Sotalol Hydrochloride

Class: beta-Adrenergic Blocking Agents
VA Class: CV100
Chemical Name: Methanesulfonamide,N-[4-[1-Hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]monohydrochloride
Molecular Formula: C₁₂H₂₀N₂O₃S•ClH
CAS Number: 959-24-0
Brands: Betapace, Sorine

• 
  

  To minimize the risk of induced arrhythmias, patients initiated or re-initiated on sotalol should be placed in a facility that can provide cardiac resuscitation and continuous ECG monitoring for at least 3 days (on maintenance dosage).^{b c} (See Proarrhythmic Effects under Cautions.)

  
  


• 
  

  Calculate Cl_cr prior to dosing.^{b c} (See General under Dosage and Administration.)

  
  


• 
  

  Sotalol is marketed in the US under separate trade names for ventricular (Betapace) or atrial (Betapace AF) arrhythmias.^{a b c}

  
  


• 
  

  Betapace is not approved for atrial arrhythmias, and should not be substituted for Betapace AF because professional labeling differs (e.g., for cautions, precautions, and contraindications; patient instructions and advice; and dosage and administration) for the products, and only Betapace AF is distributed with patient labeling appropriate for patients with atrial arrhythmias.^{a b c}

  
  

Introduction

Nonselective β-adrenergic blocking agent; a methanesulfonanilide derivative.^{1 2 7 8 63 77}

Uses for Sotalol Hydrochloride

Ventricular Arrhythmias

Treatment to suppress and prevent recurrence of documented life-threatening ventricular arrhythmias (e.g., sustained ventricular tachycardia);^{1 4 5 6 7 8 11 12 26} designated an orphan drug by FDA for such use.⁹

Alternative antiarrhythmic agent (to amiodarone) in the treatment of sustained, stable monomorphic ventricular tachycardia.⁷⁷

Because of sotalol’s arrhythmogenic potential, lack of evidence for improved survival, and risk of serious adverse effects (see Proarrhythmic Effects under Cautions), use for less severe arrhythmias, even if symptomatic, is notrecommended¹ and treatment of asymptomatic ventricular premature complexes (VPCs) should be avoided.^{1 3 4 7 8 12 14}

As effective as some other first-line antiarrhythmic agents (e.g., procainamide, quinidine) for the management of severe refractory arrhythmias.^{1 48 63 64}

Can reduce ventricular premature contractions (VPCs), paired VPCs, and nonsustained ventricular tachycardia in patients with frequent VPCs^{1 7 11 12} and can suppress the recurrence of ventricular tachyarrhythmias in patients with ventricular tachycardia and/or fibrillation.^{1 4 5 6 7 11 12}

Supraventricular Tachyarrhythmias

Betapace AF is used to maintain normal sinus rhythm in patients with highly symptomatic atrial fibrillation or flutter who are currently in sinus rhythm.^{41 63}

Only Betapace AF is approved for atrial fibrillation and flutter; Betapace or generic sotalol should not be substituted for Betapace AF.^{b d} (See Supraventricular Tachyarrhythmias under General in Dosage and Administration.)

Reserve for highly symptomatic atrial fibrillation because of the potential to cause life-threatening ventricular arrhythmias.^{41 42 51 56 57} (See Proarrhythmic Effects under Cautions.) Do not use for easily reversible paroxysmal atrial fibrillation (e.g., by the Valsalva maneuver).⁴¹

Alternative to direct-current (DC) cardioversion to control rhythm in atrial fibrillation or flutter in patients with preexcitation (Wolff-Parkinson-White [WPW]) syndrome† and preserved ventricular function when the duration of the arrhythmia is ≤48 hours.⁷⁷

Efficacy in preventing atrial fibrillation or flutter recurrences is comparable to that of quinidine or propafenone and less than that of amiodarone.^{43 44 45 47} Maintenance of sinus rhythm with oral sotalol does not appear to be related to either duration of previous episodes of atrial fibrillation (e.g., paroxysmal or persistent atrial fibrillation) or the degree of atrial enlargement.⁴⁷

Sotalol Hydrochloride Dosage and Administration

General

• 
  

  Individualize dosage carefully according to individual requirements and response, patient tolerance, renal function, and general condition and cardiovascular status.^{1 4 8 41}

  
  


• 
  

  Initiate therapy and subsequent dosage increases in an institutional setting that can provide cardiac resuscitation, continuous ECG monitoring, and calculations of Cl_cr.^{1 7 8 41 42 48}

  
  


• 
  

  Calculate Cl_cr before initiating therapy.^{b c d}

  
  


• 
  

  Estimate Cl_cr by using the following formula. If S_cr concentration is given in mcmol/L, divide the value by 88.4 (1 mg/dL = 88.4 mcmol/L).⁴¹

  
  


• 
  

  Clinical and ECG monitoring, including appropriate ambulatory ECG monitoring (e.g., Holter monitoring) is recommended.^{1 12 41} Monitor patients for at least 3 days on maintenance dosage following initiation, reinitiation, and, if necessary, dosage titration.^{1 7 8 41}

  
  

Ccr male = [(140 - age) × weight (in kg)] / [72 × serum creatinine (in mg/dL)]Ccr female = 0.85 × Ccr male

Ventricular Arrhythmias

• 
  

  Gradual upward titration and appropriate monitoring for efficacy (e.g., PES, Holter) and safety (e.g., QT interval, heart rate, electrolytes) prior to dose escalation should reduce the risk of precipitating arrhythmias.¹ (See Proarrhythmic Effects under Cautions.)

  
  

Supraventricular Tachyarrhythmias

• 
  

  Only Betapace AF is approved for atrial fibrillation and flutter; Betapace or generic sotalol should not be substituted for Betapace AF; only Betapace AF is distributed with patient information appropriate for atrial arrhythmias.^{b d} Patients with a history of symptomatic atrial fibrillation or flutter receiving Betapace for maintenance of normal sinus rhythm should be transferred to Betapace AF because of appreciable differences in labeling (i.e., patient information, dosage and administration, safety information).^{b d}

  
  


• 
  

  Determine QT interval prior to initiating therapy and 2–4 hours after each dose during inpatient dosage-titration phase.⁴¹

  
  


• 
  

  If baseline QRS interval is >100 msec, adjust dosage using the JT interval; use is contraindicated if baseline JT interval is ≥330 msec.⁴¹ (See Contraindications under Cautions.)

  
  


• 
  

  Adequate anticoagulation is recommended prior to initiating therapy.^{c 51 54 63} (See Adjunctive Antithrombotic Therapy under Dosage and Administration.)

