Sotalol hydrochloride 15 mg/mL Injection
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- That's a fair question — and I understand it feels like a lot. The reason is that sotalol can actually trigger the very type of dangerous heart rhythm it's supposed to treat, espec...
- Why do I have to start this medicine in the hospital? Can't I just take it at home?
- Some things like mild fatigue, a slightly slower heart rate, or feeling a bit lightheaded are common and often settle down. But there are symptoms you should never sit on — if you...
- What side effects should I just ride out, and which ones mean I need to call for help right away?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sotalol Hydrochloride — tap one for details:
Sotalol Hydrochloride may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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2.9 mg / 1 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sotalol hydrochloride 15 mg/mLthis 69724-0112-10 | ALTATHERA | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10512620 ↗ | Method of use | U-2769 | Aug 14, 2038 |
| US 12390431 ↗ | Method of use | U-2769 | Aug 14, 2038 |
| US 12403109 ↗ | Method of use | U-2769 | Aug 14, 2028 |
| US 11583216 ↗ | Method of use | U-3549 | Aug 21, 2039 |
| US 10799138 ↗ | Method of use | U-3549 | Apr 5, 2039 |
| US 11696902 ↗ | Method of use | U-2769 | Aug 14, 2038 |
| US 10512620 ↗ | Method of use | U-3547 | Aug 14, 2038 |
| US 10799138 ↗ | Method of use | U-3125 | Apr 5, 2039 |
| US 12569183 ↗ | Method of use | U-4456 | Apr 5, 2039 |
Is there a generic version of SOTALOL HCL 150 MG/10 ML VIAL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69724-0112-10 You're viewing this | 1 VIAL in 1 CARTON (69724-112-10) / 10 mL in 1 VIAL | 2015-10-15 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: LIFE THREATENING PROARRHYTHMIA Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. To minimize the risk of drug induced arrhythmia, initiate or up-titrate intravenous sotalol in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.1 )] Do not initiate intravenous sotalol therapy if the baseline QTc is longer than 450 ms. If the QTc prolongs to 500 ms or greater, reduce the dose or discontinue.
WARNING: LIFE THREATENING PROARRHYTHMIA See full prescribing information for complete boxed warning. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. ( 5.1 ) Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring.
( 2.3 ) Do not initiate intravenous sotalol therapy if the baseline QTc is longer than 450 ms. If the QTc prolongs to 500 ms or greater, reduce the dose or discontinue. ( 2.3 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sotalol is an antiarrhythmic indicated for: the treatment of life-threatening ventricular tachycardia. ( 1.1 ) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL). ( 1.2 ) Limitations of Use Sotalol 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 )
1.1Life-Threatening Ventricular Arrhythmia Sotalol is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia in adult and pediatric patients. Limitations of Use: Sotalol has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias.
1.2Delay in Recurrence of Atrial Fibrillation/Atrial Flutter Sotalol is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)) in adults and pediatric 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Intravenous sotalol can substitute for oral sotalol using a regimen that mimics oral exposure ( 2.2 ) Under close medical monitoring, intravenous sotalol can be used to achieve near steady-state exposure to sotalol prior to initiating or increasing oral dosing. ( 2.3 ) Recommended dosage depends on target oral dose and creatinine clearance. Refer to full prescribing information. ( 2.2 , 2.3 , 2.4 )
2.1General Considerations and Safety Measures For either indication, intravenous sotalol can substitute for oral sotalol in patients unable to take oral drugs or be used to achieve steady state concentration faster compared to the conventional oral dosing. Intravenous sotalol must be diluted for infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dilute intravenous sotalol in Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer’s Injection. Choose a volume convenient for administration and consistent with fluid restriction. Use a volumetric infusion pump.
Patients should be initiated or re-initiated on intravenous sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Withdraw other antiarrhythmic drug therapy before starting intravenous sotalol if the patient's clinical condition permits. Perform a baseline ECG to determine the QTc interval and measure and normalize serum potassium and magnesium levels before initiating therapy.
If the baseline QTc is >450 ms, sotalol is contraindicated. Assess renal function in order to establish the appropriate dosing interval. Monitor QTc 2 to 4 hours after each up-titration in dose [see Dosage and Administration (2.3) and Use in Specific Populations (8.6)].
