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Hemangeol

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Hemangeol

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
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

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.

Reaction Placebo
N=236
HEMANGEOL 1.2 mg/kg/day
N=200
HEMANGEOL 3.4 mg/kg/day
N=224
Sleep disorder 5.90% 17.50% 16.10%
Bronchitis 4.7 8 13.4
Peripheral coldness 0.4 8 6.7
Agitation 2.1 8.5 4.5
Diarrhea 1.3 4.5 6.3
Somnolence 0.4 5 0.9
Nightmare 1.7 2 6.3
Irritability 1.3 5.5 1.3
Decreased appetite 0.4 2.5 3.6
Abdominal pain 0.4 3.5 0.4

The following adverse events have been observed during clinical studies, with an incidence of less than 1%:

Cardiac disorders: Second degree atrioventricular heart block, in a patient with underlying conduction disorder, required definitive treatment discontinuation [see WARNINGS AND PRECAUTIONS].

Skin and subcutaneous tissue disorders: Urticaria, alopecia

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.

Postmarketing Experience

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) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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