Generic Viagra Professional (Sublingual) ( Sildenafil Citrate )

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Viagra Professional (Sublingual) is a fast‑acting sublingual tablet formulation of sildenafil citrate, the same active ingredient found in traditional Viagra®. It is used for the treatment of erectile dysfunction (ED) by relaxing the smooth muscles of the penile arteries and increasing blood flow to the corpus cavernosum during sexual stimulation. The sublingual tablet is designed to dissolve rapidly under the tongue, bypassing the digestive system and first‑pass liver metabolism, resulting in a faster onset of action and a more predictable effect compared with standard oral tablets.

Usual adult dose: The recommended dose is one 100 mg sublingual tablet placed under the tongue and allowed to dissolve completely, taken as needed approximately 15 to 30 minutes before anticipated sexual activity. The tablet should not be swallowed, chewed, or taken with water. The maximum recommended dosing frequency is once per day. This dose provides the maximum standard therapeutic effect of sildenafil and should not be exceeded. Sexual stimulation is required for an erection to occur.

Dosage form: Sublingual tablet containing 100 mg of sildenafil citrate. The tablet is formulated to dissolve rapidly under the tongue.

Onset of action: Because sublingual administration bypasses the gastrointestinal tract, the onset of action is typically faster than with standard oral sildenafil. Many men notice an effect within 15 to 30 minutes after the tablet has dissolved. A high‑fat meal has minimal impact on absorption, allowing for greater flexibility.

Duration of action: The therapeutic effect for ED persists for up to 4 to 6 hours after a single dose, consistent with the elimination half‑life of sildenafil of approximately 4 hours. The sublingual route does not alter the duration of action; it primarily improves the time to onset.

Alcohol recommendation: Alcohol consumption should be limited or avoided while taking Viagra Professional. Drinking alcohol can temporarily reduce the ability to get an erection, may lower blood pressure further, and can increase the risk of side effects such as headache, dizziness, flushing, and orthostatic hypotension.

Most common side effects: Headache (16%), facial flushing (10%), dyspepsia (indigestion, 7%), nasal congestion (4%), dizziness (3%), and visual disturbances (e.g., blue‑tinged vision, increased sensitivity to light, blurred vision; 3%). These effects are generally mild to moderate and temporary. A rare but serious side effect is priapism, a prolonged and painful erection lasting more than 4 hours, which requires immediate medical attention. Sudden vision loss and sudden hearing loss have also been reported rarely.

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General Information about Viagra Professional (Sublingual) (Sildenafil Citrate)

• INN (International Nonproprietary Name): Sildenafil Citrate
• Brand names available in Canada: Viagra Professional (Sublingual) is not an approved or marketed brand in Canada. The active ingredient, sildenafil citrate, is legally available in Canada as Viagra® (Pfizer Canada Inc.) and as generic sildenafil tablets (25 mg, 50 mg, 100 mg). Viagra Professional is an internationally sourced sublingual formulation obtained by our pharmacy through the international supply chain for personal importation.
• ATC code: G04BE03 (urologicals, drugs used in erectile dysfunction).
• Dosage forms and strengths: Sublingual tablet: 100 mg of sildenafil citrate. This formulation is not available in standard Canadian pharmacies; it is sourced internationally.
• Manufacturers in Canada: None. Viagra Professional is not manufactured in Canada. It is produced internationally by various pharmaceutical companies for markets where sublingual PDE5 inhibitor formulations are registered. Our pharmacy obtains it through the international supply chain.
• Registration status in Canada: Not marketed in Canada. Viagra Professional has not been issued a Notice of Compliance by Health Canada and is not listed in the Drug Product Database. The active ingredient sildenafil citrate is approved only in the standard oral tablet form. Sublingual formulations are not approved by Health Canada.
• OTC / Rx classification: Prescription only (Rx). Sildenafil is a Schedule I drug under the Controlled Drugs and Substances Act. It requires a valid prescription from a licensed Canadian healthcare professional. Our pharmacy fulfills this prescription for the internationally sourced sublingual product.

