hemangeol
Hemangeol (Propranolol Hydrochloride) is a beta-adrenergic blocker used to treat Angina Pectoris, Esophageal and Gastric Varices, Heart Failure, Hypertension.
Propranolol Hydrochloride · by Eton
Available as a generic: Propranolol Hydrochloride
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Key facts
- Active ingredient
- Propranolol Hydrochloride
- Drug class
- Beta-Adrenergic Blocker
- Form
- Solution
- Strength
- Propranolol Hydrochloride 4.28MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Eton
- 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
- NDA205410
What is Hemangeol?
From the FDA label:HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol. Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1- methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride. Its structural formula is shown in Figure 1: Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol. HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water. structure
How to use
Initiate treatment at ages 5 weeks to 5 months. The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.7 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child’s weight increases. To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting [see Warnings and Precautions (5.1)]. Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see Warnings and Precautions (5.2)]. If hemangiomas recur, treatment may be re-initiated [see Clinical Studies (14)]. HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child’s mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle. • Initiate treatment at ages 5 weeks to 5 months. (2) • Starting dose is 0.15 mL/kg (0.6 mg/kg) twice daily. After 1 week, increase dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks, increase to a maintenance dose of 0.4 mL/kg (1.7 mg/kg) twice daily.(2) • Administer doses at least 9 hours apart…
Side effects
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 may not reflect the rates observed in clinical practice. Clinical Trials Experience with HEMANGEOL in Infants with proliferating infantile hemangioma In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions (>10%) in infants treated with HEMANGEOL were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients. Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with HEMANGEOL at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization. The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo). The following adverse events have been observed during clinical studies, with an incidence of less than 1%: Cardiac disorders: Second…
Warnings
Important safety information
5.1 Hypoglycemia HEMANGEOL prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. HEMANGEOL can cause hypoglycemia, at any time during treatment. Risk is increased during a fasting period (e.g., poor oral food intake, infection, vomiting) or when glucose demands are increased (e.g., cold, stress, infections). Withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. Discontinue HEMANGEOL if hypoglycemia develops and treat appropriately Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [see Drug Interactions (7)]. 5.2 Bradycardia and Hypotension HEMANGEOL may cause or worsen bradycardia or hypotension. In the studies of HEMANGEOL for infantile hemangioma the mean decrease in heart rate was about 7 bpm with little effect on blood pressure. Monitor heart rate and blood pressure after treatment initiation or increase in dose. Discontinue treatment if severe (<80 beats per minute) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mmHg) occurs. 5.3 Bronchospasm HEMANGEOL can cause bronchospasm; do not use in patients with asthma or a history of bronchospasm. Interrupt treatment in the event of a lower respiratory tract infection associated with dyspnea and wheezing. 5.4 Cardiac Failure Sympathetic stimulation supports circulatory function in patients with congestive heart failure, beta blockade may precipitate more severe failure. 5.5 Increased Risk of Stroke in PHACE Syndrome By dropping blood pressure, HEMANGEOL may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies. Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to HEMANGEOL therapy. 5.6 Hypersensitivity Beta-blockers will interfere with epinephrine used to treat serious anaphylaxis. • Hypoglycemia: Administer during or after feeding. Do not use in patients who are not able to feed or are vomiting (4, 5.1, 6, 10, 17). • Bradycardia and hypotension (4, 5.2, 17) • Bronchospasm: Avoid use in patients with asthma or lower respiratory infection. (4, 5.3, 6, 10, 17) • Increased risk of stroke in PHACE syndrome (5.5)
Who should not take Hemangeol
HEMANGEOL is contraindicated in the following conditions: • Premature infants with corrected age < 5 weeks • Infants weighing less than 2 kg • Known hypersensitivity to propranolol or any of the excipients [see Description (11)] • Asthma or history of bronchospasm • Heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure • Blood pressure <50/30 mmHg • Pheochromocytoma • Premature infants with corrected age <5 weeks(4) • Infants weighing less than 2 kg (4) • Known hypersensitivity to propranolol or excipients(4) • Asthma or history of bronchospasm (4, 5.3, 6, 10, 17) • Bradycardia (<80 beats per minute), greater than first degree heartblock, decompensated heart failure (4, 5.2, 5.4, 10, 17) • Blood pressure <50/30 mmHg (4, 5.2, 10, 17) • Pheochromocytoma (4)
Overdose — what happens if you take too much
Few cases of propranolol overdose were reported. For a single intake, the maximum dose was 20 mg/kg. Symptomatic cases featured hypotension, hypoglycemic seizure, and restlessness/euphory/insomnia; for most cases, propranolol was maintained or reintroduced. The toxicity of beta-blockers is an extension of their therapeutic effects: - Cardiac symptoms of mild to moderate poisoning are decreased heart rate and hypotension. Atrioventricular blocks, intraventricular conduction delays, and congestive heart failure can occur with more severe poisoning. - Bronchospasm may develop particularly in patients with asthma. - Hypoglycemia may develop and manifestations of hypoglycemia (tremor, tachycardia) may be masked by other clinical effects of beta-blocker toxicity. Support and treatment: Place the patient on a cardiac monitor, and monitor vital signs, mental status and blood glucose. Give intravenous fluids for hypotension and atropine for bradycardia. Glucagon then catecholamines should be considered if the patient does not respond appropriately to IV fluid. Isoproterenol and aminophylline may be used for bronchospasm. Propranolol is not dialyzable.
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
In the absence of specific studies in children, the drug interactions with propranolol are those known in adults. Consider both the infant’s medications and those of a nursing mother. Pharmacokinetic drug interactions Impact of co-administered drugs on propranolol: CYP2D6, CYP1A2 or CYP2C19 inhibitors increase propranolol plasma concentration. CYP1A2 inducers (phenytoin, phenobarbital) or CYP2C19 inducers (rifampin) decrease propranolol plasma concentration when co-administered. Pharmacodynamic drug interactions Corticosteroids: Patients on corticosteroids may be at increased risk of hypoglycemia because of loss of the counter-regulatory cortisol response; monitor patients for signs of hypoglycemia.
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 Hemangeol ranks — best-rated beta-adrenergic blocker for:
Dosage forms
Solution
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 Hemangeol treat?
- Hemangeol (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 Hemangeol work?
- Hemangeol 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 much does Hemangeol 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 Hemangeol?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Hemangeol. 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 Hemangeol?
- Hemangeol is marketed by Eton. You can see Eton's full profile, rating, and other products on pharmaranks.
- Is Hemangeol a brand-name or generic drug?
- Hemangeol is a brand-name product with the active ingredient Propranolol Hydrochloride. Lower-cost generic equivalents containing Propranolol Hydrochloride are available — ask your pharmacist.
- Is Hemangeol available over the counter?
- No. Hemangeol 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 Hemangeol come in?
- Hemangeol is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Hemangeol?
- Hemangeol is classified as beta-adrenergic blocker, per the FDA's Established Pharmacologic Class.
- Is Hemangeol FDA-registered?
- Hemangeol is on record with the U.S. FDA under application number NDA205410. You can verify this on its official FDA label.
- Is Hemangeol safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Hemangeol. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Hemangeol?
- Hemangeol's side effects are taken directly from its FDA label. From the label: 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 may not reflect the rates observed in clinical practice.… 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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