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Dosage & administration

2 DOSAGE AND ADMINISTRATION

Initiate treatment at ages 5 weeks to 5 months.

The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) 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.

To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting [see Warnings and Precautions (5.1) ] .

Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see Warnings and Precautions (5.2) ].

If hemangiomas recur, treatment may be re-initiated [see Clinical Studies (14) ] .

HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child’s mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle.

Table 1. Dose Titration According to Weight

Week 1	Week 2	Week 3 (maintenance)
Weight (kg)	Volume administered	Volume administered	Volume administered
Weight (kg)	twice a day	twice a day	twice a day
2 to <2.5	0.3 mL	0.6 mL	0.8 mL
2.5 to <3	0.4 mL	0.8 mL	1 mL
3 to <3.5	0.5 mL	0.9 mL	1.2 mL
3.5 to <4	0.5 mL	1.1 mL	1.4 mL
4 to <4.5	0.6 mL	1.2 mL	1.6 mL
4.5 to <5	0.7 mL	1.4 mL	1.8 mL
5 to <5.5	0.8 mL	1.5 mL	2 mL
5.5 to <6	0.8 mL	1.7 mL	2.2 mL
6 to <6.5	0.9 mL	1.8 mL	2.4 mL
6.5 to <7	1 mL	2 mL	2.6 mL
7 to <7.5	1.1 mL	2.1 mL	2.8 mL
7.5 to <8	1.1 mL	2.3 mL	3 mL
8 to <8.5	1.2 mL	2.4 mL	3.2 mL
8.5 to <9	1.3 mL	2.6 mL	3.4 mL
9 to <9.5	1.4 mL	2.7 mL	3.6 mL
9.5 to <10	1.4 mL	2.9 mL	3.8 mL
10 to <10.5	1.5 mL	3 mL	4 mL
10.5 to <11	1.6 mL	3.2 mL	4.2 mL
11 to <11.5	1.7 mL	3.3 mL	4.4 mL
11.5 to <12	1.7 mL	3.5 mL	4.6 mL
12 to <12.5	1.8 mL	3.6 mL	4.8 mL

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Hemangeol prescribing information

Indications & Usage

1 INDICATIONS AND USAGE

HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION

Initiate treatment at ages 5 weeks to 5 months.

To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting [see Warnings and Precautions (5.1) ] .

Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see Warnings and Precautions (5.2) ].

If hemangiomas recur, treatment may be re-initiated [see Clinical Studies (14) ] .

Table 1. Dose Titration According to Weight

Week 1	Week 2	Week 3 (maintenance)
Weight (kg)	Volume administered	Volume administered	Volume administered
Weight (kg)	twice a day	twice a day	twice a day
2 to <2.5	0.3 mL	0.6 mL	0.8 mL
2.5 to <3	0.4 mL	0.8 mL	1 mL
3 to <3.5	0.5 mL	0.9 mL	1.2 mL
3.5 to <4	0.5 mL	1.1 mL	1.4 mL
4 to <4.5	0.6 mL	1.2 mL	1.6 mL
4.5 to <5	0.7 mL	1.4 mL	1.8 mL
5 to <5.5	0.8 mL	1.5 mL	2 mL
5.5 to <6	0.8 mL	1.7 mL	2.2 mL
6 to <6.5	0.9 mL	1.8 mL	2.4 mL
6.5 to <7	1 mL	2 mL	2.6 mL
7 to <7.5	1.1 mL	2.1 mL	2.8 mL
7.5 to <8	1.1 mL	2.3 mL	3 mL
8 to <8.5	1.2 mL	2.4 mL	3.2 mL
8.5 to <9	1.3 mL	2.6 mL	3.4 mL
9 to <9.5	1.4 mL	2.7 mL	3.6 mL
9.5 to <10	1.4 mL	2.9 mL	3.8 mL
10 to <10.5	1.5 mL	3 mL	4 mL
10.5 to <11	1.6 mL	3.2 mL	4.2 mL
11 to <11.5	1.7 mL	3.3 mL	4.4 mL
11.5 to <12	1.7 mL	3.5 mL	4.6 mL
12 to <12.5	1.8 mL	3.6 mL	4.8 mL

Dosage Forms & Strengths

3 DOSAGE FORMS AND STRENGTHS

Oral solution: 4.28 mg/mL propranolol hydrochloride.

Alcohol-, paraben- and sugar-free.

Pregnancy & Lactation

8 USE IN SPECIFIC POPULATIONS

Pediatric Use

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 patients greater than 1 year of age.