Mechanism of Action and Pharmacology

Sildenafil citrate is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP)‑specific phosphodiesterase type 5 (PDE5). During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum of the penis. Nitric oxide activates the enzyme guanylate cyclase, which increases the intracellular concentration of cGMP. This leads to relaxation of the smooth muscle in the penile arteries and the corpus cavernosum, allowing blood to flow in and produce an erection. PDE5 normally breaks down cGMP, terminating the erectile response. By inhibiting PDE5, sildenafil allows cGMP to accumulate and persist, significantly enhancing and prolonging the erection in the presence of sexual stimulation. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum smooth muscle without sexual stimulation.

Viagra Professional utilizes a sublingual tablet that dissolves rapidly under the tongue, allowing sildenafil to be absorbed directly through the oral mucosa into the systemic circulation. This route bypasses the gastrointestinal tract and first‑pass hepatic metabolism, resulting in a faster onset of action and less variability related to food intake. The active drug is then metabolized primarily by the cytochrome P450 isoenzyme CYP3A4 (major route) and CYP2C9 (minor route) to an active N‑desmethyl metabolite. The elimination half‑life of sildenafil and its active metabolite is approximately 4 hours, and the drug is excreted as metabolites predominantly in the faeces (80%) and to a lesser extent in the urine (13%). The sublingual route does not alter the fundamental pharmacology or the duration of action; it primarily improves the time to onset and reduces the impact of meals.

Indications

• Treatment of erectile dysfunction (ED) in adult men, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. Viagra Professional offers the same therapeutic benefit as standard sildenafil, with the advantage of a faster onset due to sublingual absorption. Sexual stimulation is required.
• This product is not indicated for pulmonary arterial hypertension (PAH), benign prostatic hyperplasia (BPH), or any condition other than ED.
• Not indicated for use in women or in children and adolescents under 18 years of age.

Important Warnings and Precautions

At‑risk groups

• Pregnancy and breastfeeding: Viagra Professional is not indicated for use by women. There are no adequate and well‑controlled studies of sildenafil in pregnant or breastfeeding women.
• Paediatrics (< 18 years): Sildenafil is not approved for use in children or adolescents for the treatment of ED.
• Elderly: No dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the vasodilatory effects of sildenafil, and the risk of orthostatic hypotension may be increased. A lower starting dose of 25 mg or 50 mg is often recommended; the 100 mg sublingual tablet may be too potent for some elderly patients and should be used with caution.
• Cardiovascular disease: Sexual activity carries a degree of cardiac risk for patients with pre‑existing cardiovascular disease. Sildenafil has vasodilatory properties and can cause mild and transient decreases in blood pressure. It is contraindicated in patients with severe cardiovascular disease, including unstable angina, severe heart failure, and recent myocardial infarction or stroke (within the last 6 months).
• Use with nitrates: Sildenafil potentiates the hypotensive effects of nitrates and nitric oxide donors (e.g., nitroglycerin, isosorbide mononitrate, amyl nitrate). Concomitant use is absolutely contraindicated and can lead to a life‑threatening drop in blood pressure. This applies to all forms of sildenafil, including the sublingual tablet.
• Use with guanylate cyclase stimulators: Concomitant use of sildenafil with riociguat (Adempas®) is contraindicated due to the risk of severe hypotension.
• Priapism: Prolonged erection (longer than 4 hours) has been reported rarely with PDE5 inhibitors. This is a medical emergency that can lead to permanent impotence. Patients should seek immediate medical attention if priapism occurs.
• Vision loss: Non‑arteritic anterior ischaemic optic neuropathy (NAION), a cause of sudden vision loss, has been reported rarely. Men with sudden vision loss should stop the drug and seek immediate medical care.
• Hearing loss: Sudden decrease or loss of hearing has been reported. Discontinue and seek prompt medical attention.
• Renal impairment: No dose adjustment is required in mild to moderate renal impairment. In severe renal impairment (creatinine clearance < 30 mL/min), the maximum recommended dose is 25 mg; the 100 mg sublingual tablet is contraindicated in this population.
• Hepatic impairment: In patients with hepatic impairment (e.g., cirrhosis), the maximum recommended dose is 25 mg. The 100 mg sublingual tablet is contraindicated in these patients.
• Alpha‑blockers: Concomitant use with alpha‑adrenergic blockers (e.g., tamsulosin, doxazosin) may cause additive hypotension. The patient should be stable on alpha‑blocker therapy before initiating sildenafil, and sildenafil should be started at the lowest dose (25 mg). The 100 mg sublingual tablet may not be appropriate when combined with alpha‑blockers.
• Anatomical deformation: Use with caution in patients with penile anatomical deformation (e.g., Peyronie’s disease) or conditions predisposing to priapism.
• Allergy: Do not take Viagra Professional if you have a known hypersensitivity to sildenafil citrate or any of the tablet’s excipients.

