INDERIDE LA 160/50
Clinical safety rating: caution
Comprehensive clinical and safety monograph for INDERIDE LA 160/50 (INDERIDE LA 160/50).
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.
| 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. |
| Molecular Weight | 418.5 |
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. |
| 1st trimester | Associated with congenital malformations, especially cardiovascular and neural tube defects. Use only if benefit outweighs risk. |
| 2nd trimester | May cause fetal bradycardia, intrauterine growth restriction, and decreased placental perfusion. Avoid if possible. |
| 3rd trimester | Risk of neonatal bradycardia, hypoglycemia, and respiratory depression. Avoid near term. |
Clinical note
Comprehensive clinical and safety monograph for INDERIDE LA 160/50 (INDERIDE LA 160/50).
| Placental transfer | Propranolol crosses the placenta readily; hydrochlorothiazide crosses in small amounts. |
| Breastfeeding | Propranolol and hydrochlorothiazide are excreted in breast milk. Low doses unlikely to cause adverse effects in infant, but monitor for bradycardia, drowsiness, and poor feeding. |
■ 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.
| Serious Effects |
Bronchial asthmaSinus bradycardiaHeart block greater than first degreeCardiogenic shockAnuriaHypersensitivity to sulfonamide-derived drugsConcurrent use with thioridazine
| 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. |
| Food/Dietary | Avoid high-potassium foods (e.g., bananas, oranges, spinach, salt substitutes) in excess, as hydrochlorothiazide affects potassium balance. Limit alcohol consumption. Maintain a low-sodium diet to reduce fluid retention and enhance antihypertensive effect. Avoid grapefruit products as they may alter drug metabolism. |
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| Lactation Rating |
| L3 (Moderately Safe) |
| 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. |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, serum electrolytes (especially potassium in hydrochlorothiazide component). Fetal monitoring: serial ultrasound for growth restriction, nonstress test or biophysical profile in third trimester. Neonatal monitoring for bradycardia, hypoglycemia, and electrolyte imbalances. |
| Fertility Effects | No established effects on fertility. Beta-blockers like propranolol may rarely cause sexual dysfunction in males. Thiazide diuretics have not been associated with fertility impairment. |
| Clinical Pearls | INDERIDE LA 160/50 combines propranolol HCl (160 mg) and hydrochlorothiazide (50 mg). Monitor heart rate and blood pressure regularly; propranolol can mask hypoglycemia symptoms in diabetics and thyrotoxicosis. Hydrochlorothiazide may cause electrolyte disturbances; check potassium, magnesium, and sodium. Avoid abrupt withdrawal due to risk of angina exacerbation or MI. Use with caution in patients with asthma, COPD, bradycardia, or heart block. |
| Patient Advice | Take this medication exactly as prescribed, usually once daily in the morning. · Do not stop taking this medication suddenly without consulting your doctor, as this may worsen chest pain or increase risk of heart attack. · This drug may cause dizziness or lightheadedness; avoid driving if affected and rise slowly from sitting or lying position. · Monitor your blood pressure regularly and keep a log to share with your healthcare provider. · If you have diabetes, check your blood sugar more often; propranolol can hide signs of low blood sugar like rapid heartbeat. · Avoid alcohol as it may increase side effects like dizziness or drowsiness. · Report any unusual weight gain, swelling, excessive thirst, dry mouth, or muscle cramps to your doctor. · Do not take other medications for blood pressure or heart conditions without doctor approval. · Limit caffeine intake as it may increase heart rate and counteract the effects. |