2.2Use for Substitution of Oral Sotalol To match the exposure to oral sotalol, intravenously infuse the adjusted dose at the same dosing frequency as the oral dose based on glomerular filtration rate (see Table 1) over 5 hours. Table 1: Intravenous doses for sotalol infusion when used as a substitute for oral sotalol Individual GFR should be derived as follows: 〖GFR〗_i= eGFR/1.73 ×BSA; whereby, eGFR is GFR estimated by a GFR estimating equation, and BSA is individual body surface area. Current Oral dose Dose of intravenous sotalol based on GFR GFR 60 mL/min GFR 30 to < 60 mL/min GFR 10 to < 30 mL/min 80 mg 75 mg every 12 hours 67.5 mg every 24 hours 67.5 mg every 36 to 48 hours 120 mg 112.5 mg every 12 hours 105 mg every 24 hours 105 mg every 36 to 48 hours 160 mg 150 mg every 12 hours 142.5 mg every 24 hours 135 mg every 36 to 48 hours
2.3Use for Loading Dose Initiate or up-titrate intravenous sotalol in a facility that can provide continuous ECG monitoring and cardiac resuscitation. Personnel should be trained in the management of serious ventricular arrhythmias. Withdraw other antiarrhythmic therapy before starting sotalol hydrochloride.
Measure and normalize serum potassium and magnesium levels before initiation. If the baseline QTc is >450 ms (JT >330 ms if QRS over 100 ms), sotalol is contraindicated. The intravenous loading dose depends on the target oral dose and estimated glomerular filtration rate; the dosing interval for oral administration of sotalol and the minimum delay between the end of the infusion and the first oral dose also depend on renal function; see Table 2 [see Clinical Studies (14.4)] .
Infuse the loading dose over one hour. Monitor QTc interval every 15 minutes during infusion. Continue to monitor QTc at peak serum concentration (2 to 4 hours post-dose) following the first oral dose (in all patients) and second oral dose (in patients with GFR ≥60 mL/min).
If the QTc interval prolongs to >500 ms or increases 20% from baseline when initiating for an oral dose of 80 mg twice daily, discontinue drug; if initiating for an oral dose of 120 mg twice daily discontinue drug and consider a lower dose. If re-in…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 150 mg/10 mL (15 mg/mL) single-dose vial containing sotalol hydrochloride ( 3 ) Injection: 10-mL vial containing sotalol hydrochloride 150 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sotalol hydrochloride is contraindicated in patients with: Sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree atrioventricular (AV) block without a pacemaker [See Warnings and Precautions ( 5.2 , 5.3 )] Congenital or acquired long QT syndromes, QTc interval >450 ms [See Warnings and Precautions ( 5.1 )] Cardiogenic shock, decompensated heart failure [See Warnings and Precautions ( 5.5 )] Serum potassium <4 mEq/L [See Warnings and Precautions ( 5.1 )] Bronchial asthma or related bronchospastic conditions [See Warnings and Precautions ( 5.6 )] Known hypersensitivity to sotalol [See Warnings and Precautions ( 5.9 )] Bradyarrhythmia, sick sinus syndrome or 2 nd or 3 rd degree atrioventricular (AV) block without a pacemaker ( 4 ) Congenital or acquired long QT syndrome ( 4 ) Cardiogenic shock or decompensated heart failure ( 4 ) Serum potassium < 4mEq ( 4 ) Bronchial asthma or related bronchospastic conditions ( 4 ) Hypersensitivity to sotalol ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS QT prolongation, risk of life-threatening ventricular arrhythmias, particularly torsade de pointes ( 5.1 ) Bradyarrhythmia, AV block, sick sinus syndrome ( 5.2 , 5.3 ) Negative inotropy: hypotension, heart failure ( 5.4 , 5.5 ) Bronchospasm ( 5.6 ) Masked hypoglycemia ( 5.7 ) Masked hyperthyroidism ( 5.8 ) Anaphylaxis ( 5.9 )
5.1Proarrhythmia Sotalol can cause serious and potentially fatal ventricular arrhythmias , primarily Torsade de Pointes (TdP), a polymorphic ventricular tachycardia associated with QTc prolongation. QTc prolongation is directly related to the concentration of sotalol. Factors such as reduced renal function, female sex, higher dose, bradycardia, history of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF), atrial fibrillation with sinus node dysfunction, and heart failure increase the risk of TdP.
