Hezkue (Sildenafil Oral Spray)

What is Hezkue?

Hezkue is an oromucosal spray formulation of Sildenafil Citrate, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It is designed as a convenient alternative to tablets for men with erectile dysfunction.

Key Benefits

• Fast absorption – starts within ~5 minutes vs sildenafil tablets 100mg
• Demonstrated faster absorption post-meal vs. oral sildenafil tablets
• Flexible metered dosing with up to 20 doses per bottle (for 25mg per dose dosing)
• Mint flavour for pleasant administration

Mechanism of Action

Think of the process of getting an erection as a chain reaction that requires a "key" and a "lock". Sexual stimulation releases a chemical "key" called Nitric Oxide (NO). This key turns on a "lock" (an enzyme called guanylate cyclase) inside the blood vessels of the penis, which produces another chemical messenger called cGMP. cGMP acts like a signal telling the blood vessels to relax and widen, allowing more blood to flow in, resulting in an erection.

In some men with ED, this process is interrupted because an enzyme called PDE5 breaks down the cGMP signal too quickly. Hezkue (Sildenafil) works by blocking the PDE5 enzyme. This allows the cGMP signal to last longer, helping to maintain the blood flow necessary for a firm and lasting erection, but only when you are sexually stimulated.

What is Hezkue Used For?

Hezkue is indicated for the treatment of erectile dysfunction (ED) in adult men. ED is defined as the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

Target Patient Population: Adult men diagnosed with ED of various causes (psychogenic, organic, or mixed). It is not indicated for use by women or individuals under 18 years of age.

Before Using Hezkue

A thorough medical history and physical examination should be conducted to diagnose ED and identify any underlying causes before starting treatment.

Medical History Assessment Checklist

Inform your doctor if you have or have ever had:

• Heart problems (e.g., angina, heart failure, irregular heartbeat, recent heart attack or stroke)
• Low or high blood pressure
• Liver or kidney disease
• Blood cell disorders (e.g., sickle cell anaemia, leukaemia, multiple myeloma)
• A history of priapism (a prolonged, painful erection)
• Anatomical deformity of the penis (e.g., Peyronie's disease, angulation, cavernosal fibrosis)
• Stomach ulcers or bleeding disorders
• Eye problems, especially retinitis pigmentosa or NAION

Cardiovascular Risk: Sexual activity carries a degree of cardiac risk. Your doctor will assess your cardiovascular health to ensure it is safe for you to engage in sexual activity and use Hezkue. Not to be used in men for whom sexual activity is inadvisable.

Hezkue Contraindications

Absolute Contraindications (Do NOT use if):

• You are allergic to sildenafil or any of the other ingredients of this medicine.
• You are taking any medicines that contain nitrates or nitric oxide donors.
• You are taking medicines called guanylate cyclase stimulators (e.g., riociguat).
• You have severe hepatic impairment.
• You have severe hypotension (blood pressure <90/50 mmHg).
• You have had a recent stroke or myocardial infarction.
• You have a known hereditary degenerative retinal disorder such as retinitis pigmentosa.
• You have ever had loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was related to previous PDE5 inhibitor exposure.
• Not to be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).

Special Population Considerations

Elderly (≥65 years)

• Dosage adjustment is not typically required, but older patients may be more sensitive to the medicine.
• The starting dose of 25 mg (2 sprays) or 50 mg (4 sprays) is appropriate.

Renal Impairment

• Mild to Moderate Impairment: No dose adjustment needed.
• Severe Impairment (Creatinine Clearance < 30 mL/min): A starting dose of 25 mg (2 sprays) is recommended. The dose can be increased to a maximum of 100 mg (8 sprays) based on response and tolerability.

Hepatic Impairment

• Mild to Moderate Impairment (e.g., Child-Pugh A and B): A starting dose of 25 mg (2 sprays) is recommended. The dose can be increased to a maximum of 100 mg (8 sprays) based on response and tolerability.
• Severe Impairment: Hezkue is contraindicated.

Paediatric Population

• Hezkue is not indicated for use in children and adolescents under 18 years of age.

Hezkue and Other Medicines

Always tell your doctor about all the medicines you are taking, including prescription, over-the-counter, and herbal products.

