TADALAFIL tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Sunshine Lake Pharma Co., Ltd.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Tadalafil is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) 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 diseases (23%). Tadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Do not use nitrates within 48 hours of the last dose of tadalafil. Tadalafil potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway [see Clinical Pharmacology ( 12.2)] . Coadministration of GC stimulators such as riociguat with tadalafil is contraindicated. Tadalafil may potentiate the hypotensive effects of GC stimulators. Tadalafil is contraindicated in patients with a known serious hypers

পণ্য সারাংশ:

Tadalafil tablets USP are supplied as follows:20 mg, yellow, capsular film-coated tablets, debossed with “C24” on one side and blank on the other side.            Bottles of 60           NDC 48792-7915-1 Preserve in tight containers as defined in USP. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

TADALAFIL- TADALAFIL TABLET, FILM COATED
SUNSHINE LAKE PHARMA CO., LTD.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TADALAFIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TADALAFIL TABLETS.
TADALAFIL TABLETS FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of pulmonary arterial hypertension (PAH)
(WHO Group 1) 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 diseases (23%). ( 1.1)
DOSAGE AND ADMINISTRATION
40 mg once daily, with or without food. ( 2.1)
Dividing the dose (40 mg) over the course of the day is not
recommended. ( 2.1)
Use with ritonavir requires dosage adjustments. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 20 mg ( 3)
CONTRAINDICATIONS
Concomitant organic nitrates ( 4.1)
Concomitant Guanylate Cyclase (GC) Stimulators ( 4.2)
History of known serious hypersensitivity reaction to tadalafil
tablets or CIALIS ( 4.3)
WARNINGS AND PRECAUTIONS
Hypotension: Carefully consider whether patients with certain
underlying cardiovascular disease could be adversely
affected by vasodilatory effects of tadalafil. Not recommended in
patients with pulmonary veno-occlusive disease. ( 5.1,
5.2)
Effects on the eye: Sudden loss of vision could be a sign of
non-arteritic ischemic optic neuropathy (NAION) and may
be permanent. ( 5.3)
Hearing impairment: Cases of sudden decrease or loss of hearing have
been reported with CIALIS. ( 5.4)
Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5
inhibitors. ( 5.5)
Prolonged erection: Advise patients to seek emergency treatment if an
erection lasts >4 hours. ( 5.6)
ADVERSE REACTIONS
The most common adverse reaction is headache. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT H