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Sotalol | CAS No: 3930-20-9 | GMP-certified suppliers
A medication that treats life-threatening ventricular arrhythmias and maintains normal sinus rhythm in patients with atrial fibrillation or flutter.
Therapeutic categories
Primary indications
- Sotalol is indicated to treat life threatening ventricular arrhytmias and maintain normal sinus rhythm in patients with atrial fibrillation or flutter
- There are also oral solutions and intravenous injections indicated for patients requiring sotalol, but for whom a tablet would not be appropriate
- [Label,L6373,L6376]
Product Snapshot
- Sotalol is available as oral tablets and intravenous solution formulations
- It is used primarily for managing life-threatening ventricular arrhythmias and maintaining normal sinus rhythm in atrial fibrillation or flutter
- Sotalol products are approved for use in the US and Canadian markets
Clinical Overview
Pharmacologically, sotalol exhibits a dual mechanism of action. It competitively inhibits the rapid component of the delayed rectifier potassium current, which prolongs the cardiac action potential duration and refractory period in both atrial and ventricular myocardium. This potassium channel blockade is noted to increase its effect at lower heart rates, contributing to the risk of QT interval prolongation and associated proarrhythmic events such as torsades de pointes, particularly at bradycardic states. Additionally, the L-enantiomer of sotalol exhibits non-selective beta-adrenergic receptor antagonism at plasma concentrations above 800 ng/L, contributing to further action potential prolongation, slowing of sinus node automaticity, and negative inotropic effects. The D-enantiomer lacks beta-blocking activity but also influences heart rate dynamics under orthostatic or exercise conditions.
Key ADME characteristics include absorption via the oral route with bioavailability close to 100%, minimal hepatic metabolism, and primary renal excretion, necessitating careful dose adjustment in patients with renal impairment to avoid accumulation and toxicity.
Safety considerations include the potential for proarrhythmia, notably torsades de pointes due to QT prolongation, and beta-blocker class effects such as bradycardia and negative inotropy. Sotalol also affects glucose metabolism; in type II diabetics, beta-blockade may induce hyperglycemia through inhibition of insulin secretion, while in insulin-dependent diabetics it can mask hypoglycemic symptoms and prolong hypoglycemia by increasing peripheral glucose uptake. These effects warrant close monitoring in diabetic patients.
Sotalol’s therapeutic use requires attention to renal function and electrocardiographic monitoring to optimize safety. It is a narrow therapeutic index drug and a substrate of cytochrome P450 CYP2D6. Its classification includes adrenergic antagonists and QT-prolonging agents, highlighting the necessity for rigorous clinical oversight.
For API sourcing, stringent quality controls must ensure chemical purity, stereochemical integrity of the racemic mixture, and absence of impurities or degradation products that could affect pharmacologic activity or safety. Compliance with pharmacopeial standards and regulatory guidance is essential, especially given sotalol’s narrow therapeutic index and critical safety profile.