  
  


• 
  

  Do not discharge from institutional setting within 12 hours of pharmacologic or electrical cardioversion to normal sinus rhythm.⁴¹

  
  


• 
  

  For maintenance therapy, measure Cl_cr and QT interval periodically as medically warranted.⁴¹

  
  

Adjunctive Antithrombotic Therapy

• 
  

  Patients with persistent (i.e., >48 hours’ duration) atrial fibrillation (e.g., geriatric patients <75 years of age, those with hypertension, atrial and ventricular dysfunction, diabetes mellitus, recent heart failure, prior history of stroke or transient ischemic attacks) must be adequately anticoagulated (INR of 2–3), generally for at least 3 weeks before administration of antiarrhythmic agents and continued for 4 weeks after cardioversion.^{51 54 59}

  
  


• 
  

  In marginal patients, in addition to anticoagulation, consultation with a cardiologist and diagnostic procedures to exclude atrial thrombi recommended.⁴¹

  
  


• 
  

  In patients who require earlier cardioversion, use transesophageal echocardiography to identify atrial thrombi; patients without preexisting thrombi may receive anticoagulation with heparin, cardioversion within 1–2 days of initiation of anticoagulation, followed by administration of warfarin for 4 weeks.^{51 54}

  
  


• 
  

  Aspirin may be administered to prevent stroke in patients who cannot tolerate anticoagulation.⁵¹

  
  

Transfer from Antiarrhythmic Agents

• 
  

  A transition period is recommended for patients being transferred from another antiarrhythmic agent to sotalol.^{1 41}

  
  


• 
  

  In general, withdraw current antiarrhythmic agent and delay initiation of sotalol for at least 2–3 elimination half-lives of the other drug; monitor carefully during this period.^{1 41}

  
  


• 
  

  In patients being transferred from amiodarone, withhold sotalol until the QT interval has normalized.^{1 41}

  
  


• 
  

  Sotalol has been initiated in some patients prior to discontinuance of IV lidocaine without ill effect.^{1 41}

  
  


• 
  

  Transfer patients with a history of symptomatic atrial fibrillation or flutter who are receiving Betapace for maintenance of sinus rhythm to Betapace AF because of appreciable differences in labeling (i.e., patient information, dosage and administration, safety information) provided by the manufacturer.^{41 c}

  
  

Administration

Oral Administration

Administer orally with or without food, at approximately the same time(s) each day.^{1 41 46}

Do not administer aluminum oxide and magnesium hydroxide-containing antacids within 2 hours of administration of sotalol.^{1 41 46} (See Specific Drugs and Laboratory Tests under Interactions.)

May give in 2 or 3 divided doses daily; administration > twice daily usually is not necessary since the drug has a long terminal elimination half-life.¹ (See Elimination under Pharmacokinetics.)

Extemporaneous Oral Solution

Prepare sotalol 5 mg/mL solution using Simple Syrup with 0.1% sodium benzoate (Syrup N.F.).^{b c}

Add 5 tablets (120 mg each) to 120 mL of Simple Syrup in an oversized (180 mL) plastic (PET) prescription bottle to allow more effective shaking of the mixture.^{b c}

May add tablets intact to syrup, add syrup to tablets, or crush tablets (making sure to add entire quantity of tablet powder to syrup).^{b c}

If intact tablets are used, shake the mixture to wet tablets, allow to hydrate for at least 2 hours, then shake intermittently over another 2 hours until dispersion of fine particles is obtained; may hydrate overnight to simplify disintegration process.^{b c}

If tablets are crushed, shake until a dispersion of fine particles is obtained.^{b c}

Resulting preparation contains 5 mg/mL of sotalol hydrochloride in solution with suspended inactive solid particles (water-insoluble tablet ingredients); shake well before each use to assure dose of inactive tablet particles remains constant.^{b c}

Dosage

Prior to dose escalation, monitor for efficacy (e.g., PES, Holter) and safety (e.g., QT interval, heart rate, electrolytes) to reduce the risk of precipitating arrhythmias.¹ (See Proarrhythmic Effects under Cautions.)

Pediatric Patients

Dosage for children ≤2 years of age must be calculated by multiplying the recommended initial dosage for children ≥2 years of age (i.e., 30 mg/m² 3 times daily) by an age-dependent factor obtained from the age and factor graph in the manufacturer prescribing information.^{b c} (See Table 1.)

For children ≥2 years of age, normalize initial and incremental dosage based on body surface area.^{b c}

The manufacturer states that reaching plasma concentrations occurring within the therapeutic adult range is an appropriate guide.^{b c}

Oral

To obtain dosages for ages not mentioned in this table, see age/factor graph in manufacturer prescribing information

See age/factor graph in manufacturer prescribing information for age-dependent factor

Table 1. Initial Pediatric Dosages (age-adjusted)bc

Age	Initial dosage calculation (dosage for children ≥2 years of age [30 mg/m2] multiplied by an age-dependent factor)	Total Initial Daily Dosage
Neonates about 1 week of age	30 mg/m2 X 0.3 (9 mg/m2) three times daily	27 mg/m2 daily
Infants 1 month of age	30 mg/m2 X 0.68 (20 mg/m2) three times daily	60 mg/m2 daily
Infants 20 months of age	30 mg/m2 X 0.97 (29.1 mg/m2) three times daily	87.3 mg/m2 daily
Children ≥2 years of age	30 mg/m2 X 1 (30 mg/m2) three times daily	90 mg/m2 daily (equivalent to initial 160 mg daily adult dosage)

Children ≤2 years of age: dosage may be increased using similar calculations (e.g., multiply dose by age-dependent factor).^{b c} (See age and factor graph in manufacturer prescribing information).^{b c}

Children ≥2 years of age: dosage may be increased gradually up to 60 mg/m² three times daily (equivalent to 360 mg daily adult dosage).^{b c}

Allow at least 36 hours between dose increments to attain steady state plasma concentrations.^{b c}

Time to reach steady-state plasma concentration is longer in neonates and infants, and decreases with increasing age up to about 2 years of age; in neonates, time to steady-state may be a week or longer.^{b c}

Adults

Life-threatening Ventricular Arrhythmias

Oral

Initially, 80 mg twice daily.¹ If necessary, dosage may be increased gradually after appropriate evaluation to 240–320 mg daily given in divided doses; allow 3 days between dosing increments.¹

Usual maintenance dosage: 160–320 mg daily in divided doses.¹

May increase to 480–640 mg daily in divided doses, but risk of potentially serious toxicity increases with such doses; use only when potential benefits outweigh the possible risks.¹ (See Proarrhythmic Effects under Cautions.)