Driving and alcohol

Sildenafil may cause dizziness, blurred vision, or altered colour perception. Patients should be aware of how they react before driving or operating machinery. Alcohol consumption should be limited, as it may impair erectile function, lower blood pressure, and increase the risk of headache, dizziness, and orthostatic hypotension.

Dosage Instructions

• Standard adult dose: Place one 100 mg sublingual tablet under the tongue. Allow it to dissolve completely without chewing or swallowing; this usually takes 1 to 2 minutes. Do not take with water or food while the tablet is dissolving. Take approximately 15 to 30 minutes before sexual activity. The maximum recommended frequency is once per day.
• Elderly, renally impaired, hepatically impaired patients, or those taking CYP3A4 inhibitors or alpha‑blockers: The 100 mg strength is generally not recommended as a starting or sole dose. A lower dose (25 mg or 50 mg) of the standard oral tablet should be used. The 100 mg sublingual tablet is contraindicated in severe renal or hepatic impairment.
• Administration: Place the tablet under the tongue and let it dissolve. A mild tingling or sweet taste may be noticed; this is normal. Once dissolved, any remaining residue can be swallowed. Do not crush or chew the tablet. Avoid food and drink until the tablet is fully absorbed.
• Missed dose: Viagra Professional is taken as needed only; a missed dose concept does not apply.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Headache (16%) and flushing (10%).
• Common side effects (1‑10%): Dyspepsia (7%), nasal congestion (4%), dizziness (3%), and visual disturbances (colour tinge, increased sensitivity to light, blurred vision; 3%).
• Serious adverse reactions: Priapism, sudden vision loss (NAION), sudden hearing loss, and serious cardiovascular events (myocardial infarction, stroke) occurring in temporal association with sexual activity. Hypotension and syncope may occur, particularly with higher doses or in combination with alcohol or antihypertensives.
• Contraindications: Concomitant use of organic nitrates in any form, or nitric oxide donors. Concomitant use of riociguat. Known hypersensitivity to sildenafil citrate. Severe cardiovascular disease, recent myocardial infarction or stroke (within 6 months). Severe hepatic impairment. The 100 mg dose is contraindicated in patients with severe renal impairment (CrCl < 30 mL/min) and in those taking potent CYP3A4 inhibitors (e.g., ritonavir, ketoconazole).

Drug Interactions

• Nitrates and nitric oxide donors — contraindicated: Co‑administration can cause profound hypotension, fainting, shock, or death.
• Guanylate cyclase stimulators — contraindicated: Riociguat.
• Alpha‑blockers: Additive hypotension; sildenafil should be started at 25 mg, not 100 mg sublingual, when co‑administered with alpha‑blockers.
• Potent CYP3A4 inhibitors (e.g., ritonavir, ketoconazole): Significantly increase sildenafil levels. The maximum recommended dose of sildenafil is 25 mg, and not more than once every 48 hours with ritonavir. The 100 mg dose is contraindicated with these inhibitors.
• Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): May increase sildenafil exposure; monitor for side effects, consider a lower dose.
• Antihypertensives: Additive blood‑pressure‑lowering effect; monitor.
• Alcohol: Increases risk of hypotension and headache; limit intake.

