Rythmodan® 100mg Caps, 6X14 Blister

RYTHMODAN® 100mg Caps, 6X14 Blister

SKU: 065914108631
DIN: 02224801
SIZE: 2×14 blister pack
INDICATIONS: RYTHMODAN controls the uneven beating of the heart and returns it to normal rhythm
DIRECTIONS: Dosing may be modified based on indication and patient profile

Product Description

INDICATIONS AND CLINICAL USE

RYTHMODAN® (disopyramide) is indicated for the treatment of documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. RYTHMODAN® may also be used for the treatment of patients with documented symptomatic ventricular arrhythmias when the symptoms are of sufficient severity to require treatment. Because of the proarrhythmic effects of RYTHMODAN® its use should be reserved for patients in whom, in the opinion of the physician, the benefit of treatment clearly outweighs the risks.

For patients with sustained ventricular tachycardia, RYTHMODAN® therapy should be initiated in the hospital. Hospitalization may also be required for certain other patients depending on their cardiac status and underlying cardiac disease.

The effects of RYTHMODAN® in patients with recent myocardial infarction have not been adequately studied and, therefore, its use in this condition cannot be recommended

CONTRAINDICATIONS

RYTHMODAN® is contraindicated in the presence of shock, renal failure, severe intraventricular conduction defects (i.e. bundle-branch block associated with first-degree atrioventricular block, double block [left posterior or anterior hemiblock and right bundle-branch Hypersensitivity to omeprazole, substituted benzimidazoles or any of the components of this medication block]), pre-existing second and third-degree A-V block (if no pacemaker is present), known hypersensitivity to the drug or to any ingredient in the formulation.

RYTHMODAN® is contraindicated in patients with a pre-existing long QT.

RYTHMODAN® is contraindicated in patients with severe sinus node dysfunction.

RYTHMODAN® should not be used in the presence of uncompensated or inadequately compensated congestive heart failure.

RYTHMODAN® is contraindicated in most patients with extensive myocardial disease, but may on occasion be used in these patients under the close supervision of a cardiologist if in their opinion the patient’s condition justifies it. When used in these patients continuous ECG monitoring in a CCU facility is mandatory.

Due to its anticholinergic activity, RYTHMODAN® is contraindicated in patients with glaucoma or in patients in whom urinary retention is present.

Concomitant administration of RYTHMODAN® with other antiarrhythmics or other drugs liable to provoke ventricular arrhythmias and especially torsade de pointes is contraindicated

WARNINGS

All antiarrhythmic drugs can produce unwanted effects when they are used to treat symptomatic but not life-threatening arrhythmia; the expected benefit should be balanced against their risks. Proarrhythmia and cardiac decompensation are special risks associated with the use of
antiarrhythmic drugs in patients with structural heart disease. Special caution should be exercised when prescribing in this context.
Life-threatening and hemodynamically significant arrhythmia are difficult to treat and affected patients are at high risk. Treatment of these arrhythmias, whatever modality, must be initiated in the hospital.

ADVERSE REACTIONS

The rare occurrence of congestive heart failure (CHF), hypotension, widening QRS, sinus arrest, nodal rhythm dissociation, cardiac arrest, and cardiovascular collapse have been reported. An occasional paradoxical ventricular tachycardia, evolving sometimes to fibrillation has been
observed. A definite relationship to the drug was not always established in the above cardiovascular effects.

Intra-cardiac conduction abnormalities may occur QT interval prolongation, atrioventricular block, and bundle-branch block.

Other types of arrhythmia have been reported: bradycardia, sinus block

The most common adverse reactions which are dose-dependent are associated with the anticholinergic properties of the drug. These may be transitory, but may be persistent and can be severe. Urinary retention is the most serious anticholinergic effect. Please refer to the product monograph for a comprehensive list of adverse reactions

ABOUT THE DISEASE

Arrhythmia:

An arrhythmia is an uneven heartbeat. It means your heart is out of its usual rhythm.It may feel like your heart skipped a beat, added a beat, or is “fluttering.” It might feel like it’s beating too fast (which doctors call tachycardia) or too slow (called bradycardia). Or you might not notice anything.Arrhythmias can be an emergency, or they could be harmless. If you feel something unusual happening with your heartbeat, get medical help right away so doctors can find out why it’s happening and what you need to do about it.