Supraventricular Arrhythmias

Individualize dosage carefully according to renal function and QT interval.⁴¹ Use not recommended if baseline QT interval is >450 msec.^{41 42} (See Contraindications under Cautions.)

If a dose is missed, take only the next scheduled dose; do not double a dose.^{41 46}

Initiation and Dosage Titration

Initially, 80 mg twice daily in adults with normal renal function (Cl_cr > 60 mL/minute) and a near normal QT interval (≤450 msec).^{41 42 61} If arrhythmia is well controlled (e.g., no recurrences of atrial fibrillation or flutter) during first 3 days of inpatient monitoring and QT interval is <500 msec, may discharge patient on current treatment with an adequate supply to allow uninterrupted therapy until the outpatient prescription is filled.⁴¹

Discontinue or reduce dosage if QT interval is ≥500 msec during inpatient dosage-titration phase.^{26 41 42}

If atrial fibrillation or flutter recur during initiation, may increase dosage gradually to 120 or 160 mg twice daily (the maximum recommended dosage), allowing 3 days of inpatient monitoring between dosing increments.^{26 41 47 50}

For recurrences after completion of inpatient monitoring despite therapy at lower than maximum recommended dosage, readmit to an institutional setting and increase dosage gradually after appropriate evaluation to maximum of 160 mg twice daily, allowing inpatient monitoring for an additional 3 days for each increase in dosage.^{26 41}

In a large dose-ranging study, 120 mg twice daily was most effective in delaying the time to a recurrence of atrial fibrillation or flutter.^{41 42 45}

Maintenance Dosage

If QT interval is ≥520 msec or if JT interval is ≥430 msec in patients with a QRS interval >100 msec, reduce dosage and monitor until the QT or JT interval returns to <520 or 430 msec, respectively.⁴¹

Discontinue therapy if QT interval is ≥520 msec at the lowest maintenance dosage of 80 mg twice daily.⁴¹

Prescribing Limits

Adults

Life-threatening Ventricular Arrhythmias

Oral

Maximum 480–640 mg daily in divided doses.¹

Supraventricular Arrhythmias

Oral

Maximum 320 mg daily (160 mg twice daily);^{26 41} increased incidence of torsades de pointes with higher dosages.^{41 47} (See Proarrhythmic Effects under Cautions.)

Special Populations

Renal Impairment

Adjust dosage if Cl_cr is <60 mL/minute.^{1 26 41}

Dosage in children with renal impairment has not been established.^{b c} However, decreased dosage or increased dosage intervals are recommended for all age groups with renal impairment.^{b c}

Ventricular Arrhythmias

Oral

Initially, in adults, 80 mg; modify frequency according to Table 2.^{1 26 b}

Table 2. Dosing Interval in Renal Impairment

Clcr (mL/minute)	Dosing Interval (hours)
>60	12
30–59	24
10–29	36–48
<10	individualize

Increase dosage only after a given dose has been repeated at least 5 or 6 times at the dosing interval appropriate for the degree of renal impairment.^{1 8}

Administer with extreme caution in patients with renal failure undergoing hemodialysis; possible increased elimination half-life in anuric patients.¹ (See Special Populations under Pharmacokinetics.)

Supraventricular Arrhythmias

Contraindicated if Cl_cr <40 mL/minute.^{41 42 46} (See Contraindications under Cautions.)

If a dose is missed, take only the next scheduled dose; do not double a dose (may increase risk of sotalol-induced arrhythmias).^{41 46}

Initiate therapy in a setting that can provide dosage adjustments based on Cl_cr and continuous ECG monitoring (e.g., QT interval) for at least 5–6 days (when steady-state plasma concentrations are reached) after initiation.^{41 42}

Initiation and Dosage Titration

Initially, 80 mg once daily for Cl_cr of 40–60 mL/minute.⁴¹ If arrhythmia is well controlled (e.g., no recurrences of atrial fibrillation or flutter) during inpatient monitoring of the first 5–6 doses and the QT interval is <500 msec, may discharge patient on current treatment.⁴¹

Reduce dosage or discontinue if QT_c interval is prolonged to ≥500 msec after first or subsequent daily dosage.⁴¹

If recurrences of atrial fibrillation or flutter occur during initiation of therapy at a daily dosage of 80 mg, may increase dosage gradually after appropriate evaluation to 120 or 160 mg once daily, allowing inpatient monitoring for 5–6 doses between dosing increments.^{26 41 47}

For recurrences after completion of inpatient monitoring despite therapy at lower than maximum recommended dosage, readmit to an institutional setting and increase dosage gradually after appropriate evaluation to a maximum of 160 mg once daily, allowing inpatient monitoring for 5–6 doses between dosing increments.⁴¹

>160 mg once daily is not recommended⁴¹ (increased incidence of torsades de pointes).⁴¹

Geriatric Patients

Modification of dosage based on age alone is not necessary.¹

Because geriatric patients may have decreased renal function and because patients with renal impairment may be at increased risk of sotalol-induced toxicity, monitor closely and adjust dosage accordingly.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Sotalol Hydrochloride

Contraindications

• 
  

  Bronchial asthma.^{1 41 42 43 44 46 47 48 49 b c d}

  
  


• 
  

  Sinus bradycardia (<50 bpm while awake).^{1 41 42 43 44 46 47 48 49 b c d}

  
  


• 
  

  Sick sinus syndrome or second or third degree AV block unless a functioning pacemaker is present.^{1 41 42 43 44 45 46 47 48 49 b c d}

  
  


• 
  

  Congenital or acquired long QT interval syndromes.^{1 41 42 43 44 46 47 48 49 b c d}

  
  


• 
  

  Baseline QT interval >450 msec (JT interval of ≥330 msec if QRS >100 msec).^{41 42 c}

  
  


• 
  

  Cardiogenic shock.^{1 41 42 43 44 46 47 48 49 b c d}

  
  


• 
  

  Uncontrolled heart failure.^{1 41 42 43 44 46 47 48 49 b c d}

  
  


• 
  

  Hypokalemia (<4 mEq/L) in patients with supraventricular arrhythmias (atrial fibrillation or flutter);^{41 42 46 c} do not use in hypokalemia or hypomagnesemia prior to correction of imbalance in patients with ventricular arrhythmias.^{1 41 42 45 48 b d}

  
  


• 
  

  Cl_cr <40 mL/minute in patients with supraventricular arrhythmias (atrial fibrillation or flutter).^c

  
  


• 
  

  Known hypersensitivity to sotalol or any ingredient in the formulation.^{1 41 42 43 44 46 47 48 49 b c d}

  
  

