SILDENAFIL- sildenafil citrate powder, for suspension

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Taro Pharmaceuticals U.S.A. Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Adults Sildenafil for Oral Suspension 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 use information is approved for Viatris Specialty LLC's REVATIO ® (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Sildenafil for Oral Suspension is contraindicated in patients with: - Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)] . - Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Risk Summary 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 Considerations). Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. Data Animal Data No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m 2 basis, 32- and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. In a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m 2 basis). Risk Summary Limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. There is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation. The safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age. Pediatric use information is approved for Viatris Specialty LLC's REVATIO ® (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Clinical studies of Sildenafil for Oral Suspension did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)] . No dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology (12.3)] . No dose adjustment is required (including severe impairment CLcr <30 mL/min) [see Clinical Pharmacology (12.3)] . Instructions for Use Sildenafil (sil den⸍ a fil) Oral Suspension Read this Instructions for Use before you start taking sildenafil oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Important information: - Ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension. - Your pharmacist will mix (reconstitute) sildenafil oral suspension before it is given to you. Do not take or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. - Always use the oral dosing syringe that comes with sildenafil oral suspension. If your carton does not come with an oral dosing syringe, contact your pharmacist. - Do not take or give sildenafil oral suspension if the bottle adaptor is not in the bottle. If the bottle adaptor is not in the bottle, contact your pharmacist. - Sildenafil oral suspension should not be mixed with any other medicine or flavoring. Supplies you will need to take or give a dose of sildenafil oral suspension (See Figure A): - 1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor - 1 oral dosing syringe (provided in the carton) How should I store sildenafil oral suspension? - Store mixed (reconstituted) sildenafil oral suspension below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C). - Do not freeze mixed sildenafil oral suspension - Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. See the "Discard after" date written on the bottle label. Keep sildenafil oral suspension and all medicines out of the reach of children. Pediatric use information is approved for Viatris Specialty LLC's REVATIO ® (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc . Hawthorne, NY 10532 This Instruction for Use has been approved by the U.S. Food and Drug Administration. Revised: December 2023

產品總結:

Sildenafil 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. Recommended storage for Sildenafil 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.

授权状态:

Abbreviated New Drug Application

产品特点

SILDENAFIL- SILDENAFIL CITRATE POWDER, FOR SUSPENSION
TARO PHARMACEUTICALS U.S.A. INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SILDENAFIL FOR ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR SILDENAFIL FOR
ORAL SUSPENSION.
SILDENAFIL FOR ORAL SUSPENSION
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
Sildenafil 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)
DOSAGE AND ADMINISTRATION
Adults: 20 mg three times a day. ( 2.1)
DOSAGE FORMS AND STRENGTHS
For oral suspension: 10 mg/mL (when reconstituted) ( 3)
CONTRAINDICATIONS
Use with organic nitrates or riociguat. ( 4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet, injection, or oral
suspension. ( 4)
WARNINGS AND PRECAUTIONS
Vasodilation effects may be more common in patients with hypotension
or on antihypertensive therapy.
( 5.1)
Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary
edema and is not
recommended. ( 5.2)
Hearing or visual impairment: Seek medical attention if sudden
decrease or loss of vision or hearing
occurs. ( 5.4, 5.5)
Pulmonary hypertension (PH) secondary to sickle cell disease:
Sildenafil may cause serious vaso-
occlusive crises. ( 5.8)
ADVERSE REACTIONS
Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back
pain and diarrhea. ( 6.1, 6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO PHARMACEUTICALS
U.S.A., INC. AT 1-
866-923-4914 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Use with strong CYP3A inhibitors: Not recommended. ( 7, 12.3)
Concomitant PDE-5 inhibitors: Avoid use with Viagra
or other PDE-5 inhibitors. ( 5.6)
_Pediatric use information is approved for Viatr