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InnoPran XL
Overview
What is InnoPran XL?
INNOPRAN XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INNOPRAN XL is available as 80 mg and 120 mg capsules which contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol.
The active ingredient in INNOPRAN XL is a synthetic beta-adrenergic receptor-blocking agent chemically described as 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is:
Propranolol hydrochloride is a stable, white, crystalline solid, which is readily soluble in water and ethanol. Its molecular weight is 295.81. Each capsule for oral administration contains sugar spheres, ethylcellulose, povidone, hypromellose phthalate, diethyl phthalate, hypromellose, polyethylene glycol, gelatin, titanium dioxide, and black iron oxide. In addition, INNOPRAN XL 120 mg capsules contain yellow iron oxide.
What does InnoPran XL look like?
What are the available doses of InnoPran XL?
Capsules: 80 mg, 120 mg. ()
What should I talk to my health care provider before I take InnoPran XL?
How should I use InnoPran XL?
INNOPRAN XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
INNOPRAN XL should be administered once daily at bedtime and should be taken consistently either on an empty stomach or with food. Initiate dosing at 80 mg and titrate to 120 mg daily as needed for blood pressure control. Doses above 120 mg have no additional effects on blood pressure . The time needed for full antihypertensive response is variable, but is usually achieved within 2 to 3 weeks.
What interacts with InnoPran XL?
Sorry No Records found
What are the warnings of InnoPran XL?
Sorry No Records found
What are the precautions of InnoPran XL?
Sorry No Records found
What are the side effects of InnoPran XL?
Sorry No records found
What should I look out for while using InnoPran XL?
INNOPRAN XL is contraindicated in patients with:
What might happen if I take too much InnoPran XL?
Most overdoses of propranolol are mild and respond to supportive care.
Propranolol is not significantly dialyzable.
Hypotension and bradycardia have been reported following propranolol overdose and should be treated appropriately. Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a propranolol overdose.
Glucagon should be administered as 50-150 mcg/kg intravenously followed by continuous drip of 1-5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine or phosphodiesterase inhibitors may also be useful. Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.
Monitor the electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance. Isoproterenol and aminophylline may be used for bronchospasm.
How should I store and handle InnoPran XL?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. INNOPRAN XL (propranolol hydrochloride) Extended Release Capsules are supplied as capsules containing either 80 mg or 120 mg propranolol hydrochloride. They are available as follows:80 mg: A gray/white capsule, imprinted with ‘InnoPran XL’, ‘80’, and 2 segmented bands, is available in bottles of 30 capsules (NDC 62559-590-30) and professional samples of 7 capsules (NDC 62559-590-77).120 mg: A gray/off-white capsule, imprinted with ‘InnoPran XL’, ‘120’, and 3 segmented bands, is available in bottles of 30 capsules (NDC 62559-591-30) and professional samples of 7 capsules (NDC 62559-591-77).Storage:INNOPRAN XL (propranolol hydrochloride) Extended Release Capsules are supplied as capsules containing either 80 mg or 120 mg propranolol hydrochloride. They are available as follows:80 mg: A gray/white capsule, imprinted with ‘InnoPran XL’, ‘80’, and 2 segmented bands, is available in bottles of 30 capsules (NDC 62559-590-30) and professional samples of 7 capsules (NDC 62559-590-77).120 mg: A gray/off-white capsule, imprinted with ‘InnoPran XL’, ‘120’, and 3 segmented bands, is available in bottles of 30 capsules (NDC 62559-591-30) and professional samples of 7 capsules (NDC 62559-591-77).Storage:INNOPRAN XL (propranolol hydrochloride) Extended Release Capsules are supplied as capsules containing either 80 mg or 120 mg propranolol hydrochloride. They are available as follows:80 mg: A gray/white capsule, imprinted with ‘InnoPran XL’, ‘80’, and 2 segmented bands, is available in bottles of 30 capsules (NDC 62559-590-30) and professional samples of 7 capsules (NDC 62559-590-77).120 mg: A gray/off-white capsule, imprinted with ‘InnoPran XL’, ‘120’, and 3 segmented bands, is available in bottles of 30 capsules (NDC 62559-591-30) and professional samples of 7 capsules (NDC 62559-591-77).Storage:INNOPRAN XL (propranolol hydrochloride) Extended Release Capsules are supplied as capsules containing either 80 mg or 120 mg propranolol hydrochloride. They are available as follows:80 mg: A gray/white capsule, imprinted with ‘InnoPran XL’, ‘80’, and 2 segmented bands, is available in bottles of 30 capsules (NDC 62559-590-30) and professional samples of 7 capsules (NDC 62559-590-77).120 mg: A gray/off-white capsule, imprinted with ‘InnoPran XL’, ‘120’, and 3 segmented bands, is available in bottles of 30 capsules (NDC 62559-591-30) and professional samples of 7 capsules (NDC 62559-591-77).Storage:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of the antihypertensive effect of propranolol has not been established. Among factors that contribute to the antihypertensive action are: (1) decreased cardiac output, (2) inhibition of renin release by the kidneys, and (3) diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase initially, it readjusts to or below the pretreatment level with chronic use. Effects of propranolol on plasma volume appear to be minor and somewhat variable.
Non-Clinical Toxicology
INNOPRAN XL is contraindicated in patients with:Drug Interactions:
Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity.
Patients receiving high doses of salicylates concomitantly with furosemide, as in rheumatic diseases, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium's renal clearance and add a high risk of lithium toxicity.
Furosemide combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Furosemide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of furosemide concomitantly with chloral hydrate is therefore not recommended.
Phenytoin interferes directly with renal action of furosemide.
Methotrexate and other drugs that, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both furosemide and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of furosemide.
Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and furosemide is associated with increased risk of gouty arthritis secondary to furosemide-induced hyperuricemia and cyclosporine impairment of renal urate excretion.
One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.
Following abrupt discontinuation of therapy with beta-blockers, exacerbations of angina pectoris and myocardial infarction have occurred.
When discontinuing chronically administered INNOPRAN XL, particularly in patients with ischemic heart disease, gradually reduce the dose over a period of 1-2 weeks and monitor the patients. If angina markedly worsens or acute coronary insufficiency develops, promptly resume therapy, at least temporarily and take other measures appropriate for the management of unstable angina. Warn patients against interruption or discontinuation of therapy without physician’s advice.
Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of INNOPRAN XL therapy even in patients treated only for hypertension.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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