Assurans
✅ Treats pulmonary hypertension
✅ Improves exercise capacity
✅ Dilates blood vessels
✅ Reduces pulmonary artery pressure
✅ Enhances oxygen delivery
Assurans contains Sildenafil.
✓ Medically reviewed by Morgan Ellis — Pharmacy Researcher · 8 years experience · Last reviewed: May 2026
⚡ Quick Answer — What is Assurans?
Assurans 20 mg contains sildenafil citrate as an oral tablet from Cipla. At this dose and dosing schedule, Assurans is FDA-approved for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) — a serious progressive vascular disease of the lung arteries. Internationally equivalent to Revatio (Pfizer), the branded PAH formulation of sildenafil. Dose: 20 mg orally THREE TIMES DAILY (every 6-8 hours) — this is NOT the on-demand erectile-dysfunction regimen. Lowers pulmonary arterial pressure, improves exercise capacity (6-minute walk distance), and reduces WHO functional class. Specialist (pulmonary hypertension clinic) decision only — PAH is a rare, progressive disease that requires dedicated expert management. Absolute contraindications: nitrates in any form, riociguat (another PAH drug). Common side effects: headache, flushing, epistaxis (nosebleed), diarrhoea, back/limb pain. At 20 mg three times daily, Assurans is NOT prescribed for erectile dysfunction — ED sildenafil uses higher on-demand doses (50-100 mg) given once before activity.
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What Is Assurans 20 mg?
Assurans 20 mg is an oral sildenafil citrate 20 mg tablet from Cipla, supplied in packs of 30 / 60 / 90 / 180 tablets. Assurans is Cipla’s sildenafil citrate 20 mg oral tablet licensed for pulmonary arterial hypertension (PAH). From a manufacturer whose respiratory and cardiovascular medicines are used by the WHO and international pulmonary-care programmes, Assurans is the Cipla equivalent of Pfizer’s Revatio. The 20 mg strength is the specific formulation licensed for pulmonary arterial hypertension (PAH) — distinct from the 25 / 50 / 100 mg on-demand formulations licensed for male erectile dysfunction.
Sildenafil was originally developed in the 1980s as a pulmonary vasodilator candidate; its erectile-function side effects were observed in early hypertension trials and led to its 1998 FDA approval as Viagra for ED. The pulmonary hypertension development continued in parallel and sildenafil was separately FDA-approved for PAH in 2005 under the brand name Revatio (Pfizer). Assurans is the generic bioequivalent of Revatio, with the same active and strength for the PAH indication.
How Assurans Works in PAH
Pulmonary arterial hypertension is driven by pathological remodelling, vasoconstriction, and in-situ thrombosis of the small pulmonary arteries. The nitric oxide (NO) → cGMP pathway is impaired in PAH — endothelial NO production is reduced and cGMP turnover is elevated.
- Sildenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. PDE5 is abundantly expressed in pulmonary vascular smooth muscle.
- By inhibiting PDE5, sildenafil prolongs the vasodilator action of cGMP on pulmonary arterial smooth muscle, lowering pulmonary vascular resistance and pulmonary arterial pressure.
- Effects on exercise capacity, WHO functional class, and haemodynamic parameters are well established — the SUPER-1 trial (Galiè et al., NEJM 2005) was the pivotal study that earned Revatio its FDA approval. 6-minute walk distance improved by an average of 45 metres over placebo at 12 weeks of 20 mg TID.
- Half-life ≈ 4 hours, so three-times-daily dosing is required to maintain steady-state plasma levels.
- Metabolised primarily by CYP3A4 (major) and CYP2C9 (minor).
Sildenafil in PAH does NOT cure the disease — it is a symptomatic and haemodynamic treatment that slows progression and improves quality of life. Many patients progress on PDE5-inhibitor monotherapy and require add-on treatment with endothelin receptor antagonists and/or prostanoids. The treatment plan is managed by the PAH specialist.
