Rythmol

Generic Name: Propafenone Hydrochloride
Class: Class Ic Antiarrhythmics
VA Class: CV300
Chemical Name: 1-Propanone,1-[2-[2-hydroxy-3-(propylamino)propoxy]phenyl]-3- phenylpropan-1-one hydrochloride
Molecular Formula: C₂₁H₂₇NO₃
CAS Number: 34183-22-7

Introduction

Local anesthetic-type class IC antiarrhythmic agent.^{3 10 38 134 289 310}

Uses for Rythmol

Paroxysmal Atrial Fibrillation/Flutter and Paroxysmal Supraventricular Tachyarrhythmias

Used (as conventional [immediate-release] tablets) to prolong the time to recurrence of symptomatic, disabling paroxysmal supraventricular tachycardia (PSVT) (e.g., AV nodal reentrant tachycardia or AV reentrant tachycardia [Wolff-Parkinson-White syndrome, WPW syndrome]) and symptomatic, disabling paroxysmal atrial fibrillation/flutter (PAF) in patients without structural heart disease.^{1 3 67 68 90 91 92 93 94 99 101 102 105 107 108 109 110 132 133 173 187 206 211}

Comparably effective to quinidine, disopyramide, flecainide, procainamide, sotalol in preventing recurrences of PAF and maintaining sinus rhythm following successful cardioversion of atrial fibrillation.^{3 68 89 129 133 183 200 201 202 204 205}

Used (as extended-release capsules) to prolong the time to recurrence of symptomatic PAF in patients without structural heart disease.²⁸⁹

Safety and efficacy of extended-release capsules not established in patients with exclusively PSVT or atrial flutter.²⁸⁹

Safety and efficacy not established in patients with chronic atrial fibrillation.^{1 289} Generally, do not use to control ventricular rate in patients with atrial fibrillation, but conventional (immediate-release) tablets may be useful in controlling ventricular response rate in patients with stable but rapid atrial fibrillation/flutter and ventricular preexcitation via an accessory pathway (e.g., WPW syndrome).^{269 272 288}

Treatment of PSVT (using IV† propafenone [IV dosage form not commercially available in the US]) in patients with preserved ventricular function refractory to vagal maneuvers, IV adenosine (the drug of choice), AV nodal blocking agents (e.g., calcium-channel blocking agents), and electrical cardioversion therapy or in whom such therapy is not feasible or desirable.²⁸⁸

Conversion of Atrial Fibrillation to Normal Sinus Rhythm

Used (as conventional [immediate-release] tablets and IV†) in the conversion of recent-onset (≤48 hours duration)³¹⁰ atrial fibrillation (e.g., after open-heart surgery) to normal sinus rhythm†; some consider propafenone first-line therapy.^{15 68 88 89 90 101 103 104 109 110 111 195 196 197 198 199 207 208 211 272}

Self-administration for Conversion of PAF

Used for out-of-hospital self-administration (“pill-in-the-pocket” approach) as a single oral loading dose† (conventional (immediate-release) tablets) to terminate recent-onset PAF†; may result in reduced hospitalizations and emergency room visits of patients with mild or no heart disease.^{158 160 211 272 290 294 309}

Ventricular Arrhythmias

As conventional (immediate-release) tablets, suppresses and prevents recurrence of documented life-threatening ventricular arrhythmias (e.g., sustained VT, VF).^{1 3} (See Mortality under Cautions.)

Rythmol Dosage and Administration

General

• 
  

  Individualize dosage according to individual requirements, response, tolerance, general condition, and cardiovascular status.^{1 2 3 9 15 28 47 68}

  
  


• 
  

  Initiate therapy (conventional [immediate-release] tablets) for life-threatening ventricular arrhythmias in a hospital.^{1 273}

  
  


• 
  

  Clinical and ECG evaluation (e.g., Holter monitoring) is recommended during propafenone therapy.^{1 3 289}

  
  

Administration

Administer orally.

