What is Viagra (Sildenafil Citrate) and how is it used?
Viagra (Sildenafil Citrate) is a prescription medicine used to treat the symptoms of erectile dysfunction. Viagra may be used alone or with other medications.
- Viagra belongs to a class of drugs called PAH, PDE-5 Inhibitors, Phosphodiesterase-5 Enzyme Inhibitors.
- It is not known if Viagra is safe and effective in children.
What are the possible side effects of Viagra (Sildenafil Citrate)?
Viagra (Sildenafil Citrate) may cause serious side effects including:
- chest pain or pressure,
- pain spreading to your jaw or shoulder,
- nausea,
- sweating,
- vision changes,
- sudden vision loss,
- an erection that is painful or lasts longer than 4 hours,
- severe shortness of breath,
- cough with foamy mucus,
- ringing in your ears,
- sudden hearing loss,
- irregular heartbeat,
- swelling in your hands, ankles, or feet,
- seizure (convulsions), and
- lightheadedness
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Viagra (Sildenafil Citrate) include:
- flushing (warmth, redness, or tingly feeling),
- headache,
- dizziness,
- abnormal vision,
- blurred vision,
- changes in the color of your vision,
- sleep problems (insomnia),
- runny or stuffy nose,
- nosebleed,
- muscle pain,
- back pain, and
- upset stomach
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Viagra. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
DESCRIPTION
Viagra (Sildenafil Citrate) (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 5 (PDE5).
Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
 |
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: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake.
INDICATIONS
Viagra (Sildenafil Citrate) is indicated for the treatment of erectile dysfunction.
DOSAGE AND ADMINISTRATION
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 sexual activity. The maximum recommended dosing frequency is once per day.
Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.
Use With Food
Viagra (Sildenafil Citrate) may be taken with or without food.
Dosage Adjustments In Specific Situations
VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see CONTRAINDICATIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].
When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at 25 mg [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].
Dosage Adjustments Due To Drug Interactions
Ritonavir
The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].
CYP3A4 Inhibitors
Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dosage Adjustments In Special Populations
Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance < 30 mL/minute) because administration of VIAGRA in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
HOW SUPPLIED
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 VGR25, VGR50 or VGR100 on the other to indicate the dosage strengths.
Storage And Handling
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 obverse and reverse sides as follows:
| 25 mg | 50 mg | 100 mg | |
| Obverse | VGR25 | VGR50 | VGR100 |
| Reverse | PFIZER | PFIZER | PFIZER |
| Bottle of 30 | NDC-0069-4200-30 | NDC-0069-4210-30 | NDC-0069-4220-30 |
| Bottle of 100 | N/A | NDC-0069-4210-66 | NDC-0069-4220-66 |
| Carton of 30 (1 tablet per Single Pack) | N/A | NDC 0069-4210-33 | NDC 0069-4220-33 |
Recommended Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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