When Assurans Is Used
FDA-approved / EMA-approved indications
- Pulmonary arterial hypertension (PAH, WHO Group 1) in adults — the primary indication. Includes idiopathic PAH, heritable PAH, drug-induced / toxin-induced PAH, PAH associated with connective tissue disease (systemic sclerosis, mixed connective tissue disease, lupus, rheumatoid arthritis), PAH associated with congenital heart disease, and PAH associated with HIV infection.
- Paediatric PAH (ages 1-17) — FDA approved 2012 with caution following the STARTS-2 trial observations. Use only in specialist paediatric PAH clinics, with attention to the dose-dependent mortality signal seen at higher paediatric doses (see FDA Drug Safety Communication, 2012 and 2014).
Off-label / specialist use
- High-altitude pulmonary oedema (HAPE) prevention and treatment — specialist mountain medicine use
- Persistent pulmonary hypertension of the newborn (PPHN) — neonatal intensive care setting
- PAH associated with left-heart disease (WHO Group 2) — generally NOT recommended; evidence suggests harm or no benefit
- Severe Raynaud’s phenomenon and digital ulcers in systemic sclerosis — specialist rheumatology decision
Uses that are NOT appropriate
- Erectile dysfunction — the 20 mg TID regimen is not the right dose profile for ED. ED requires higher (50-100 mg) on-demand doses. Patients wanting sildenafil for ED should use a dedicated 50-100 mg product such as Cenforce or Caverta — not a 20 mg PAH product.
- Unexplained breathlessness or fatigue — requires diagnostic workup (echocardiogram, right heart catheterisation, cardiopulmonary exercise testing) to identify the cause; PAH is one possibility among many.
- Left-sided heart failure (HFpEF or HFrEF) without confirmed PAH — sildenafil is NOT indicated and may be harmful.
- Chronic obstructive pulmonary disease (COPD) — not indicated for pulmonary hypertension secondary to COPD (WHO Group 3).
- Sleep apnoea-related pulmonary hypertension — treat the sleep apnoea first (CPAP/BiPAP); sildenafil is not the primary treatment.
Assurans Dose and How to Take
Standard adult dose
- 20 mg orally three times daily, approximately 4-6 hours apart (e.g. 08:00, 14:00, 20:00)
- Take with or without food — food delays absorption by about 1 hour but does not reduce total exposure
- Swallow the tablet whole with water. Do not crush or split.
- Consistency is essential — missing doses produces gaps in pulmonary vasodilation. Set reminders.
- If a dose is missed, take it as soon as you remember unless it is close to the next scheduled dose, in which case skip the missed dose — never double up.
Higher doses and titration
Although 80 mg three times daily has been studied in adult PAH, the additional benefit over 20 mg TID is minimal at best and side effects rise substantially. Current ESC/ERS and CHEST PAH guidelines recommend 20 mg TID as the standard adult dose. Higher doses are reserved for specialist cases.
Dose adjustment
- Severe hepatic impairment (Child-Pugh C): start at lower dose; specialist hepatology input
- Severe renal impairment (CrCl < 30 mL/min): clearance is reduced; start cautiously
- Concurrent strong CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone): dose reduction or avoidance required — specialist guidance
- Elderly (>65): no routine dose adjustment but monitor for side effects and drug interactions
Paediatric dose (specialist use only)
FDA-approved paediatric doses for PAH in children 1-17 years are 10 mg three times daily for body weight ≤ 20 kg, or 20 mg three times daily for body weight > 20 kg. However, the 2012 FDA Drug Safety Communication specifically cautioned against higher-than-recommended doses in children following the STARTS-2 trial mortality signal at 40 / 80 mg TID paediatric doses. Paediatric use should be confined to specialist paediatric PAH clinics.