High-Risk Interactions

• Nitrates: CONTRAINDICATED. Can cause a dangerous drop in blood pressure.
• Riociguat (Adempas): CONTRAINDICATED. Used for pulmonary hypertension.
• Concomitant use with ritonavir is not advised.
• Potent CYP3A4 Inhibitors:
  • Ketoconazole, Itraconazole: A starting dose of 25 mg (2 sprays) is recommended.
  • Erythromycin, Clarithromycin: A starting dose of 25 mg (2 sprays) should be considered.
• Alpha-Blockers (e.g., Doxazosin, Tamsulosin): May lead to symptomatic low blood pressure (dizziness, light-headedness). You should be stable on your alpha-blocker therapy before starting Hezkue, and a starting dose of 25 mg (2 sprays) is recommended. Patients should be advised what to do in the event of postural hypotensive symptoms.

Effect on Bleeding

Sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Sildenafil should be administered to these patients only after careful benefit-risk assessment.

Pregnancy & Breastfeeding

Hezkue is not indicated for use by women. There are no adequate and well-controlled studies of sildenafil in pregnant or breastfeeding women.

Driving & Machine Operation

Hezkue may have a minor influence on the ability to drive and use machines. Some patients may experience dizziness, visual disturbances, or a drop in blood pressure. You should be aware of how you react to the medicine before driving or operating machinery.

Hezkue Ingredients

Active Substance

• Sildenafil Citrate (equivalent to 12.5 mg sildenafil per 0.5 mL actuation)

Excipients

• Sodium benzoate (preservative)
• Anhydrous citric acid
• Sucralose (sweetener)
• Acesulfame potassium (sweetener)
• Hypromellose
• Xanthan gum
• Peppermint flavour
• Masking flavour
• Purified water

Allergen/Specific Information

• This product contains 1 mg sodium benzoate per mL.

How to Use Hezkue Spray

Hezkue is for oromucosal use. The spray is directed onto the tongue and swallowed immediately.

Hezkue Dosage Guidelines

Standard Dosing Schedule

Patient Group Recommendations

* Dose may be increased step-wise based on efficacy and tolerability.

Timing & Onset

• Absorption may begin in ~5 minutes - faster than sildenafil tablets
• Effects typically last 4-5 hours
• Can be taken with or without food - demonstrated faster absorption post-meal vs. oral sildenafil tablets
• Sexual stimulation is required for the medicine to work

Administration Instructions

Step-by-step administration guide:

Preparation (First Use)

1. Shake the bottle well.
2. Fit the pump and nozzle.
3. Prime with 3 pumps and discard these sprays.

Before Each Use

1. Shake the bottle.
2. There is no need to re-prime unless the pump has not been used for several days.

Administration Process

1. Spray onto your tongue, swallow immediately.
2. The recommended dose is 2-8 sprays. You do not need to spray them all at once; you can administer them one after the other.

After Use

1. Remove and wash the pump.
2. Let it dry and replace with the original lid on the bottle.

Missed Dose Management

Hezkue is taken "as needed," not on a regular schedule. Therefore, the concept of a "missed dose" does not apply. Do not take more than one dose (maximum 8 sprays) in a 24-hour period.

Overdose Information

Symptoms

• Severe headache
• Intense flushing
• Dizziness
• Indigestion
• Prolonged or painful erection (priapism)
• Visual disturbances
• Fainting

Management

1. If you have taken more than the recommended dose, seek immediate medical attention.
2. If you experience an erection lasting more than 4 hours, seek emergency medical care to prevent permanent tissue damage.
3. Standard supportive measures should be adopted; renal dialysis is not effective.

Possible Side Effects

Very Common (more than 1 in 10 people)

• Headache

Common (1 in 10 to 1 in 100 people)

• Dizziness
• Visual colour distortions (chloropsia, chromatopsia, cyanopsia, erythropsia, xanthopsia)
• Visual disturbance
• Vision blurred
• Flushing
• Nasal congestion
• Nausea
• Dyspepsia (indigestion)

Uncommon (1 in 100 to 1 in 1,000 people)

• Hypotension (low blood pressure)
• Eye pain
• Rash
• Myalgia (muscle pain)

How to Store Hezkue

Storage Conditions

• This medicinal product does not require any special storage conditions.
• Keep the bottle tightly closed when not in use.

Shelf Life

• 24 months unopened
• 10 months after first opening

Pack Information

Pack Components

• Hezkue is supplied in a 30 mL white HDPE bottle closed with a child-resistant closure.
• A separate 0.5 mL/actuation pump is provided in the outer carton.

Contents

• Each bottle contains 30 mL of suspension
• Provides up to 20 doses at 25mg, 10 doses at 50mg, or 5 doses at 100mg

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