INDERIDE LA 160/50

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INDERIDE LA 160/50 (INDERIDE LA 160/50).

How it works

Propranolol: Non-selective beta-adrenergic receptor antagonist (blocks β1 and β2 receptors). Hydrochlorothiazide: Thiazide diuretic inhibiting Na+/Cl- cotransporter in distal convoluted tubule, reducing intravascular volume by increasing sodium and water excretion.

What the body does with it

Metabolism	Propranolol: Hepatic via CYP2D6 and glucuronidation; active metabolite 4-hydroxypropranolol. Hydrochlorothiazide: Not extensively metabolized, excreted unchanged in urine.
Excretion	Propranolol: primarily hepatic metabolism to inactive metabolites, <1% excreted unchanged in urine; Hydrochlorothiazide: 50-70% excreted unchanged in urine, remainder as metabolites via renal and biliary routes.
Half-life	Propranolol: 3-6 hours (parent drug), 8-12 hours (4-hydroxypropranolol active metabolite) with prolonged half-life in hepatic impairment; Hydrochlorothiazide: 6-15 hours, extended in renal impairment (creatinine clearance <30 mL/min).
Protein binding	Propranolol: 90-95% bound to albumin; Hydrochlorothiazide: 40-68% bound to albumin.
Volume of Distribution	Propranolol: 3-5 L/kg, indicating extensive tissue penetration; Hydrochlorothiazide: 0.83-1.14 L/kg, consistent with distribution into extracellular fluid.
Bioavailability	Propranolol: 25-30% due to extensive first-pass hepatic metabolism; Hydrochlorothiazide: 65-75% after oral administration.
Onset of Action	Oral: propranolol anti-hypertensive effect onset in 1-2 hours, peak at 2-4 hours; diuretic effect of hydrochlorothiazide begins within 2 hours, peaks at 4-6 hours.
Duration of Action	Propranolol: beta-blockade persists 6-12 hours for anti-hypertensive effect; Hydrochlorothiazide: diuretic effect lasts 6-12 hours, anti-hypertensive effect extends up to 24 hours.

Classification & Brands

Dosing & administration

One capsule orally once daily. Each capsule contains propranolol hydrochloride 160 mg and hydrochlorothiazide 50 mg. Dosage should be individualized; typical maintenance dose is 1 capsule per day.

Dosage form	CAPSULE, EXTENDED RELEASE
Renal impairment	For GFR <30 mL/min: contraindicated due to thiazide component. For GFR 30-60 mL/min: reduce dose or increase interval based on clinical response; monitor electrolytes and renal function.
Liver impairment	In Child-Pugh A: reduce propranolol dose by 50%. Child-Pugh B or C: avoid use or use with extreme caution; propranolol undergoes extensive hepatic metabolism.
Pediatric use	Safety and efficacy not established; not recommended for use in pediatric patients.
Geriatric use	Initiate at lower dose (e.g., one-half capsule) due to increased sensitivity and age-related renal/hepatic decline; titrate slowly. Monitor orthostatic 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 160/50 (INDERIDE LA 160/50).

Breastfeeding	Both propranolol and hydrochlorothiazide are excreted into breast milk. Propranolol M/P ratio: 0.5-1.5. Hydrochlorothiazide may suppress lactation. American Academy of Pediatrics considers propranolol compatible but caution with hydrochlorothiazide. Monitor infant for bradycardia, hypotension, and electrolyte disturbances.
Teratogenic Risk	Propranolol (component of Inderide LA 160/50) crosses the placenta and is associated with intrauterine growth restriction, neonatal hypoglycemia, bradycardia, and respiratory depression, especially with third-trimester exposure. First-trimester use may increase risk of spontaneous abortion. Risk cannot be excluded; use only if benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

No black box warning is listed for INDERIDE LA 160/50 in standard FDA labeling. Propranolol may exacerbate angina and precipitate myocardial infarction with abrupt discontinuation; taper dose gradually.

