CAPOZIDE 25/25
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CAPOZIDE 25/25 (CAPOZIDE 25/25).
Captopril: angiotensin-converting enzyme (ACE) inhibitor that blocks conversion of angiotensin I to angiotensin II, reducing vasoconstriction and aldosterone secretion. Hydrochlorothiazide: thiazide diuretic that inhibits sodium-chloride symporter in distal convoluted tubule, increasing sodium, chloride, and water excretion.
| Metabolism | Captopril: metabolized to disulfide dimers via oxidation. Hydrochlorothiazide: not metabolized; excreted unchanged in urine. |
| Excretion | Captopril: renal 95% (40-50% unchanged), biliary/fecal <5%. Hydrochlorothiazide: renal >95% (unchanged), biliary/fecal minimal. |
| Half-life | Captopril: ~2 hours (increased in renal impairment). Hydrochlorothiazide: 6-15 hours (prolonged in renal impairment). Clinical context: trough effect may diminish with once-daily dosing; twice-daily dosing often used. |
| Protein binding | Captopril: 25-30% (mainly albumin). Hydrochlorothiazide: 40-68% (albumin). |
| Volume of Distribution | Captopril: 0.6-0.7 L/kg (widely distributed, including into breast milk). Hydrochlorothiazide: 0.8-1.0 L/kg (crosses placenta, minimal CNS). |
| Bioavailability | Captopril oral: 60-75% (reduced by food). Hydrochlorothiazide oral: 65-70%. |
| Onset of Action | Captopril oral: 15-30 min (peak effect 60-90 min). Hydrochlorothiazide oral: 2 hours (peak diuresis at 4-6 hours). |
| Duration of Action | Captopril: 6-12 hours (dose-dependent, antihypertensive effect). Hydrochlorothiazide: 6-12 hours (diuresis). Clinical note: once-daily dosing may require higher doses for 24-hour blood pressure control. |
| Molecular Weight | 432.49 |
1 tablet (captopril 25 mg / hydrochlorothiazide 25 mg) orally once daily initially; may titrate up to 2 tablets per day as needed.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-50 mL/min: Captopril maximum 75 mg/day. CrCl <30 mL/min: Avoid use. Not recommended due to thiazide inefficacy. |
| Liver impairment | Mild to moderate impairment (Child-Pugh A or B): Use with caution; no specific dose adjustment guidelines. Severe impairment (Child-Pugh C): Avoid use due to risk of electrolyte imbalance and encephalopathy. |
| Pediatric use | Not recommended; safety and efficacy not established in children. |
| Geriatric use | Initiate with lowest dose (e.g., captopril 12.5 mg/hydrochlorothiazide 12.5 mg) and titrate slowly. Monitor renal function and electrolytes frequently. |
| 1st trimester | Avoid use in first trimester; may cause oligohydramnios and fetal harm. |
| 2nd trimester | Contraindicated in second trimester; risk of fetal hypotension, anuria, and renal failure. |
| 3rd trimester | Contraindicated in third trimester; risk of neonatal hypotension, hyperkalemia, and oliguria. |
Clinical note
Comprehensive clinical and safety monograph for CAPOZIDE 25/25 (CAPOZIDE 25/25).
| Placental transfer | Captopril crosses the placenta; hydrochlorothiazide crosses the placenta with detectable levels in fetal blood. |
| Breastfeeding | Captopril and hydrochlorothiazide are excreted in human milk in low amounts. Potential for adverse effects in nursing infants, including electrolyte disturbances and renal impairment. Use only if benefit outweighs risk. |
■ FDA Black Box Warning
Fetal toxicity: drugs acting directly on renin-angiotensin system can cause fetal morbidity and death. Discontinue as soon as possible when pregnancy is detected.
| Serious Effects |
PregnancyHistory of angioedema with ACE inhibitorsAnuriaHypersensitivity to sulfonamide-derived drugs (hydrochlorothiazide)Concomitant use with aliskiren in patients with diabetes
| Precautions | Angioedema, Hypotension, Renal impairment, Hyperkalemia, Sulfonamide allergy cross-reactivity, Electrolyte disturbances, Exacerbation of gout, Systemic lupus erythematosus exacerbation |
| Food/Dietary | Avoid high-potassium foods (e.g., bananas, oranges, tomatoes, spinach) unless directed; captopril can raise potassium. Limit alcohol intake as it may enhance hypotensive effects. Avoid salt substitutes with potassium chloride. |
Loading safety data…
| Lactation Rating |
| L3 - Moderately Safe |
| Teratogenic Risk | First trimester: Increased risk of congenital malformations (neural tube defects, cardiac anomalies) based on ACE inhibitor class. Second and third trimesters: Fetal renal dysfunction, oligohydramnios, skull hypoplasia, hypotension, anuria, and death. Capozide contains captopril (ACE inhibitor) and hydrochlorothiazide. Thiazide diuretics may cause fetal electrolyte disturbances, thrombocytopenia, and jaundice. |
| Fetal Monitoring | Monitor maternal renal function, serum electrolytes, blood pressure, and urine output. Obtain fetal ultrasound for oligohydramnios and renal abnormalities. Monitor fetal growth and amniotic fluid index. Assess umbilical artery Doppler if indicated. |
| Fertility Effects | ACE inhibitors have been associated with reversible decrease in testosterone and sperm motility in animal studies; clinical significance in humans is uncertain. Thiazide diuretics have not been linked to significant fertility impairment. |
| Clinical Pearls | CAPOZIDE 25/25 is a fixed-dose combination of captopril 25 mg and hydrochlorothiazide 25 mg. Monitor serum potassium closely; hydrochlorothiazide can cause hypokalemia while captopril can cause hyperkalemia, so net effect may be variable. Check renal function and electrolytes at baseline and periodically. Discontinue if angioedema occurs. Avoid use in pregnancy (ACE inhibitors can cause fetal injury). |
| Patient Advice | Take exactly as prescribed, usually once or twice daily. Do not stop without consulting your doctor. · This medication can cause dizziness or lightheadedness, especially when standing up quickly. Rise slowly from sitting or lying down. · Report any signs of angioedema: swelling of face, lips, tongue, or difficulty breathing. Seek emergency help immediately. · Avoid salt substitutes containing potassium unless approved by your doctor. · Stay well-hydrated, but avoid excessive fluid intake to prevent electrolyte imbalance. · This drug may interact with NSAIDs (e.g., ibuprofen) and lithium. Inform your doctor of all medications. · If you become pregnant or plan to become pregnant, stop the medication and notify your doctor immediately. |