SILDENAFIL- sildenafil tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Camber Pharmaceuticals, Inc.

INN (International Name):

SILDENAFIL CITRATE

Composition:

SILDENAFIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults Sildenafil tablets are 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) Sildenafil tablets are 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 underly improvements in exercise [see Clinical Studies ( 14 )] .  Sildenafil 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 stimulat

Product summary:

Sildenafil Tablets USP, are supplied as white to off white colored, round shaped, biconvex, film coated tablets debossed with 'J' on one side and '95' on the other side. The tablets are available as follows Bottle of 90's                                                                                              NDC 31722-776-90 Bottle of 500's                                                                                            NDC 31722-776-05 Blister card of 10 Unit dose tablets (PVC)                                                 NDC 31722-776-31 Blister pack of 100 (10 x 10's) Unit dose tablets (PVC)                             NDC 31722-776-32 Blister card of 10 Unit dose tablets (PVC/PVdC)                                       NDC 31722-776-33 Blister pack of 100 (10 x 10's) Unit dose tablets (PVC/PVdC)                   NDC 31722-776-34 Recommended Storage for Sildenafil Tablets: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SILDENAFIL - SILDENAFIL TABLET, FILM COATED
CAMBER PHARMACEUTICALS, 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
Indications and Usage ( 1) 1/2023
Dosage and Administration ( 2.1, 2.2) 1/2023
INDICATIONS AND USAGE
Adults
Sildenafil tablets are 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)
Sildenafil tablets are 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
Adults: 20 mg three times a day Dose may be increased based on
symptoms and tolerability. ( 2.1)
Pediatric patients ( 2.2)
≤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.
DOSAGE FORMS AND STRENGTHS
• Tablets: 20 mg ( 3)
CONTRAINDICATIONS
Use with organic nitrates or riociguat. ( 4)
History of hypersensitivity reaction to sildenafil or any component of
the tablet. ( 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 ser