SOTYLIZE- sotalol hydrochloride solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)

Commercializzato da:

Azurity Pharmaceuticals, Inc.

INN (Nome Internazionale):

SOTALOL HYDROCHLORIDE

Composizione:

SOTALOL HYDROCHLORIDE 5 mg in 1 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

SOTYLIZE is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. Limitation of Use SOTYLIZE has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use Because sotalol can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given SOTYLIZE. For the treatment of AFIB/AFL or ventricular arrhythmias, SOTYLIZE is contraindicated in patients with: - Baseline QT interval ˃450 msec - Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present - Congenital or acquired long QT syndromes - Cardiogenic shock or decompensated heart failure - Serum potassium <4 mEq/L - Bronchial asthma or related bronchospastic conditions - Hypersensitivity to sotalol Risk Summary Both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate (see Clinical Considerations ). In animal reproduction studies in rats, early resorptions were increased at 15 times the maximum recommended human dose (MRHD). In rabbits an increase in fetal death was observed at 2 times the MRHD administered as single dose. Sotalol did not reveal any teratogenic potential in rats or rabbits at 15 and 2 times the MRHD respectively (see Data ). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the United States (U.S.) general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations The incidence of VT is increased and may be more symptomatic during pregnancy. Most tachycardia episodes are initiated by ectopic beats and the occurrence of arrhythmia episodes may, therefore, increase during pregnancy. Breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. Fetal/Neonatal Adverse Reactions Sotalol has been shown to cross the placenta and is found in amniotic fluid. From published observational studies, the potential fetal adverse effects of sotalol use during pregnancy are growth restriction, transient fetal bradycardia, hyperbilirubinemia, hypoglycemia, uterine contractions, and possible intrauterine death. Sotalol may have a greater effect on QT prolongation in the immature heart than in the adult heart, and therefore, conveys an increased risk of serious fetal arrhythmia and/or possible intrauterine death. Monitor newborns for symptoms and adverse reactions associated with beta-blockers. Labor or Delivery Generally, risk of arrhythmias increases during labor and delivery process; therefore, considering the proarrhythmia potential of the drug, patients treated with sotalol should be monitored continuously during labor and delivery. Data Animal Data Reproduction studies in rats and rabbits administered sotalol during organogenesis at 15 times and 2 times the MRHD as mg/m2 , respectively, did not reveal any teratogenic potential associated with sotalol. In pregnant rats, sotalol doses administered during organogenesis at approximately 15 times the MRHD as mg/m2 , increased the number of early resorptions, while no increase in early resorptions was noted at 2 times the MRHD as mg/m2 . In reproductive studies in rabbits, a sotalol dose (160 mg/kg/day) at 5 times the MRHD as mg/m2 produced a slight increase in fetal death, and maternal toxicity. However, one study from published data reported an increase in fetal deaths in rabbits receiving a single dose (50 mg/kg) at 2 times the MRHD as mg/m2 on gestation day 14. Risk Summary Limited available data from published literature report that sotalol is present in human milk. The estimated daily infant dose of sotalol received from breastmilk is 0.8-3.4 mg/kg, estimated at 22 to 25.5% of the maternal weight-adjusted dosage of SOTYLIZE (see Data ). The amount of drug in breast milk is similar to the neonatal therapeutic dosage. Therefore, there is potential for bradycardia and other symptoms from beta-blockers such as dry mouth, skin or eyes, diarrhea or constipation in the breastfed infant. There is no information regarding the effects of sotalol on milk production. Because of the potential serious adverse reactions to the breastfed child and high level of sotalol in breast milk, advise women not to breastfeed while on treatment with SOTYLIZE. Data Sotalol is present in human milk in high levels. A prospective study evaluated 20 paired samples of breast milk and maternal blood from 5 mothers who elected to breastfeed. Breast milk samples had a mean sotalol concentration of 10.5 g µg/mL (± 1.1 µg/mL; range: 4.8 to 20.2 µg/mL compared to a simultaneous mean maternal plasma concentration of 2.3 µg/mL (± 0.3 µg/mL; range: 0.8 to 5.0 µg/mL). The mean milk plasma ratio was 5:4:1 (range: 2.2 to 8.8.). The estimated daily infant dose was 0.8 -3.4 mg/kg, estimated at 22 to 25.5% of the maternal weight-adjusted dosage of sotalol. This is similar to recommended therapeutic dose in neonates. None of the mothers reported any adverse reactions in the breastfed infant. Infertility Based on the published literature, beta-blockers (including sotalol) may cause erectile dysfunction. The safety and effectiveness of sotalol in children have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see Dosage and Administration (2.2) and Clinical Pharmacology (12.2)] . Associated side effects of sotalol use in pediatric patients are those typical of a beta-blocking agent, and lead to discontinuation of the drug in 3 to 6% of patients. As in adults, the Class III antiarrhythmic action of sotalol in pediatric patients is associated with a significant proarrhythmic potential for adverse effects. In pediatric patients, the incidence of proarrhythmic side effects of sotalol varies from 0 to 22%; however, sotalol-induced Torsade de Pointes tachycardias are observed less frequently in the pediatric population. Proarrhythmic effects of sotalol in pediatric patients included increased ventricular ectopy and exacerbation of bradycardia, the latter predominantly in patients with sinus node dysfunction following surgery for congenital cardiac defects. Bradycardia may require emergency pacemaker implantation. Close in-patient monitoring is recommended for several days. Sotalol is mainly eliminated via the kidneys. Adjust dosing intervals based on creatinine clearance [see Dosage and Administration (2.5)] .

