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VIAGRA (SILDENAFIL CITRATE): PRESCRIBING INFORMATION

DESCRIPTION

Viagra, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Sildenafil Citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1Hpyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate.

Sildenafil Citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.

Viagra (Sildenafil Citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, triacetin, lactose, and FD & C Blue #2 aluminum lake.


CLINICAL PHARMACOLOGY

  • Viagra clinical pharmacology


    PHARMACOKINETICS

  • Viagra pharmacokinetics


    PHARMACODYNAMICS

  • Viagra pharmacodynamics


    CLINICAL STUDIES

  • Viagra clinical studies


    INDICATION AND USAGE

    Sildenafil Citrate (Viagra) is indicated for the treatment of ED (erectile dysfunction).


    CONTRAINDICATIONS

    Consistent with its known effects on the nitric oxide/cGMP pathway, Sildenafil Citrate (Viagra) tablets were shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated.

    After patients have taken Viagra tablets, it is unknown when nitrates, if necessary, can be safely administered. Based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL). In the following patients: age > 65, hepatic impairment (e.g., cirrhosis), severe renal impairment (e.g., creatinine clearance < 30 mL/min), and concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin), plasma levels of sildenafil at 24 hours post dose have been found to be 3 to 8 times higher than those seen in healthy volunteers. 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. VIAGRA is contraindicated in patients with a known hypersensitivity to any component of the tablet.


    DOSAGE AND ADMINISTRATION

  • Viagra dosage and administration


    WARNINGS

  • Viagra warnings


    PRECAUTIONS

  • Viagra precautions


    DRUG INTERACTIONS

  • Viagra drug interactions


    SPECIAL PRECAUTIONS

  • Viagra special precautions


    ADVERSE REACTIONS

  • Viagra adverse reactions


    OVERDOSAGE

    In studies with healthy volunteers of single doses of Sildenafil (Viagra) tablets up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates and severities were increased.

    In cases of overdose by Sildenafil Citrate (Viagra), standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.


    STORAGE / HOW SUPPLIED

    Viagra (Sildenafil Citrate) is supplied in bottles and pharmaceutical blisters as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:

  • Viagra 25 mg: Obverse "VGR25", Reverse "PFIZER"
  • Viagra 50 mg: Obverse "VGR50", Reverse "PFIZER"
  • Viagra 100 mg: Obverse "VGR100", Reverse "PFIZER"

    Storage

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

    Manufactured and distributed by Pfizer pharmaceutical company and its divisions.

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