SILDENAFIL- sildenafil citrate powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Tris Pharma Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Sildenafil for oral suspension was added to background epoprostenol therapy [see Clinical Studies (14)] . Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II–III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)] . 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

Product summary:

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 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. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SILDENAFIL- SILDENAFIL CITRATE POWDER, FOR SUSPENSION
TRIS PHARMA 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
INDICATIONS AND USAGE
Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5)
inhibitor indicated for the treatment of
pulmonary arterial hypertension (PAH) (WHO Group I) in adults to
improve exercise ability and delay clinical
worsening. Studies establishing effectiveness were short-term (12 to
16 weeks), and included
predominately patients with NYHA Functional Class II–III symptoms.
Etiologies were idiopathic (71%) or
associated with connective tissue disease (25%). ( 1)
Limitation of Use: Adding sildenafil to bosentan therapy does not
result in any beneficial effect on exercise
capacity. ( 1, 14)
DOSAGE AND ADMINISTRATION
Oral suspension: 5 mg or 20 mg three times a day, 4 to 6 hours apart;
see full prescribing information
for reconstitution instructions for the Powder for Oral Suspension. (
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 oral suspension ( 4)
WARNINGS AND PRECAUTIONS
Increased mortality with increasing doses in pediatric patients. Not
recommended for use in pediatric
patients. ( 5.1)
Vasodilation effects may be more common in patients with hypotension
or on antihypertensive therapy.
( 5.2)
Use in pulmonary veno-occlusive disease may cause pulmonary edema and
is not recommended. (
5.3)
Hearing or visual impairment: Seek medical attention if sudden
decrease or loss of vision or hearing
occurs. ( 5.5, 5.6)
Pulmonary hypertension secondary to sickle cell disease: Sildenafil
may cause serious vaso-occlusive
crises. ( 5.9)
ADVERSE REACTIONS
Most common