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VIAGRA Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

U.S. Pharmaceuticals

Λέξεις κλειδιά

63539-421 63539-422

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1. Indications and Usage

VIAGRA is indicated for the treatment of erectile dysfunction.

2. Dosage and Administration

2.1 Dosage Information For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before ...

3. Dosage Forms and Strengths

VIAGRA is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with PFIZER on one side and ...

4. Contraindications

4.1 Nitrates Consistent with its known effects on the nitric oxide/cGMP pathway <em>[see Clinical Pharmacology (12.1, 12.2)]</em>, VIAGRA was shown to potentiate the hypotensive effects of nitrates, and ...

5. Warnings and Precautions

5.1 Cardiovascular There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including VIAGRA, should ...

6. Adverse Reactions

The following are discussed in more detail in other sections of the labeling: Cardiovascular <em>[see Warnings and Precautions (5.1)]</em> Prolonged Erection and Priapism <em>[see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of VIAGRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Nitrates Administration of VIAGRA with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, ...

8.1. Pregnancy

Risk Summary VIAGRA is not indicated for use in females. There are no data with the use of VIAGRA in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction ...

8.2. Lactation

Risk Summary VIAGRA is not indicated for use in females. Limited data indicate that sildenafil and its active metabolite are present in human milk. There is no information on the effects on the breastfed ...

8.4. Pediatric Use

VIAGRA is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.

8.5. Geriatric Use

Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N-desmethyl metabolite, ...

8.6. Renal Impairment

No dose adjustment is required for mild (CLcr=50–80 mL/min) and moderate (CLcr=30–49 mL/min) renal impairment. In volunteers with severe renal impairment (Clcr<30 mL/min), sildenafil clearance was reduced, ...

8.7. Hepatic Impairment

In volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for C<sub>max</sub> and 85% for AUC). The pharmacokinetics ...

10. Overdosage

In studies with healthy volunteers of single doses up to 800 mg, adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased. In cases of overdose, standard ...

11. Description

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

12.1. Mechanism of Action

The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results ...

12.2. Pharmacodynamics

Effects of VIAGRA on Erectile Response In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved ...

12.3. Pharmacokinetics

VIAGRA is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 25–63%). The pharmacokinetics of sildenafil are dose-proportional over the recommended dose range. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 20- ...

14. Clinical Studies

In clinical studies, VIAGRA was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain ...

16.1. How Supplied

VIAGRA (sildenafil citrate) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the ...

16.2. Storage and Handling

<u>Recommended Storage:</u> Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians should discuss with patients the contraindication of VIAGRA with regular and/or intermittent use of ...
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