Symptoms of Arrhythmias

An arrhythmia can be silent, meaning you don’t notice any symptoms. Your doctor may spot an uneven heartbeat during a physical exam. If you have symptoms, they may include:

  • Palpitations (a feeling of skipped heartbeats, fluttering, or “flip-flops”)
  • Pounding in your chest
  • Dizziness or feeling lightheaded
  • Fainting
  • Shortness of breath
  • Chest pain or tightness
  • Weakness or fatigue
  • Anxiety
  • Blurry vision
  • Sweating

Arrhythmia Causes

You could have arrhythmia even if your heart is healthy. Or it could happen because of:

  • Heart disease
  • The wrong balance of electrolytes (such as sodium or potassium) in your blood
  • Heart injury or changes such as reduced blood flow or stiff heart tissue
  • Healing process after heart surgery
  • Certain medications
  • Problems with the electrical signals in your heart
  • Strong emotions, stress, or surprise
  • Things in your daily life like alcohol, tobacco, caffeine, or exercise

CLINICAL TRIALS

Please check back later

RESOURCES

PRODUCT MONOGRAPH

Click here to download the Product Monograph

 

FREQUENTLY ASKED QUESTIONS

How does this medication work? What will it do for me?

Disopyramide belongs to the class of medications called antiarrhythmics. It is used to treat abnormal heart rhythms. It works in various areas of the heart to help normalize abnormal heart rhythms.

How should I use this medication?

The dose of disopyramide is individualized for each person, depending on the person’s weight and response to the medication. The usual dose of disopyramide capsules is 100 mg to 200 mg every 6 hours. In certain circumstances, the doctor may start with a higher dose for the first dose only. People with reduced kidney or liver function may need lower daily doses.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

What happens if I miss a dose?
If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
What form(s) does this medication come in?
RYTHMODAN® 100 mg capsules are presented in green/yellow, hard gelatin capsules marked RY RL. Each capsule contains 100 mg disopyramide. The capsules are available in blister packs of 84 (6 x 14)
Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to disopyramide or any ingredients of the medication
  • are in shock
  • are taking other medications to treat abnormal heart rhythms or medications that may cause abnormal heart rhythms (e.g., amiodarone, quinidine, sotalol, verapamil, diltiazem, pimozide)
  • have cardiomyopathy (a disease of the heart muscle)
  • have certain severe heart rhythm disorders (i.e., bundle-branch block associated with first-degree AV block, double block, or second- and third-degree AV block with no pacemaker)
  • have extensive heart disease
  • have glaucoma
  • have kidney failure
  • have long QT interval
  • have severe or uncontrolled congestive heart failure
  • have severe sinus node (the heart’s natural pacemaker) dysfunction
  • have urinary retention

What side effects are possible with this medication?

  • Rare occurrence of congestive heart failure (CHF), hypotension, widening QRS, sinus arrest,
    nodal rhythm dissociation, cardiac arrest and cardiovascular collapse have been reported. An
    occasional paradoxical ventricular tachycardia, evolving sometimes to fibrillation has been
    observed. A definite relationship to the drug was not always established in the above
    cardiovascular effects.
  • Intra-cardiac conduction abnormalities may occur: QT interval prolongation, atrioventricular
    block and bundle-branch block.
  • Other types of arrhythmia have been reported: bradycardia, sinus block.
  • The most common adverse reactions which are dose-dependent are associated with the
    anticholinergic properties of the drug. These may be transitory, but may be persistent and can be
    severe. Urinary retention is the most serious anticholinergic effect.
  • The following reactions were reported in more than 10% of patients:
    • Anticholinergic: dry mouth (16-30%), urinary retention (7-13%), constipation.
    • Gastrointestinal: nausea, indigestion, vomiting, diarrhea, flatulence, bad taste in the mouth,
      anorexia.
  • The following reactions were reported in 1 to 10% of patients:
    • Anticholinergic: blurred vision, dry eyes/nose/throat.
    • Cardiovascular: hypotension with or without CHF, increased CHF, cardiac conduction
      disturbances, proarrhythmic effects (6%), œdema, dyspnea, cyanosis, chest
      pain.
    • Dermatologic: skin reactions including pruritus, urticaria, morbilliform eruption, abdominal
      rash, photosensitization.
    • General: dizziness, vertigo, drowsiness, profuse sweating.
    • Genitourinary: urinary hesitancy and frequency.
    • Other: raised SGOT levels

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breastfeeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: Certain medications used to treat abnormal heart rhythms, including disopyramide, can also cause new abnormal heart rhythms, some of which can be life-threatening. Treatment with disopyramide should be started in the hospital, where appropriate monitoring and treatment can be provided.

Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, droperidol, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with disopyramide. If you are taking other medications, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

What other drugs could interact with this medication?
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors,
vitamins, minerals, natural supplements, or alternative medicines.

Please refer to the patient leaflet for a comprehensive list of drugs that may interact with RYTHMODAN®