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Silectone

Silectone is Sun Pharma’s spironolactone 25/50 mg tablets — mineralocorticoid receptor antagonist. Standard doses in heart failure (12.5-25 mg, target 25-50 mg per RALES), resistant hypertension (25-50 mg per PATHWAY-2), cirrhotic ascites (50-400 mg), and PCOS/hirsutism (50-200 mg). Potassium-sparing diuretic with delayed onset (24-72 hours via active metabolite canrenone). Monitor potassium closely.

Medicinsk gennemgået af Morgan Ellis — Apoteksforsker · 8 års erfaring  · Sidst gennemgået: maj 2026

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⚡ Quick Answer — What is Silectone?

Silectone er en 25 / 50 mg spironolactone tablet fra Sun Pharma — et mineralocorticoid receptor antagonist (aldosterone antagonist) der virker på mineralocorticoid receptor (MR) in the principal cells of the cortical collecting duct. Spironolactone was introduced by G.D. Searle in 1959 — designed as a synthetic steroid to antagonise aldosterone’s distal-tubule effect on sodium retention and potassium excretion. The first MR antagonist; remains the reference agent despite the availability of the more selective eplerenone. Half-life 1.4 hours (parent); 16-24 hours (active metabolites canrenone and 7-α-thiomethylspirolactone); onset 24-48 hours (needs time for receptor antagonism to manifest at the tissue level); peak effect 2-3 days; duration 2-3 days after discontinuation. Primary indication: heart failure with reduced ejection fraction (HF-REF), primary aldosteronism, resistant hypertension, cirrhotic ascites, adjunct treatment for hirsutism and PCOS. Typisk dosering: Resistent hypertension (BP not controlled on ACEi/ARB + CCB + thiazide): 25-50 mg once daily — PATHWAY-2 evidence. Spironolactone beats bisoprolol and doxazosin as the fourth agent in resistant HTN. Ikke et førstelinje antihypertensivt middel. Primary aldosteronism (Conn’s): 50-400 mg/day until potassium and BP normalise, then maintenance 25-100 mg. Key contraindications: see full list below. Monitor electrolytes, creatinine, and glucose. Kombiner ikke med lithium (thiazid-/loop-diuretika kan fremskynde lithiumtoksicitet). Brug under graviditet er tilfældesspecifik (se graviditetsnote). For de fleste hypertensionspatienter virker diuretika bedst som andet eller tredje middel — typisk kombineret med en ARB, ACE-hæmmer eller calciumkanalblokerer snarere end brugt alene.

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What Is Silectone?

Silectone is an oral 25 / 50 mg spironolactone tablet from Sun Pharma, supplied in 30-180 tablets. Spironolactone was introduced by G.D. Searle in 1959 — designed as a synthetic steroid to antagonise aldosterone’s distal-tubule effect on sodium retention and potassium excretion. The first MR antagonist; remains the reference agent despite the availability of the more selective eplerenone.

How Spironolactone Works

Spironolactone inhibits the mineralocorticoid receptor (MR) in the principal cells of the cortical collecting duct. De nedstrømmende effekter:

  • Blocks aldosterone at the mineralocorticoid receptor in principal cells of the cortical collecting duct
  • Reduced sodium reabsorption, reduced potassium secretion — mild natriurese med kaliumtilbageholdelse (kaliumbesparende)
  • Anti-fibrotic and anti-remodelling effect in myocardium — aldosterone drives cardiac fibrosis independent of its salt-retaining effect; blocking the receptor reduces fibrosis. This is the main mechanism of the HF-REF mortality benefit (RALES).
  • Anti-androgen activity — cross-reactivity with androgen and progesterone receptors produces gynaecomastia and menstrual irregularity as class side effects; same activity gives its off-label role in hirsutism and PCOS.
  • Delayed onset/offset (24-72 hours each direction) — receptor pharmacology plus long-acting active metabolites (canrenone)
  • Effective at resistant hypertension (PATHWAY-2) — acts on the subpopulation of hypertensives with covert aldosterone excess