Identification & chemistry
| Generic name | Sotalol |
|---|---|
| Molecule type | Small molecule |
| CAS | 3930-20-9 |
| UNII | A6D97U294I |
| DrugBank ID | DB00489 |
Pharmacology
| Summary | Sotalol functions as a non-selective beta-adrenergic receptor antagonist and a potent inhibitor of rapid potassium channels (hERG), leading to prolonged cardiac action potentials and QT interval extension. These effects collectively slow atrioventricular conduction, increase refractory periods, and decrease myocardial contractility. It is primarily utilized to manage ventricular arrhythmias and maintain sinus rhythm in atrial fibrillation or flutter. |
|---|---|
| Mechanism of action | Sotalol inhibits beta-1 adrenoceptors in the myocardium as well as rapid potassium channels to slow repolarization, lengthen the QT interval, and slow and shorten conduction of action potentials through the atria. The action of sotalol on beta adrenergic receptors lengthens the sinus node cycle, conduction time through the atrioventricular node, refractory period, and duration of action potentials. |
| Pharmacodynamics | Sotalol is a competitive inhibitor of the rapid potassium channel. This inhibition lengthens the duration of action potentials and the refractory period in the atria and ventricles. The inhibition of rapid potassium channels is increases as heart rate decreases, which is why adverse effects like torsades de points is more likely to be seen at lower heart rates. L-sotalol also has beta adrenergic receptor blocking activity seen above plasma concentrations of 800ng/L. The beta blocking ability of sotalol further prolongs action potentials. D-sotalol does not have beta blocking activity but also reduces a patient's heart rate while standing or exercising. These actions combine to produce a negative inotropic effect that reduces the strength of contractility of muscle cells in the heart. Extension of the QT interval is also adversely associated with the induction of arrhythmia in patients. Hyperglycemia is a greater risk for non insulin dependant diabetics than insulin dependant diabetics. Beta blockers inhibit insulin secretion which may cause hyperglycemia in type II diabetes mellitus. The risk of hypoglycemia is higher in insulin dependant diabetes than non insulin dependant diabetics. Beta blockers decrease secretion of insulin, which may mask hypoglycemia in an insulin dependant patient. Beta blockers also increase glucose uptake into cells which may prolong or potentiate hypoglycemia. Further information regarding adverse reactions can be found here. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Beta-1 adrenergic receptor | Humans | antagonist |
| Beta-2 adrenergic receptor | Humans | antagonist |
| Potassium voltage-gated channel subfamily H member 2 | Humans | inhibitor |
ADME / PK
| Absorption | Sotalol is 90-100% bioavailable.[Label,A178483] When taken with a meal, adsorption is lowered by 18%.[Label,A178483] In patients with a creatinine clearance >80mL/min, the maximum concentration is 6.25±2.19. |
|---|---|
| Half-life | The terminal elimination half life is 10-20 hours in healthy patients.[Label,A178483] In patients with a creatinine clearance >80mL/min, the half life is 17.5±0.97h. In patients with a creatinine clearance 30-80mL/min, the half life is 22.7±6.4h. In patients with a creatinine clearance 10-30mL/min, the half life is 64±27.2h. In patients with a creatinine clearance <10mL/min, the half life is 97.9±57.3h. |
| Protein binding | 0%.[Label,A178483] |
| Metabolism | Sotalol is not metabolized.[Label,A178483] |
| Route of elimination | 80-90% of a given dose is excreted in the urine as unchanged sotalol.[Label,A178483] A small fraction of the doses is excreted in the feces as unchanged sotalol.[Label,A178483] |
| Volume of distribution | The apparent volume of distribution is 1.2-2.4L/kg.[Label,A178483] |
| Clearance | In patients with a creatinine clearance >80mL/min, the plasma clearance is 6.78±2.72L/h and the renal clearance is 4.99±1.43L/h. In patients with a creatinine clearance 30-80mL/min, the plasma clearance is 2.74±0.53L/h and the renal clearance is 2.00±0.67L/h. In patients with a creatinine clearance 10-30mL/min, the plasma clearance is 1.56±0.44L/h and the renal clearance is 0.65±0.31L/h. In patients with a creatinine clearance <10mL/min, the plasma clearance is 0.65±0.20L/h and the renal clearance is 0.27±0.13L/h. |
Formulation & handling
- Sotalol is available as both oral tablets and intravenous injection formulations, requiring consideration for route-specific handling and formulation.
- This small molecule exhibits moderate water solubility and a slightly hydrophilic character (LogP -0.4), influencing dissolution and bioavailability profiles.
- Oral administration can be with or without food, though food intake reduces absorption by approximately 20%, which may impact formulation strategies.