The risk of TdP can be reduced by adjustment of the sotalol dose according to renal function and by monitoring the ECG for excessive increases in QTc. Correct hypokalemia or hypomagnesemia prior to initiating sotalol hydrochloride, as these conditions can increase the degree of QTc prolongation and potential for TdP. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.
Proarrhythmic events should be anticipated upon initiating therapy and with every up-titration of sotalol. Avoid sotalol with other drugs known to cause QTc prolongation [see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7.1 )].
5.2Bradycardia/Atrioventricular (AV) Block Sotalol can cause bradycardia, sinus pauses or sinus arrest. Sotalol-induced bradycardia increases the risk of Torsade de Pointes, particularly following cardioversion. Monitor the ECG in patients receiving concomitant negative chronotropes [see Drug Interactions ( 7.2 , 7.3 , 7.4 )] .
5.3Sick Sinus Syndrome Sotalol is contraindicated in patients with sick sinus syndrome, because it may cause sinus bradycardia, sinus pauses, or sinus arrest. Sotalol augments bradycardia and QTc prolongation following cardioversion.
5.4Hypotension Sotalol produces significant reductions in both systolic and diastolic blood pressures. Monitor hemodynamics during administration.
5.5Heart Failure New onset or worsening heart failure may occur during initiation or up-titration of sotalol because of its beta-blocking effects. Monitor for signs and symptoms of heart failure and discontinue treatment if symptoms occur.
5.6Bronchospasm Avoid beta-blockers, like sotalol, in patients with bronchospastic diseases. If sotalol is required, use the smallest effective dose.
5.7Hypoglycemia Beta-blockade may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or pediatric patients who are fasting (i.e., surgery, not eating regularly, or vomiting). Monitor blood glucose as appropriate.
5.8Thyroid Abnormalities Avoid abrupt withdrawal of beta-blockade which might be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Beta-blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.
5.9Anaphylaxis While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.
5.10Anesthesia The impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere: Proarrhythmia [see Warnings and Precautions ( 5.1 , 5.2 )] Negative inotropy [see Warnings and Precautions ( 5.3 , 5.4 )] Adverse reactions related to sotalol use are those which are typical of its Class II (beta- blocking) and Class III (cardiac action potential duration prolongation) effects. The common documented beta-blocking adverse reactions (bradycardia, dyspnea, and fatigue) and Class III effects (QT interval prolongation) are dose related.
Bradycardia, dyspnea, fatigue, QTc prolongation To report SUSPECTED ADVERSE REACTIONS, contact AltaThera Pharmaceuticals LLC at 1-800-524-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Additive to other negative chronotropes ( 7.2 , 7.3 , 7.4 ) Additive to other QT-prolonging drugs ( 7.1 , 7.2 ) Antagonizes effect of beta-agonists ( 7.6 )
7.1Antiarrhythmic and other QT Prolonging Drugs Withdraw other Class I or Class III antiarrhythmic agents prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy, because of their potential for additive QTc prolongation [see Warnings and Precautions ( 5.1 )].
7.2Negative Chronotropes Both digitalis glycoside and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
7.3Calcium Blocking Drugs Sotalol and calcium blocking drugs can be expected to have additive effects slowing atrioventricular conduction, ventricular function, and blood pressure.
7.4Catecholamine-Depleting Agents Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta- blocker may produce an excessive reduction of resting sympathetic nervous tone. Monitor such patients for hypotension and marked bradycardia which may produce syncope.
7.5Insulin and Oral Antidiabetics Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment. Symptoms of hypoglycemia may be masked.
7.6Beta-2-Receptor Stimulants Beta-agonists such as albuterol, terbutaline and isoproterenol may have to be administered in increased dosages when used concomitantly with sotalol.