Hepatic Impairment

There is no experience in infants with hepatic impairment .

Renal Impairment

There is no experience in infants with renal impairment .

Contraindications

4 CONTRAINDICATIONS

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

Warnings & Precautions

5 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 )

Hypoglycemia

HEMANGEOL prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. HEMANGEOL can cause hypoglycemia at any time during treatment. Risk is increased during a fasting period (e.g., poor oral food intake, infection, vomiting) or when glucose demands are increased (e.g., cold, stress, infections). Withhold the dose under these conditions. Hypoglycemia may present in
the form of seizures, lethargy, or coma. Discontinue HEMANGEOL if hypoglycemia develops and treat appropriately Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [ see Drug Interactions (7) ] .

Bradycardia and Hypotension

HEMANGEOL may cause or worsen bradycardia or hypotension. In the studies of HEMANGEOL for infantile hemangioma the mean decrease in heart rate was about 7 bpm with little effect on blood pressure. Monitor heart rate and blood pressure after treatment initiation or increase in dose. Discontinue treatment if severe (<80 beats per minute) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mmHg) occurs.

Bronchospasm

HEMANGEOL can cause bronchospasm; do not use in patients with asthma or a history of bronchospasm. Interrupt treatment in the event of a lower respiratory tract infection associated with dyspnea and wheezing.

Cardiac Failure

Sympathetic stimulation supports circulatory function in patients with congestive heart failure, beta blockade may precipitate more severe failure.

Increased Risk of Stroke in PHACE Syndrome

By dropping blood pressure, HEMANGEOL may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies.
Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to HEMANGEOL therapy.

Hypersensitivity

Beta-blockers will interfere with epinephrine used to treat serious anaphylaxis.

Adverse Reactions

6 ADVERSE REACTIONS

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 (5.1) ].
Bronchospasm [see Warnings and Precautions (5.3) ].

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	5.9%	17.5%	16.1%
Bronchitis	4.7	8.0	13.4
Peripheral coldness	0.4	8.0	6.7
Agitation	2.1	8.5	4.5
Diarrhea	1.3	4.5	6.3
Somnolence	0.4	5.0	0.9
Nightmare	1.7	2.0	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 (5.4 ) ] .

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, dermatitis psoriasform

Drug Interactions

7 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.

Description

11 DESCRIPTION

HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol.

Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1-methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride. Its structural formula is shown in Figure 1:

Referenced Image

Figure 1. Propranolol HCl Structure

Molecular formula: C ₁₆H ₂₁NO ₂-HCl

Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol.

HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.

Pharmacology

12 CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism of HEMANGEOL’s effects on infantile hemangiomas is not well understood.

Pharmacodynamics

Propranolol is a nonselective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor stimulating agents for available receptor sites. When access to beta-receptor sites is blocked by propranolol, chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately.

Propranolol selectively blocks beta-adrenergic receptors, leaving alpha-adrenergic responses intact. There are two well-characterized subtypes of beta receptors (beta1 and beta2); propranolol interacts with both subtypes equally.

Beta1-adrenergic receptors are found primarily in the heart. Blockade of cardiac beta1-adrenergic receptors leads to a decrease in the activity of both normal and ectopic pacemaker cells and a decrease in A-V nodal conduction velocity. Blockade of cardiac beta1-adrenergic receptors also decreases the myocardial force of contraction and may provoke cardiac decompensation in patients with minimal cardiac reserve.

Beta2-adrenergic receptors are found predominantly in smooth muscle-vascular, bronchial, gastrointestinal and genitourinary. Blockade of these receptors results in constriction. Propranolol’s beta-blocking effects are attributable to its S(-) enantiomer.

Pharmacodynamic drug interactions

Alpha blockers: Co-administration of beta-blockers with alpha blockers (prazosin) has been associated with prolongation of first dose hypotension and syncope.

Antidepressants : The hypotensive effect of MAO inhibitors and tricyclic antidepressants is exacerbated when administered with beta-blockers.

Nonsteroidal anti-inflammatory drugs : Nonsteroidal anti-inflammatory drugs (NSAIDs) may attenuate the antihypertensive effect of beta-adrenoreceptor blocking agents. Monitor blood pressure.

Pharmacokinetics

Adults

Absorption: Propranolol is almost completely absorbed after oral administration. However, it undergoes an extensive first-pass metabolism by the liver and on average; only about 25% of propranolol reaches the systemic circulation. Peak plasma concentrations occur about 1 to 4 hours after an oral dose. Administration of protein-rich foods increases the bioavailability of propranolol by about 50% with no change in time to peak concentration.