Regulatory status
| Lifecycle | The API is currently protected by multiple patents in the United States with expiry dates extending from 2034 to 2039. It is marketed in the US and Canada, indicating it is in the mature patent-protected phase with limited generic competition expected until patent expirations. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Sotalol includes multiple originator and generic pharmaceutical companies, indicating a competitive supply environment. Branded products such as Betapace have a strong presence primarily in the US and Canadian markets. Active patents with expiry dates extending into the mid-to-late 2030s suggest limited current generic competition and a sustained period of brand exclusivity. |
|---|
Safety
| Toxicity | Patients experiencing an overdose may present with bradycardia, congestive heart failure, hypotension, bronchospasm, and hypoglycemia. Larger intentional overdoses may present as hypotension, bradycardia, cardiac asystole, prolonged QT interval, torsade de pointes, ventricular tachycardia, and premature ventricular complexes. Stop administering sotalol and observe the patient until the QT interval returns to normal and the heart rate rises above 50 beats per minute. Hemodialysis may help lower plasma concentrations of sotalol as it is not bound to plasma proteins. Bradycardia and cardiac asystole may be treated with [atropine], other anticholinergic drugs, beta adrenergic agonists, or transvenous cardiac pacing.. Second or third degree heart block may be treated with a transvenous cardiac pacemaker. Hypotension may be treated with [epinephrine] or [norepinephrine]. Bronchospasm may be treated with [aminophylline] or a beta-2 agonist, possibly at higher than normal doses. Torsade de pointes may be treated with DC cardioversion, transvenous cardiac pacing, epinephrine, or [magnesium sulfate]. The oral LD50 for rats is 3450mg/kg, intraperitoneal LD50 for rats is 680mg/kg, oral LD50 for mice is 2600mg/kg, and intraperitoneal LD50 for mice is 670mg/kg.[MSDS] Pregnant rabbits given 6 times the maximum recommended human dose showed an increase in fetal death and maternal toxicity, while rats given 18 times the maximum recommended human dose had an increased number of fetal resorptions. Sotalol is present in human breast milk so patients taking sotalol should not breast feed. Sotalol has not been found to be carcinogenic. No studies have been performed regarding mutagenicity or clastogenicity. In animal studies, sotalol was not associated with a reduction in fertility aside from smaller litter sizes. Further information regarding adverse reactions can be found here. |
|---|
- Sotalol exhibits moderate acute toxicity with oral LD50 values ranging from 2600 to 3450 mg/kg in rodent models
- Overdose may result in severe cardiac effects including bradycardia, hypotension, and arrhythmias such as torsade de pointes
- Cardiac monitoring is recommended during handling in clinical settings
Sotalol is a type of Beta blockers
Beta blockers are a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the medical field. These medications work by blocking the effects of adrenaline and other stress hormones on the beta receptors in the body. This action helps to reduce the heart rate and blood pressure, making them effective in treating various cardiovascular conditions.
Beta blockers are commonly prescribed to manage conditions such as hypertension (high blood pressure), angina (chest pain), arrhythmias (irregular heart rhythms), and certain types of heart failure. They can also be used in the prevention of migraines and to alleviate symptoms associated with anxiety disorders.
By targeting the beta receptors, these APIs provide a significant impact on the sympathetic nervous system, reducing the fight-or-flight response and promoting a state of calmness. This mechanism of action allows beta blockers to be effective in controlling heart-related conditions.
Some well-known beta blockers include metoprolol, propranolol, atenolol, and carvedilol. These APIs are available in various forms such as tablets, capsules, and injectables, allowing for flexibility in administration and dosage.
It is important to note that the use of beta blockers should be done under medical supervision due to potential side effects and contraindications. Common side effects may include fatigue, dizziness, cold hands and feet, and sexual dysfunction. Patients with certain conditions like asthma or diabetes may require cautious monitoring while using beta blockers.
In conclusion, beta blockers are a vital subcategory of pharmaceutical APIs used to treat cardiovascular conditions by blocking the effects of stress hormones. Their effectiveness and versatility make them a valuable tool in managing various medical conditions, enhancing the well-being of patients.
Sotalol (Beta blockers), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Sotalol API manufacturers & distributors
Compare qualified Sotalol API suppliers worldwide. We currently have 6 companies offering Sotalol API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Arevipharma | Producer | Germany | Unknown | CEP, CoA, FDA | 25 products |
| Cambrex | Producer | Italy | Unknown | CoA, USDMF | 104 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Spain | CoA, GMP, ISO9001, MSDS | 170 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, USDMF | 50 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 142 products |
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