Has been administered IV†.^{3 17 31 76 88 89 90 95 96 97 98 100 102 104 106 110 119 122 133 183}

Oral Administration

Administer conventional (immediate-release) tablets in a consistent manner relative to food intake.^{6 9 128 256 272 273}

Administer conventional (immediate-release) tablets in 3 equally divided doses daily at 8-hour intervals.¹

Administer extended-release capsules in equally divided doses every 12 hours without regard to meals.²⁸⁹

Swallow extended-release capsules whole; do not crush.²⁸⁹

Avoid grapefruit juice.^{272 273} (See Drugs, Foods, and Herbal Supplements under Interactions.)

Dosage

Adjust dosage carefully according to individual requirements and response, patient tolerance, and the general condition and cardiovascular status of the patient.^{1 2 3 9 15 28 47 68 289}

Consider dosage reduction in patients who develop excessive prolongation of the PR interval, excessive QRS widening, or second- or third-degree AV block.^{1 2 3 15 90}

Usually do not use oral loading doses (conventional [immediate-release] tablets) since acute toxicity may occur.^{3 6 272 273} However, oral loading doses (e.g., 450–750 mg as conventional [immediate-release] tablets) have been used with apparent safety for conversion of recent-onset atrial fibrillation to normal sinus rhythm† in individuals without heart failure.^{68 89 90 101 109 160 195 196 208 272}

Pediatric Patients

Supraventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Maximum daily dosage 600 mg/m².²⁷²

Adults

Paroxysmal Atrial Fibrillation/Flutter and Paroxysmal Supraventricular Tachyarrhythmias

Oral (conventional [immediate-release] tablets)

Initially, 150 mg every 8 hours.^{1 2 68}

Increase dosage after 3–4 days to 225 mg 3 times daily (every 8 hours) if necessary.^{1 68 90}

If desired therapeutic response is not attained after an additional 3–4 days, increase dosage to 300 mg 3 times daily (every 8 hours).^{1 68 90}

Oral (extended-release capsules)

Initially, 225 mg every 12 hours.²⁸⁹

Increase dosage after ≥5 days to 325 mg every 12 hours if necessary.²⁸⁹

If desired therapeutic response is not attained after an additional 5 days, increase dosage to 425 mg every 12 hours.²⁸⁹

If a dose is missed, only administer the next scheduled dose; do not double next dose.²⁸⁹

When switching from conventional (immediate-release) tablets to extended-release capsules, the dosage conversion ratio is not a 1:1 substitution (e.g., a patient who currently is receiving 150 mg every 8 hours of conventional (immediate-release) tablets may be switched to 325 mg of extended-release capsules every 12 hours).^{289 308}

Conversion of Atrial Fibrillation to Normal Sinus Rhythm†

Oral (conventional [immediate-release] tablets)

150–600 mg, as a single dose.^{158 211}

IV†

2 mg/kg (over 10 minutes) as a single dose.^{158 211}

Self-administration for Conversion of PAF†

Oral (conventional [immediate-release] tablets)

Adults weighing 70 kg or more: May use a single oral loading dose of 600 mg 5 minutes after noting the onset of palpitations.^{290 309}

Adults weighing < 70 kg: May use a single oral loading dose of 450 mg 5 minutes after noting the onset of palpitations.^{290 309}

Do not take more than a single oral dose during a 24-hour period.²⁹⁰

Ventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Initially, 150 mg every 8 hours.^{1 2 68}

Increase dosage after 3–4 days to 225 mg 3 times daily if necessary.^{1 68 90}

If desired therapeutic response is not attained after an additional 3–4 days, increase dosage to 300 mg 3 times daily.^{1 68 90}

Prescribing Limits

Pediatric Patients

Supraventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Maximum daily dosage is 600 mg/m².²⁷²

Adults

Supraventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Maximum daily dosage is 900 mg.^{1 9 90 272 273}

Life-threatening Ventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Maximum daily dosage is 900 mg.^{1 9 90 272 273}