Warnings/Precautions

Warnings

Mortality

Substantially increased mortality (total, short- and long-term) and nonfatal cardiac arrest rates occurred with encainide or flecainide studied for treatment of recent MI, mild-to-moderate left ventricular dysfunction, and asymptomatic or mildly symptomatic ventricular arrhythmias.^{1 17 18 19 20 21 b d} Relevance to other patient populations (e.g., without recent MI or with life-threatening ventricular arrhythmias)^{1 17 18 19 22} and other class I antiarrhythmic agents currently is not known.¹

Sotalol is devoid of class I antiarrhythmic activity; no evidence of excess mortality associated with sotalol dosages up to 320 mg daily studied in patients with recent MI (but not necessarily concurrent ventricular arrhythmias).^{1 10 41}

Possible early (within 2 weeks) sudden death with initial (i.e., not titrated) dosage of 320 mg daily, and with high dosages (320 mg twice daily).^{1 41} Use with caution; titrate dosage carefully during the first 2 weeks following an acute MI, particularly with markedly impaired ventricular function.¹ Observe usual precautions regarding heart failure, avoidance of hypokalemia, bradycardia, or prolonged QT interval.⁴¹

Proarrhythmic Effects

Can cause serious ventricular arrhythmias, principally torsades de pointes, associated with prolonged QT interval; risk increases progressively with QT interval prolongation.^{1 6 8 28 b c}

Arrhythmogenic events occur most often during the initial 7 days of instituting sotalol therapy or an upward dosage adjustment.^{1 3 4 7 41 47}

QT interval prolongation is dose-related.^{41 1 41 b c}

Increased torsades de pointes risk with decreased Cl_cr, female gender, larger doses, reduction of heart rate, hypokalemia,^{1 3 41 b c} presence of sustained ventricular tachycardia, excessive QT_c interval prolongation, history of cardiomegaly or CHF.^c Decrease risk by adjusting dosage based on Cl_cr and monitoring ECG for excessive QT interval prolongation.^{b c d}

For ventricular arrhythmias, use particular caution if QT_c interval is >500 msec on therapy, and seriously consider discontinuing if QT_c interval is >550 msec, but use caution regardless of the QT_c interval because of multiple risk factors for torsades de pointes.^{b d}

Cardiac Failure

Possible precipitation of CHF.^{1 41} Use contraindicated in patients with overt CHF.^{1 41 46} Use cautiously in patients with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics);^{1 41 46} sotalol and cardiac glycosides slow AV conduction.^{1 b d} Use with caution in patients with inadequate cardiac function and when initiating therapy if there is any evidence of left ventricular dysfunction.^{1 41}

Electrolyte Disturbances

Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia) may exaggerate the degree of QT prolongation and increase the risk of torsades de pointes.^{1 3 41} Use not recommended until these imbalances are corrected.^{1 41 42 45 48}

Carefully monitor electrolyte and acid-base balance in patients with severe or prolonged diarrhea and in patients receiving diuretics concomitantly.^{1 45 47 50}

Bradycardia

Potential bradycardia in patients treated for supraventricular arrhythmias; associated with increased risk of torsades de pointes.^c

Abrupt Withdrawal of Therapy

Abrupt withdrawal may exacerbate angina symptoms and/or precipitate MI and ventricular arrhythmias in patients with CAD, or may precipitate thyroid storm in patients with thyrotoxicosis.^{1 41} Avoid abrupt discontinuance.^{1 41} Gradually decrease dosage over a period of 1–2 weeks, particularly in patients with CAD or suspected thyrotoxicosis and monitor patients carefully; consider temporary use of another β-blocker if appropriate.^{1 41 46} If exacerbation of angina occurs or acute coronary insufficiency develops, reinstitute therapy promptly (at least temporarily).^{1 23 24 25 41}

Bronchospastic Disease

Possible inhibition of bronchodilation produced by endogenous catecholamines; use generally not recommended in patients with bronchospastic disease.^{1 41 43 46 77}

Use caution with nonallergic bronchospasm (e.g., chronic bronchitis, emphysema);^{1 41} use smallest effective dosage to minimize inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of β₂-adrenergic receptors.^{1 41}

History of Anaphylactic Reactions

Possible increased reactivity to a variety of allergens; patients may be unresponsive to usual doses of epinephrine used to treat anaphylactic reactions.^{1 41}

Major Surgery

Possible increased risks associated with general anesthesia (e.g., severe, protracted hypotension; difficulty in restarting or maintaining a heart beat);^{1 34 35 36 41} however, withdrawal of β-adrenergic blocking agent prior to major surgery is controversial.^{1 34 35 36 37 41} Use with caution in patients undergoing major surgery involving general anesthesia.^{1 34 41}

Effects of sotalol can be reversed by administration of β-agonists (e.g., dobutamine, isoproterenol).^{34 77}

Use particular caution if patients continue to receive sotalol prior to surgery and if anesthetics that depress the myocardium are used (e.g., cyclopropane, ether, trichloroethylene); use the lowest possible dosage of sotalol.³⁴ (See Specific Drugs and Laboratory Tests under Interactions.)

Diabetes Mellitus

Possible decreased signs and symptoms of acute hypoglycemia (e.g., tachycardia); use caution in patients with diabetes mellitus (especially labile diabetes) or history of episodic spontaneous hypoglycemia.^{1 41 c}

Sick Sinus Syndrome

Potential for sinus bradycardia, pauses, or arrest; use only with extreme caution in patients with sick sinus syndrome associated with symptomatic arrhythmia.^{1 41}

Possible increased risk of torsades de pointes in patients with atrial fibrillation and sinus node dysfunction, especially after cardioversion.^{41 49 50} Use contraindicated in patients with atrial fibrillation or flutter and sick sinus syndrome, unless a functioning pacemaker is present.^{41 45 46 48}

Thyrotoxicosis

Signs of hyperthyroidism (e.g., tachycardia) may be masked.^{1 41} Possible thyroid storm if therapy is abruptly withdrawn; closely monitor patients having or suspected of developing thyrotoxicosis.^{1 41} (See Abrupt Withdrawal of Therapy under Cautions.)