Side Effects
Common (>10%)
- Headache (mild to moderate — often settles after 1-2 weeks)
- Facial flushing
- Dyspepsia, indigestion
Less common (1-10%)
- Epistaxis (nosebleed) — recognised PAH-sildenafil side effect; seek review if recurrent/severe
- Diarrhoea
- Back pain, limb pain, myalgia
- Nasal congestion
- Visual disturbances (blue-tinted vision, light sensitivity)
- Dizziness
- Insomnia
- Dyspnoea (though this is often a PAH feature rather than a drug side effect; distinguish with specialist)
Rare but serious — seek urgent medical attention
- Sudden vision loss (non-arteritic ischaemic optic neuropathy, NAION)
- Sudden hearing loss
- Severe hypotension, particularly with concomitant nitrates or alpha-blockers
- Pulmonary vascular obstructive disease worsening in patients with subclinical PVOD (rare)
- Stevens-Johnson syndrome (very rare)
- Prolonged priapism (erection >4 hours) in male patients — urgent urology
Contraindications & Warnings
- Nitrates in any form (nitroglycerin, isosorbide mono/dinitrate, amyl nitrite “poppers”) — ABSOLUTE contraindication; severe hypotension and death
- Riociguat (another PAH drug, soluble guanylate cyclase stimulator) — ABSOLUTE contraindication; both drugs raise cGMP, producing severe hypotension
- Pulmonary veno-occlusive disease (PVOD) — sildenafil can worsen pulmonary oedema
- Severe hepatic impairment — specialist decision
- Severe hypotension (baseline SBP < 90 mmHg) — relative contraindication
- Recent stroke or myocardial infarction (within 6 months)
- Hereditary retinitis pigmentosa or history of NAION
- Known hypersensitivity to sildenafil
- Pregnancy (Category B) — animal data reassuring but human data limited. PAH itself is a relative contraindication to pregnancy due to very high maternal mortality (>30% historically, ~15% with modern care). Specialist maternal-fetal-medicine + PAH clinic decision.
- Paediatric high-dose use — FDA-warned after STARTS-2 mortality signal; stay within guideline doses
Drug Interactions
| Drug / class | Effect |
|---|---|
| Nitrates (nitroglycerin, isosorbide mono/dinitrate, amyl nitrite) | ABSOLUTE contraindication — severe hypotension, death |
| Riociguat (Adempas, sGC stimulator for CTEPH / PAH) | ABSOLUTE contraindication — additive hypotension via cGMP |
| Other PDE5 inhibitors (tadalafil, vardenafil, avanafil) | Do not combine — no additional benefit, additive side effects |
| Endothelin receptor antagonists (bosentan, macitentan, ambrisentan) | Commonly combined in PAH — specialist-managed. Bosentan reduces sildenafil exposure via CYP3A4 induction; dose adjustment may be needed. |
| Prostacyclin analogues (epoprostenol, treprostinil, iloprost, selexipag) | Commonly combined in PAH — specialist-managed |
| Strong CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, clarithromycin) | Sildenafil levels rise substantially — dose reduction or avoidance |
| CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St John’s wort) | Sildenafil levels fall — may reduce efficacy |
| Alpha-blockers (doxazosin, tamsulosin, prazosin) | Additive hypotension — separate dosing or specialist advice |
| Anticoagulants / antiplatelets (warfarin, DOACs, aspirin, clopidogrel) | Sildenafil raises epistaxis risk; monitor more closely |
| Grapefruit juice | Inhibits CYP3A4 — raises sildenafil levels; avoid regular intake |
Storage
Store Assurans below 25°C in the original blister pack, away from direct sunlight and humidity. Keep out of reach of children. Use before the printed expiry date.
Frequently Asked Questions
Is Assurans the same as Viagra?
The active ingredient is the same (sildenafil citrate), but the strength (20 mg), dosing schedule (three times daily, continuous) and licensed indication (pulmonary arterial hypertension) are completely different from Viagra for erectile dysfunction. Assurans is the generic equivalent of Revatio (Pfizer’s PAH sildenafil), not Viagra. The two are not interchangeable.
Can I use Assurans for erectile dysfunction?