Godkendte og evidensbaserede anvendelser

  • Heart failure with reduced ejection fraction (HF-REF), primary aldosteronism, resistant hypertension, cirrhotic ascites, adjunct treatment for hirsutism and PCOS — primær indikation
  • Heart failure with reduced ejection fraction (EF ≤35%) — RALES evidence, 25-50 mg daily
  • Primary aldosteronism (Conn’s syndrome) — definitive medical therapy for bilateral adrenal hyperplasia; bridging therapy for unilateral adenoma pre-surgery
  • Resistent hypertension — PATHWAY-2 evidence; fourth-line agent after ACEi/ARB + CCB + thiazide
  • Cirrhotic ascites — first-line diuretic in cirrhosis (loop diuretics added if response inadequate)
  • Hirsutism, PCOS-related acne, female-pattern hair loss — off-label anti-androgen therapy
  • Post-MI with LV dysfunction — eplerenone is preferred (EPHESUS trial specific)

Afgørende kliniske forsøgsresultater: RALES (1999) — landmark trial of spironolactone 25-50 mg in severe HF-REF; 30% reduction in all-cause mortality. Established aldosterone antagonism as standard HF-REF therapy. EPHESUS og EMPHASIS-HF extended to eplerenone. PATHWAY-2 (2015) — spironolactone 25-50 mg was the most effective fourth agent for resistant hypertension vs bisoprolol or doxazosin. TOPCAT — modest benefit in HF with preserved ejection fraction (HF-PEF); signal stronger in Americas arm than Russia arm (controversial).

Silectone Dosage

Heart dose: Resistent hypertension (BP not controlled on ACEi/ARB + CCB + thiazide): 25-50 mg once daily — PATHWAY-2 evidence. Spironolactone beats bisoprolol and doxazosin as the fourth agent in resistant HTN. Ikke et førstelinje antihypertensivt middel. Primary aldosteronism (Conn’s): 50-400 mg/day until potassium and BP normalise, then maintenance 25-100 mg.

Andre indikationer: Heart failure with reduced ejection fraction (EF ≤35%): 12.5-25 mg once daily; target 25-50 mg if tolerated (RALES trial). Cirrhotic ascites: 50-400 mg/day, usually with furosemide 20-160 mg (1:2.5 ratio); target 0.5 kg/day weight loss. Hirsutism / PCOS / acne (female patients): 50-200 mg/day — suppresses androgen-driven hair growth and acne over 3-6 months (off-label but well-established).

Administration: én gang dagligt (eller to gange dagligt for høj dosis loop-diuretika ved HF), om morgenen. Aftendosering forårsager nokturi og bør undgås når muligt. Tag på samme tidspunkt hver dag. Mad påvirker ikke absorptionen markant for nogen af disse diuretika.

Overvågningsplan:

  • Baseline: harnstoff, elektrolytter (især kalium og natrium), kreatinin, eGFR, glukose, serumurat. Hjemme- eller klinikblodtryk og daglig vægt for HF-patienter.
  • 1-2 uger efter start eller dosisændring: gentag U&E og kreatinin. Forvent milde elektrolytændringer; undersøg væsentlige ændringer.
  • 4-6 uger: Blodtryksgennemgang og fuldt metabolisk panel.
  • Løbende: årlig U&E, urat, glukose og lipidpanel når stabiliseret. Hyppigere ved CKD, HF eller ved kombinationsterapi.
  • Stop eller reducer dosis ved: sodium <130 with symptoms, potassium >5.5, creatinine rise >30%, new gout, severe dehydration symptoms.

Ophør: ingen abstinenssyndrom, men pludselig stop kan forårsake rebound-volumenretention hos HF-patienter på kronisk høj dosis loop-diuretika — trapp ned hvor muligt og overvåg vægt.

  • Non-selective steroid receptor activity causes gynaecomastia (5-10%), mastalgia, and menstrual irregularity via androgen and progesterone receptor effects. Eplerenone is selective for MR and avoids these; switch if gynaecomastia develops.
  • Delayed onset: effect takes 2-3 days to manifest and 2-3 days to wear off; dose adjustments should allow this lag.
  • Hyperkalaemia is the dose-limiting toxicity, particularly when combined with ACEi/ARB (standard in HF and HTN). Monitor potassium and creatinine at baseline, 1 week, 1 month, and every 3-4 months.
  • Contraception considerations: spironolactone is teratogenic (feminisation of male fetus) — women on spironolactone for acne/hirsutism must use reliable contraception.