General Precautions

Other Precautions

Shares the toxic potentials of other nonselective β-adrenergic blocking agents; observe usual precautions of these agents.^{1 3 4 5 6 7 8 41}

Specific Populations

Pregnancy

Category B.^{b c d}

Lactation

Distributed into milk.^{b c d} Discontinue nursing or the drug.^{b c d}

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 26 41 b c d}

Class III electrophysiologic and β-blocking effects, pharmacokinetics and the relationship between plasma concentrations and effects (e.g., QT_c intervals, resting heart rate) have been evaluated in children 3 days to 12 years of age.^{b c d}

Has been effective in a limited number of infants <3 months of age^{29 30} and children <18 years of age³⁰ for supraventricular arrhythmias; ^{29 30} less effective for ventricular arrhythmias.³⁰

Mild sinus bradycardia occurred in most infants;²⁹ fatigue occurred in several children and required discontinuance in a few.³⁰

Recommendations on sotalol use are not included in current guidelines for cardiopulmonary resuscitation and emergency cardiovascular care in pediatric advanced life support (PALS).^{63 77}

Geriatric Use

Insufficient experience in geriatric patients to determine whether safety and efficacy in geriatric patients differ from safety and efficacy in younger adults; however clinical trials of sotalol included many patients >50 years of age.^{3 4 5 6 8}

Overall risk of cardiac death was associated with increasing age in clinical trials.⁸

Monitor closely and adjust dosage accordingly due to greater frequency of decreased renal function and increased risk of toxicity observed in the elderly.¹

Renal Impairment

Clearance is decreased depending on degree of renal impairment.^{b c} (See Special Populations under Pharmacokinetics.)

Dosage adjustments necessary based on degree of renal impairment.^{a b c d} (See Renal Impairment under Dosage and Administration.)

Partially removed by dialysis; plasma concentrations usually rebound when dialysis is completed.¹ Monitor closely for efficacy of arrhythmia control and adverse effects (changes in heart rate and/or QT interval).¹

Common Adverse Effects

Sinus bradycardia (heart rate <50 bpm),^{1 3 4 5 28 41} arrhythmogenic effects,^{1 41} chest pain,^{1 3 28} palpitation,^{1 3 28} hypotension,¹ fatigue,^{1 3 28 41 42} dizziness,^{1 3 28 42} asthenia,^{1 3 28} lightheadedness,¹ dyspnea,^{1 3 28 41} nausea,^{1 3 41} vomiting.¹

Striant

Generic Name: testosterone buccal system (tes TOSS ter one)

Brand Names: Striant

What is testosterone buccal system?

Testosterone is a naturally occurring "male" sex hormone necessary for many processes in the body.

Testosterone buccal system is used to treat men with low testosterone levels.

Testosterone buccal system may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about testosterone buccal system?

Notify your doctor if you experience nausea; vomiting; swelling of the ankles; changes in skin color; too frequent or prolonged erections; breathing disturbances, including those associated with sleep; yellowing of the skin or eyes; dark colored urine; or problems with urination. Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

What should I discuss with my healthcare provider before using testosterone buccal system?

Do not use testosterone buccal system if you have cancer of the breast or prostate. Testosterone may worsen some cancers of these types.

Before using testosterone buccal system, tell your doctor if you have

• 
  

  had a previous allergic reaction to testosterone;

  
  


• 
  

  diabetes;

  
  


• 
  

  sleep apnea (brief periods of not breathing during sleep) or if you have risk factors for sleep apnea (e.g., obesity, chronic lung disease);

  
  


• 
  

  difficulty with urination due to enlargement of the prostate;

  
  


• 
  

  heart disease; or

  
  


• liver disease or kidney disease.

You may not be able to use testosterone buccal system, or you may need a dosage adjustment or special monitoring if you have any of the conditions listed above.

Testosterone buccal system is not approved for use by women and must not be used by women. Testosterone buccal system is in the FDA pregnancy category X. This means that testosterone is known to cause birth defects in an unborn baby. Do not use testosterone buccal system if you are pregnant or could become pregnant during treatment. Testosterone buccal system is not approved for use by women and must not be used by women. It is not known whether testosterone from the buccal system will pass into breast milk.Do not use testosterone buccal system if you are breast-feeding a baby. Men over 65 years of age that use testosterone buccal system may be at increased risk for the development of prostatic enlargement or cancer. You may not be able to use buccal system testosterone, or you may require a lower dose or special monitoring.

How should I use testosterone buccal system?

Use testosterone buccal system exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To use the testosterone buccal system (Striant):

• 
  

  Hold one buccal system with the flat side on your fingertip. Place the curved side onto your gum, as high as possible above the left or right incisor tooth. Hold your finger on the outside of your lip over the system for 30 seconds to ensure the system is attached to the gum. If the system sticks to the cheek and not the gum, this is acceptable.

  
  


• 
  

  The buccal system should remain in place for 12 hours. To remove the system, move it slightly toward the back or front of the mouth then slide it toward the teeth from removal. With each new application, rotate to alternate sides of the mouth. This avoids scratching the gum. Check to see that the system is in place after eating, drinking, brushing the teeth, or using mouthwash.

  
  


• 
  

  As the buccal system absorbs moisture from the mouth, it will begin to soften and will mold to the shape of the gum. The system does not dissolve completely, but will remain in place. It will not move until you remove it.

  
  


• 
  

  If a buccal system falls off before 8 hours of use, remove it and replace it with a new system in the same place.

  
  


• 
  

  Change the buccal system and alternate sides of the mouth 12 hours after application of the original system. If a buccal system falls off after 8 hours but before 12 hours of use, remove the system and replace it with a new system above the opposite incisor. This will serve as the second dose for the day.

  
  


• 
  

  Do not chew or swallow the testosterone buccal system.

  
  


• 
  

  Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

  
  

Your doctor may want to perform tests to monitor the amount of testosterone in the body, liver function, prostate function, cholesterol levels, or other factors during treatment with testosterone buccal system.

It is important to use testosterone buccal system regularly to get the most benefit.

Dispose of all used systems properly, out of the reach of children and pets.

Store testosterone buccal system at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the next system as soon as you remember. Do not use two doses simultaneously, unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of testosterone buccal system is not likely to threaten life. If you do suspect an overdose, or if a system has been ingested, call an emergency room or poison control center for advice.

What should I avoid while using testosterone buccal system?

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Testosterone buccal system side effects

If you experience any of the following serious side effects, stop using testosterone buccal system and seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  nausea or vomiting;

  
  


• 
  

  changes in skin color;

  
  


• 
  

  swelling of the ankles or legs;

  
  


• 
  

  breathing disturbances, including those associated with sleep;

  
  


• 
  

  too frequent or prolonged erections;

  
  


• 
  

  liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue); or

  
  


• 
  

  dark colored urine or problems with urination.

  
  

Other, less serious side effects may be more likely to occur. Continue to use testosterone buccal system and talk to your doctor if you experience

• 
  

  irritation or changes in the gum at the system application site;

  
  


• 
  

  bitter or unusual taste in the mouth;

  
  


• 
  

  headache;

  
  


• 
  

  emotional changes;

  
  


• 
  

  increased blood pressure;

  
  


• 
  

  decreased interest in sex;

  
  


• 
  

  changes in blood cholesterol or number of red blood cells (detected by blood tests);

  
  


• 
  

  prostate changes or difficulty urinating;

  
  


• 
  

  enlarged, swollen or tender breasts; or

  
  


• 
  

  acne.

