SILDENAFIL tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)

Sẵn có từ:

Teva Pharmaceuticals USA, Inc.

INN (Tên quốc tế):

SILDENAFIL CITRATE

Thành phần:

SILDENAFIL 25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Sildenafil tablets are indicated for the treatment of erectile dysfunction. Consistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets were shown to potentiate the hypotensive effects of nitrates, and their administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely coadministered at this time point [see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2) ]. Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO® , or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [see Adverse Reactions (6.1) ]. Do not use sildenafil tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including sildenafil tablets, may potentiate the hypotensive effects of GC stimulators. Risk Summary Sildenafil is not indicated for use in females. There are no data with the use of sildenafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (MRHD) of 100 mg/day on a mg/m2 basis (see Data ). Data Animal Data No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. These doses represent, respectively, about 16 and 32 times the MRHD on a mg/m2 basis in a 50 kg subject. In the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days, about 2 times the MRHD on a mg/m2 basis in a 50 kg subject. Risk Summary Sildenafil is not indicated for use in females. Limited data indicate that sildenafil and its active metabolite are present in human milk. There is no information on the effects on the breastfed child, or the effects on milk production. Sildenafil is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients. Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy young volunteers (18 to 45 years) [see Clinical Pharmacology (12.3) ]. Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively [see Clinical Pharmacology (12.3) ]. Of the total number of subjects in clinical studies of sildenafil, 18% were 65 years and older, while 2% were 75 years and older. No overall differences in safety or efficacy were observed between older (≥ 65 years of age) and younger (< 65 years of age) subjects. However, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 25 mg should be considered in older subjects due to the higher systemic exposure [see Dosage and Administration (2.5) ]. No dose adjustment is required for mild (CLcr = 50 to 80 mL/min) and moderate (CLcr = 30 to 49 mL/min) renal impairment. In volunteers with severe renal impairment (Clcr < 30 mL/min), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (~2 fold), approximately doubling of Cmax and AUC. A starting dose of 25 mg should be considered in patients with severe renal impairment [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ]. In volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for Cmax and 85% for AUC). The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child-Pugh Class C) have not been studied. A starting dose of 25 mg should be considered in patients with any degree of hepatic impairment [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ].

Tóm tắt sản phẩm:

Sildenafil tablets USP, 25 mg are available as white to off-white, film-coated, modified oval-shaped, convex tablets debossed with “TEVA” on one side and “5341” on the other side, in bottles of 30 (NDC 0093-5341-56). Sildenafil tablets USP, 50 mg are available as white to off-white, film-coated, modified oval-shaped, convex tablets debossed with “TEVA” on one side and “5342” on the other side, in bottles of 30 (NDC 0093-5342-56) and 100 (NDC 0093-5342-01). Sildenafil tablets USP, 100 mg are available as white to off-white, film-coated, modified oval-shaped, convex tablets debossed with “TEVA” on one side and “5343” on the other side, in bottles of 30 (NDC 0093-5343-56) and 100 (NDC 0093-5343-01). Recommended Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SILDENAFIL- SILDENAFIL TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SILDENAFIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SILDENAFIL TABLETS.
SILDENAFIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Effects on the Eye (5.3) 08/2017
INDICATIONS AND USAGE
Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor
indicated for the treatment of erectile dysfunction (ED) (1)
DOSAGE AND ADMINISTRATION
For most patients, the recommended dose is 50 mg taken, as needed,
approximately 1 hour before sexual activity.
However, sildenafil tablets may be taken anywhere from 30 minutes to 4
hours before sexual activity (2.1)
Based on effectiveness and toleration, may increase to a maximum of
100 mg or decrease to 25 mg (2.1)
Maximum recommended dosing frequency is once per day (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, 100 mg (3)
CONTRAINDICATIONS
Administration of sildenafil tablets to patients using nitric oxide
donors, such as organic nitrates or organic nitrites in any
form. Sildenafil tablets were shown to potentiate the hypotensive
effect of nitrates (4.1, 7.1, 12.2)
Known hypersensitivity to sildenafil or any component of tablet (4.2)
Administration with guanylate cyclase (GC) stimulators, such as
riociguat (4.3)
WARNINGS AND PRECAUTIONS
Patients should not use sildenafil if sexual activity is inadvisable
due to cardiovascular status (5.1)
Patients should seek emergency treatment if an erection lasts > 4
hours. Use sildenafil with caution in patients
predisposed to priapism (5.2)
Patients should stop sildenafil and seek medical care if a sudden loss
of vision occurs in one or both eyes, which could
be a sign of non arteritic anterior ischemic optic neuropathy (NAION).
Sildenafil should be used with caution, and only
when the anticipated benefits outweigh the risks, in patients with a
history of NAION. Patients