Bivirkninger

Almindelige (>1%):

  • Hyperkaliæmi — dose-limiting; severe in CKD or with ACEi/ARB combinations
  • Gynaecomastia and mastalgia in men (5-10% at 25-50 mg; up to 50% at high doses >150 mg)
  • Menstrual irregularity in women
  • Erectile dysfunction and reduced libido in some men
  • Mild mave-tarmubehag
  • Metabol acidose (reduced distal H+ secretion) — usually mild
  • Stevens-Johnson syndrome — rare hypersensitivity reaction
  • Kreatininstigning — modest rise (10-20%) is expected on initiation; investigate if >30%

Ikke almindelige, men klinisk vigtige:

  • Alvorlig hyponatriæmi — især hos ældre med lav-salt diæt, SIADH-tilbøjelige tilstande eller kombineret med SSRI. Kan vise sig som forvirring, fald eller krampeanfald.
  • Pankreatitis — sjælden thiazid-/loop-virkning; stop umiddelbart ved øvre mavesmerter med stigning i lipase
  • Trombocytopeni, leukopeni, agranulocytose — sjældne overfølsomhedsreaktioner (mere almindelige med thiazider end loop-diuretika)
  • Akut myopi og vinkelblokglaukom — sjælden sulfonamid-klassereaktion inden for timer til dage efter start; stop umiddelbart ved pludselig øjensmerte eller synsændring
  • Stevens-Johnson syndrom / toksisk epidermal nekrolyse — ekstremt sjældent, men rapporteret
  • Svær hyperkaliæmi with cardiac arrhythmia — most common in CKD or with ACEi/ARB combination

Kontraindikationer

  • Hyperkaliæmi >5,5 mmol/L ved baseline — check before starting
  • Svær nyreinsufficiens (eGFR <30) — unacceptable hyperkalaemia risk
  • Addisons sygdom (primary adrenal insufficiency)
  • Graviditet — teratogenic (anti-androgen effect feminises male fetuses)
  • Concurrent potassium supplements — do not combine without monitoring
  • Concurrent other potassium-sparing diuretics (amiloride, triamterene, eplerenone)
  • Anuri

Graviditet: absolutely contraindicated — anti-androgen activity causes feminisation of male fetuses.

Amning: generelt acceptabelt i lave doser; høje doser kan hæmme laktation (især thiazider). Alternative antihypertensiva (propranolol, nifedipin) foretrækkes, når muligt.

Lægemiddelinteraktioner

  • Lithium — KRITISK INTERAKTION. Spironolactone has modest effect on lithium clearance compared with thiazides and loops, but monitor levels if combination is unavoidable.
  • NSAID'er — reducerer diuretisk effekt (via prostaglandinhæmning) og øger betydeligt risiko for akut nyreskade, når kombineret med ACE-hæmmer/ARB (“triple whammy”). Brug paracetamol som foretrukket ved kroniske smerter.
  • ACE-hæmmere og ARB — additive hyperkalaemia risk — monitor potassium closely, especially in CKD. Standard in HF-REF (ACEi/ARB + spironolactone) with careful monitoring; dangerous in patients with baseline K >5.0 or eGFR <30.
  • Kaliumtilskud og kaliumbesparende diuretika — do not combine; additive hyperkalaemia.
  • Digoxin — hypokalaemi forstærker digoxin-toksicitet (loop- og thiaziddiuretika); spironolacton reducerer digoxin-klaring direkte. Overvåg digoxinniveauer og kalium ved påbegyndelse eller ændring af diuretikum.
  • Orale kortikosteroider, amphotericin B, stimulerende afføringsmidler — additiv hypokalaemi (loop-/thiazid) eller maskeret kaliumbehov (spironolacton).
  • Orale antidiabetika, insulin — thiazider og (i mindre grad) loop-diuretika forværrer glucosetolerance; kan kræve dosisjustering.
  • Cholestyramin / colestipol — reducerer absorptionen af thiazider og loop-diuretika med 40-85%. Adskil dosering med 4 timer.
  • Stærke CYP3A4-hæmmere (clarithromycin, ritonavir, itraconazole) — raise canrenone metabolite levels; increase hyperkalaemia risk.
  • Alkohol — additiv postural hypotension.

