AMTURNIDE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMTURNIDE (AMTURNIDE).
AMTURNIDE is a combination of amiloride, a potassium-sparing diuretic that inhibits sodium reabsorption in the distal convoluted tubule and collecting duct, and hydrochlorothiazide, a thiazide diuretic that inhibits sodium chloride reabsorption in the distal convoluted tubule. The combination produces additive diuretic and antihypertensive effects with reduced potassium loss.
| Metabolism | Amiloride is not metabolized and is excreted unchanged in the urine. Hydrochlorothiazide is not extensively metabolized; the majority is excreted unchanged in the urine via renal tubular secretion. |
| Excretion | Primarily renal excretion as unchanged drug (70%) and glucuronide conjugate (15%); biliary/fecal elimination accounts for 10%. |
| Half-life | Terminal elimination half-life is 12 hours (range 10–14 hours); steady-state achieved within 2–3 days. |
| Protein binding | 98% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd = 0.15–0.25 L/kg; indicates primarily extracellular distribution. |
| Bioavailability | Oral: 40–50% due to first-pass metabolism. |
| Onset of Action | Oral: 30–60 minutes; intravenous: within 5 minutes. |
| Duration of Action | 12–24 hours; clinical effect persists for up to 24 hours in patients with normal renal function. |
10 mg to 20 mg orally once daily, with or without food.
| Dosage form | TABLET |
| Renal impairment | eGFR ≥30 mL/min/1.73 m²: no adjustment. eGFR 15-29 mL/min/1.73 m²: reduce dose to 10 mg once daily. eGFR <15 mL/min/1.73 m² or dialysis: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose to 10 mg once daily. Child-Pugh C: not recommended. |
| Pediatric use | Safety and efficacy not established; no recommended dose. |
| Geriatric use | No specific dose adjustment required, but monitor renal function closely due to age-related decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMTURNIDE (AMTURNIDE).
| Breastfeeding | No data on presence in human milk. Finerenone and its metabolites are excreted in rat milk. M/P ratio not determined in humans. Due to potential for serious adverse reactions in nursing infants (e.g., hyperkalemia, hypotension), breastfeeding is not recommended during therapy. |
| Teratogenic Risk | FDA Pregnancy Category C. In animal studies, amturnide (finerenone) caused embryofetal toxicity (reduced fetal body weight, delayed ossification, and increased resorptions) at maternal toxic doses. There are no adequate human studies. Risk cannot be ruled out; use only if potential benefit justifies potential risk. First trimester: unknown risk. Second/third trimester: potential for fetal renal effects due to mineralocorticoid receptor blockade. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Anuria","Acute or chronic renal insufficiency","Severe renal impairment (eGFR <30 mL/min)","Hyperkalemia (serum potassium >5.5 mEq/L)","Hypersensitivity to amiloride, hydrochlorothiazide, or sulfonamide-derived drugs","Concomitant use with potassium-sparing diuretics, potassium supplements, or other drugs that increase potassium (e.g., ACE inhibitors, ARBs)"]
| Precautions | ["Hyperkalemia: Risk is increased in patients with renal impairment, diabetes, or elderly. Monitor serum potassium levels.","Hypersensitivity reactions: May occur with sulfonamide derivatives (hydrochlorothiazide).","Acute angle-closure glaucoma: Has been reported with sulfonamide derivatives.","Electrolyte imbalances: Including hyponatremia, hypochloremia, hypomagnesemia, and hypokalemia.","Renal impairment: Use with caution; may precipitate azotemia.","Hepatic impairment: Use with caution; may precipitate hepatic encephalopathy.","Diabetes: Thiazides may impair glucose tolerance.","Gout: Thiazides may increase serum uric acid levels.","SLE exacerbation: Thiazides may exacerbate systemic lupus erythematosus."] |
| Food/Dietary |
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| Fetal Monitoring | Monitor maternal serum potassium, blood pressure, and renal function (serum creatinine, eGFR) at baseline and periodically. Fetal monitoring: ultrasound assessment for growth restriction and amniotic fluid volume if used in second/third trimester. |
| Fertility Effects | In animal studies, no adverse effects on fertility observed in male or female rats at exposures up to 10 times the human AUC. Human data are lacking; theoretical risk of hormonal disruption cannot be excluded. |
| Administration with food decreases absorption and may reduce efficacy. Take at least 30 minutes before a meal. No specific food-drug interactions reported. |
| Clinical Pearls | AMTURNIDE is a first-in-class guanylate cyclase-C receptor agonist for irritable bowel syndrome with constipation (IBS-C). It increases intestinal fluid secretion and transit without significant systemic absorption. Onset of action may occur within 24 hours, but full response may take 2-4 weeks. Avoid in patients with known or suspected mechanical gastrointestinal obstruction. Dose adjustment not required for renal or hepatic impairment. |
| Patient Advice | Take once daily on an empty stomach at least 30 minutes before the first meal of the day. · Do not crush or chew the capsule; swallow whole with water. · Common side effects include diarrhea, abdominal pain, and flatulence; diarrhea is most frequent. · Seek medical attention if you experience severe or bloody diarrhea. · Notify your doctor if you are pregnant, breastfeeding, or have a history of bowel obstruction. |