innopran xl
Pharmaranks rates Innopran XL 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Innopran XL (Propranolol Hydrochloride) is a beta-adrenergic blocker used to treat Angina Pectoris, Esophageal and Gastric Varices, Heart Failure, Hypertension.
Propranolol Hydrochloride · by Ani Pharms
Available as a generic: Propranolol Hydrochloride
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Propranolol Hydrochloride
- Drug class
- Beta-Adrenergic Blocker
- Form
- Capsule, extended release
- Strength
- Propranolol Hydrochloride 120MG · Propranolol Hydrochloride 80MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ani Pharms
- Half-life
- about 3 to 6 hours (plasma half-life, immediate-release, in healthy adults) (how long it stays in your system)
- What the pharmacy pays
- ~$2.49 for 30 — not your price
- FDA application
- NDA021438
What is Innopran XL?
From the FDA label:INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules 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. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. • Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol). • Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol). The active ingredient in INDERAL 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. The ink contains FD&C Blue #2 Aluminum Lake. In addition, INDERAL XL 120 mg capsules contain yellow…
How to use
INDERAL 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 [see Clinical Studies ( 14.1 )] . Full antihypertensive response is usually achieved within 2 to 3 weeks. • Administer once daily at bedtime consistently either on an empty stomach or with food. ( 2 ) • Initiate dosage at 80 mg and titrate up to 120 mg if needed. ( 2 )
Side effects
The most commonly reported adverse reactions (≥3% and greater than placebo) included the following: fatigue, dizziness, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions occurring at a rate of ≥3%, excluding those reported more commonly in placebo, encountered in the INDERAL XL placebo-controlled hypertension trials and plausibly related to treatment are shown in Table 1. Table 1. Treatment-Emergent Adverse Reactions Reported In ≥3% of Subjects INDERAL XL Body System Placebo (N=88) 80 mg (N=89) 120mg (N=85) Fatigue 3 (3%) 4 (5%) 6 (7%) Dizziness (except vertigo) 2 (2%) 6 (7%) 3 (4%) Constipation 0 3 (3%) 1 (1%) 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following reactions have been identified during post-marketing use of INDERAL XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal…
Warnings
Important safety information
Abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) • May worsen congestive heart failure. ( 5.2 ) • Avoid discontinuing therapy prior to major surgery. ( 5.3 ) • Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor. ( 5.4 ) • Bradycardia. ( 5.6 ) 5.1 Cardiac Ischemia after Abrupt Discontinuation Following abrupt discontinuation of therapy with beta-blockers, exacerbations of angina pectoris and myocardial infarction have occurred. When discontinuing chronically administered INDERAL 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 INDERAL XL therapy even in patients treated only for hypertension. 5.2 Cardiac Failure Beta-blockers, like INDERAL XL, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of INDERAL XL or to discontinue it. 5.3 Maintain During Major Surgery Chronically administered beta-blocking therapy, including INDERAL XL, should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. 5.4 Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment. 5.5 Thyrotoxicosis INDERAL XL may mask clinical signs of hyperthyroidism, such as tachycardia. Avoid abrupt withdrawal of beta-blockade, which may precipitate a thyroid storm. 5.6 Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of INDERAL XL. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders (including Wolff-Parkinson-White) may be at increased risk. The concomitant use of beta-adrenergic blockers and non-dihydropyridine calcium channel blockers (e.g., verapamil and diltiazem), digoxin or clonidine increases the risk of significant bradycardia. Monitor heart rate and rhythm in patients receiving INDERAL XL. If severe bradycardia develops, reduce or stop INDERAL XL. 5.7 Reduced Effectiveness of Epinephrine in Treating Anaphylaxis Beta-adrenergic blocker-treated patients treated with epinephrine for a severe anaphylactic reaction may be less responsive to the typical doses of epinephrine. In these patients, consider other medications (e.g., intravenous fluids, glucagon).
