HYDROMOX R

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HYDROMOX R (HYDROMOX R).

How it works

Thiazide-like diuretic that inhibits sodium-chloride cotransport in the distal convoluted tubule, increasing excretion of sodium, chloride, and water.

What the body does with it

Metabolism	Primarily hepatically metabolized via cytochrome P450 enzymes (CYP3A4 and others).
Excretion	Renal: approximately 70% as unchanged drug; biliary/fecal: approximately 30% as unchanged drug and metabolites.
Half-life	Terminal elimination half-life is approximately 2 hours in patients with normal renal function; may be prolonged in renal impairment.
Protein binding	Approximately 90% bound to plasma proteins, primarily albumin.
Volume of Distribution	Approximately 3 L/kg; indicates extensive tissue distribution.
Bioavailability	Oral bioavailability is approximately 65-70% due to first-pass metabolism.
Onset of Action	Oral: within 2 hours; peak effect at 3-6 hours.
Duration of Action	Approximately 12-24 hours; diuresis continues for about 12 hours after oral administration.

Classification & Brands

Dosing & administration

Oral, 50 mg once daily, increased to 100 mg once daily if needed.

Dosage form	TABLET
Renal impairment	GFR 10-50 mL/min: 50 mg every 48 hours; GFR <10 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 50 mg every 48 hours; Child-Pugh C: not recommended.
Pediatric use	Not established; safety and efficacy not determined.
Geriatric use	Initiate at 25 mg once daily; titrate cautiously due to increased sensitivity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for HYDROMOX R (HYDROMOX R).

Breastfeeding	Excreted in breast milk in low concentrations; M/P ratio unknown. Use with caution in nursing mothers, especially neonates with jaundice or electrolyte imbalances.
Teratogenic Risk	First trimester: No evidence of major malformations in human studies, but animal studies show fetal toxicity at high doses. Second and third trimesters: Use may cause fetal or neonatal jaundice, thrombocytopenia, and electrolyte disturbances. Avoid use for pregnancy-induced hypertension due to decreased placental perfusion.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

Anuria, hypersensitivity to thiazide diuretics or sulfonamides, severe hepatic impairment, severe hyponatremia, history of gout or hyperuricemia with symptoms.

Clinical Precautions

Precautions

May cause hypokalemia, hypomagnesemia, and hyperuricemia; monitor electrolytes and renal function. May precipitate hepatic coma in patients with hepatic cirrhosis. Increased risk of photosensitivity and lupus-like reactions.

Clinical Tips & Counseling

Drug interactions

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HYDROMOX R

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HYDROMOX R (HYDROMOX R).

How it works

Thiazide-like diuretic that inhibits sodium-chloride cotransport in the distal convoluted tubule, increasing excretion of sodium, chloride, and water.

What the body does with it

Metabolism	Primarily hepatically metabolized via cytochrome P450 enzymes (CYP3A4 and others).
Excretion	Renal: approximately 70% as unchanged drug; biliary/fecal: approximately 30% as unchanged drug and metabolites.
Half-life	Terminal elimination half-life is approximately 2 hours in patients with normal renal function; may be prolonged in renal impairment.
Protein binding	Approximately 90% bound to plasma proteins, primarily albumin.
Volume of Distribution	Approximately 3 L/kg; indicates extensive tissue distribution.
Bioavailability	Oral bioavailability is approximately 65-70% due to first-pass metabolism.
Onset of Action	Oral: within 2 hours; peak effect at 3-6 hours.
Duration of Action	Approximately 12-24 hours; diuresis continues for about 12 hours after oral administration.

Classification & Brands

Dosing & administration

Oral, 50 mg once daily, increased to 100 mg once daily if needed.

Dosage form	TABLET
Renal impairment	GFR 10-50 mL/min: 50 mg every 48 hours; GFR <10 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 50 mg every 48 hours; Child-Pugh C: not recommended.
Pediatric use	Not established; safety and efficacy not determined.
Geriatric use	Initiate at 25 mg once daily; titrate cautiously due to increased sensitivity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for HYDROMOX R (HYDROMOX R).

Breastfeeding	Excreted in breast milk in low concentrations; M/P ratio unknown. Use with caution in nursing mothers, especially neonates with jaundice or electrolyte imbalances.
Teratogenic Risk	First trimester: No evidence of major malformations in human studies, but animal studies show fetal toxicity at high doses. Second and third trimesters: Use may cause fetal or neonatal jaundice, thrombocytopenia, and electrolyte disturbances. Avoid use for pregnancy-induced hypertension due to decreased placental perfusion.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

Anuria, hypersensitivity to thiazide diuretics or sulfonamides, severe hepatic impairment, severe hyponatremia, history of gout or hyperuricemia with symptoms.