Rythmodan® 100mg Caps, 6X14 Blister

DIN

02224801

Size

84 Capsules

SKU

065914108631

Directions

The dosage should be individualized for each patient, based upon response and tolerance and patient weight.

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INFORMATION FOR THE PATIENT

What the medication is used for:

RYTHMODAN® belongs to a group of medications called antiarrhythmics. This means it acts to correct irregular heartbeats to a normal rhythm and to slow an overactive heart. This allows the heart to work more efficiently.
RYTHMODAN® is used to treat and prevent ventricular arrhythmias (irregular heartbeat).
What it does:

RYTHMODAN® controls the uneven beating of your heart and returns it to the normal rhythm.
It is used for controlling your heartbeat in the following situations:

  • Arrhythmias – where your heartbeats are uneven, or unusually fast or slow
  • To keep your heart beating at a normal rhythm
  • To stop unusual heartbeats (arrhythmias) happening after a heart attack
  • To stop unusual heartbeats (arrhythmias) during an operation

When it should not be used:

Do not take RYTHMODAN® Capsules:

  • If you are allergic to disopyramide or any of the other ingredients of this medicine
  • Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue.
  • If you have any other heart problems – apart from unusual heartbeats (arrhythmias).
  • If you are taking other medicines to control your heart rhythm.
  • If you are taking other medicines which could cause unusual heartbeats

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking RYTHMODAN® Capsules

What the medicinal ingredient is:

Disopyramide

What the nonmedicinal ingredients are:

Corn starch, magnesium stearate, pregelatinized starch, talc.
Capsule Body and Head: FD&C Blue #2, gelatin, titanium dioxide, yellow iron oxide

What dosage forms it comes 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)

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

PATIENT 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®