Propranolol is a substrate for the intestinal efflux transporter, P-glycoprotein (P-gp). However, studies suggest that P-gp is not dose-limiting for intestinal absorption of propranolol in the usual therapeutic dose range.

Distribution: Approximately 90% of circulating propranolol is bound to plasma proteins (albumin and alpha1 acid glycoprotein). The volume of distribution of propranolol is approximately 4 L/kg. Propranolol crosses the blood-brain barrier and the placenta, and is distributed into breast milk.

Propranolol is extensively metabolized with most metabolites appearing in the urine.

Metabolism: Propranolol is metabolized through three primary routes: aromatic hydroxylation (mainly 4-hydroxylation), N-dealkylation followed by further side-chain oxidation, and direct glucuronidation. The percentage contributions of these routes to total metabolism are 42%, 41% and 17%, respectively, but with considerable variability between individuals. The four major final metabolites are propranolol glucuronide, naphthyloxylactic acid and glucuronic acid, and sulfate conjugates of 4-hydroxy propranolol. In vitro studies indicated that CYP2D6 (aromatic hydroxylation), CYP1A2 (chain oxidation) and to a less extent CYP2C19 were involved in propranolol metabolism.

In healthy subjects, no difference was observed between CYP2D6 extensive metabolizers (EMs) and poor metabolizers (PMs) with respect to oral clearance or elimination half-life.

Elimination:The plasma half-life of propranolol ranges from 3 to 6 hours. Less than 1% of a dose is excreted as unchanged drug in the urine.

Infants

The pharmacokinetics of propranolol and 4-OH-propranolol were evaluated in a multiple dose 12 week study conducted in 23 male and female infants 35 to 150 days of age with hemangioma. The infants were stratified by age (35 to 90 days and 91 to 150 days). The starting dose was 1.2 mg/kg/day which was titrated to the target dose of 3.4 mg/kg/day in 1.1 mg/kg/day increments at weekly intervals. At steady state, following administration of 3.4 mg/kg/day twice daily, peak plasma propranolol concentrations were observed within 2 hours of oral administration. Clearance of propranolol in infants was similar across the age range studied (2.7 (SD=0.03) L/h/kg in infants <90 days of age and 3.3 (SD=0.35) L/h/kg in infants >90 days of age) and to that in adults when adjusted by body weight. The median elimination half-life of propranolol was about 3.5 hours. Plasma propranolol concentrations approximate a dose proportional increase in the dose range of 1.2 mg/kg/day to 3.4 mg/kg/day.

Plasma concentration of 4-OH-propranolol, the main metabolite, was about 5% of total plasma exposure of propranolol.

Sex

There is no known dependence of pharmacokinetics of propranolol by sex in infants.

Race

There is little information on dependence of pharmacokinetics of propranolol by race in infants.

A study conducted in 12 Caucasian and 13 African-American adult male subjects taking propranolol, showed that at steady state, the clearance of R(+)- and S(-)-propranolol were about 76% and 53% higher in African-Americans than in Caucasians, respectively.

Chinese adult subjects had a greater proportion (18% to 45% higher) of unbound propranolol in plasma compared to Caucasians, which was associated with a lower plasma concentration of alpha1 acid glycoprotein.

Drug Interaction Studies

Impact of propranolol on co-administered drugs: The effect of propranolol on plasma concentration of co-administered drug is presented in the table below.

Table 3. Effect of propranolol on co-administered drugs

Co-administered drug	Effect on plasma concentration of co-administered drug
Amide anesthetics (lidocaine, bupivacaine, mepivacaine)	Increase
Warfarin	Increase
Propafenone	Increase > 200 %
Nifedipine	Increase 80 %
Verapamil	No change
Pravastatin, lovastatin	Decrease 20%
Fluvastatin	No change
Zolmitriptan	Increase 60 %
Rizatriptan	Increase 80 %
Thioridazine	Increase 370 %
Diazepam	Increase
Oxazepam, triazolam, lorazepam, alprazolam	No change
Theophylline	Increase 70 %

Impact of co-administered drugs on propranolol: The effect of co-administered drugs on propranolol plasma concentration is presented in the table below.

