TADALAFIL tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

REMEDYREPACK INC.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Tadalafil tablets are 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 tablets are 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 tablets. 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 tablets is contraindicated. Tadalafil may potentiate the hypotensive effects of GC stimulators. Tadalafil tablet is contraind

Tuoteyhteenveto:

Tadalafil tablets, USP are supplied as follows: Brown colored, capsule shaped, biconvex film coated tablet with 'Cipla' debossed on one side and 526 on other side. NDC: 70518-2606-00 PACKAGING: 12 in 1 BOTTLE PLASTIC Store at 25°C (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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at 25°C (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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

TADALAFIL- TADALAFIL TABLET, FILM COATED
REMEDYREPACK INC.
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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
RECENT MAJOR CHANGES
Contraindications ( 4.1, 4.2) 09/2020
Warnings and Precautions-Cardiovascular Effects Removed
( 5.1) 09/2020
Warnings and Precautions-Use with Potent Removed
CYP3A Inhibitors or Inducers ( 5.2) 09/2020
Warnings and Precautions-Use in Renal Removed
Impairment ( 5.3) 09/2020
Warnings and Precautions-Use in Hepatic Removed
Impairment ( 5.4) 09/2020
Warnings and Precautions-Effects on Bleeding Removed
(5.9) 09/2020
Warnings and Precautions-Hypotension ( 5.1) 09/2020
Warnings and Precautions-Worsening Pulmonary 09/2020
Vascular Occlusive Disease ( 5.2)
Warnings and Precautions-Visual Loss ( 5.3) 09/2020
Warnings and Precautions-Hearing Impairment ( 5.4) 09/2020
Warnings and Precautions-Combination with 09/2020
Other PDE5 Inhibitors ( 5.5)
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 or
CIALIS ( 4.3)
WARNINGS AND PRECAUTIONS
Hypotension: Carefully consider whether pa