Practical Advice

• Administration: Take exactly as prescribed. Place the tablet under the tongue and let it dissolve completely without swallowing. The medication works only with sexual stimulation. Do not exceed one tablet per day.
• Monitoring: No routine laboratory monitoring is required. Medical evaluation is recommended before starting ED therapy, especially at the 100 mg dose. Seek immediate attention for priapism, vision or hearing loss, or chest pain.
• Storage: Store at room temperature (15‑30 °C) in a dry place. Keep in original packaging. Keep out of reach of children.
• Lifestyle: Address underlying health factors (smoking, alcohol, weight, diabetes, hypertension). Do not combine with other PDE5 inhibitors.
• Emergency: Priapism (> 4 hours) or sudden vision/hearing loss requires emergency care. Inform all healthcare providers of sildenafil use before any treatment, especially if nitrates are being considered for chest pain.

Alternative Medications

• Standard oral sildenafil (Viagra®, generics): The same active ingredient in a traditional tablet, available in 25 mg, 50 mg, and 100 mg strengths. It has a standard onset of 30 to 60 minutes.
• Tadalafil (Cialis®): A PDE5 inhibitor with a much longer duration of action (up to 36 hours), available for on‑demand or once‑daily use.
• Vardenafil (Levitra®): A PDE5 inhibitor with a duration similar to sildenafil, available as a tablet or orally disintegrating tablet.
• Avanafil (Stendra®): A fast‑acting PDE5 inhibitor with an onset as little as 15 minutes, similar to Viagra Professional.
• Alprostadil (Caverject®): An injectable or intraurethral therapy that does not rely on PDE5 inhibition and can be used when nitrates are necessary.
• Non‑pharmacological: Vacuum erection devices, penile implants, and psychological counselling.

Clinical Efficacy

Sildenafil citrate is a well‑established therapy for ED. The 100 mg dose has been shown in numerous placebo‑controlled trials to significantly improve the ability to achieve and maintain erections in approximately 82% of men with ED, compared with 24% on placebo. The sublingual formulation is designed to be bioequivalent to the standard oral tablet, with the primary difference being a more rapid absorption profile. Pharmacokinetic studies indicate that sublingual sildenafil achieves peak plasma concentrations earlier than film‑coated tablets, which translates into a faster onset of action for the patient. The efficacy, safety, and tolerability of the 100 mg dose in the sublingual form are comparable to the standard oral tablet, with the same expected side‑effect profile. Generic sildenafil, including internationally sourced sublingual products, contains the same active ingredient and is designed to deliver the same therapeutic effect.

Important:

Viagra Professional (Sublingual) (sildenafil citrate) is a prescription medication that should be used only under the supervision of a qualified healthcare professional. The most critical safety warning is that sildenafil, in any form, must never be taken with any form of organic nitrate (e.g., nitroglycerin, isosorbide mononitrate, “poppers”). This combination can cause a severe, sudden, and potentially fatal drop in blood pressure. If you experience chest pain or an erection lasting longer than 4 hours, stop using the medication and seek emergency medical attention immediately. The 100 mg sublingual tablet is a high‑dose formulation; do not exceed one tablet per day. It is not suitable for patients with severe kidney or liver problems, or for those taking certain medications (e.g., ritonavir, ketoconazole). Sexual activity carries a cardiac risk in patients with pre‑existing cardiovascular disease. If you are taking alpha‑blockers, you should be stable on that therapy before starting sildenafil, and the dose of sildenafil should be reduced. Do not drink large amounts of alcohol. This product is for adult men and is not intended for use by women or children. If you experience sudden vision or hearing loss, seek immediate medical attention. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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