Dettagli prodotto:

SOTYLIZE (sotalol hydrochloride) is supplied as follows: Store at 20°C to 25°C (68°F -77°F); excursions permitted between 15°C and 30°C (59°F-86°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

SOTYLIZE- SOTALOL HYDROCHLORIDE SOLUTION
AZURITY PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOTYLIZE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SOTYLIZE.
SOTYLIZE (SOTALOL HYDROCHLORIDE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE-THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SOTALOL CAN CAUSE LIFE-THREATENING VENTRICULAR TACHYCARDIA ASSOCIATED
WITH QT INTERVAL
PROLONGATION.
IF THE QT INTERVAL PROLONGS TO 500 MSEC OR GREATER, REDUCE THE DOSE,
LENGTHEN THE
DOSING INTERVAL, OR DISCONTINUE THE DRUG.
INITIATE OR REINITIATE IN A FACILITY THAT CAN PROVIDE CARDIAC
RESUSCITATION AND
CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING.
ADJUST THE DOSING INTERVAL BASED ON CREATININE CLEARANCE.
INDICATIONS AND USAGE
SOTYLIZE is an antiarrhythmic indicated for:
The treatment of life-threatening ventricular arrhythmias (1.1)
The maintenance of normal sinus rhythm in patients with highly
symptomatic atrial fibrillation/flutter
(AFIB/AFL) (1.2)
Limitations of Use
SOTYLIZE has not been shown to enhance survival in patients with life
threatening ventricular
arrhythmias (1.1)
Avoid use in patients with minimally symptomatic or easily reversible
AFIB/AFL (1.2)
DOSAGE AND ADMINISTRATION
Initiate therapy at 80 mg twice daily. Increase the dose as needed in
increments of 80 mg/day, every 3
days to a maximum 320 mg total daily dose (2.2)
If creatinine clearance is between 60 and 40 mL/min, administer once
daily, if less than 40 mL/min,
sotalol is not recommended (2.1)
Pediatrics: Dosage depends on age (2.4)
DOSAGE FORMS AND STRENGTHS
5 mg/mL oral solution (3)
CONTRAINDICATIONS
For the treatment of AFIB/AFL or ventricular arrhythmias
Baseline QT interval ˃450 msec (4)
Sinus bradycardia, 2
or 3 degree AV block, sick sinus syndrome (4)
Congenital or acquired long QT syndromes (4)
Serum potassium ˂4 mEq/L (4)
Cardiogenic shock, decompensated heart failure (4)
Bronchial asthma or rel