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Hemangeol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Hemangeol (propranolol hydrochloride) Oral Solution is a beta-blocker used to treat proliferating infantile hemangioma requiring systemic therapy. Common side effects include sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting.
The recommended starting dose of Hemangeol is 0.15 mL/kg (0.6 mg/kg) 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. Hemangeol may interact with phenytoin, phenobarbital, rifampin, and corticosteroids. Consider both the infant's medications and those of a nursing mother. Tell your doctor all medications and supplements you and your child use. Hemangeol is not intended to be prescribed to pregnant or breastfeeding women.
Our Hemangeol (propranolol hydrochloride) Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Hemangeol FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypoglycemia and related events, like hypoglycemic seizure [see WARNINGS AND PRECAUTIONS].
- Bronchospasm [see WARNINGS AND PRECAUTIONS].
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).
Table 2: Treatment-emergent adverse events occurring
at least 3% more often on HEMANGEOL than on placebo.
|HEMANGEOL 1.2 mg/kg/day
|HEMANGEOL 3.4 mg/kg/day
The following adverse events have been observed during clinical studies, with an incidence of less than 1%:
Investigations: Decreased blood glucose, decreased heart rate
Compassionate Use Program
More than 600 infants received HEMANGEOL in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of HEMANGEOL was 2.2 mg/kg/day and mean treatment duration was 7.1 months.
The adverse reactions reported in the CUP were similar to the ADRs observed during clinical trials but some were more severe.
The following adverse reactions have been identified during post-approval use of propranolol. 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 relationship to drug exposure.
These adverse reactions are as follows:
Blood and lymphatic system disorders: Agranulocytosis
Psychiatric disorders: Hallucination
Skin and subcutaneous tissues disorders: Purpura
Read the entire FDA prescribing information for Hemangeol (Propranolol Hydrochloride Oral Solution) »
Additional Hemangeol Information
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