REVATIO- sildenafil citrate tablet, film coated REVATIO- sildenafil citrate injection, solution REVATIO- sildenafil citrate po

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

PFIZER LABORATORIES DIV PFIZER INC

INN (Nama Antarabangsa):

SILDENAFIL CITRATE

Komposisi:

SILDENAFIL 20 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Adults REVATIO is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)] . Pediatric Patients (1 to 17 Years old) REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14)] . REVATIO is contraindicated in patients with: Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. There are risks to the mother and fetus from untreated pulmonary arterial hypertension (see Clinical Consider

Ringkasan produk:

REVATIO tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: REVATIO Tablets Package Configuration Strength NDC Engraving on Tablet Bottle of 90 Tablets 20 mg 0069-4190-68 RVT20 Recommended Storage for REVATIO Tablets: Store at controlled room temperature 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] . REVATIO injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-use glass vial. REVATIO Injection Package Configuration Strength NDC Vial individually packaged in a carton 10 mg /12.5 mL 0069-0338-01 Recommended Storage for REVATIO Injection: Store at controlled room temperature 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] . REVATIO powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the total volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press‑in bottle adaptor are also provided. REVATIO Powder for Oral Suspension Package Configuration Strength NDC Powder for oral suspension - bottle 10 mg/mL (when reconstituted) 0069-0336-21 Recommended storage for REVATIO for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. Recommended storage for reconstituted oral suspension: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.

Status kebenaran:

New Drug Application

Ciri produk

REVATIO- SILDENAFIL CITRATE TABLET, FILM COATED
REVATIO- SILDENAFIL CITRATE INJECTION, SOLUTION
REVATIO- SILDENAFIL CITRATE POWDER, FOR SUSPENSION
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REVATIO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REVATIO.
REVATIO (SILDENAFIL) TABLETS, FOR ORAL USE
REVATIO (SILDENAFIL) FOR ORAL SUSPENSION
REVATIO (SILDENAFIL) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Indications and Usage (1) 1/2023
Dosage and Administration (2.1, 2.2, 2.3) 1/2023
INDICATIONS AND USAGE
Adults
REVATIO is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the
treatment of pulmonary arterial
hypertension (PAH) (World Health Organization [WHO] Group I) in adults
to improve exercise ability and
delay clinical worsening. (1)
Pediatric Patients (1 to17 years old)
REVATIO is indicated in pediatric patients 1 to 17 years old for the
treatment of pulmonary arterial
hypertension (PAH) (WHO Group I) to improve exercise ability and, in
pediatric patients too young to
perform standard exercise testing, pulmonary hemodynamics thought to
underly improvements in
exercise (1, 14)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Adults: 20 mg three times a day Dose may be increased based on
symptoms and tolerability. (2.1)
Pediatric patients (2.2)
o
o
o
≤20 kg: 10 mg three times a day
20 kg to 45 kg: 20 mg three times a day
>45 kg: 20 mg three times a day. Dose may be increased based on
symptoms and tolerability.
Injection (Adults): 10 mg three times a day administered as an
intravenous bolus injection. (2.1)
Tablets: 20 mg (3)
For oral suspension: 10 mg/mL (when reconstituted) (3)
Injection: 10 mg/12.5 mL in a single use vial (3)
Use with organic nitrates or riociguat. (4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet, injectio