  
  

Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect testosterone buccal system?

Before using testosterone buccal system, tell your doctor if you are taking any of the following medicines:

• 
  

  warfarin (Coumadin);

  
  


• 
  

  insulin or an oral diabetes medication such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), repaglinide (Prandin), rosiglitazone (Avandia), pioglitazone (Actos), and others;

  
  


• 
  

  propranolol (Inderal, Inderal LA, others); or

  
  


• 
  

  a corticosteroid such as hydrocortisone (Cortef, Hydrocortone, Solu-Cortef), dexamethasone (Decadron, Hexadrol others), methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisolone (Prelone, Pediapred), prednisone (Deltasone, Orasone, others), and others.

  
  

You may not be able to use testosterone buccal system, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with testosterone buccal system. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Striant resources

• Striant Side Effects (in more detail)
• Striant Use in Pregnancy & Breastfeeding
• Drug Images
• Striant Drug Interactions
• Striant Support Group
• 0 Reviews for Striant - Add your own review/rating

• Striant MedFacts Consumer Leaflet (Wolters Kluwer)


• Striant Advanced Consumer (Micromedex) - Includes Dosage Information


• Striant Consumer Overview


• Striant Prescribing Information (FDA)


• Testosterone Monograph (AHFS DI)


• Testosterone Prescribing Information (FDA)


• Testosterone Professional Patient Advice (Wolters Kluwer)


• AndroGel Prescribing Information (FDA)


• AndroGel Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Androderm Advanced Consumer (Micromedex) - Includes Dosage Information


• Androderm Patch MedFacts Consumer Leaflet (Wolters Kluwer)


• Androderm Prescribing Information (FDA)


• Androgel Consumer Overview


• Androgel Advanced Consumer (Micromedex) - Includes Dosage Information


• Axiron Prescribing Information (FDA)


• Axiron Consumer Overview


• Axiron Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Delatestryl Prescribing Information (FDA)


• Delatestryl MedFacts Consumer Leaflet (Wolters Kluwer)


• Depo-Testosterone Prescribing Information (FDA)


• Depo-Testosterone MedFacts Consumer Leaflet (Wolters Kluwer)


• Fortesta Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Fortesta Consumer Overview


• Testim Prescribing Information (FDA)


• Testim Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Testosterone Cypionate Prescribing Information (FDA)


• Testosterone Enanthate Prescribing Information (FDA)

Compare Striant with other medications

• Hypogonadism, Male

Where can I get more information?

• Your pharmacist has additional information about testosterone buccal system written for health professionals that you may read.

See also: Striant side effects (in more detail)

Samsca

Generic Name: tolvaptan (Oral route)

tol-VAP-tan

Oral route(Tablet)

Tolvaptan should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (eg, greater than 12 mEq/L/24 hrs) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. Slower rates of correction may be advisable in susceptible patients (eg, severely malnourished, alcoholics, or those with advanced liver disease) .

Commonly used brand name(s)

In the U.S.

• Samsca

Available Dosage Forms:

• Tablet

Pharmacologic Class: Vasopressin Receptor Antagonist, V2

Uses For Samsca

Tolvaptan is used to treat hyponatremia, which means there is not enough sodium in your blood. Patients with heart failure, liver problems (e.g., cirrhosis), and the syndrome of inappropriate antidiuretic hormone (SIADH) may have hyponatremia.

Sodium is a chemical that the body needs to be able to function well. If you have a low sodium blood level, your body will not function normally and you may not feel well. Tolvaptan works in the kidneys to help maintain the right amount of sodium for the body.

This medicine is available only with your doctor's prescription.

Before Using Samsca

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tolvaptan in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tolvaptan in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir


• Clarithromycin


• Indinavir


• Itraconazole


• Ketoconazole


• Nefazodone


• Nelfinavir


• Ritonavir


• Saquinavir


• Telithromycin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amobarbital


• Amprenavir


• Aprepitant


• Butabarbital


• Carbamazepine


• Diltiazem


• Efavirenz


• Erythromycin


• Fluconazole


• Fosamprenavir


• Modafinil


• Nevirapine


• Oxcarbazepine


• Pentobarbital


• Phenobarbital


• Phenytoin


• Pioglitazone


• Rifabutin


• Rifampin


• Rifapentine


• Secobarbital


• St John's Wort


• Verapamil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcoholism, chronic or


• Cirrhosis (a liver disease) or


• Liver disease, severe or


• Malnutrition (poor nutrition or undernourished condition)—May increase risk for more serious side effects.

• Anuria (not able to pass urine) or


• Hypovolemic hyponatremia (low blood sodium with low blood fluid) or


• Not able to sense or respond to thirst—Should not be used in patients with these conditions.

• Dehydration or


• Hyperkalemia (high potassium in the blood) or


• Hypovolemia (low blood volume) or


• Stomach or intestinal bleeding—Use with caution. May make these conditions worse.

Proper Use of Samsca

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For hyponatremia:
    
    • Adults—At first, 15 milligrams (mg) once a day. Your doctor will adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Samsca

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

You should not use any of the following medicines while you are using tolvaptan:

• Clarithromycin (e.g., Biaxin®)


• Indinavir (e.g., Crixivan®)


• Itraconazole (e.g., Sporanox®)


• Ketoconazole (e.g., Nizoral®)


• Nefazodone (e.g., Serzone®)


• Nelfinavir (e.g., Viracept®)


• Ritonavir (e.g., Norvir®)


• Saquinavir (e.g., Fortovase®, Invirase®)


• Telithromycin (e.g., Ketek®)

Check with your doctor right away if you have drowsiness; confusion; mood changes; muscle weakness in the arms or legs; seizures (convulsions); or trouble with speaking, swallowing, or controlling body movements. These may be symptoms of a serious and rare condition called osmotic demyelination syndrome (ODS). This may occur if the sodium blood level rises too fast.

Certain medicines or illnesses, such as vomiting or diarrhea, may cause you to lose too much body water (dehydration). If you think you are dehydrated, tell your doctor right away. Always have water available to drink if you are thirsty, unless your doctor tells you otherwise.