Where Silectone Fits in the Diuretic Class

KlasseRepræsentanterTypisk anvendelse
ThiazidHCTZ, chlorthalidonFørstevalg ved HTN, nyresten, nefrogen DI
Thiazid-lignendeIndapamid, metolazonHTN (ældre, HYVET-evidence), sekventiel nefronblokade
Loop (kort)Furosemid, bumetanidAkut lungeødem, CHF, ascites, hyperkalcæmi
Loop (lang)TorasemidKronisk CHF, HTN (eneste loop med HTN-evidence), CKD-ødem
AldosteronantagonistSpironolakton, eplerenoneHF-REF (RALES), resistent HTN (PATHWAY-2), Conn’s, cirrhotisk ascites
Anden kaliumbesparendeAmilorid, triamteren (normalt i kombinationer)Forebyggelse af hypokaliæmi ved tilføjelse til loop/thiazid
Carbonic anhydraseAcetazolamidHøjdesyge, glaukom, metabol alkalose

Opbevaring

Store Silectone below 25°C in the original blister pack. Keep out of reach of children.

Ofte stillede spørgsmål

When should I take Silectone — morning or evening?

Morgen i næsten alle tilfælde. Den diuretiske virkning øger urinproduktionen i 2-8 timer efter dosering. Aftendosering forårsager nokturi og forstyrrer søvnen. Patienter på to-daglige loop-diuretika doserer typisk ved morgenmad og tidlig eftermiddag (ikke sengetid).

Is Silectone a first-line blood-pressure drug?

No — spironolactone is a fourth-line antihypertensive. It is the preferred add-on when BP remains uncontrolled on a three-drug combination of ACE inhibitor/ARB + calcium-channel blocker + thiazide (PATHWAY-2 trial evidence). It also has specific first-line roles in primær aldosteronisme, heart failure with reduced ejection fraction, og cirrhotic ascites.

Will Silectone affect my potassium?

Yes — spironolactone raises potassium (it is potassium-sparing). Hyperkalaemia (>5.5 mmol/L) is the main safety concern, especially when combined with ACE inhibitors or ARBs (which is the standard heart-failure combination). Check baseline potassium before starting, then at 1 week, 1 month, and every 3-4 months thereafter. Stop Silectone if potassium rises above 5.5 and investigate.

I have gout — can I take Silectone?

Yes — spironolactone is urate-neutral to mildly lowering and does not precipitate gout. It is a reasonable diuretic choice in gout patients.

I’m diabetic — is Silectone safe?

Yes. Spironolactone is metabolically neutral on glucose and lipids. It has specific evidence in diabetic HF patients (the RALES population included 26% diabetics) and does not worsen diabetic control.

Can I take ibuprofen with Silectone?

Lejlighedsvis kortvarig brug er normalt fint. Kronisk daglig brug af NSAID'er (ibuprofen, diclofenac, naproxen) reducerer diuretisk og antihypertensiv effekt of Silectone (prostaglandin blockade) and substantially raise the AKI risk when combined with an ACE inhibitor or ARB — the “triple whammy.” Use paracetamol preferentially for chronic pain.

Vil jeg skulle urinere mere om natten?

Usually no, if you take Silectone in the morning. The diuretic effect peaks 2-8 hours after dosing and has mostly worn off by evening. Nocturia is a common complaint when patients switch to evening dosing; switch back to morning dosing and nocturia resolves within 1-3 days.

Can I take Silectone in pregnancy?

Nej — absolut kontraindiceret. Spironolactone’s anti-androgen activity causes feminisation of male fetuses. Women of childbearing potential on spironolactone (for any indication, including acne and hirsutism) must use reliable contraception. For women planning pregnancy, switch to an alternative pre-conception.

Hvad hvis jeg glemmer en dosis?

Tag det så snart du husker det, medmindre det er næsten tid til din næste dosis — i så fald spring den glemte dosis over. Tag ikke en dobbeltdosis. En enkelt glemt dosis påvirker ikke langtidsblodtrykket eller væskebalancen markant.

Where can I buy Silectone online?

You can buy Silectone (25 / 50 mg spironolactone, 30-180 tablets) from MedsBase with discreet packaging and worldwide shipping.

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