GNH USA

Europe — EMA

Hemangiol

Hemangiol (propranolol hydrochloride) oral solution for infantile hemangioma – indications, side effects, precautions, and drug interactions.

Propranolol Hydrochloride

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What is Propranolol Hydrochloride?

Hemangiol is a prescription oral formulation that contains the active ingredient propranolol hydrochloride. It is marketed in the European Union and is classified as a beta‑adrenergic antagonist. Hemangiol is used under medical supervision to treat specific vascular growths in infants. The medication works by blocking beta‑adrenergic receptors, which influences blood flow and cellular growth processes associated with hemangiomas.

What is Propranolol Hydrochloride used for?

Hemangiol is indicated for the management of infantile hemangioma, a common benign vascular tumor in early childhood. It may be prescribed when lesions are proliferative, cause functional impairment, or present a risk of complications.

- Treatment of superficial or deep infantile hemangiomas requiring systemic therapy - Management of hemangiomas affecting vision, airway, or feeding - Use in cases where rapid tumor regression is clinically desirable - Adjunct to other therapeutic approaches when monotherapy is insufficient - Consideration for hemangiomas with ulceration or risk of scarring

What are the side effects of Propranolol Hydrochloride?

Side effects of Hemangiol vary in frequency and severity. Patients should be monitored for any new or worsening symptoms during treatment.

Common: - Fatigue or tiredness - Mild gastrointestinal upset such as nausea or abdominal discomfort - Low blood pressure (hypotension) - Slow heart rate (bradycardia) - Cold extremities or reduced circulation to hands and feet - Sleep disturbances or vivid dreams

Serious: - Severe hypotension or syncope - Marked bradycardia requiring medical attention - Bronchospasm or worsening asthma symptoms - Hypoglycemia, particularly in infants with limited feeding - Signs of heart failure such as swelling or rapid breathing

What precautions apply to Propranolol Hydrochloride?

Before initiating Hemangiol, clinicians should evaluate patient history and monitor specific parameters throughout therapy.

- Assess cardiovascular status, including heart rate and blood pressure - Review respiratory conditions, especially asthma or chronic bronchospasm - Monitor blood glucose levels in infants at risk for hypoglycemia - Conduct baseline liver function tests and repeat as needed - Evaluate for contraindications such as severe heart block or untreated heart failure - Counsel caregivers on signs of serious adverse events and when to seek medical care

What does Propranolol Hydrochloride interact with?

Hemangiol can interact with several medication classes, influencing its safety and effectiveness.

Avoid: - Other non‑selective beta‑blockers or agents that markedly lower heart rate - Calcium channel blockers that may exacerbate bradycardia or hypotension - Certain anti‑arrhythmic drugs (e.g., amiodarone, digoxin) - Strong CYP2D6 inhibitors that could increase propranolol levels

Use with caution: - Asthma medications, particularly beta‑agonists, due to potential bronchoconstriction - Antidiabetic agents, as propranolol may mask hypoglycemia symptoms - Antidepressants such as SSRIs that can affect heart rate - NSAIDs that may influence renal function when combined with beta‑blockade

Frequently asked questions

What is the mechanism of action of Hemangiol in treating infantile hemangioma?+
Hemangiol contains propranolol, a non‑selective beta‑adrenergic antagonist that blocks β1 and β2 receptors, reducing cardiac output and renin release while also inhibiting angiogenic pathways that contribute to hemangioma growth.
Is Hemangiol approved for use in newborns with hemangioma?+
Hemangiol is prescribed for infants with proliferating hemangiomas when the lesions pose functional or cosmetic concerns, but the decision to treat newborns depends on clinical assessment and physician judgment.
Can Hemangiol be used for hemangiomas located near the eye?+
Yes, Hemangiol may be considered for peri‑ocular hemangiomas that threaten vision, as systemic therapy can reduce lesion size and prevent visual impairment.
What monitoring is recommended while a child is taking Hemangiol?+
Regular monitoring of heart rate, blood pressure, blood glucose, and liver function is recommended, along with clinical assessment for respiratory symptoms and signs of hypoglycemia.
Are there any dietary restrictions while using Hemangiol?+
There are no specific dietary restrictions, but caregivers should ensure consistent feeding patterns to help prevent hypoglycemia, especially in infants.
How does Hemangiol differ from topical treatments for hemangioma?+
Hemangiol is an oral systemic therapy that reaches deeper vascular tissue, whereas topical agents act locally and are generally used for superficial lesions with limited depth.
What are common side effects parents should watch for?+
Common side effects include fatigue, mild nausea, low blood pressure, slowed heart rate, cold extremities, and occasional sleep disturbances.
When should a caregiver seek immediate medical attention while a child is on Hemangiol?+
Seek urgent care if the child experiences severe dizziness, fainting, markedly low heart rate, difficulty breathing, signs of bronchospasm, or symptoms of low blood sugar such as seizures.
Can Hemangiol be taken with asthma inhalers?+
Hemangiol can be used with asthma inhalers, but clinicians may advise caution and close monitoring because beta‑blockade can potentially worsen bronchospasm.
Is Hemangiol classified as a controlled substance?+
No, Hemangiol is not a controlled substance; it is a prescription‑only medication classified as a beta‑adrenergic antagonist.
What is the ATC classification for Hemangiol?+
Hemangiol is classified under ATC code C07AA05, which corresponds to non‑selective beta‑blocking agents.
Can Hemangiol be used during pregnancy?+
The pregnancy safety category for Hemangiol is listed as unknown; it should only be used during pregnancy if the potential benefit justifies the potential risk, under medical supervision.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Propranolol Hydrochloride
Route
Oral Use
Manufacturer
Pierre Fabre Medicament
Origin
EU

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