Special Populations

Hepatic Impairment

When conventional (immediate-release) tablets are used, reduce dosage by approximately 70–80%; monitor patients for signs of toxicity, including hypotension, somnolence, bradycardia, conduction disturbances, seizures, and/or ventricular arrhythmias.^{1 115 193}

Geriatric Patients and Those with Myocardial Damage

During initiation of therapy (conventional [immediate-release] tablets), gradual dosage escalation should be performed in geriatric patients and those with marked previous myocardial ischemia.^{1 3}

Cautions for Rythmol

Contraindications

• 
  

  Patients with uncontrolled CHF (conventional [immediate-release] tablets),¹ CHF (extended-release capsules).²⁸⁹

  
  


• 
  

  Cardiogenic shock.^{1 3 289}

  
  


• 
  

  Sinoatrial, AV, or intraventricular disorders of impulse generation and/or conduction (e.g., sick sinus node syndrome, AV block) unless an artificial pacemaker is present.^{1 3 6 234 289}

  
  


• 
  

  Bradycardia.^{1 3 289}

  
  


• 
  

  Severe hypotension.^{1 3 289}

  
  


• 
  

  Bronchospastic disorders.^{1 289}

  
  


• 
  

  Marked electrolyte imbalance.^{1 3 289}

  
  


• 
  

  Known hypersensitivity to propafenone.^{1 289}

  
  

Warnings/Precautions

Warnings

Mortality

In CAST study, excessive rate of mortality and nonfatal cardiac arrest reported in patients with asymptomatic or mildly symptomatic non-life-threatening ventricular arrhythmias and recent MI (>6 days but <2 years previously) who were receiving encainide or flecainide compared with placebo.^{1 116 117 149 155 234 235 289} The applicability of these results to other populations (e.g., those without recent MI) or to other antiarrhythmic drugs is uncertain.^{1 6 48 62 118 168 234 235}

Limit use of propafenone or other class I agents in patients with ventricular arrhythmias to those with life-threatening arrhythmias;^{1 116 117} use in patients with less severe ventricular arrhythmias, even when symptomatic, is not recommended.¹

Arrhythmogenic and Cardiac Conduction Effects

Potential for new and/or more severe arrhythmias,^{1 2 3 4 6 9 15 16 17 18 47 58 67 68 75 113 116 168 230 232 233 234 235} especially in those with CHF (NYHA class III or IV]) or myocardial ischemia.²⁸⁹

Risk of clinically important conduction disturbances;^{1 6 75 136 151 310} degree of lengthening of PR and QRS intervals may increase progressively with increasing dosage and plasma propafenone concentrations.^{1 2 47 233 289 1 2 6 9 47 68 168 233 289}

Reduce dosage or discontinue the drug if 2nd- or 3rd-degree AV block occurs.¹ (See Contraindications under Cautions.)

Evaluate clinical status and ECG prior to and during propafenone therapy to monitor for appearance of arrhythmias and to determine the need for continued therapy.^{1 2 168}

Monitor patients with permanent artificial pacemakers and, if necessary, reprogram pacemakers.^{1 2 3 225 229 289}

Cardiovascular Effects

Potential for new or worsened CHF, particularly in patients with preexisting heart failure or ejection fraction <30%.^{1 2 3 4 9 13 17 47 68 75 117 289}

Use with caution (conventional [immediate-release] tablets) in patients with a history of CHF or myocardial dysfunction.^{1 117 168 235 236}

Discontinue therapy if CHF worsens (unless caused by the cardiac arrhythmia); fully compensate CHF before therapy is reinitiated.¹

Hematologic Effects

Possible reversible granulocytopenia^{3 47} and agranulocytosis.^{1 47}

Carefully evaluate patients in whom unexplained fever and/or decreased WBC counts occur (especially during the initial 3 months of therapy).^{1 289} WBC counts generally return to normal within 2 weeks following discontinuance.^{1 289}

Bronchospastic Disease

Possible inhibition of bronchodilation produced by endogenous catecholamines; use generally not recommended in patients with asthma/bronchospastic disease or nonallergic bronchospastic disease (e.g., chronic bronchitis, emphysema).^{1 3 15 40 67 68 173 215 289} (See Contraindications under Cautions.)

