"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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 in children, especially when they are not feeding regularly or are vomiting; withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. If a child has clinical signs of hypoglycemia, discontinue HEMANGEOL and call their health care provider immediately or take the child to the emergency room.
Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [see DRUG INTERACTIONS].
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.
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.
Increased Risk Of Stroke In PHACE Syndrome
Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to HEMANGEOL therapy.
Patient Counseling Information
See FDA-approved patient labeling (Medication Guide and Instructions for Use).
Advise parents or caregivers to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Instructions for using oral dosing syringe
Instruct parents or caregivers on use of the oral dosing syringe.
Risk of hypoglycemia
Inform parents or caregivers that there is a risk of hypoglycemia when HEMANGEOL is given to infants who are not feeding regularly or who are vomiting. Instruct them to skip dosing under such conditions.
Instruct parents or caregivers how to recognize the signs of hypoglycemia. Tell them to discontinue HEMANGEOL and call their health care provider immediately or take the child to the emergency room in case of suspected hypoglycemia.
risks Advise parents or caregivers that there is a potential risk for bradycardia, aggravation of pre-existing conduction disorders, and hypotension associated with the use of HEMANGEOL. Instruct them to contact their healthcare provider in case of fatigue, pallor, slow or uneven heart beats, peripheral coldness or fainting.
Inform parents or caregivers that HEMANGEOL carries risk of bronchospasm or exacerbation of lower respiratory tract infections. Instruct them to contact their healthcare provider or go to the nearest hospital emergency room if their child has breathing problems or wheezing during treatment with HEMANGEOL.
Inform parents or caregivers that changes in sleep patterns may occur during HEMANGEOL therapy.
Ask parents or caregivers to tell you all the medications they are administering to their child including prescription and over the counter medicines, vitamins, and herbal supplements. Ask breastfeeding mothers to tell you all the medications they are currently taking, as these may pass into the milk.
Carcinogenesis, Mutagenesis, 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.
Use In Specific Populations
HEMANGEOL is not intended to be prescribed to pregnant women [see INDICATIONS AND USAGE].
Pregnancy Category C
In a series of reproductive and developmental toxicology studies, propranolol hydrochloride was given to rats by gavage or in the diet throughout pregnancy and lactation. At a dose of 150 mg/kg/day [which is about 2 times the maximum recommended human oral daily dose (MRHD) of 640 mg propranolol hydrochloride in adults on a body surface area basis], treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol hydrochloride also was administered in the feed to rabbits throughout pregnancy and lactation at doses up to 150 mg/kg/day (about 5 times the maximum recommended human oral daily dose in adults). No evidence of embryo or neonatal toxicity was noted.
There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital abnormalities have been reported in neonates whose mothers received propranolol during pregnancy. Neonates whose mothers received propranolol at parturition have exhibited bradycardia, hypoglycemia, and respiratory depression. Adequate facilities for monitoring such infants at birth should be available.
HEMANGEOL is not intended to be prescribed to breastfeeding women [see INDICATIONS AND USAGE]. Propranolol is excreted in human milk.
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].
Safety and effectiveness for infantile hemangioma have not been established in pediatric patients greater than 1 year of age.
There is no experience in infants with hepatic impairment.
There is no experience in infants with renal impairment.
Last reviewed on RxList: 4/3/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Hemangeol Information
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