Jawalk Oral Solution## (strength format)

Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)

• For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity
• However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg Maximum recommended dosing frequency is once per day Dosage Information For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity
• However, sildenafil tablets 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 Sildenafil tablets may be taken with or without food
• Dosage Adjustments in Specific Situations Sildenafil tablets 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 sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions , Drug Interactions , and Clinical Pharmacology ]. …

Sildenafil tablets, USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate USP equivalent to 50 mg, or 100 mg of sildenafil. Tablets are debossed with 1A1 and 1A2 on one side and plain on the other to indicate the dosage strengths viz. 100 mg and 50 mg respectively. …

• Sildenafil is not indicated for use
• Pediatric patients
• Safety and effectiveness have not been established
• Pediatric patients

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, respectively, compared to those seen in healthy young volunteers (18-45 years) [ see Clinical Pharmacology (12.3) ]. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians should discuss with patients the contraindication of sildenafil with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications ]
• Guanylate Cyclase (GC) Stimulators Physicians should discuss with patients the contraindication of sildenafil with use of guanylate cyclase stimulators such as riociguat [ see Contraindications ]. …

• Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form
• Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates Known hypersensitivity to sildenafil or any component of tablet Administration with guanylate cyclase (GC) stimulators, such as riociguat Nitrates Consistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1 …

Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4 , 7.4 ) 7.1 Nitrates Administration of sildenafil with nitric oxide donors such as organic nitrates or organic nitrites in any fo …

Patients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1 ) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil with caution in patients predisposed to priapism ( 5.2 ) Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. …

The following are discussed in more detail in other sections of the labeling: Cardiovascular [ see Warnings and Precautions (5.1) ] Prolonged Erection and Priapism [ see Warnings and Precautions (5.2) ] Effects on the Eye [ see Warnings and Precautions (5.3) ] Hearing Loss [ see Warnings and Precautions (5.4) ] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [ see Warnings and Precautions (5.5) ] Adverse Reactions with the Concomitant Use of Ritonavir [ see Warnings and Precautions (5.6) ] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [ see Warnings and Precautions (5.7) ] Effects on Bleeding [ see Warnings and Precautions (5.8) ] C …

8.1 Pregnancy Risk Summary Sildenafil is not indicated for use in females. There are no data with the use of sildenafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human do …

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 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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.