Side Effect Profile

Serious Effects

Absolute Contraindications

Cardiogenic shock, sinus bradycardia, second- or third-degree AV block, sick sinus syndrome (without pacemaker), overt heart failure, bronchial asthma, hypersensitivity to beta-blockers or thiazides, anuria, severe renal impairment (creatinine clearance <30 mL/min).

Clinical Precautions

Precautions

Heart failure, bronchospasm (asthma/COPD), bradycardia, hypotension, peripheral vascular disease, thyrotoxicosis (may mask signs), myocardial ischemia (abrupt withdrawal), diabetes (mask hypoglycemia), electrolyte imbalance (especially hypokalemia from thiazide), hyperuricemia, systemic lupus erythematosus exacerbation.

Clinical Tips & Counseling

Drug interactions

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INDERIDE LA 160/50

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INDERIDE LA 160/50 (INDERIDE LA 160/50).

How it works

What the body does with it

Metabolism	Propranolol: Hepatic via CYP2D6 and glucuronidation; active metabolite 4-hydroxypropranolol. Hydrochlorothiazide: Not extensively metabolized, excreted unchanged in urine.
Excretion	Propranolol: primarily hepatic metabolism to inactive metabolites, <1% excreted unchanged in urine; Hydrochlorothiazide: 50-70% excreted unchanged in urine, remainder as metabolites via renal and biliary routes.
Half-life	Propranolol: 3-6 hours (parent drug), 8-12 hours (4-hydroxypropranolol active metabolite) with prolonged half-life in hepatic impairment; Hydrochlorothiazide: 6-15 hours, extended in renal impairment (creatinine clearance <30 mL/min).
Protein binding	Propranolol: 90-95% bound to albumin; Hydrochlorothiazide: 40-68% bound to albumin.
Volume of Distribution	Propranolol: 3-5 L/kg, indicating extensive tissue penetration; Hydrochlorothiazide: 0.83-1.14 L/kg, consistent with distribution into extracellular fluid.
Bioavailability	Propranolol: 25-30% due to extensive first-pass hepatic metabolism; Hydrochlorothiazide: 65-75% after oral administration.
Onset of Action	Oral: propranolol anti-hypertensive effect onset in 1-2 hours, peak at 2-4 hours; diuretic effect of hydrochlorothiazide begins within 2 hours, peaks at 4-6 hours.
Duration of Action	Propranolol: beta-blockade persists 6-12 hours for anti-hypertensive effect; Hydrochlorothiazide: diuretic effect lasts 6-12 hours, anti-hypertensive effect extends up to 24 hours.

Classification & Brands

Dosing & administration

One capsule orally once daily. Each capsule contains propranolol hydrochloride 160 mg and hydrochlorothiazide 50 mg. Dosage should be individualized; typical maintenance dose is 1 capsule per day.

Dosage form	CAPSULE, EXTENDED RELEASE
Renal impairment	For GFR <30 mL/min: contraindicated due to thiazide component. For GFR 30-60 mL/min: reduce dose or increase interval based on clinical response; monitor electrolytes and renal function.
Liver impairment	In Child-Pugh A: reduce propranolol dose by 50%. Child-Pugh B or C: avoid use or use with extreme caution; propranolol undergoes extensive hepatic metabolism.
Pediatric use	Safety and efficacy not established; not recommended for use in pediatric patients.
Geriatric use	Initiate at lower dose (e.g., one-half capsule) due to increased sensitivity and age-related renal/hepatic decline; titrate slowly. Monitor orthostatic 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 160/50 (INDERIDE LA 160/50).

Breastfeeding	Both propranolol and hydrochlorothiazide are excreted into breast milk. Propranolol M/P ratio: 0.5-1.5. Hydrochlorothiazide may suppress lactation. American Academy of Pediatrics considers propranolol compatible but caution with hydrochlorothiazide. Monitor infant for bradycardia, hypotension, and electrolyte disturbances.
Teratogenic Risk	Propranolol (component of Inderide LA 160/50) crosses the placenta and is associated with intrauterine growth restriction, neonatal hypoglycemia, bradycardia, and respiratory depression, especially with third-trimester exposure. First-trimester use may increase risk of spontaneous abortion. Risk cannot be excluded; use only if benefit outweighs risk.