You should not eat grapefruit or drink grapefruit juice while you are taking this medicine. Grapefruit or grapefruit juice may increase the effects of tolvaptan in your body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Samsca Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• blurred vision


• dry mouth


• flushed, dry skin


• frequent urination


• fruit-like breath odor


• increased hunger


• increased thirst


• increased urination


• increased volume of pale, dilute urine


• nausea


• sweating


• thirst


• troubled breathing


• unexplained weight loss


• unusual tiredness or weakness


• vomiting

Less common

• Abdominal or stomach tenderness


• anxiety


• blood in the urine


• bloody stools


• blue lips, fingernails, or skin


• bruising


• chest pain


• confusion


• cough


• coughing or vomiting blood


• dark-colored urine


• dizziness or lightheadedness


• fainting


• fast, slow, irregular or shallow heartbeat


• fever


• irregular, fast or slow, or shallow breathing


• loss of consciousness


• muscle cramps or spasms


• muscle pain or stiffness


• pain, redness, or swelling in the arm or leg


• persistent bleeding or oozing from puncture sites, mouth, or nose


• pink or red urine


• rash


• rectal bleeding


• shortness of breath


• sudden shortness of breath or troubled breathing


• sweating


• vaginal bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty having a bowel movement (stool)


• lack or loss of strength

Less common

• Loss of appetite


• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Samsca side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Samsca resources

• Samsca Side Effects (in more detail)
• Samsca Dosage
• Samsca Use in Pregnancy & Breastfeeding
• Samsca Drug Interactions
• Samsca Support Group
• 0 Reviews for Samsca - Add your own review/rating

• Samsca Prescribing Information (FDA)


• Samsca Consumer Overview


• Samsca Monograph (AHFS DI)


• Samsca MedFacts Consumer Leaflet (Wolters Kluwer)


• Tolvaptan Professional Patient Advice (Wolters Kluwer)

Compare Samsca with other medications

• Euvolemic Hyponatremia
• Hyponatremia

Synalgos-DC

Generic Name: aspirin, caffeine, and dihydrocodeine (AS pir in, KAF een, and dye HYE dro KOE deen)

Brand Names: Synalgos-DC

What is Synalgos-DC (aspirin, caffeine, and dihydrocodeine)?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Dihydrocodeine is related to codeine. It is in a group of drugs called narcotic pain relievers.

The combination of aspirin, caffeine, and dihydrocodeine is used to treat moderate to severe pain.

Aspirin, caffeine, and dihydrocodeine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Synalgos-DC (aspirin, caffeine, and dihydrocodeine)?

Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take aspirin, caffeine, and dihydrocodeine before the MAO inhibitor has cleared from your body. Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you are allergic to aspirin, caffeine, or dihydrocodeine, or if you have porphyria, a stomach ulcer, a bleeding or blood clotting disorder; or if you are allergic to any NSAID (non-steroidal anti-inflammatory drug). Do not use any other over-the-counter cold, flu, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of stomach bleeding while you are taking aspirin. Dihydrocodeine may be habit-forming and should be used only by the person this medicine was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking Synalgos-DC (aspirin, caffeine, and dihydrocodeine)?

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take aspirin, caffeine, and dihydrocodeine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to aspirin, caffeine, or dihydrocodeine, or if you have:

• 
  

  porphyria;

  
  


• 
  

  stomach ulcer;

  
  


• 
  

  a bleeding or blood clotting disorder; or

  
  


• 
  

  an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

  
  

Before taking aspirin, caffeine, and dihydrocodeine, tell your doctor if you have:

• kidney or liver disease;


• 
  

  asthma;

  
  


• 
  

  urination problems;

  
  


• 
  

  an enlarged prostate;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

Dihydrocodeine may be habit-forming and should be used only by the person this medicine was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. FDA pregnancy category C. Aspirin may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Dihydrocodeine could cause addiction or withdrawal symptoms in a newborn if the mother takes the medicine during pregnancy. Do not take aspirin, caffeine, and dihydrocodeine without telling your doctor if you are pregnant or plan to become pregnant during treatment. Dihydrocodeine may also cause addiction and withdrawal symptoms in a nursing infant. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

How should I take Synalgos-DC (aspirin, caffeine, and dihydrocodeine)?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take with food or milk to ease stomach upset. You may have withdrawal symptoms when you stop using aspirin, caffeine, and dihydrocodeine after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using aspirin, caffeine, and dihydrocodeine. You may need to stop using the medicine for a short time.

Store this medication at room temperature away from moisture and heat. Keep track of how many capsules have been used from each new bottle of this medicine. Dihydrocodeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Synalgos-DC dosage (in more detail)

What happens if I miss a dose?

Since aspirin, caffeine, and dihydrocodeine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of aspirin, caffeine, and dihydrocodeine can be fatal.

Overdose symptoms may include extreme drowsiness or insomnia, restless feeling, tremors, fast heart rate, pinpoint pupils, nausea, vomiting, dark urine, confusion, ringing in your ears, fainting, weak pulse, seizure (convulsions), blue lips, shallow breathing, or no breathing.

What should I avoid while taking Synalgos-DC (aspirin, caffeine, and dihydrocodeine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use any other over-the-counter cold, flu, or pain medication without first asking your doctor or pharmacist. Aspirin and caffeine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains aspirin or caffeine. Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of stomach bleeding while you are taking aspirin.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, antidepressants, or seizure medication can add to sleepiness caused by dihydrocodeine, or could slow your breathing. Tell your doctor if you need to use any of these other medicines while you are taking aspirin, caffeine, and dihydrocodeine.

Synalgos-DC (aspirin, caffeine, and dihydrocodeine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  shallow breathing, slow heart rate;

  
  


• 
  

  fast or pounding heart rate, muscle twitching;

  
  


• 
  

  confusion, unusual thoughts or behavior;

  
  


• 
  

  black, bloody, or tarry stools; or

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds.

  
  

Less serious side effects may include:

• 
  

  feeling dizzy, shaky, anxious, or agitated;

  
  


• 
  

  heartburn, mild nausea, vomiting, upset stomach, constipation, diarrhea;

  
  


• 
  

  itching or rash;

  
  


• 
  

  mood changes, sleep problems (insomnia);

  
  


• 
  

  sweating, urinating more than usual;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  dry mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Synalgos-DC (aspirin, caffeine, and dihydrocodeine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

  
  

This list is not complete and there may be other drugs that can interact with aspirin, caffeine, and dihydrocodeine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Synalgos-DC resources

• Synalgos-DC Side Effects (in more detail)
• Synalgos-DC Dosage
• Synalgos-DC Use in Pregnancy & Breastfeeding
• Drug Images
• Synalgos-DC Drug Interactions
• Synalgos-DC Support Group
• 0 Reviews for Synalgos-DC - Add your own review/rating

• Synalgos-DC Prescribing Information (FDA)


• Synalgos-DC Advanced Consumer (Micromedex) - Includes Dosage Information


• Synalgos-DC MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Synalgos-DC with other medications

• Pain

Where can I get more information?