General Precautions

Hepatic Impairment

Extensively metabolized in liver; use with caution in those with hepatic impairment.^{1 3 8 11 15 33 68 178 289}

Renal Impairment

Several metabolites excreted by kidneys; use with caution in those with renal impairment.^{1 13 289}

Antinuclear Antibodies.

Possible positive antinuclear antibody (ANA) titers.^{1 289}

Monitor carefully patients who develop an abnormal ANA test following initiation of therapy; consider discontinuation of therapy if titers remain elevated or increase further.^{1 289}

Impaired Spermatogenesis

Transient, reversible decreases (within normal range) in sperm count may occur.^{1 289}

Myasthenia Gravis

Possible exacerbation of myasthenia gravis.^{1 52 289} Avoid use in patients with this condition.³

Specific Populations

Pregnancy

Category C.^{1 289}

Lactation

Distributed into milk.^{3 289} Caution if used in nursing women.²⁸⁹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 273 289}

Has been used successfully and without unusual adverse effects in a limited number of infants and children† for the management of various refractory supraventricular (e.g., PSVT, junctional ectopic tachycardia, atrial fibrillation or flutter) and ventricular (e.g., VPCs, VT) arrhythmias.^{3 68 146 212 213 214 216 217 218 220 272} However, adenosine is the drug of choice for treatment of supraventricular tachycardia in children.^{288 310}

Geriatric Use

Conventional (immediate-release) tablets: Insufficient experience to determine whether geriatric patients ≥65 years of age respond differently than younger adults.¹ Select dosage with caution; start at the lower end of dosing range due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.¹

Extended-release capsules: No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.²⁸⁹

Hepatic Impairment

Extensively metabolized in liver; use with caution.^{1 3 8 11 15 33 68 178 289} Careful monitoring for excessive pharmacological effects recommended.¹ Reduce dosage.^{1 3 8 11 15 33 68 178 289} (See Special Populations under Dosage and Administration.)

Renal Impairment

Use with caution.¹ Careful monitoring for excessive pharmacological effects recommended.¹

Common Adverse Effects

Conventional (immediate-release) tablets: Unusual taste, nausea and/or vomiting, dizziness, constipation, headache, fatigue, blurred vision, and weakness.¹ First-degree AV block and intraventricular conduction delay in patients with ventricular arrhythmia.¹

Extended-release capsules: Constipation, diarrhea, dry mouth, nausea, vomiting, unusual taste, fatigue, weakness, dizziness, headache, somnolence, anxiety, dyspnea, ecchymosis, upper respiratory infection, abnormalities in liver function tests (e.g., increased serum concentrations of alkaline phosphatase), hematuria.²⁸⁹

Interactions for Rythmol

Metabolized by CYP2D6 and to a lesser extent by CYP1A2, CYP3A4.^{1 131 190 285 286 289}

Inhibits CYP2D6.^{1 289}

Drugs and Foods Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP2D6, CYP1A2, or CYP3A4 with possible alteration in metabolism of propafenone and/or other drugs.^{1 131 190 285 286 289} Monitor patients.¹

Drugs Metabolized by p-Glycoprotein Transporter

Effect of propafenone on the p-glycoprotein transport system not evaluated.^{1 289}

Drugs Affecting QT Interval

Do not use with drugs that prolong the QT interval.²⁸⁹

Antiarrhythmic Agents

Use extreme caution when propafenone is administered with 1 or more antiarrhythmic agents.^{3 68 288}

Reserve concomitant use for management of life-threatening arrhythmias unresponsive to monotherapy with propafenone (immediate-release tablets) or another antiarrhythmic agent.^{3 68 288}

Do not use propafenone (extended-release capsules) with class Ia or III antiarrhythmic agents.²⁸⁹

