Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)
Pierre Fabre Pharmaceuticals, Inc.
PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE 4.28 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
HEMANGEOL- PROPRANOLOL HYDROCHLORIDE SOLUTION Pierre Fabre Pharmaceuticals, Inc. ---------- 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 Lestu allt skjalið
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 Lestu allt skjalið