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:

STAT RX USA LLC

INN (इंटरनेशनल नाम):

TADALAFIL

रचना:

TADALAFIL 10 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

CIALIS is indicated for the treatment of erectile dysfunction. 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. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)] . CIALIS is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCATM ). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)] . Pregnancy Category B — CIALIS (tadalafil) is not indicated for use in women. There are no adequate and well controlled studies of CIALIS use in pregnant women. Animal reproduction studies in rats and mice revealed no evidence of fetal harm. Non-teratogenic effects — Animal reproduction studies showed no evidence of te

उत्पाद समीक्षा:

CIALIS (tadalafil) is supplied as follows: Four strengths of film-coated, almond-shaped tablets (not scored) are available in different sizes and different shades of yellow, and supplied in the following package sizes: 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
STAT RX USA LLC
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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) TABLET, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Contraindications, Hypersensitivity Reactions (4.2) 07/2009
Warnings and Precautions, Combination With Other PDE5 Inhibitors or
Erectile Dysfunction Therapies (5.11)
02/2010
INDICATIONS AND USAGE
CIALIS
is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile
dysfunction (ED) (1.1).
DOSAGE AND ADMINISTRATION
CIALIS for use as needed: Starting dose: 10 mg up to once daily.
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 (2.1).
CIALIS for once daily use: 2.5 mg taken once daily, without regard to
timing of sexual activity. May increase to 5 mg
based upon efficacy and tolerability (2.1).
CIALIS may be taken without regard to food (2.2).
DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 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)
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 units) may lead to
hypotension (5.6, 5.9).
If taking potent inhibitors of CYP3A4, dose should be adjusted: CIALIS
for use as needed: ≤10 mg every 72 hours. For
once daily use: dose not to exceed 2.5 mg (5.10).
Patients should seek emergency treatment if an erection lasts >4
hours. Use CIALIS with caution in patients
predisposed to priapism (5.3).
Patients should stop CIALIS and seek medical care if a s