Specific Drugs and Foods

Drug or Food	Interaction	Comments
Amiodarone	Possible increased incidence of cardiovascular effects1 13 287 288 289 Increased propafenone concentrations1 289	Concomitant use not recommended 1 289
β-adrenergic blocking agents (e.g., metoprolol, propranolol)	Increased β-adrenergic blocking agent concentrations and terminal elimination half-life1 246 247 289	Use concomitantly with caution; consider β-adrenergic blocking agent dosage reduction1 6 9 13 247 289
Calcium channel-blocking agents	No evidence of clinically important adverse interactions1 289
Cimetidine	Increased propafenone steady-state plasma concentrations1 289
Cyclosporine	Increased cyclosporine concentrations1 250 289
Desipramine	Increased propafenone concentrations1 289 Increased desipramine serum concentrations1	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289 Consider desipramine dosage reduction1
Digoxin	Increased serum or plasma digoxin concentrations1 3 9 85 124 125 245 279 280 281 282 283 289	Carefully monitor serum digoxin concentrations and adjust digoxin dosage 1 3 9 85 124 125 245 283 289
Diuretics	No evidence of clinically important adverse interactions1 289
Erythromycin	Increased propafenone concentrations1 289 1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Fluoxetine	In extensive-metabolizer phenotypes, increased peak plasma concentrations and AUC of propafenone1 289
Grapefruit juice	Possible increased plasma concentrations of unchanged propafenone and potential adverse effects1 257 258 259 260 261 262 289	Avoid concomitant use272 273
Haloperidol	Increased haloperidol concentrations1 289	Use concomitantly with caution; consider haloperidol dosage reduction1 289
Imipramine	Increased imipramine concentrations1 289	Use concomitantly with caution; consider imipramine dosage reduction1 289
Ketoconazole	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Lidocaine	Possible pharmacologic interaction (additive or antagonistic cardiac effects and additive toxicity) 1 2 9 13 122 289
Orlistat	Possible limited absorption of propafenone1 289 Possibility of severe adverse effects with abrupt discontinuance of orlistat1 289
Paroxetine	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Phenobarbital	Decreased plasma propafenone concentrations3
Quinidine	Increased plasma propafenone concentrations1 3 123 289 Possible increased incidence of cardiovascular effects288	Concomitant use not recommended 1 289
Rifampin	Increased metabolism of propafenone resulting in decreased plasma propafenone concentrations and antiarrhythmic activity1
Ritonavir	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Saquinavir	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Sertraline	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Theophylline	Increased serum theophylline concentrations and toxicity1 289
Venlafaxine	Increased venlafaxine concentrations1 289	Use concomitantly with caution; consider venlafaxine dosage reduction1 289
Warfarin	Increased plasma warfarin concentrations and corresponding PTs1 3 6 9 13 15 248 289	Monitor PTs or INRs;275 adjust warfarin dosage 1 3 9 13 248 289

Rythmol Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration of conventional (immediate-release) tablets.^{1 3 15 17 33 40 67 68 133 136}

Absolute bioavailability of conventional (immediate-release) tablets is 5–50%.^{33 174 180}

Bioavailability of 325-mg extended-release capsules (given twice daily) similar to 150-mg conventional (immediate-release) tablets (given 3 times daily).²⁸⁹

Food

Food does not appear to affect bioavailability of conventional (immediate-release) tablets or extended-release capsules during multiple-dose administration.^{2 289}

Special Populations

In patients with marked hepatic impairment, bioavailability of conventional (immediate-release) tablets is about 60–70%.^{1 2 178 289}

Distribution

Extent

Rapidly distributed into lung, liver, and heart tissue.^{3 4 15}

Propafenone crosses the placenta and is distributed into milk.^{3 64 72}

Plasma or Serum Protein Binding

81–97% (mainly α₁ acid glycoprotein).^{3 138 187 188 289}

Special Populations

In patients with severe hepatic dysfunction, approximately 88% of propafenone is bound to plasma proteins.²⁸⁹

