RYTHMOL *
Manufacturer DetailsKNOLL INC
Compositions:
Propafenone 150mg fc. tabs,
Propafenone 150mg fc. tabs,
| Strength | Rate | Packing Style |
|---|---|---|
| 0.00 | Tab |
List of Related Indications:
- Ventricular arrhythiamas
List Of Drugs:
- Propafenone @ ( *** ) - Antiarrhythmic agents
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Other Information
Patient Information
Pharmacology/ Pharmacokinetics
Interaction with Food
Pregnancy and lactation
Drug Interaction:
Ventricular arrhythmias
Interacting drugs - summary
+ Propafenone-
Anesthesics
may increase risks of CNS side effects
Cimetidine
Propafenone concentration increased,with increased effect
Quinidine
serum Propafenone levels increased in rapid extensive matabolisers
of the drug (app 90% of patients) increasing the pharamcologic effects
Rifampicin
increased Popafenone clearance, loss of effect
Propafenone +
Anticoagulants
may increase the anticoagulant effect of warfarin or anisindione
due to anticoagulants hepatic metabolism. May increase the
risk of bleeding
Beta-blockers
phamacological effect of Beta-blocker increased
Cyclosporine
whole blood Cyclosporine,decreased renl clearance
Digoxin
serum digoxin levels increased
Indication:
Ventricular arrhythmias
Adverse Reaction:
Adverse reactions occur most frequently in the GI, cardiovascular and CNS.
about 20% of patients discontinued due to adverse reactions
Most common- dizziness, unusual taste, first-degree AV block, intraventricular conduction delay, nausea or vomiting,and constipation. Headache was common but not increased compated to placebo
Cardiovascular- atrial flutter, AV dissociation, cardiac arrest, flushing, hot flushes, sick sinus syndrome, sinus pause,or arrest, supraventriculat tachycardia.
CNS- abnormal dreams, speech or vision, apnea, coma, confusion,depression, memory loss, numbness, parasthesias,psycosis/mania, seizures, tinnitus, unusual smell sensation, vertigo
GI- cholestasis, (0.1% ) elevated liver enzymes, (alkaline phosphatase, serum transaminases, gastroenteritis, hepatitis ( 0.03% )
Hematologic- agranulocytosis, anemia, bruising, granulocytopenia, increased bleeding timee. leukpopenia, purpura,thrombocytopenia
Miscellaneous- alopecia, eye irritation, hyponatremia/inappropriate ADH secretion, impotence, increased glucose,kidney failure, positive ANA ( 0.7% ) lupus erythematous, muscle cramps, muscle weakness, nephrotic syndrome, pain,
pruritus.
Drug/Food interaction- food did not change bioavailability significantly during multiple dose administration.
Contra-Indications:
Severe CCF,marked hypotension,severe bradycardia and heart block.
Special precautions:
Severe pulmonary obstructive diseases,impaired renal/hepatic function,cardiac pacemaker.
Elevated ANS titers- postive ANA titers have occurred. They have been revesible upon cessation of treatment and may disappear even with continued therapy.
Renal/hepaticchanges-fatty degeneative changes of the liver were found in rats following chronic administration of propapenone at dose levels 19 times the maximum recommended human doses.
Warnings-
Survival- as with other antiarrhythmics, there is no evidence that propafenone favorably affects survival or the incidence of sudden death.
Non-life threatening ventricular arrhythmias- use of propafenone is not recommended in patients with less severe ventricular arrhythmias, even if the patients are symptomatic
Proarrhythmic effects- propafenone can cause new or worsened arrhythmias
Non allergic bronchospasm- eg chronic bronchitis, emphysema- in general these patients should not receive propafenone or other agents with beta-adrenergic blocking activity.
Congestive heart failure- new or worsened CHF has occured in 3.7% of patients of those, 0.9% were probably related to propafenone, 80% had preexisting heart failure and 85% had coronary heart disease.
Conduction disturbances- experience in patients with sick sinus node syndrome is limited and these patients should not be treated with propafenone
Effects on pace maker threshold- pacing and sensing threshold of artificial pacemaker may be altered.
Hematologic disturbances- unexpalined fever or decrease in white count particularly during trhe first 3 months of theapy, warrants consideration of possible granulocytosis/ granulocytopenia. Instruct patient to promptly report the development of any signs of infection such as fever,sore throat or chills.
Renal function impairment- administer cautiously to patients with impaired renal function. Carefuly monitor for overdosage.
Hepatic function impairment- propafenone is highly metabolised by the liver,administer cautiously in patients with impaired hepatic function.
