ALDORIL D30
Clinical safety rating
cautionComprehensive clinical and safety monograph for ALDORIL D30 (ALDORIL D30).
Aldoril D30 is a combination of methyldopa, a centrally acting alpha-2 adrenergic agonist that reduces sympathetic outflow, and hydrochlorothiazide, a thiazide diuretic that inhibits the sodium-chloride symporter in the distal convoluted tubule, decreasing plasma volume and peripheral resistance.
| Metabolism | Methyldopa is metabolized by conjugation (catechol-O-methyltransferase) and hepatic sulfation; hydrochlorothiazide is not extensively metabolized and is excreted unchanged by the kidney. |
| Excretion | Renal: approximately 50% as parent drug and metabolites; biliary/fecal: minimal, less than 5%. |
| Half-life | Terminal elimination half-life of hydrochlorothiazide is 6-15 hours; methyldopa half-life is 1.8 hours (normal renal function). In renal impairment, half-life of both components is prolonged. |
| Protein binding | Methyldopa: <10% bound to plasma proteins; hydrochlorothiazide: 40-68% bound to albumin. |
| Volume of Distribution | Methyldopa: Vd 0.2-0.3 L/kg (distributes into tissues, crosses placenta); hydrochlorothiazide: Vd 0.75-1.5 L/kg (extensively distributed, does not cross blood-brain barrier significantly). |
| Bioavailability | Oral bioavailability of methyldopa is approximately 25% (variable, influenced by gut metabolism); hydrochlorothiazide bioavailability is 65-75%. |
| Onset of Action | Oral: antihypertensive effect begins within 2-3 hours for methyldopa; diuretic effect of hydrochlorothiazide starts within 2 hours. |
| Duration of Action | Oral: antihypertensive effect lasts 12-24 hours (methyldopa); diuretic effect of hydrochlorothiazide lasts 6-12 hours. |
| Molecular Weight | Methyldopa: 211.22 Da; Hydrochlorothiazide: 297.74 Da |
Oral: 1 tablet (hydrochlorothiazide 30 mg / methyldopa 500 mg) twice daily; maximum dose: 2 tablets twice daily.
| Dosage form | TABLET |
| Renal impairment | GFR 30-60 mL/min: reduce dose by 50%; GFR <30 mL/min: not recommended. |
| Liver impairment | Child-Pugh Class B or C: contraindicated; use not recommended. |
| Pediatric use | Not recommended for use in pediatric patients due to lack of safety and efficacy data. |
| Geriatric use | Start with lowest dose; monitor for hypotension, electrolyte imbalance, and CNS effects; consider reduced initial dose. |
| 1st trimester | Use only if clearly needed; risk of teratogenicity not fully excluded. Hydrochlorothiazide may cause fetal/neonatal adverse effects. Methyldopa is preferred antihypertensive in pregnancy. |
| 2nd trimester | May cause fetal/neonatal adverse effects including electrolyte disturbances, hypotension, and hypoglycemia. Use only if benefit outweighs risk. |
| 3rd trimester | May cause fetal/neonatal adverse effects including electrolyte disturbances, hypotension, and hypoglycemia. Avoid in prolonged labor or preeclampsia. |
Clinical note
Comprehensive clinical and safety monograph for ALDORIL D30 (ALDORIL D30).
| Placental transfer | Both components cross the placenta. Methyldopa achieves fetal concentrations similar to maternal; hydrochlorothiazide crosses and may cause fetal effects. |
| Breastfeeding | Both methyldopa and hydrochlorothiazide are excreted in breast milk. Methyldopa is considered compatible; hydrochlorothiazide may suppress lactation and cause neonatal electrolyte disturbances. Use with caution. |
| Lactation Rating | L3 (Methyldopa L2; Hydrochlorothiazide L3) |
| Teratogenic Risk | First trimester: Limited data; no clear evidence of major malformations but methyldopa crosses placenta. Second and third trimesters: Associated with reduced placental perfusion; possible fetal bradycardia and neonatal hypotension. Hydrochlorothiazide may cause fetal/neonatal jaundice, thrombocytopenia, and electrolyte disturbances. |
| Fetal Monitoring | Regular maternal blood pressure monitoring; fetal heart rate monitoring; ultrasound for fetal growth and amniotic fluid volume; neonatal monitoring for hypotension and electrolyte imbalance post-delivery. |
| Fertility Effects | No data indicate adverse effects on fertility from methyldopa or hydrochlorothiazide. Thiazides may rarely cause erectile dysfunction, but no known female fertility impairment. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to methyldopa, hydrochlorothiazide, or sulfonamide-derived drugsActive hepatic disease or cirrhosisMonoamine oxidase (MAO) inhibitor therapyAnuriaSevere renal impairment (creatinine clearance <30 mL/min)
| Precautions | May cause hemolytic anemia, liver disorders, positive Coombs test, sedation, depression, and hypersensitivity reactions. Hydrochlorothiazide may cause electrolyte imbalance, hyperuricemia, photosensitivity, and exacerbation of systemic lupus erythematosus. Use with caution in renal impairment, hepatic disease, and in patients with a history of drug-induced hemolytic anemia. |
| Food/Dietary | Food may decrease absorption of methyldopa. Avoid excessive intake of high-potassium foods (e.g., bananas, oranges) unless directed. Hydrochlorothiazide may cause potassium depletion; maintain adequate dietary potassium. Avoid natural licorice as it can worsen hypokalemia. |
| Clinical Pearls | ALDORIL D30 combines methyldopa (central alpha-2 agonist) and hydrochlorothiazide (thiazide diuretic). Monitor for orthostatic hypotension, especially at initiation. Taper not needed for methyldopa but discontinue if fever or liver dysfunction occurs. Interferes with urinary catecholamine measurements (false elevation). Hydrochlorothiazide may cause hyponatremia, hypokalemia, and hyperglycemia; check electrolytes and glucose periodically. |
| Patient Advice | Take exactly as prescribed, preferably with food to reduce stomach upset. · Rise slowly from sitting or lying down to prevent dizziness. · This drug may make you drowsy; avoid driving or operating machinery until you know how it affects you. · Report fever, unexplained fatigue, jaundice, or dark urine immediately. · Weigh yourself daily and report rapid weight gain or swelling. · Limit alcohol intake as it can increase side effects. · Do not use salt substitutes containing potassium without consulting your doctor. |
Loading safety data…