Who should not take Innopran XL
INDERAL XL is contraindicated in patients with: • Cardiogenic shock or decompensated heart failure • Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place • Bronchial asthma • Known hypersensitivity (e.g., anaphylactic reaction) to propranolol hydrochloride or any of the components of INDERAL XL • Cardiogenic shock and decompensated heart failure. ( 4 ) • Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place. ( 4 ) • Bronchial asthma. ( 4 ) • Hypersensitivity to propranolol or any of the components of INDERAL XL. ( 4 )
Overdose — what happens if you take too much
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 to 150 mcg/kg intravenously followed by continuous drip of 1 to 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
CYP2D6, 1A2, or 2C19 enzyme inhibitors increase propranolol levels. ( 7.1 ) • CYP1A2 and 2C19 inducers decrease propranolol levels. ( 7.1 ) • Monitor prothrombin time when propranolol is co-administered with warfarin. ( 7.1 ) 7.1 Pharmacokinetic Drug-Drug Interactions Impact of Propranolol on Other Drugs Warfarin: Warfarin concentrations are increased when administered with propranolol. Monitor prothrombin time accordingly [see Clinical Pharmacology ( 12.7 )] . Propafenone: Co-administration of propranolol increases the plasma concentrations of propafenone. Monitor patients for symptoms of excessive exposure to propafenone including bradycardia and postural hypotension [see Clinical Pharmacology ( 12.7 )] . Impact of Other Drugs on Propranolol CYP2D6, CYP1A2 and CYP2C19 Inhibitors: CYP2D6 inhibitors (e.g. bupropion, fluoxetine, paroxetine, quinidine), CYP1A2 inhibitors (e.g., ciprofloxacin, enoxamine, fluvoxamine) and CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) increase exposure to propranolol when co-administered with INDERAL XL. Monitor patients for bradycardia and hypotension [see Clinical Pharmacology ( 12.7 )] . CYP1A2 and CYP2C19 Inducers: CYP1A2 inducers (e.g., phenytoin, montelukast, smoking) and CYP2C19 inducers (e.g. rifampin) decrease the plasma levels of propranolol resulting in a loss of efficacy [see Clinical Pharmacology ( 12.7 )] . Cholestyramine and Colestipol: Co-administered cholestyramine or colestipol significantly reduces the plasma concentrations of co-administered propranolol which may result in loss of efficacy [see Clinical Pharmacology ( 12.7 )] . 7.2 Pharmacodynamic Drug-Drug Interactions Adrenergic Agonists: Beta-blockers may antagonize the antihypertensive effects of clonidine, and rebound hypertension may result if clonidine is withdrawn abruptly. If clonidine and a beta-blocker are co-administered, withdraw the beta-blocker several days before the withdrawal of clonidine. Alpha Blockers: Co-administration of beta-blockers with alpha-blocker (e.g., prazosin) has been associated with prolongation of first dose hypotension and syncope. Dobutamine: Propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia. Antidepressants: The hypotensive effect of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers. Monitor patients for postural hypotension. Nonsteroidal Anti-Inflammatory Drugs: Nonsteroidal anti-inflammatory drugs (NSAIDs) may attenuate the antihypertensive effect of beta-adrenoreceptor blocking agents. Monitor blood pressure.
How long does Propranolol Hydrochloride stay in your body?
The elimination half-life of propranolol hydrochloride is about 3 to 6 hours (plasma half-life, immediate-release, in healthy adults) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Label figure is for immediate-release propranolol; extended-release products differ. Propranolol has an active metabolite, 4-hydroxypropranolol, formed after oral dosing; the label notes it is pharmacologically active but does not state a half-life for it, so no metabolite half-life is reported here. Half-life lengthens in the populations the label names: in older adults it is prolonged (about 11 hours vs. about 5 hours in young subjects), and in hepatic impairment (cirrhosis) it rises to about 11 hours vs. about 4 hours in controls, with roughly 3-fold higher unbound levels. In chronic renal failure the label reports a shorter (reduced) plasma half-life, yet peak and total plasma levels are 3 to 4 times higher, so a shorter number does not mean faster overall clearance. CYP2D6 poor vs. extensive metabolizer status did not change elimination half-life.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Propranolol Hydrochloride tablets — DailyMed label, Clinical Pharmacology / Pharmacokinetics.
Drug class
How this class works, per Beta Blockers — StatPearls, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
- angina pectoris
- esophageal and gastric varices
- heart failure
- hypertension
- myocardial infarction
- pheochromocytoma
See how Innopran XL ranks — best-rated beta-adrenergic blocker for:
Dosage forms
Capsule, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Innopran XL treat?
- Innopran XL (Propranolol Hydrochloride) may be used to treat angina pectoris, esophageal and gastric varices, heart failure, hypertension, myocardial infarction, pheochromocytoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Innopran XL work?
- Innopran XL is a beta-adrenergic blocker. Beta-blockers block adrenaline (epinephrine) and noradrenaline from acting on beta-adrenergic receptors, mainly in the heart. This slows the heart rate, reduces how forcefully the heart contracts, and lowers blood pressure, easing the workload on the heart.
- How is Innopran XL rated?
- pharmaranks gives Innopran XL a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Innopran XL cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.49 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Atenolol — about $0.76 on the same basis.
- Is there a coupon or discount for Innopran XL?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Innopran XL. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Innopran XL?
- Innopran XL is marketed by Ani Pharms. You can see Ani Pharms's full profile, rating, and other products on pharmaranks.
- Is Innopran XL a brand-name or generic drug?
- Innopran XL is a brand-name product with the active ingredient Propranolol Hydrochloride. Lower-cost generic equivalents containing Propranolol Hydrochloride are available — ask your pharmacist.
- Is Innopran XL available over the counter?
- No. Innopran XL is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Innopran XL come in?
- Innopran XL is currently marketed as capsule, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Innopran XL?
- Innopran XL is classified as beta-adrenergic blocker, per the FDA's Established Pharmacologic Class.
- Is Innopran XL FDA-registered?
- Innopran XL is on record with the U.S. FDA under application number NDA021438. You can verify this on its official FDA label.
- Has Innopran XL been recalled by the FDA?
- Innopran XL has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Innopran XL safe?
- There's no single safe-or-not verdict. pharmaranks gives Innopran XL a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Innopran XL?
- Innopran XL's side effects are taken directly from its FDA label. From the label: The most commonly reported adverse reactions (≥3% and greater than placebo) included the following: fatigue, dizziness, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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