PRONESTYL
Manufacturer DetailsSARABHAI
Compositions:
Procainam. 250mg,
Procainam. 250mg,
| Strength | Rate | Packing Style |
|---|---|---|
| 100mg/ml | 0.00 | Tab |
| 250mg | 0.00 | Tab |
List of Related Indications:
- Tachycardia
- Premature ventric contraction
- Paroxysmal supraventricular tachycardia
- Atrial fibrillation
List Of Drugs:
- Procainamide @ ( ** ) - 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:
Interacting drugs-summary
+ Procainamide:
Beta-blockers
Propanolol may increase Procainamide level
Ethanol
actions of procinamide could be altered but because of main metabolite
( NAPA ) is also an antiarrhythmic , specific effects are unclear
Histamine antagonists
Cimetidine & Ranitidine increase bioavailability
Quinidine
pharmacologic effect of Procainamde may be increased, elevated
procainamide and NAPA (major meatbolite ) plasma levels with
toxicity may occur
Trimethoprim
Procainamide levels increased
PABA
PABA inhibits procainamide conversion to N-acetyl
procainamide and inhibits renal excretion of N-acetyl procain
Cimetidine
cimetidine may increase plasma levels of procainamide and its
cardioselective metabolite n-acetyl procainamide (NAPA) by
decreasing renal tubular secretion
Amiodarone
increased procainamide or NAPA serum levels, may occur
Procainamide +
Lidocaine
additive cardiodepressant effect
Succinylcholine
neuromuscular blockade potentiated
Metformin
Cationic drugs( eg amiloride, digoxin, morphine, procainamide,
quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin)
that are eliminated by renal tubular secretion, theorically have the
potential for interaction with metformin by competing for common
renal transport systems.Careful patient monitoring and dose adjustment
of metformin or interfering drug is recommended
Atracurium
These medications may enhance the neuromuscular blocking action of
atrcurium. Neuromuscular blockade was prolonged by halothane,
enflurane and isoflurane
Indication:
Ventricular arrhythmias.
Adverse Reaction:
PROCIAINAMIDE-
------------------------
CARDIOVASCULAR - Palpitations 1.3% Chest pain 1.3% Angina like pain 2.6%
Increased ventricular arrhythmias 2.6%
CNS Dizziness/lightheadedness 14.1 Tremor 3.8 % Coordination difficulties 1.3% Changes in sleep habits 11.5% Weakness 7.7% Nervousness 6.4% Fatigue 5% Confusion 3.8% Numbness 2.6% Depression 1.3%
GI Nausea/Vomiting/ heartburn 33% Diarrhea 2.6% Constipation 6.4%
MISCELLANEOUS Blurred vision 5% Headache 8% Rash 10% Dyspnea 5% Dry mouth 5% Arthalgia 5% Fever 3%
In controlled trials, the most frequent adverse reactions were upper GI distress ( 41% ),
tremor ( 12.6 ) lightheadedness ( 10.5% ) and coodrination difficulties ( 10.2 % ).
these reactions were generally serious. these were dose related and were reversible if the
dosage was reduced, if the drug was taken with food or antacids or if it was discontinued.
however they still led to discontinuation in 40%
Lab test abnormalities-
Abnormal liver function tests, positive ANA, thrombocytopenia, leukopenia,
including neutropenia, and agranulocytosis,myelofibrosis
Contra-Indications:
Heart block,heart failure,myasthenia gravis,digitalis intoxification,hypersens.
Special precautions:
Impaired ventricular function,renal/liver diseases.
Monitoring- After acheiving and maintaining therapeutic plasma concentrations and satifactory ECG and clinical responses, continue frequent periodic moinitoring of vtal signs and ECG.
Embolization- in conversion of atrial fibrillation to normal sinus rhythm by any means, dislodgement of mural thrombi may lead to embolization.
Drug/lab interactions- suprapharmacologic concentrations of lidocaine and meprobamate may inhibit flurosecence of procainamide and NAPA and propranol shows a natve flurosecence close to procainamide /NAPA peaks wavelenghts therfore, tests that depend on fluoresence measurements may be affected.
Blood dyscrasias- agranulocytosis, bone marrow depression, neutropenia, hypoplastic anemia, and thrombocytopenia in patients receiving procainamide have been reported. Most of the patients received procainamide within the normal recommended dosage range.Sine most of these events have been noted during the first 12 weeks of therapy,
it is recommended that complete blood counts including white cell, differential and platelet counts be performed at weekly intervals for the first three months of therapy and periodically therafter.
Survival- antiarrhythmic drugs have not been shown to enhance survival in patients with ventricuar arrhythmias.
Complete heart block- do not administer to patients with completre heart block because of its effect in supressing nodal and ventricular pacemakers and the hazads of asytole.
Torsedes de pointes- administration of procainamide in such casaes may aggravate this special type of ventricular extrasystole or tachycardia instead of suppressing it.
Lupus erythematous - an established diagnoisis of systemic lupus erythematous is a contraindication to procainamide therapy, since aggravation of symptoms is highly likely.
Asymptomatic ventricular premature contrations- avoid treatment of patients with this condition.
Digitalis intoxication- excercise caution in use of procainamide in arrhythmias associated with digitalis intoxication
First degree heart block- excercise caution if the patient exhibits or develops first-degree heart block while taking procainamide , dosage reduction is advised in such cases.
Predigitalization for atrial flutter or fibrillation- cardiovert or digitalize patients with atrial flutter or fibrillation prior to procainamide administration to avoid enhancement of AV conduction which may result in vetntricular rate accelaration beyond tolerable limits.