At 20 mg, Assurans is below the usual on-demand ED starter dose of 50 mg. Taking three 20 mg tablets at once (60 mg total) is pharmacologically similar to a 50 mg ED dose, but it is an off-label, unmonitored use, and not the intended purpose of the product. For erectile dysfunction, use a dedicated 50 or 100 mg product such as Cenforce, Caverta, or Penegra. Do not repurpose your PAH medication for ED without specialist guidance — missing PAH doses to redirect them to on-demand use is harmful.
Why three times daily? Can I take it once?
Sildenafil has a plasma half-life of about 4 hours. Once-daily dosing produces large troughs where the PDE5-inhibitor effect on the pulmonary vasculature is largely gone. Three-times-daily dosing maintains steady-state coverage for the continuous pulmonary-pressure-lowering effect needed in PAH. Changing to once or twice daily reduces efficacy. Tadalafil (Adcirca), with its much longer half-life, is the once-daily PDE5 option for PAH — discuss with your pulmonary hypertension clinic if adherence to TID dosing is difficult.
How quickly will I feel better?
Subjective improvement in exercise tolerance and breathlessness often emerges over 4-8 weeks of consistent treatment. Objective improvement on the 6-minute walk test typically takes 12 weeks in clinical trials. Haemodynamic improvement (right heart catheterisation) can be assessed at 12-24 weeks. PAH is a chronic condition — do not stop Assurans based on a “good day” or “bad day” — consistent long-term treatment is what slows disease progression.
What if I forget a dose?
Take the missed dose as soon as you remember unless it is within 2 hours of the next scheduled dose — in that case skip the missed dose and resume the normal schedule. Never double up. Consistency matters; use a phone alarm or a pill organiser.
Can I take Assurans with my other PAH medications?
PAH is commonly managed with combination therapy — sildenafil/tadalafil plus an endothelin receptor antagonist (bosentan, macitentan, ambrisentan), with prostanoid (epoprostenol, treprostinil, iloprost) added in advanced disease. These combinations are normal and specialist-managed. The ABSOLUTE exception is riociguat (Adempas), another soluble guanylate cyclase stimulator — this must NEVER be combined with sildenafil. Your PAH specialist manages these choices.
Can I take Assurans during pregnancy?
This is a specialist decision. Pulmonary arterial hypertension in pregnancy is associated with very high maternal mortality (around 15% with current care), and pregnancy is generally advised against in women with PAH. If pregnancy occurs, sildenafil is sometimes continued under joint PAH-clinic + maternal-fetal-medicine care — Category B data is reassuring in animal studies with limited human experience. Do not stop or start without specialist input.
Can my child take Assurans for paediatric PAH?
Paediatric PAH is an FDA-approved indication at weight-based doses (10 mg TID for ≤20 kg, 20 mg TID for >20 kg). However, the 2012 FDA Drug Safety Communication warned against higher-than-recommended paediatric doses following the STARTS-2 trial mortality signal at 40-80 mg TID in children. Paediatric use must be in a specialist paediatric PAH clinic, within FDA-recommended weight-based doses, with close monitoring.
What should I do if I develop a nosebleed?
Mild, infrequent nosebleeds are a recognised sildenafil-PAH side effect — manage with humidification, avoidance of nose-picking, and over-the-counter saline nasal spray. Seek urgent medical attention for: recurrent nosebleeds (several per week), nosebleeds lasting >15 minutes despite pressure, or large-volume bleeding. If you are on warfarin or a direct oral anticoagulant alongside Assurans, your anticoagulant may need temporary adjustment during active bleeding.
Where can I order Assurans online?
You can order Assurans 20 mg from MedsBase in pack sizes of 30 / 60 / 90 / 180 tablets. Orders ship worldwide with discreet packaging. Assurans is specialist-supervised in all jurisdictions; you should have a confirmed PAH diagnosis and specialist pulmonary hypertension clinic supervision.
Related Products on MedsBase
- Cenforce — sildenafil 25-200 mg for erectile dysfunction (different indication, different dose schedule)
- Caverta — sildenafil 50/100 mg for ED
- Penegra — sildenafil 100 mg for ED
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