INDERIDE LA 120/50

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INDERIDE LA 120/50 (INDERIDE LA 120/50).

How it works

Propranolol is a nonselective beta-adrenergic receptor antagonist that blocks beta-1 and beta-2 receptors, decreasing heart rate, myocardial contractility, and blood pressure. Hydrochlorothiazide is a thiazide diuretic that inhibits the Na+/Cl- symporter in the distal convoluted tubule, reducing sodium reabsorption and promoting diuresis.

What the body does with it

Metabolism	Propranolol is extensively metabolized in the liver primarily by CYP2D6 and to a lesser extent CYP1A2, with three major metabolites (4-hydroxypropranolol, naphthoxylactic acid, glucuronide conjugates). Hydrochlorothiazide is not metabolized and excreted unchanged in urine.
Excretion	Primarily hepatic metabolism (90%+), with <5% excreted unchanged in urine. Biliary/fecal elimination accounts for negligible amounts.
Half-life	Propranolol: 3-6 hours; Hydrochlorothiazide: 6-15 hours. Note: Inderide LA is an extended-release formulation; effective half-life extended to approximately 8-12 hours for propranolol component.
Protein binding	Propranolol: 90% bound primarily to albumin and alpha-1-acid glycoprotein; Hydrochlorothiazide: 40-68% bound to albumin.
Volume of Distribution	Propranolol: 4 L/kg, indicating extensive tissue distribution; Hydrochlorothiazide: 3-4 L/kg, distributing into extracellular fluid.
Bioavailability	Propranolol: 25-30% due to extensive first-pass metabolism; Hydrochlorothiazide: 65-75%. For Inderide LA, bioavailability of propranolol is approximately 30% relative to immediate-release.
Onset of Action	Oral: 1-2 hours for beta-blockade; diuretic effect begins within 2 hours.
Duration of Action	24 hours for once-daily dosing due to extended-release formulation. Antihypertensive effect persists for at least 24 hours.

Classification & Brands

Dosing & administration

One capsule orally once daily, containing 120 mg propranolol HCl and 50 mg hydrochlorothiazide.

Dosage form	CAPSULE, EXTENDED RELEASE
Renal impairment	Contraindicated in anuria; for GFR 15-29 mL/min, reduce dose or increase interval; for GFR <15 mL/min, avoid use.
Liver impairment	Child-Pugh Class B: reduce propranolol dose by 50%; Child-Pugh Class C: avoid use due to propranolol accumulation.
Pediatric use	Not recommended for pediatric use due to fixed-dose combination; safety and efficacy not established.
Geriatric use	Initiate with lowest available strength (e.g., half capsule) and titrate slowly; monitor for hypotension, bradycardia, and electrolyte disturbances.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for INDERIDE LA 120/50 (INDERIDE LA 120/50).

Breastfeeding	Propranolol is excreted into breast milk in low amounts (M/P ratio ~0.8). Hydrochlorothiazide appears in milk but in small quantities. Combined, risk to infant is low, but monitor for bradycardia, hypotension, and diuretic effects. Use caution in preterm infants or with compromised renal function.
Teratogenic Risk	First trimester: Epidemiological studies do not indicate a significant increase in congenital anomalies; however, beta-blockers can cause fetal bradycardia and growth restriction starting in second trimester. Third trimester: Risk of neonatal bradycardia, hypoglycemia, and respiratory depression due to beta-blockade. Considered compatible if benefit outweighs risk; avoid near term.

Warnings & precautions

■ FDA Black Box Warning

Exacerbation of ischemic heart disease: Do not abruptly discontinue therapy; taper dose over 1-2 weeks. If exacerbation occurs, reinstate beta-blocker therapy temporarily.

Side Effect Profile

Serious Effects

Absolute Contraindications

Sinus bradycardia, heart block greater than first degree, cardiogenic shock, overt cardiac failure, bronchial asthma, hypersensitivity to propranolol or hydrochlorothiazide, anuria (thiazide component).