Congestive heart failure- (CHF) - use with caution in pastients with CHF and in those with ischemic heart disease or cardiomyopathy since slight depression of myocardial contractility may further reduce cardiac output of damaged of heart.
Concurrent antiarrhythmic agents- concurrent use of procainamide with other group of !A antiarrhythmics agents eg quinidine, disopyramide,, may produce enhanced prolongation of conduction or depression of contractility and hypotension especally in patients with cardiac decompensation.
Myastena gravis- patients may show worsening of symptoms from procainamide due to its procainamide due to its procaine like effect on diminishing acetylcholine release at skeletal muscle motor nerve endings.
Renal insufficiency- may lead to accumulation of high plasma levels from conventional oral doses of procainamide with effects similar to those of overdosage, unless dosage is adjusted for the individual patient.
Pregnancy- give to pregnant woman only if clearly needed.
Lactation- because of the potential for adverse reactions, in nursing infants, decide whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Children- safey and efficacy have not been established.
Dosages/ Overdosage Etc:
Indications:
Ventricular arrhythmias.
Dosage:
Initial total daily dose upto 50mg/kg may be given in divided doses.For older patients more
than 50 years of age.Lesser amounts may be given.
Overdosage-
Symptoms
Progresive widening of QRScomplex, prolonged QTand PR intervals, lowering of
R and T waves,as well as increasing AV block, may be seen with doses which are
excessive for a given patient.
Increased ventricular extrasystoles, or ventricular tachycardia or fibrillation may occur.
After IV administration but seldom after oral therapy, transient high plasma levels induce
hypotension, affecting systolic more than diastolic pressures, especially in hypertensive
patients. Such high levels may also produce CNS depression, tremor, and even respiratory depression.
Overdosage symptoms may result following a single 2g dose, while 3g may be dangerous, especially if the patient is a slow acetylator and has decreased renal function or underlying organic heart disease
Treatment
1. Includes general supportive measures,close observation,monitoring of vital signs and possibly IV pressor agents and mechanical cardiorespirtory support.
2. If available, procainamide and NAPA plasma evels may be helpful in assessing the potential degree of toxicity and response to therapy.
3. Both procainamide and NAPA are removed from the circulation by hemodialysis but not peritoneal dialysis.
4. No specific antidote for procainamide is known.
Missed dose-
1. If you miss a dose of this medicine and remember 2 hours( 4 hours if you are taking the
long-acting tablets), take it as soon as possible
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:
Pericarditis- ( 1150 )
Pain is an important but not an invaluable symptom in various forms of acute pericarditis, it is invariable symptoms
in various forms presumed to be related to hypersentivity or autoimuunity. Oain is often absent in in a slowly developing
tuberculosis, postirradiation or neoplastic pericarditis.
Drugs causing adverse reactions- ( 386 )
1. Procainamide
2. Hydralazine
3. Methysergide
4. Emetine
Patient Information:
PROCAINAMIDE - ANTIARRHYTMIC AGENT
1.Take procainamide exactly as prescribed by the doctor.
2.Swallow the tablet whole without breaking,crushing or chewing it.
3. Do not miss any dose. It is best to take dose at evenly spaced times day and night.
4.Allergies- tell your doctor if you have ever had any unusual or allergic reaction to procainamide, procaine, or other -caine- type medicine. Also tell your doctor if you are allergic to any other substances, such as foods, presevatives or dyes.
5.Pregnancy - before you take this medicine make sure that your doctor knows whether you are pregnant or if you become pregnant
6.Breast feeding- proacinamide passes into breast milk.
7. Children - in effective doses the medicine has not shown to cause different side effects or problems than it does in adults.
8.Elderly- dizziness or lightheaededness is more likely to occur the elderly.
9. Other medicines -
Antiarrhythmics - efects on the haert may be increased
Antihypertensives- effects on blood pressure may be increased
Antimyastathenics - effects may be blocked by procainamide
Pimozide- may increase the risk of herat rhythm problems
10. Other medical problems -
Tell your doctor if you have any other medical problems especially -
Asthma - possible allergic reaction
Kidney disease or
Liver disease - effects may be increased becuase of slower removal of procainamide from the body
Lupus erythematosus - procainamide may casue the condition to become active
Myasthnia gravis- procainamide may increase muscle weakness
11. Missed dose -
If you miss a dose of this medicine, take it as soon as possible. however, if it is almost time for the next dose, skip the missed dose. Do not double doses.
12. Storage -
Keep out of reach of children. Store away from heat or direct sunlight. Do not store
the capsule in bathroom, near the kitchen sink, or in other damp places.
13. Outdated medicines -
Do not keep outdated medicine or medicine no longer needed. Be sure that any
discarded medicine is out of reach of children.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Acts by increasing the effective refractory period of the atria,and to a lesser extent the bundle His-Purkinje system and ventricles of the heart. it reduces the impulse conduction velocity of the atria.
Pharmacokinetics:
The drug is well absorbed from the entire small intestine. Following oral administration,plasma levels reach about 50% of peak in 30 minutes,90% at 1 hour and peak at about 90 to 120 minutes.
Interaction with Food:
None reported
Pregnancy and lactation:
Pregnancy:
Give to pregnant woman only if required.
Lactation: Excercise caution and decide whether to discontinue nursing or discontinue the drug taking into account the importance of drug to the mother.
Children- Safety and efficacy have not been established.
