Sildenafil Citrate
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
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HUMAN PRESCRIPTION DRUG LABEL
Nov 24, 2023
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sildenafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SILDENAFIL CITRATE
INFORMATION FOR PATIENTS SECTION
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
sildenafil tablets with regular and/or intermittent use of nitric oxide
donors, such as organic nitrates or organic nitrites in any form [see Contraindications (4.1)].
Concomitant Use with Drugs Which Lower Blood Pressure
****Physicians should advise patients of the potential for sildenafil tablets
to augment the blood pressure lowering effect of alpha-blockers and anti-
hypertensive medications. Concomitant administration of sildenafil tablets and
an alpha-blocker may lead to symptomatic hypotension in some patients.
Therefore, when sildenafil tablets are co-administered with alpha-blockers,
patients should be stable on alpha-blocker therapy prior to initiating
sildenafil tablets treatment and sildenafil tablets should be initiated at the
lowest dose [see Warnings and Precautions (5.5)].
Cardiovascular Considerations
****Physicians should discuss with patients the potential cardiac risk of
sexual activity in patients with preexisting cardiovascular risk factors.
Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea)
upon initiation of sexual activity should be advised to refrain from further
activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].
Sudden Loss of Vision
****Physicians should advise patients to stop use of all PDE5 inhibitors,
including sildenafil tablets, and seek medical attention in the event of a
sudden loss of vision in one or both eyes. Such an event may be a sign of non-
arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased
vision including possible permanent loss of vision, that has been reported
rarely post-marketing in temporal association with the use of all PDE5
inhibitors. Physicians should discuss with patients the increased risk of
NAION in individuals who have already experienced NAION in one eye. Physicians
should also discuss with patients the increased risk of NAION among the
general population in patients with a “crowded” optic disc, although evidence
is insufficient to support screening of prospective users of PDE5 inhibitor,
including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)].
Sudden Hearing Loss
****Physicians should advise patients to stop taking PDE5 inhibitors,
including sildenafil tablets, and seek prompt medical attention in the event
of sudden decrease or loss of hearing. These events, which may be accompanied
by tinnitus and dizziness, have been reported in temporal association to the
intake of PDE5 inhibitors, including sildenafil tablets. It is not possible to
determine whether these events are related directly to the use of PDE5
inhibitors or to other factors [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].
Priapism
****Physicians should warn patients that prolonged erections greater than 4
hours and priapism (painful erections greater than 6 hours in duration) have
been reported infrequently since market approval of sildenafil tablets. In the
event of an erection that persists longer than 4 hours, the patient should
seek immediate medical assistance. If priapism is not treated immediately,
penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].
Avoid Use with other PDE5 Inhibitors
****Physicians should inform patients not to take sildenafil tablets with
other PDE5 inhibitors including REVATIO or other pulmonary arterial
hypertension (PAH) treatments containing sildenafil. Sildenafil is also
marketed as REVATIO for the treatment of PAH. The safety and efficacy of
sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not
been studied [see Warnings and Precautions (5.7)].
Sexually Transmitted Disease
****The use of sildenafil tablets offers no protection against sexually
transmitted diseases. Counseling of patients about the protective measures
necessary to guard against sexually transmitted diseases, including the Human
Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].
Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.
Made in India.
Revised: 12/2022