Elderly- because of the possible incrased risk of impaired hepatic or renal functin inthis age group, use with caution.
Pregnancy- use during pregnancy only if the potential benefits justifies the potential risk to the fetus.
Lactation- decide whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
Children- the safety and efficacy of propafenone in children have not been established.
Dosages/ Overdosage Etc:
Approved by FDA in 1989
Indications:
Ventricular arrhythmias
Dosage:
Individual dose:
Initiate with 150mg every 8 hours(450mg/day).Dosage may be increased at a minimum of 3 to 4
Days intervals to 225mg every 8 hours(675mg/day).
Overdosage-
Symptoms
Symptoms which are usually severe within 3 hours of ingestion may include,hypootension, somnolence, bradycardia, intra-atrial and intraventricular conduction disturbances, and rarely convulsions and high grade ventricular arrhythmias
Treatment
1. Defribillation as wsell as infusion of dopamine and isoproternol have been effective in controlling rhythm and blood pressure.
2. Convulsions have been alleviated with IV diazepam.
3. General supportive measures such as ventilatory assistance and cardiopulmonary resustication may be necessary.
4. Hemodialysis dose not appear to alter drug clearance.
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible unless the dose is less than 4 hours.
2. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Other Information:
Not available
Patient Information:
PROPAFENONE- ANTIARRHYTHMICS
1.Palpitations,chest pain,blurred or abnormal vision,or difficult breathing may occur. Notify
physician if these become bothersome.
2.Notify the physician if signs of infection develop such as fever,sore throat,chills or unusual
bruising or bleeding.
3.Be aware of overdose or toxicity such as hypertension,excessive drowsiness,decreased
heart rate or abnormal heart beat.
4. Individual allergy -
Tell your doctor if you have ever had any unusual or allergic reaction to amiodarone. Also
tell your doctor if you are allergic to any other substances, such as foods, preservatives.
5. Pregnancy -
Propafenone has not been studied in pregnant women. Though this medicine has not been
shown to cause birth defects in animal studies it has been shown to reduce fertility rates in
monkeys ,dogs,rabbits, and rabbits.Before taking propafenone make sure your doctor knows
if you are pregnant or if you may become pregnant.
6. Breast feeding -
Propafenone passes into breast milk, However, this medicine has not been reported to cause
problems in nursing babies.
7. Children -
Propafenone can cause serious side efects in any patient. Discuss with the childs doctor
the good that this medicine may do as weell as the risks of using it.
8. Older adults- no specific iformati comaring theuse of propafenone itheelderly with use in othe
age groups
9.Other medicines -
Tell your doctor if you ae taking any of the following-
Digoxin or
Warfarin -effects of these medicines may be increased when used with propafenone
10. Other medical problems-- Make sure that you tell your doctor if you have other medical problems-
Asthma or
Bronchitis or
Emphysema -propafenone canincrease trouble in breathing
Bradycardia (unusally slow heartbeat) there is arisk of offurther decreased herat function
Congestive heart failure -propafenone make the codition worse
Kidney or
Liver disease- effects of propafenone may be increased because of slower removal from the body
Recent heart attack- riskof irrgular heart bet may be increased
If you have apace maker -propafeone may intrfere with thevpacemaker andrequire more careful
follow up by the doctor
6. Dose -
The dose of propafenone is different for different patients. Follow the instructions of your doctor.
7. Missed dose -
If you miss a dose of this medicine, and remember within 4 hours take it as soon as possble,if you
do not remember until later, skip the missed dose and go back to your regular dosing schedule.
Do not double doses
8. Storage -
Keep out of reach of children. Store away from heat and direct light. Do not store in
the bath room or near the kitchen sink. Moisture or heat may cause the medicine to break
down.
Do not jkeep otdated medicines or mdicine no longer in use. Make sure that youkeep
outdated medicine out of reach of children.
Pharmacology/ Pharmacokinetics:
Pharmacology: Propafenone is a Class 1C antiarrhythmic with local anaesthetic effects and direct stabilizing action on myocardial membranes.
Pharmacokinetics: Nearly completely absorbed after oral administration with peak plasma levels occuring approximately 3.5 hours after asdministration in most individuals.
Interaction with Food:
Food does not change significantly the bioavailability, during multiple dose administeration.
Pregnancy and lactation:
Pregnancy: Use during prenancy only if the potential benefit justifies the potential risks to the fetus.
Lactation: Use with caution and decide whether to discontinue the drug or discontinue nursing taking into account the importance of the drug to the mother.
Children- The safety and efficacy of propafenone in children have not been established.
