HEMANGEOL- propranolol hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)

Available from:

Pierre Fabre Pharmaceuticals, Inc.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 4.28 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. 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 Of 460 infants with proliferating infantile hemangioma requiring systemic therapy who were treated with HEMANGEOL starting at 5 weeks to 5 months of age, 60% had complete or nearly complete resolution of their hemangioma at Week 24 [see  Clinical Studies (14)]. Safety and effectiveness for infantile hemangioma have not been established in pediatric

Product summary:

HEMANGEOL is supplied as an oral solution. Each 1 mL contains 4.28 mg propranolol. HEMANGEOL is supplied in a carton containing one 120 mL bottle with syringe adapter and one 5-mL oral dosing syringe. NDC 64370-375-01 Bottle 120 mL Store at 25 °C (77 °F); excursions permitted from 15° to 30 °C (59° to 86 °F). [See USP Controlled Room Temperature.] Do not freeze. Do not shake the bottle before use. Dispense in original container with enclosed oral dosing syringe. The product can be kept for 2 months after first opening. See instructions for using enclosed oral dosing syringe.

Authorization status:

New Drug Application

Patient Information leaflet

HEMANGEOL- PROPRANOLOL HYDROCHLORIDE SOLUTION
Pierre Fabre Pharmaceuticals, Inc.
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MEDICATION GUIDE
HEMANGEOL ® (he-man je-ohl)
(propranolol hydrochloride oral solution)
What is the most important information I should know about HEMANGEOL?
HEMANGEOL can cause serious side effects, including:
•
Low blood sugar (hypoglycemia), especially if your child is not taking
feedings, or is vomiting.
HEMANGEOL may make it more difficult to recognize the signs and
symptoms of low blood
sugar in your child.
To help reduce the risk of low blood sugar with HEMANGEOL:
•
Give HEMANGEOL during or shortly after feeding your child.
•
Feed your child regularly during treatment. Tell your doctor if your
child has a poor appetite.
•
If your child is not taking feedings, for example, due to an illness
or vomiting, do not give
HEMANGEOL until your child is taking feedings normally again.
If your child has any of the signs or symptoms of low blood sugar
listed below during treatment with
HEMANGEOL, stop giving your child HEMANGEOL, call your healthcare
provider immediately or go
to the emergency room. If the child is conscious, give him/her a drink
of liquid containing sugar.
Signs or symptoms of low blood sugar include: pale, blue or purple
skin color, sweating, irritability,
crying for no apparent reason, irregular or fast heartbeat, poor
feeding, low body temperature, unusual
sleepiness, seizures, breathing stops for short periods of time, and
loss of consciousness.
What is HEMANGEOL?
HEMANGEOL is a prescription medicine used to treat proliferating
infantile hemangioma that requires
treatment with a medicine that spreads throughout the body.
Who should not take HEMANGEOL?
Do not give HEMANGEOL to your child if your child:
•
was born prematurely and has not reached the corrected age of 5 weeks
•
weighs less than 4 ½ pounds
•
is allergic to propranolol or any of the other ingredients in
HEMANGEOL. See the end of this
Medication Guide for a list of ingredients in HEMANGEOL
•
has asthma or a history of breathing p

Summary of Product characteristics

HEMANGEOL- PROPRANOLOL HYDROCHLORIDE SOLUTION
PIERRE FABRE PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEMANGEOL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HEMANGEOL.
HEMANGEOL® (PROPRANOLOL HYDROCHLORIDE ORAL SOLUTION)
INITIAL U.S. APPROVAL: 1967
INDICATIONS AND USAGE
HEMANGEOL oral solution is a beta-adrenergic blocker indicated for the
treatment of proliferating infantile
hemangioma requiring systemic therapy. ( 1)
DOSAGE AND ADMINISTRATION
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 during or after feeding. ( 2)
Readjust dose for changes in the child’s weight. ( 2)
Monitor heart rate and blood pressure for 2 hours after the first dose
or increasing dose. ( 2)
DOSAGE FORMS AND STRENGTHS
Oral solution: 4.28 mg/mL propranolol hydrochloride ( 3)
CONTRAINDICATIONS
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 heart
block, decompensated heart
failure ( 4, 5.2, 5.4, 10, 17)
Blood pressure <50/30 mmHg ( 4, 5.2, 10, 17)
Pheochromocytoma ( 4)
WARNINGS AND PRECAUTIONS
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)
ADVERSE REACTIONS
The most common adverse reactions to HEMANGEOL (occurring ≥ 10% of
patients) were sleep disorders,
aggravated respiratory trac