Basic Assurans Information

Product Detail	Information
INN (Active Ingredient)	Sildenafil citrate
Australian Brands	Assurans (primary), Revatio® for PAH
ATC Codes	C02KX05 (PAH), G04BE03 (erectile dysfunction)
Forms & Dosages	20mg film-coated tablets in blister packs (10-30 tablets)
Australian Manufacturer	Cipla Ltd (distributed via pharmacies)
TGA Registration	Prescription-only (Rx)
Storage Requirements	Below 30°C in original packaging

Assurans contains sildenafil citrate, the same active ingredient used in Revatio® for pulmonary arterial hypertension management. These 20mg tablets appear as film-coated pills commonly packaged in blister packs containing between 10-30 tablets. As a prescription-only medicine in Australia, Assurans requires TGA-approved registration before dispensing. This medication features specific storage requirements - always keep tablets in their original packaging away from moisture and heat sources. Proper storage maintains the sildenafil citrate stability throughout its maximum three-year shelf life.

How Assurans Works in Your Body

Assurans works as a PDE5 inhibitor that blocks phosphodiesterase type 5 enzymes. This action increases cyclic guanosine monophosphate, causing relaxation of pulmonary artery muscles. For pulmonary hypertension treatment, this mechanism improves blood flow through lung vessels by reducing vascular resistance.

After swallowing Assurans tablets, your liver metabolizes sildenafil citrate primarily through the CYP3A4 enzyme pathway. Most people experience peak effects within 60 minutes, with effects lasting approximately four hours due to the medication's half-life duration. Notable interactions require attention:

• Dangerous combinations: Never combine with nitrates or α-blockers due to severe hypotension risk
• Moderate interactions: HIV protease inhibitors or erythromycin increase sildenafil concentrations

High-fat meals cause delayed medication absorption, while alcohol consumption increases dizziness risks. Understanding this mechanism helps manage timing considerations with food and other medicines.

Therapeutic Uses of Assurans

Assurans carries TGA approval specifically for pulmonary arterial hypertension management in WHO Group 1 patients to ease breathing difficulties and exercise intolerance. While primarily indicated for PAH treatment, Australian clinicians sometimes prescribe it off-label for altitude sickness prevention and Raynaud's phenomenon symptom management.

Special population considerations include:

• Pregnancy: Generally avoided (Category B1) unless clinical benefits significantly outweigh fetal risks
• Elderly: Initiate therapy at 20mg dosage with blood pressure monitoring
• Children: Weight-based dosing permitted for paediatric PAH cases above age one

Note that Assurans' formulation differs from erectile dysfunction treatments despite sharing sildenafil citrate components. Its 20mg strength specifically addresses pulmonary vascular requirements rather than sexual function issues.

Dosing Guidelines For Different Patients

The standard pulmonary arterial hypertension treatment involves taking 20mg Assurans tablets three times daily, ideally spaced 4-6 hours apart. Dose adjustments become necessary for specific health conditions:

Patient Profile	Recommended Adjustment
Hepatic impairment	Avoid completely in severe cases; reduce to 10mg in moderate impairment
Renal impairment (CrCl <30)	Decrease to 10mg three times daily
Elderly patients	Begin with lower 10-20mg dosages
Children (20-45kg)	10mg three times daily
Children (>45kg)	20mg three times daily

For missed doses, skip the forgotten tablet if nearing the next scheduled dose rather than doubling the amount. Overdose situations require urgent medical attention - symptoms include prolonged painful erections, severe lightheadedness, or fainting episodes indicating potentially dangerous hypotension.

Proper Usage and Storage Practices

Assurans administration involves swallowing tablets whole with water, avoiding grapefruit juice consumption due to interaction risks. You may take these tablets with or without meals, though high-fat foods could delay medication absorption.

Correct storage preserves medication potency:

• Maintain temperatures below 30°C
• Keep tablets in original blister packaging
• Store in dry, dark locations
• Never refrigerate these tablets

When traveling, carry Assurans in hand luggage with your prescription documentation. Regularly inspect tablets for discoloration changes and discard any expired medications beyond their three-year shelf life. Following these protocols preserves medication effectiveness and safety throughout your treatment.

Assurans Safety: Essential Warnings and Contraindications

Absolute Contraindications When Assurans Must Be Avoided

Some medical situations completely rule out Assurans use due to serious health risks. Anyone taking nitrate medications for heart conditions (like angina or heart failure) must not use this medicine. Combining Assurans with nitrates can cause dangerously low blood pressure. Patients with severe cardiovascular issues including unstable angina, recent heart attacks, or advanced heart failure should also avoid treatment. Known allergy to sildenafil or any tablet ingredient is an absolute barrier. Severe liver impairment (Child-Pugh Class C) and certain rare eye conditions like retinitis pigmentosa also prohibit use due to safety concerns.

Conditional Risks Requiring Medical Evaluation

Several health conditions require cautious assessment and potential dosage adjustments. Low baseline blood pressure (under 90/50 mmHg) warrants careful monitoring due to blood-pressure-lowering effects. Patients with uncontrolled hypertension face increased cardiovascular strain. Mild to moderate liver impairment necessitates lower starting doses or extended dosing intervals since sildenafil metabolism occurs here through the CYP3A4 pathway. Anatomical penis abnormalities including Peyronie’s disease or risk factors for priapism require evaluation before prescribing. Physicians will assess benefits versus potential complications for anyone with severe kidney impairment.

Special Considerations For Ongoing Treatment

People with a history of stroke, heart rhythm disturbances, or life-threatening arrhythmias need thorough cardiac clearance before starting therapy. Neurological events during treatment require immediate medical assessment. Users should report sudden vision changes or hearing loss immediately as some PDE5 inhibitors have been linked with these effects in rare cases. Bleeding disorders or active stomach ulcers require monitoring due to potential bleeding complications. Patients on blood pressure medications (especially alpha-blockers) may experience additive blood pressure drops and require medication adjustment.

Approved and Off-Label Uses of Assurans

Assurans contains sildenafil citrate and is officially approved in Australia for treating pulmonary arterial hypertension (PAH). This condition involves high blood pressure in the lung arteries, making it harder for the heart to pump blood. If you've been diagnosed with World Health Organization Group 1 PAH, this medication helps relax lung blood vessels and improve exercise capacity.

Healthcare providers sometimes prescribe Assurans off-label for conditions not listed in official guidelines. In Australian practice, you'll occasionally see it used for preventing high-altitude sickness during mountain climbing and managing severe Raynaud's phenomenon causing poor circulation. These uses require careful medical supervision and aren't universally recommended.

Special Population Considerations

For pregnancy, Assurans isn't routinely recommended (Category B1). We reserve it for situations where the potential benefit clearly outweighs risks. Elderly patients typically start at 20mg three times daily, with close blood pressure monitoring due to higher fall and hypotension risks. For children aged 1 year and older with PAH, weight-adjusted dosing comes into play under specialist guidance.

Important note: Don't use Assurans for erectile dysfunction despite its active ingredient being familiar for this purpose. The 20mg strength and frequent dosing schedule in Assurans differ significantly from single higher doses used in ED medications. Using incorrect dosing could pose health risks.