• Your pharmacist can provide more information about aspirin, caffeine, and dihydrocodeine.

See also: Synalgos-DC side effects (in more detail)

Stavzor

Generic Name: valproic acid (val PRO ik A sid)

Brand Names: Depakene, Stavzor

What is valproic acid?

Valproic acid affects chemicals in the body that may be involved in causing seizures.

Valproic acid is used to treat various types of seizure disorders. Valproic acid is sometimes used together with other seizure medications.

Valproic acid may also be used for purposes not listed in this medication guide.

What is the most important information I should know about valproic acid?

Valproic acid may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby.

Valproic acid may also affect cognitive development in children born to mothers who take this medication during pregnancy. Studies have shown that these children may score lower on cognitive tests (reasoning, intelligence, and problem-solving) than children whose mothers took other seizure medications during pregnancy.

Tell your doctor right away if you become pregnant while taking valproic acid for seizures. Do not start or stop taking valproic acid during pregnancy without your doctor's advice. In rare cases, valproic acid has caused life-threatening liver failure, especially in children younger than 2 years old.

Valproic acid has also caused rare cases of life-threatening pancreatitis (inflammation of the pancreas). Pancreatitis can come on suddenly and symptoms may start even after you have been taking valproic acid for several years.

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, upper stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking valproic acid?

In rare cases, valproic acid has caused life-threatening liver failure, especially in children younger than 2 years old. Children of this age may be at even greater risk for liver problems if they use more than one seizure medication, if they have a metabolic disorder, or if they have a brain disease causing mental impairment (such as Creutzfeldt-Jacob disease, Huntington disease, multiple sclerosis, or a brain injury or infection). Valproic acid has also caused rare cases of life-threatening pancreatitis (inflammation of the pancreas). Pancreatitis can come on suddenly and symptoms may start even after you have been taking valproic acid for several years. Do not take valproic acid if you have liver disease or a urea cycle disorder. You should not take this medication if you are allergic to valproic acid, or if you have severe liver disease or a urea cycle disorder.

To make sure you can safely take valproic acid, tell your doctor if you have any of these other conditions:

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  liver disease;

  
  


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  a bleeding or blood clotting disorder;

  
  


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  a history of head injury, brain disorder, or coma;

  
  


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  a family history of a urea cycle disorder;

  
  


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  a family history of infant deaths with unknown cause; or

  
  


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  HIV or CMV (cytomegalovirus) infection.

  
  

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

FDA pregnancy category D. Valproic acid can cause birth defects. Do not start taking valproic acid without telling your doctor if you are pregnant or planning to become pregnant. Use effective birth control while you are taking valproic acid.

Valproic acid may also affect cognitive development in children born to mothers who take this medication during pregnancy. Studies have shown that these children may score lower on cognitive tests (reasoning, intelligence, and problem-solving) than children whose mothers took other seizure medications during pregnancy.

Although valproic acid may harm an unborn baby, having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking valproic acid, do not stop taking the medicine without your doctor's advice. Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking valproic acid. There may be other seizure medications that can be more safely used during pregnancy. Follow your doctor's instructions about taking valproic acid while you are pregnant. Valproic acid can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using valproic acid.

How should I take valproic acid?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Drink plenty of water while you are taking this medication. Your dose may need to be changed if you do not get enough fluids each day.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

To be sure this medication is not causing harmful effects, your liver function will need to be tested often. Visit your doctor regularly.

Do not stop using valproic acid without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using valproic acid suddenly. You may need to use less and less before you stop the medication completely. Swallow the capsule whole. Do not crush, chew, or break a capsule because the medicine may irritate your mouth or throat when you swallow it. Wear a medical alert tag or carry an ID card stating that you take valproic acid. Any medical care provider who treats you should know that you are taking a seizure medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include sleepiness or drowsiness, shallow breathing, weak pulse, or loss of consciousness.

What should I avoid while taking valproic acid?

Drinking alcohol can increase certain side effects of valproic acid. Valproic acid may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid exposure to sunlight or tanning beds. Valproic acid can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Valproic acid side effects

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, upper stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these other serious side effects:

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  unexplained weakness with vomiting and confusion or fainting;

  
  


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  easy bruising or bleeding, blood in your urine;

  
  


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  fever, chills, body aches, swollen glands, flu symptoms;

  
  


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  urinating less than usual;

  
  


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  hallucinations (seeing things that aren't there);

  
  


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  extreme drowsiness, lack of coordination;

  
  


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  double vision or back-and-forth movements of the eyes; or

  
  


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  severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

  
  

Less serious side effects may include:

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  mild drowsiness or weakness;

  
  


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  diarrhea, constipation, upset stomach;

  
  


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  changes in your menstrual periods;

  
  


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  enlarged breasts;

  
  


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  tremor (shaking);

  
  


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  hair loss;

  
  


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  weight changes;

  
  


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  vision changes; or

  
  


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  unusual or unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect valproic acid?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by valproic acid. Tell your doctor if you regularly use any of these medicines, or any other seizure medication.

Tell your doctor about all other medications you use, especially:

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  topiramate (Topamax);

  
  


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  tolbutamide (Orinase);

  
  


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  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


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  aspirin or acetaminophen (Tylenol);

  
  


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  zidovudine (Retrovir);

  
  


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  clozapine (Clozaril, FazaClo);

  
  


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  diazepam (Valium);

  
  


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  meropenem (Merrem) or imipenem and cilastatin (Primaxin);

  
  


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  rifampin (Rifadin, Rimactane, Rifater); or

  
  


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  ethosuximide (Zarontin).

  
  

This list is not complete and other drugs may interact with valproic acid. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Stavzor resources

• Stavzor Side Effects (in more detail)
• Stavzor Use in Pregnancy & Breastfeeding
• Stavzor Drug Interactions
• Stavzor Support Group
• 1 Review for Stavzor - Add your own review/rating

• Stavzor Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Stavzor Advanced Consumer (Micromedex) - Includes Dosage Information


• Stavzor Prescribing Information (FDA)


• Stavzor Consumer Overview


• Valproic Acid Monograph (AHFS DI)


• Depacon Prescribing Information (FDA)


• Depacon Advanced Consumer (Micromedex) - Includes Dosage Information


• Depacon MedFacts Consumer Leaflet (Wolters Kluwer)


• Depakene Prescribing Information (FDA)


• Depakene MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Stavzor with other medications

• Hyperekplexia
• Mania
• Migraine Prevention
• Schizoaffective Disorder
• Seizure Prevention
• Seizures

Where can I get more information?

• Your pharmacist can provide more information about valproic acid.

See also: Stavzor side effects (in more detail)