Table 4. Effect of co-administered drugs on propranolol

Co-administered drug	Effect on propranolol plasma concentration
CYP2D6, CYP1A2 or CYP2C19 inhibitors	Increase
CYP1A2 or CYP2C19 inducers	Decrease
Quinidine	Increase > 200 %
Nisoldipine	Increase 50 %
Nicardipine	Increase 80 %
Chlorpromazine	Increase 70 %
Cimetidine	Increase 50 %
Cholestyramine, colestipol	Decrease 50 %
Alcohol	Increase (acute use), decrease (chronic use)
Diazepam	No change
Verapamil	No change
Metoclopramide	No change
Ranitidine	No change
Lansoprazole	No change
Omeprazole	No change
Propafenone	Increase 200 %
Aluminum hydroxide	Decrease 50 %

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY

Carcinogenesis and Mutagenesis and Impairment of Fertility

In studies of mice and rats fed propranolol hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. On a body surface area basis, this dose in the mouse and rat is about 3 and 7 times, respectively, the MRHD of 3.4 mg/kg/day propranolol hydrochloride in children.

Based on differing results from bacterial reverse mutation (Ames) tests performed by different laboratories, there is equivocal evidence for mutagenicity in one strain ( S. typhimurium strain TA 1538).

In a study in which both male and female rats were exposed to propranolol hydrochloride via diet at concentrations of up to 0.05% (about 50 mg/kg or less than the MRHD of 640 mg propranolol hydrochloride in adults) started from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. The potential effects of propranolol hydrochloride on fertility of juvenile rats were evaluated following daily oral administration from post-natal Day 4 (PND 4) to PND 21 at dose-levels of 0, 11.4, 22.8 or 45.6 mg/kg/day. No propranolol related effects on reproductive parameters or reproductive development were observed up to the highest dose level of 45.6 mg/kg/day, a dose that represents a systemic exposure of 3 times that seen in children at the MRHD.

Animal Toxicology and/or Pharmacology

This study in juvenile rats with propranolol hydrochloride described above was intended to cover the period of development corresponding to infancy, childhood and adolescence. Neurologic effects including hypoactivity and delayed air righting reflex, increased germinal centers of lymph nodes, and increased white blood cells and lymphocytes were seen at a propranolol hydrochloride dose 45.6 mg/kg/day that represents a systemic exposure of 3 times that seen in children at the MRHD. Body weights were transiently decreased, and transient decreases in urine volume were associated with higher incidences of minimal renal cysts and dilation of kidney tubules at doses about equal to the MRHD in children.

Clinical Studies

14 CLINICAL STUDIES

A randomized, double-blind study in 460 infants, aged 35 days to 5 months at inclusion, with proliferating infantile hemangiomas (IH) requiring systemic therapy (excluding life-threatening IH, function-threatening IH, and ulcerated IH with pain and lack of response to simple wound care measures) compared four regimens of HEMANGEOL (1.2 or 3.4 mg/kg/day in twice daily divided doses for 3 or 6 months; N=99-103 per group) to placebo (N=55). Clinical efficacy was evaluated by counting complete or nearly complete resolution of the target hemangioma, which was evaluated by blinded centralized independent assessments of photographs at Week 24 compared to baseline.

Demographic patient characteristics and hemangioma characteristics were similar among the five regimens. For the whole population, 29% were male, 37% were in the lower age group (35-90 days), and 72% were Caucasian. Overall, 70% had a target hemangioma on the head, most commonly cheek (13%) and forehead (11%).

The main reason for treatment discontinuation was the treatment inefficacy, which happened in 58% of patients randomized to placebo, 25-30% of patients randomized to HEMANGEOL for 3 months (mainly after the switch to placebo), and 7-9% of patients randomized to HEMANGEOL for 6 months.

Overall, 2 out of 55 patients (4%) in the placebo arm and 61 out of 101 patients (60%) on HEMANGEOL 3.4 mg/kg/day for 6 months had complete or nearly complete resolution of their hemangioma at Week 24 (p <0.0001).

There were no significant differences in response by age (35-90 days / 91-150 days), sex, or hemangioma site. There were too few non-Caucasians to assess differences in effects by race.

Of patients on HEMANGEOL 3.4 mg/kg/day for 6 months who were considered successes, 10% required retreatment for recurrence of hemangiomas.

A second uncontrolled study in 23 patients with proliferating IH included function-threatening IH, IH in certain anatomic locations that often leave permanent scars or deformity, large facial IH, smaller IH in exposed areas, severe ulcerated IH, pedunculated IH. Target lesions resolved in 36% of patients by 3 months.

How Supplied/Storage & Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

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

Storage and Handling

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.

Instructions for Use

Instructions for Use

HEMANGEOL ^®(he-man je-ohl)

(propranolol hydrochloride oral solution)

Read these Instructions for Use before giving a dose of HEMANGEOL to your child for the first time and each time you get a refill. There may be new information. Your doctor or pharmacist should show you how to correctly measure and give a dose of HEMANGEOL to your child before you give it for the first time.

