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Hemangeol

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Hemangeol

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 Hemangeol (propranolol hydrochloride oral solution) Side Effects Center for a complete guide to possible side effects

DRUG 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.

Last reviewed on RxList: 4/3/2014
This monograph has been modified to include the generic and brand name in many instances.

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