Clinical Precautions

Precautions

Cardiac failure: Avoid in patients with overt or decompensated heart failure. Bronchospastic disease: Generally contraindicated in patients with asthma or COPD. Diabetes mellitus: Beta-blockers may mask hypoglycemic symptoms. Renal impairment: Hydrochlorothiazide may precipitate azotemia. Electrolyte disturbances: Monitor for hypokalemia, hyponatremia, hypomagnesemia due to thiazide.

Clinical Tips & Counseling

Drug interactions

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INDERIDE LA 120/50

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INDERIDE LA 120/50 (INDERIDE LA 120/50).

How it works

What the body does with it

Metabolism	Propranolol is extensively metabolized in the liver primarily by CYP2D6 and to a lesser extent CYP1A2, with three major metabolites (4-hydroxypropranolol, naphthoxylactic acid, glucuronide conjugates). Hydrochlorothiazide is not metabolized and excreted unchanged in urine.
Excretion	Primarily hepatic metabolism (90%+), with <5% excreted unchanged in urine. Biliary/fecal elimination accounts for negligible amounts.
Half-life	Propranolol: 3-6 hours; Hydrochlorothiazide: 6-15 hours. Note: Inderide LA is an extended-release formulation; effective half-life extended to approximately 8-12 hours for propranolol component.
Protein binding	Propranolol: 90% bound primarily to albumin and alpha-1-acid glycoprotein; Hydrochlorothiazide: 40-68% bound to albumin.
Volume of Distribution	Propranolol: 4 L/kg, indicating extensive tissue distribution; Hydrochlorothiazide: 3-4 L/kg, distributing into extracellular fluid.
Bioavailability	Propranolol: 25-30% due to extensive first-pass metabolism; Hydrochlorothiazide: 65-75%. For Inderide LA, bioavailability of propranolol is approximately 30% relative to immediate-release.
Onset of Action	Oral: 1-2 hours for beta-blockade; diuretic effect begins within 2 hours.
Duration of Action	24 hours for once-daily dosing due to extended-release formulation. Antihypertensive effect persists for at least 24 hours.

Classification & Brands

Dosing & administration

One capsule orally once daily, containing 120 mg propranolol HCl and 50 mg hydrochlorothiazide.

Dosage form	CAPSULE, EXTENDED RELEASE
Renal impairment	Contraindicated in anuria; for GFR 15-29 mL/min, reduce dose or increase interval; for GFR <15 mL/min, avoid use.
Liver impairment	Child-Pugh Class B: reduce propranolol dose by 50%; Child-Pugh Class C: avoid use due to propranolol accumulation.
Pediatric use	Not recommended for pediatric use due to fixed-dose combination; safety and efficacy not established.
Geriatric use	Initiate with lowest available strength (e.g., half capsule) and titrate slowly; monitor for hypotension, bradycardia, and electrolyte disturbances.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for INDERIDE LA 120/50 (INDERIDE LA 120/50).

Breastfeeding	Propranolol is excreted into breast milk in low amounts (M/P ratio ~0.8). Hydrochlorothiazide appears in milk but in small quantities. Combined, risk to infant is low, but monitor for bradycardia, hypotension, and diuretic effects. Use caution in preterm infants or with compromised renal function.
Teratogenic Risk	First trimester: Epidemiological studies do not indicate a significant increase in congenital anomalies; however, beta-blockers can cause fetal bradycardia and growth restriction starting in second trimester. Third trimester: Risk of neonatal bradycardia, hypoglycemia, and respiratory depression due to beta-blockade. Considered compatible if benefit outweighs risk; avoid near term.

Warnings & precautions

■ FDA Black Box Warning

Exacerbation of ischemic heart disease: Do not abruptly discontinue therapy; taper dose over 1-2 weeks. If exacerbation occurs, reinstate beta-blocker therapy temporarily.