Viagra Tablets (Sildenafil 50 mg and 100 mg Tablets) – Product Information
Viagra (Sildenafil Citrate tablets) is indicated for the treatment of erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
We also stock Generic Sildenafil Citrate (Suhagra 25 mg, 50 mg and 100 mg tablets) which are used to treat the same indications.
Name of Drug
Viagra Tablets. Viagra Tablets are also known as Sildenafil Citrate tablets.
Manufacturer of Viagra Tablets (Sildenafil Citrate Tablets)
We supply original Viagra 50 mg and 100 mg tablets manufactured by Fareva Amboise in France. Marketed by Mylan/Viatris
Website: www.viatris.com/en
Active Pharmaceutical Ingredient
The active pharmaceutical ingredient contained in Viagra tablets is Sildenafil Citrate.
Each Viagra tablet contains Sildenafil Citrate equivalent to 50 mg or 100 mg of Sildenafil.
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 in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Sildenafil (Viagra) has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum.
When sexual stimulation causes local release of NO, inhibition of PDE5 by Sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.
Uses of Viagra (Sildenafil Citrate Tablets)
Sildenafil is used to treat men who have erectile dysfunction (also called sexual impotence).
Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.
Sildenafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension.
This is a type of high blood pressure that occurs between the heart and the lungs. When hypertension occurs in the lungs, the heart must work harder to pump enough blood through the lungs. Sildenafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.
Viagra – Dosage
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.
Missed Dosage Instructions for Viagra Tablets
Viagra isn’t a medication you take every day.
You’ll only take a dose as needed before sex, no more than once per day. You don’t have to take it regularly.
Viagra Contraindications
Viagra tablets are contraindicated in persons with a hypersensitivity (allergy) to Sildenafil Citrate or any of the other ingredients of this medicine.
Viagra (sildenafil citrate) has been shown to potentiate the hypotensive effects of nitrates in healthy volunteers and in patients, and is therefore contraindicated in patients who are taking any type of nitrate drug therapy, or who utilize short-acting nitrate-containing medications, due to the risk of developing potentially life-threatening hypotension.
Treatments for erectile dysfunction should not be generally used in men for whom sexual activity is inadvisable.
Viagra is contraindicated in patients with erectile dysfunction with previous episode of non-
arteritic anterior ischaemic optic neuropathy (NAION).
The co-administration of PDE5 inhibitors, including Viagra, with guanylate cyclase stimulators, such as Riociguat, is contraindicated as it may lead to potentially life-threatening episodes of symptomatic hypotension or syncope.
Storage Instructions for Viagra Tablets
Viagra (Sildenafil Citrate tablets) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing Sildenafil Citrate equivalent to the nominally indicated amount of Sildenafil.
It is to be stored at room temperature between 59°F and 86°F (15°C to 30°C) away from moisture, heat and light and out of the reach of children.
Warnings and Precautions to be taken when using Viagra Tablets (Sildenafil Citrate Tablets)
Before using tablets please inform your doctor about all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies.
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 not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
Prolonged Erection and Priapism: Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of Viagra. 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 could result.
Effects on the Eye: Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including Viagra, 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 rare condition and a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors.
Hearing Loss:Physicians should advise patients to stop taking PDE5 inhibitors, including Viagra, 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 Viagra.
Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including Viagra, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. Viagra has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.
In a separate drug interaction study, when Amlodipine, 5 mg or 10 mg, and Viagra, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted.
Adverse Reactions with the Concomitant Use of Ritonavir: The concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of Sildenafil (11-fold increase in AUC). If Viagra is prescribed to patients taking Ritonavir, caution should be used.
Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies: The safety and efficacy of combinations of Viagra with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Such combinations may further lower blood pressure.
Effects on Bleeding: There have been postmarketing reports of bleeding events in patients who have taken Viagra. A causal relationship between Viagra and these events has not been established. In humans, Viagra has no effect on bleeding time when taken alone or with aspirin. However, in vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside.
Counseling Patients About Sexually Transmitted Diseases: The use of Viagra 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.
Side Effects of Viagra Tablets
The most common Side Effects of Viagra tablets with an incidence rate of 2% or greater are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash.
Viagra (Sildenafil Citrate Tablets) – Drug Interactions
The drug Interactions of Viagra (Sildenafil Citrate tablets) are given below:
- Viagra can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives.
- With concomitant use of alpha blockers, initiate Viagra at 25 mg dose.
- CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole, Itraconazole, Erythromycin): Increase Viagra exposure
- Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period.
- Erythromycin or strong CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Saquinavir): Consider a starting dose of 25 mg
Sildenafil Citrate Tablets Overdosage
In studies of Viagra (Sildenafil Citrate tablets) 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 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.
Sildenafil Citrate (Viagra Tablets) During Pregnancy
Sildenafil Citrate (Viagra Tablets) is classified by the US FDA as Pregnancy Category B.
Viagra is not indicated for use in women. There are no adequate and well-controlled studies of sildenafil in pregnant women. No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 200 mg/kg/day during organogenesis. These doses represent, respectively, about 20 and 40 times the Maximum Recommended Human Dose ( MRHD) on a mg/m2 basis in a 50 kg subject.
Limited data indicate that Sildenafil and its active metabolite are present in human milk. There is no information on the effects on the breastfed child, or the effects on milk production.
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