Elimination

Metabolism

Extensively metabolized by first-pass metabolism (hydroxylation) in the liver,^{1 33 132 133 136} via CYP2D6 to an active metabolite (5-hydroxypropafenone [5-OHP])^{1 131 190 289} and dealkylation via CYP1A2 and CYP3A4 to another active metabolite (N-depropylpropafenone [NDPP]).^{1 131 289}

Elimination Route

Eliminated principally in feces via biliary excretion as metabolites and in urine or feces as unchanged drug (<1%).^{2 3 4 33 67 68 136}

Half-life

Immediate-release tablets: Averages 1–3 hours (range: 2–10 hours).^{1 2 4 6 7 10 11 12 14 15 16 28 33 37 39 67 68 71 129 133 138 181 187}

Special Populations

In patients with poor metabolizer phenotypes (approximately 5–10% of Caucasians), propafenone is metabolized principally via CYP3A4 and CYP1A2;^{1 131} CYP2D6 is subject to genetic polymorphism.^{1 131 190}

Extensive metabolizers convert propafenone rapidly into 5-OHPand NDPP,^{1 15}

Mucaryl

Mucaryl may be available in the countries listed below.

Ingredient matches for Mucaryl

Bromhexine

Bromhexine is reported as an ingredient of Mucaryl in the following countries:

• Bangladesh

International Drug Name Search

Ercoril

Ercoril may be available in the countries listed below.

Ingredient matches for Ercoril

Propantheline

Propantheline Bromide is reported as an ingredient of Ercoril in the following countries:

• Denmark

International Drug Name Search

Amlodipin +pharma

Amlodipin +pharma may be available in the countries listed below.

Ingredient matches for Amlodipin +pharma

Amlodipine

Amlodipine mesilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipin +pharma in the following countries:

• Austria

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Temozolomid Hospira

Temozolomid Hospira may be available in the countries listed below.

Ingredient matches for Temozolomid Hospira

Temozolomide

Temozolomide is reported as an ingredient of Temozolomid Hospira in the following countries:

• Germany

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Novo Dermoquinona

Novo Dermoquinona may be available in the countries listed below.

Ingredient matches for Novo Dermoquinona

Mequinol

Mequinol is reported as an ingredient of Novo Dermoquinona in the following countries:

• Spain

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Solmag

Solmag may be available in the countries listed below.

Ingredient matches for Solmag

Magnesium Oxide

Magnesium Oxide light (a derivative of Magnesium Oxide) is reported as an ingredient of Solmag in the following countries:

• Switzerland

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Azaleptinum

Azaleptinum may be available in the countries listed below.

Ingredient matches for Azaleptinum

Clozapine

Clozapine is reported as an ingredient of Azaleptinum in the following countries:

• Georgia

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Formule W

Formule W may be available in the countries listed below.

Ingredient matches for Formule W

Salicylic Acid

Salicylic Acid is reported as an ingredient of Formule W in the following countries:

• Netherlands

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Desyrel Dividose

Generic Name: trazodone (Oral route)

TRAZ-oh-done

Oral route(Tablet;Tablet, Extended Release)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

• Desyrel


• Desyrel Dividose


• Oleptro

Available Dosage Forms:

• Tablet


• Tablet, Extended Release

Therapeutic Class: Antidepressant

Chemical Class: Triazolopyridine

Uses For Desyrel Dividose

Trazodone belongs to the group of medicines known as antidepressants or "mood elevators". It is used to relieve mental depression, and depression that sometimes occurs with anxiety.

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

Before Using Desyrel Dividose

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 trazodone 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 trazodone extended-release tablets in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood), which may require caution in patients receiving trazodone.

No information is available on the relationship of age to the effects of trazodone regular tablets 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.

• Cisapride


• Dronedarone


• Linezolid


• Metoclopramide


• Pimozide


• Posaconazole


• Saquinavir


• Sparfloxacin

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.

• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Chloroquine


• Ciprofloxacin


• Citalopram


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Duloxetine


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Gatifloxacin


• Gemifloxacin


• Ginkgo


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Methylene Blue


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ondansetron


• Paliperidone


• Paroxetine


• Pazopanib


• Perflutren Lipid Microsphere


• Procainamide


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• St John's Wort


• Sunitinib


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Venlafaxine


• Voriconazole


• Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir


• Carbamazepine


• Chlorpromazine


• Clarithromycin


• Digoxin


• Foxglove


• Indinavir


• Itraconazole


• Ketoconazole


• Nefazodone


• Phenytoin


• Ritonavir


• Thioridazine


• Tipranavir


• Trifluoperazine

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.

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:

• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or


• Bleeding problems or


• Heart attack, recent or history of or


• Heart disease or


• Heart rhythm problems (e.g., QT prolongation) or


• Hyponatremia (low sodium in the blood) or


• Hypotension (low blood pressure) or


• Priapism (painful or prolonged erection of the penis)—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of trazodone

This section provides information on the proper use of a number of products that contain trazodone. It may not be specific to Desyrel Dividose. Please read with care.

Take this medicine only as directed by your doctor. 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. Talk with your doctor if you have any questions.

To lessen stomach upset and to reduce dizziness and lightheadedness, take the regular tablets with or shortly after a meal or light snack, unless your doctor tells you otherwise.

Take the extended-release tablets at the same time each day, preferably at bedtime, without food.

The tablets can be swallowed whole or given as a half tablet by breaking the tablet along the score line. Do not break the tablets unless your doctor tells you to. Do not crush or chew the tablets.

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 depression:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 150 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 375 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 150 milligrams (mg) per day, given in divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 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 Desyrel Dividose

It is very important that your doctor check your progress at regular visits, to allow for changes in your dose and to help manage any side effects.

Do not stop taking this medicine without first checking with your doctor. To prevent a possible return of your medical problem, your doctor may want you to gradually reduce the amount of medicine you are using before you stop completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking trazodone together with anesthetic medicines (numbing medicines) that are used during surgery, dental treatments, or emergency treatments may cause an increase in CNS depressant effects.

For some teenagers and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself or others. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family have bipolar disorder (manic-depressive disorder) or have tried to commit suicide.

Make sure your doctor knows about all the other medicines you are using. This medicine may cause two serious conditions called serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines that are also used for depression, mental conditions, or migraines. Check with your doctor first before taking any other medicines. Stop taking this medicine and tell your doctor right away if you have more than one of the following symptoms: agitation; confusion; diarrhea; difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; loss of bladder control; muscle twitching; overactive reflexes; poor coordination; restlessness; seizures; severe muscle stiffness; shivering; sweating; talking or acting with excitement; trembling or shaking that you are unable to control; unusually pale skin; or tiredness.

This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats, and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Trazodone may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

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 or vitamin supplements.

Desyrel Dividose 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

• Blurred vision


• confusion


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• lightheadedness


• sweating


• unusual tiredness or weakness

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• confusion about identity, place, and time


• decreased concentration


• fainting


• general feeling of discomfort or illness


• headache


• lack of coordination


• muscle tremors


• nervousness


• pounding in the ears


• shortness of breath


• slow or fast heartbeat


• swelling

Rare

• Skin rash


• unusual excitement

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Drowsiness


• loss of muscle coordination


• nausea and vomiting


• painful, inappropriate erection of the penis, continuing

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

• Dryness of the mouth (usually mild)


• muscle or bone pain


• sleeplessness


• trouble with remembering


• trouble with sleeping


• unable to sleep


• unpleasant taste

Less common

• Constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• diarrhea


• hearing loss


• muscle aches or pains


• 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: Desyrel Dividose side effects (in more detail)

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More Desyrel Dividose resources

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

• Desyrel Prescribing Information (FDA)


• Desyrel MedFacts Consumer Leaflet (Wolters Kluwer)


• Oleptro Prescribing Information (FDA)


• Oleptro Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Oleptro Consumer Overview


• Trazodone Prescribing Information (FDA)


• Trazodone Hydrochloride Monograph (AHFS DI)

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