Important : Read the Medication Guide that comes with HEMANGEOL.

To reduce the risk of your child getting low blood sugar (hypoglycemia), you must give HEMANGEOL either during a feeding or right away after a feeding.
Do not give a dose of HEMANGEOL if your child is vomiting, is not taking feedings, or is showing signs or symptoms of low blood sugar.

When you get HEMANGEOL from your doctor or pharmacist, you will receive a box that contains the supplies needed to give HEMANGEOL to your child, including:

One glass bottle of HEMANGEOL
One 5 mL oral dosing syringe (inside a plastic bag) that is marked to help you correctly measure a dose of HEMANGEOL ( See Figure A ). If the carton does not contain the oral dosing syringe, ask your pharmacist to give you an oral dosing syringe that can be used to measure HEMANGEOL.

Figure A

Referenced Image

Preparing to give your child a dose of HEMANGEOL:

Step 1. Place your box of supplies on a clean flat work surface, such as a table.

Step 2. Remove the HEMANGEOL bottle and oral dosing syringe from the box ( See Figure A above ). Do not shake the bottle before use . Keep the box for storage.

Step 3. Remove the oral dosing syringe from the plastic bag. Safely throw the plastic bag away. The barrel of the syringe has markings in milliliters (mL). Look at the markings on the barrel of the oral dosing syringe and find the mL marking that matches the HEMANGEOL dose in mL prescribed by your doctor ( See Figure B ).

Figure B

Referenced Image

Step 4. Open the bottle of HEMANGEOL by pushing down on the plastic cap while turning the cap to the left ( See Figure C ).

Write down on the box the date when you first open the bottle.

Figure C

Referenced Image

Step 5. Place the bottle on your work surface. Use one hand to hold the bottle upright.Use your other hand to insert the tip of the oral dosing syringe into the syringe adapter at the top of the bottle. Push the plunger all the way down ( See Figure D ).

Do not remove the syringe adapter. If the syringe adapter is missing talk to your pharmacist.

Figure D

Referenced Image

Step 6: Use one hand to hold the oral dosing syringe in place. With your other hand, turn the bottle upside down. Pull back on the plunger until the top of the plunger lines up with the marking on the barrel of the syringe that matches the dose of HEMANGEOL prescribed by your doctor ( See Figure E ). Your child’s dose may be different than the dose shown in Figure E.

Figure E

Referenced Image

Step 7: Check for air bubbles in the oral dosing syringe. If you see air bubbles, push up on the plunger towards the bottle just enough to remove any large air bubbles and then pull back to the measured dose ( See Figure F ).

Figure F

Referenced Image

Step 8. Turn bottle upright again and place it in on your work surface. Remove the oral dosing syringe from the bottle ( See Figure G ). Do not push the plunger in during this step. The syringe adapter should stay attached to the bottle.

Figure G

Referenced Image

Giving your child a dose of HEMANGEOL:

Step 9. Slowly squirt HEMANGEOL into your child’s mouth after placing the oral dosing syringe against the inside of the cheek ( See Figure H ).

Keep your child in an upright position for a few minutes right after giving a dose of HEMANGEOL.

Figure H

Referenced Image

If needed, you can dilute the dose of HEMANGEOL in a small amount of milk or fruit juice and give it to your child in a baby’s bottle. If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.

Step 10. Replace the plastic cap on the bottle. Close the bottle by turning the plastic cap to the right ( See Figure I ).

Figure I

Referenced Image

Cleaning the oral dosing syringe:

Step 11: Clean the oral dosing syringe after each use by rinsing with clean tap water ( See Figure J ).

Do not take apart the oral dosing syringe.
Do not use any soap or alcohol based product to clean. Wipe the outside dry.
Do not put the oral dosing syringe through a sterilizer or dishwasher.

Figure J

Referenced Image

Step 12: Place the bottle and the oral dosing syringe in the box.

How should I store HEMANGEOL?

When not in use, keep the bottle of HEMANGEOL and the oral dosing syringe in the box it comes in.
Store HEMANGEOL at room temperature, between 68 ^oF to 77 ^oF (20 ^oC to 25 ^oC). Do not freeze.
Safely throw away any opened bottle of HEMANGEOL after 2 months, even if there is medicine left in the bottle.

Keep HEMANGEOL and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Pierre Fabre Pharmaceuticals, Inc.

Parsippany, NJ 07054

Mechanism of Action

The mechanism of HEMANGEOL’s effects on infantile hemangiomas is not well understood.

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available

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