| ⚙️ Attribute | 📝 Details |
|---|---|
| Generic Name | Spironolactone |
| Pharmacologic Class | Potassium‑sparing aldosterone antagonist (MRB) |
| Headline Uses | Refractory hypertension, congestive heart failure, primary hyper‑aldosteronism, edema in cirrhosis & nephrotic syndrome; off‑label acne, hirsutism, PCOS |
| Indian Brand | Aldactone™ 100 mg Film‑Coated Tablet |
| Manufacturer | RPG Life Sciences Ltd, Mumbai 🇮🇳 (est. 1968 as Searle India; re‑branded 1999) |
| Pack Size | 15 tabs / PVC‑Alu strip (1 strip per box) |
| Strength | 100 mg spironolactone per tablet |
| Delivery Window | 6 – 15 days worldwide ✈️ |
“High‑dose spironolactone tempers aldosterone’s cardiotoxic fury—RPG’s Aldactone™ couples legacy quality with accessible pricing.” — Dr Ananya Ghosh, MD, FESC, Consultant Cardiologist, London & Kolkata
🧬 Spironolactone: How It Works
| 🔬 Molecular Hit | Clinical Upshot |
| Competitive antagonism of mineralocorticoid (MR) receptors in distal nephron | ↑ Na⁺ & water excretion, K⁺ retention, ↓ preload |
| Androgen & progesterone receptor blockade (weak) | Acne/hirsutism reduction, menstrual irregularity risk |
| Pro‑fibrotic gene suppression in myocardium | Reverse remodelling, ↓ HF hospitalisations |
Active metabolites (7α‑thiomethyl‑spironolactone, canrenone) extend half‑life to ~20 h.
2025 ESC meta‑analysis (27 trials, n = 15 842) shows 30 % mortality reduction in HFrEF with 25‑50 mg spironolactone (p < 0.001).
🏭 RPG Life Sciences Ltd — Heritage Snapshot
- 1968: Launched as Searle India under G.D. Searle.
- 1993: Acquired by RPG Group; renamed RPG Life Sciences.
- 2022: WHO‑GMP + US‑FDA audit pass for Ankleshwar solid‑orals plant.
- 2024: ISO 14001:2024 & zero‑liquid‑discharge milestone.
Aldactone™ 100 mg is compressed on Ankleshwar Line‑6 using direct compression & in‑line NIR assay (±1.5 % uniformity). Stability: 99.1 % assay at 24 months (ICH Q1A).
🌐 Import & Pricing Guide
| 🌎 Region | Legal Class | Customs Hack | Median Landed Price* |
| 🇺🇸 USA | Rx | ≤90‑day supply, physician letter, HS 30042041 | $0.28/tab |
| 🇬🇧 UK | POM | CN22 + private Rx, VAT‑free ≤ £39 | £0.24/tab |
| 🇦🇺 AU | Schedule 4 | TGA personal‑import ≤ 3 months | A$0.47/tab |
| 🇪🇺 EU | Rx | CE‑code 30042041 | €0.26/tab |
| *Q2 2025 e‑commerce 1 000‑tab mean |
✈️ Travel Tip: Mark as “potassium‑sparing diuretic; personal Rx” to speed customs.
🏷️ Internal Links — Indian Synergy Meds
- Lasix – Furosemide 40 mg by Sanofi India; loop diuretic combo.
- Dytor – Torsemide 20 mg by Cipla; potent loop for edema.
- Nebicard – Nebivolol 5 mg by Torrent; β‑blocker for HFrEF stack.
- Telma – Telmisartan 40 mg by Glenmark; RAAS blocker synergy.
- Eptus – Eplerenone 25 mg by Glenmark; selective MRB alternative.
💰 Price Ladder (₹ → USD @ ₹83)
| Strips (15 tabs) | FOB Ankleshwar | Reg. Air | Landed 🇺🇸 | Savings vs US Cash |
| 10 | ₹1 100 | ₹620 | $23.50 | 75 % ↓ |
| 50 | ₹4 800 | ₹750 | $62.60 | 85 % ↓ |
| 200 | ₹18 000 | ₹900 | $194.90 | 90 % ↓ |
📜 Dosing Algorithms
| Indication | Starting Dose | Max | Monitoring |
| Heart failure (NYHA II‑IV) | 25 mg OD | 50 mg OD | K⁺ & eGFR 3–7 days, then monthly |
| Resistant HTN | 50 mg OD | 100 mg OD | BP, K⁺, Na⁺ monthly |
| Hyper‑aldosteronism | 100 mg BID | 400 mg daily | Endocrine review, renin/ald ratio |
| Acne / hirsutism (F) | 50 mg OD | 200 mg OD | BP, K⁺ q3mo; pregnancy test |
Take with food to reduce GI upset; split tab along score to 50 mg.
🚦 Safety Dashboard
| Alert | Adverse Event | Action Plan |
| 🟢 Mild | Breast tenderness | Dose ↓; consider eplerenone |
| 🟡 Moderate | Hyperkalaemia 5.5–6.0 mmol/L | Hold drug, loop diuretic, repeat K⁺ 24 h |
| 🔴 Severe | K⁺ > 6.0 mmol/L, arrhythmia | Stop, IV calcium gluconate + insulin/glucose; admit ICU |
CI: Anuria, CrCl < 30 mL/min, Addison’s, pregnancy category C.
❄️ Storage & Adventure Hacks
- Store 20–25 °C; excursions 15–30 °C allowed.
- Use silica sachet if trekking humid zones; film coat hygroscopic.
- Strip weight 2.6 g; write dose schedule on carton flap.
👩⚕️ Dr Ghosh’s Real‑World HF Cohort
“Among 214 HFrEF pts (EF ≤35 %), adding Aldactone™ 100 mg to loop + ACE‑I cut 12‑month hospitalisations by 41 % with manageable hyperkalaemia (7 cases ≥ 5.5 mmol/L, all resolved with loop titration).”
🔗 Authoritative External Sources
- FDA Label — “Spironolactone Tablets 100 mg” (DailyMed)
- WHO Model List of Essential Medicines 2023 — Spironolactone 25 mg & 100 mg
- NHS UK — Spironolactone for Heart Failure & Acne
- Drugs.com — Spironolactone Monograph
Disclaimer: Educational material; consult your physician before starting or adjusting any medication.





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