (
1.4).
DOSAGE AND ADMINISTRATION
_CIALIS 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).
_CIALIS 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)
CIALIS may be taken without regard to food ( 2.5).
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg ( 3).
CONTRAINDICATIONS
Administration of CIALIS to patients using any form of organic nitrate
is contraindicated. CIALIS was
shown to potentiate the hypotensive effect of nitrates ( 4.1).
History of known serious hypersensitivity reaction to CIALIS or
ADCIRCA
( 4.2).
Administration with guanylate cyclase (GC) stimulators, such as
riociguat ( 4.3).
WARNINGS AND PRECAUTIONS
Patients should not use CIALIS if sex is inadvisable due to
cardiovascular status ( 5.1).
Use of CIALIS with alpha-blockers, antihypertensives or substantial
amounts of alcohol (≥5