7.7Clonidine Concomitant use with sotalol increases the risk of bradycardia. Because beta-blockers may potentiate the rebound hypertension sometime observed after clonidine discontinuation, withdraw sotalol several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension.
7.8Drug/Laboratory Test Interactions The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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 the newborn for symptoms of beta blockade. Labor or Delivery Generally, risk of arrhythmias increases during the 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/m 2 , respectively, did not reveal any teratogenic potential associated with sotalol. In pregnant rats, sotalol doses administered during organogenesis at approximately15 times the MRHD as mg/m 2 , increased the number of early resorptions, while no increase in early resorptions was noted at 2 times the MRHD as mg/m 2 . In reproductive studies in rabbits, a sotalol dose (160 mg/kg/day) at 5 times the MRHD as mg/m 2 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/m 2 as on gestation day 14.
8.2Lactation 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 sotalol (see Data ). The amount of the drug in breast milk is similar to the neonatal therapeutic dosage.
Therefore, there is potential for bradycardia and other symptoms of beta blockade 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 the high level of sotalol in breast milk, advise women not to breastfeed while on treatment with sotalol.
Data Sotalol is present in human milk in high levels. A prospective study evaluate…
🤰 Pregnancy ▾
8.1Pregnancy 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 the newborn for symptoms of beta blockade. Labor or Delivery Generally, risk of arrhythmias increases during the 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/m 2 , respectively, did not reveal any teratogenic potential associated with sotalol. In pregnant rats, sotalol doses administered during organogenesis at approximately15 times the MRHD as mg/m 2 , increased the number of early resorptions, while no increase in early resorptions was noted at 2 times the MRHD as mg/m 2 . In reproductive studies in rabbits, a sotalol dose (160 mg/kg/day) at 5 times the MRHD as mg/m 2 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/m 2 as on gestation day 14.
🧒 Pediatric Use ▾
8.4Pediatric Use Sotalol is indicated for: The treatment of documented, life-threatening VT in pediatric patients. The maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in pediatric patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. 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 pediatric patients between 3 days and 12 years of age [ see Clinical Pharmacology ( 12.3 )].
Side effects from use of other sotalol-containing drug products in pediatric patients are those typical of a beta blocking agent, and led 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. In pediatric patients, the incidence of proarrhythmic side effects of sotalol varies from 0 to 22%; and the smallest pediatric patients tended to exhibit greater QTc-prolongation [see Clinical Pharmacology ( 12.2 )] ].
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 inpatient monitoring is recommended until steady state drug levels are achieved [see Dosage and Administration ( 2.1 , 2.3 ) ].
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage with sotalol may be fatal. Symptoms and Treatment of Overdosage: The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2-16 grams) of sotalol the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of the QTc interval, Torsade de Pointes, ventricular tachycardia, and premature ventricular complexes.
If overdosage occurs, therapy with sotalol should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QTc intervals are normalized and the heart rate returns to levels >50 bpm.
The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half-life of 30 hours) thought to be due to a temporary reduction of renal function caused by the hypotension. In addition, if required, the following therapeutic measures are suggested: Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist (e.g., isoproterenol) or transvenous cardiac pacing. AV Block: (second and third degree) transvenous cardiac pacemaker.
Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful. Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant. Higher than normal doses of beta-2 stimulus may be required.
Torsade de Pointes: DC cardioversion, magnesium sulfate, potassium replacement. Once Torsade de Pointes is terminated, transvenous cardiac pacing or an isoproterenol infusion to increase heart rate can be employed.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Intravenous sotalol is a racemic mixture of d- and l-sotalol. Both isomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity.
T he beta-blocking effect of sotalol is non-cardioselective, half maximal at oral doses of about 80 mg/day and maximal at oral doses between 320 and 640 mg/day. Significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects can be seen after a single oral or IV dose of 80 or 75 mg respectively. In pediatric patients, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m 2 body surface area (BSA).
A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥90 mg/m 2 in pediatric patients.
12.2Pharmacodynamics Electrophysiology: Sotalol prolongs the plateau phase of the cardiac action potential in the isolated myocyte, as well as in isolated tissue preparations of ventricular or atrial muscle (Class III activity). In intact animals it slows heart rate, decreases AV nodal conduction and increases the refractory periods of atrial and ventricular muscle and conduction tissue. In man, the Class II (beta-blockade) electrophysiological effects of sotalol include increased sinus cycle length (slowed heart rate), decreased AV nodal conduction, and increased AV nodal refractoriness.
The Class III electrophysiological effects in man include prolongation of the atrial and ventricular monophasic action potentials, and effective refractory period prolongation of atrial muscle, ventricular muscle, and atrio-ventricular accessory pathways (when present) in both the anterograde and retrograde directions. With oral doses of 160 to 640 mg/day, the surface ECG shows dose-related mean increases of 40-100 ms in QT and 10-40 ms in QTc. Twenty-five pediatric patients in an unblinded, multicenter trial with supraventricular (SVT) and/or ventricular (VT) tachyarrhythmias, aged between 3 days and 12 years (mostly neonates and infants), received an ascending titration regimen with daily oral doses of 30, 90 and 210 mg/m 2 with dosing every 8 hours for a total of 9 doses.
During steady-state, the respective average increases above baseline of the QTc interval were 2, 14, and 29 ms at the 3 dose levels. The respective mean maximum increases in QTc above baseline were 23, 36, and 55 ms. The steady-state percent increases in the RR interval were 3, 9 and 12%.
The smallest pediatric patients (BSA <0.33 m 2 ) showed a tendency for larger Class III effects (ΔQTc) and an increased frequency of prolongations of the QTc interval compared with pediatric patients with BSA ≥0.33 m 2 . The beta-blocking effects also tended to be greater in the smaller pediatric patients (BSA<0.33 m 2 ). Hemodynamics: In a study of systemic hemodynamic function measured invasively in 12 patients with a mean LV ejection fraction of 37% and ventricular tachycardia (9 sustained and 3 non-sustained), a median dose of 160 mg twice daily of sotalol produced a 28% reduction in heart rate and a 24% decrease in cardiac index at 2 hours post-dosing at steady-state.
Concurrently, systemic vascular resistance and stroke volume showed non-significant increases of 25% and 8%, respectively. Pulmonary capillary wedge pressure increased significantly from 6 to 12 mmHg in the 11 patients who completed the study. Mean arterial pressure, mean pulmonary artery pressure and stroke work index did not significantly change.
Exercise and isoproterenol induced tachycardia are antagonized by sotalol, and total peripheral resistance increases by a small amount. In hypertensive patients, sotalol produces significant reductions in both systolic and diastolic blood pressures. Although sot…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Intravenous sotalol is a racemic mixture of d- and l-sotalol. Both isomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity.
T he beta-blocking effect of sotalol is non-cardioselective, half maximal at oral doses of about 80 mg/day and maximal at oral doses between 320 and 640 mg/day. Significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects can be seen after a single oral or IV dose of 80 or 75 mg respectively. In pediatric patients, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m 2 body surface area (BSA).
A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥90 mg/m 2 in pediatric patients.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sotalol hydrochloride Injection is a clear and colorless solution as follows: Each carton contains one single-dose vial containing 150 mg/10 mL (15 mg/mL) sotalol hydrochloride Injection NDC 69724-112-10 Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Protect from freezing and light.
📋 Description ▾
11 DESCRIPTION Sotalol hydrochloride injection is an aqueous formulation of sotalol hydrochloride for intravenous use. Sotalol is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8.
It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d, l- N - [4-[1-hydroxy-2-[(1-methylethyl) amino] ethyl] phenyl] methane-sulfonamide monohydrochloride. The molecular formula is C 12 H 20 N 2 O 3 S•HCl and is represented by the following structural formula: Intravenous sotalol Injection is supplied as a sterile, clear solution in a 10 mL single-dose vial, for intravenous administration after dilution.
Each vial contains 150 mg racemic sotalol hydrochloride (equivalent to 132.8 mg racemic sotalol) in sodium acetate buffer. The sotalol hydrochloride concentration of the formulation is 15 mg/mL. Each mL contains 2.9 mg glacial acetic acid in water for injection as an inactive ingredient.
The pH of the injection is adjusted with sodium hydroxide to be between 6.0 and 7.0. Structure