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Generic drugs pharmaceuticals news - for info.: Americo Gonzalvo, Conference in General Medicine and Family Practice Jesse Kaye, M.D., Lake Hospital, ECG Interpretation and Arrhythmia Management, July M.D., University of South Florida PROCARDIA" (mtedipine i CAPSULES For Oral Use who have had angiography the presence ot significant fixed obstructive disease is not incompatible with the diagnosis ot vasospastic angina provided that the above criteria are satisfied PROCARDIA may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been contirmed e g where pain has a variable threshold on exertion or m unstable angina where electrocardiographic findings are compatible with intermittent vasospasm or when angina is retractory to nitrates and or adeguate doses ol beta blockers If Chronic Stable Angina (Classical Etiort-Associated Angina): PROCARDIA is indicated lor the management ot chronic stable angina l effort associated anginal without evidence ot vasospasm n patients who remain symptomatic despite adeguate doses ot beta blockers and or organic nitrates or who cannot tolerate those agents In chronic stable angina (effort-associated angina) PROCARDIA has been etlective in controlled Inals ol up to eight weeks duration in reducing angina treguency and increasing exercise tolerance but confirmation ot sustained ettectiveness and evaluation ot long term safety in those patients are Controlled studies in small numbers ot patients suggest concomitant use ol PROCARDIA and beta blocking agents may be beneficial in patients with chronic stable angina but available intor mation is not sufficient to predict with confidence the etteds ot concurrent treatment especially in patients with compromised left ventricular function or cardiac conduction abnormalities When in traducing such concomitant therapy care must be taken to monitor blood pressure closely since severe hypotension can occur trom the combined effects ot the drugs (See Warnings ) CONTRAINDICATIONS Known hypersensitivity reaction to PROCARDIA WARNINGS Excessive Hypotension: Although in most patients the hypotensive ettect ot PROCARDIA is modest and well tolerated occasional patients have had excessive and poorly tolerated hypotension These responses have usually occurred during initial titration or at the time ol subseguent upward dosage adiustment and may be more likely in patients on concomitant beta Severe hypotension and or increased fluid volume regunements have been reported in patients receiving PROCARDIA together with a beta blocking agent who underwent coronary artery bypass surgery using high dose tentanyl anesthesia The interaction with high dose tentanyl appears to be due to the combination ol PROCARDIA and a beta blocker but the possibility that it may occur with analgesics cannot be ruled out In PROCARDIA treated patients where surgery using high dose tentanyl anesthesia is contemplated the physician should be aware ot these potential problems and PROCARDIA to be washed out ol the body prior to surgery Increased Angina Occasional patients have developed well documented increased treguency du ration or severity ot angina on starting PROCARDIA or at the time ot dosage increases The mechanism ot this response is not established but could result from decreased coronary perfusion associated with decreased diastolic pressure with increased heart rate or trom increased demand resulting trom increased heart rate alone Beta Blocker Withdrawal Patients recently withdrawn trom bela blockers may develop a with drawal syndrome with increased angina probably related to increased sensitivity to catecholamines Initiation ot PROCARDIA treatment will not prevent this occurrence and might be expected to exacerbate it by provoking retlex catecholamme release There have been occasional reports ol increased angina in a setting ot beta blocker withdrawal and PROCARDIA initiation It is important lo taper beta blockers it possible rather than stopping them abruptly before beginning Congestive Heart Failure Rarely patients usually receiving a beta blocker have developed hearl failure after beginning PROCARDIA Patients with light aortic stenosis may be at greater risk tor PRECAUTIONS General Hypotension Because PROCARDIA decreases peripheral vascular resistance careful monitoring ot blood pressure during the initial administration and titration ot PROCARDIA is suggested Close observation is especially recommended tor patients already taking medications that are known to lower blood pressure iSee Warnings l Peripheral edema Mild to moderate peripheral edema typically associated with arterial vasodilation and not due to left ventricular dysfunction occurs in about one in len patients treated with PROCARDIA This edema occurs primarily in the lower extremities and usually responds to diuretic therapy With patients whose angina is complicated by congestive heart failure care should be taken to differentiate this peripheral edema trom the etlects ot increasing left ventricular dysfunction Drug interactions Beta adrenergic blocking agents (See Indications and Warnings I Experience nt PROCARDIA and beta-blocking agents is usually well tolerated but there have been occasional literature reports suggesting that the combination may increase the likelihood ot congestive heart failure severe hypotension or exacerbation ol angina Long acting nitrates PROCARDIA may be safely co administered with nitrates but there have been no controlled studies to evaluate the antiangmal ettectiveness ol this combination Digitalis Administration ot PROCARDIA with digoxm increased digoxm levels in nine ol twelve goxm levels in thirteen patients with coronary artery disease In an uncontrolled study ol over two hundred patients with congestive heart failure during which digoxm blood levels were not meas ured digitalis toxicity was not observed Since there have been isolated reports ot patients with elevated digoxm levels it is recommended that digoxm levels be monitored when initiating adiust mg and discontinuing PROCARDIA to avoid possible over or under digitalization Pregnancy Category C Please see lull prescribing information with reference to teratogenicity in rats embryotoxicity m rats mice and rabbits and abnormalities m monkeys ADVERSE REACTIONS The most common adverse events include dizziness or light headedness Syncopal episodes did not recur with reduction in the dose ot PROCARDIA or concomitant antian ginal medication Additionally the following have been reported muscle cramps nervousness ness sleep disturbances blurred vision difficulties in balance dermatitis pruritus urticaria lever sweating chills and sexual difficulties Very rarely introduction ot PROCARDIA therapy was associated with an increase in anginal pain possibly due to associated hypotension In addition more serious adverse events were observed not readily distinguishable trom the nat ural history ot the disease in these patients It remains possible however that some or many ot Laboratory Tests: Rare mild to moderate transient elevations ot enzymes such as alkaline phos phatase CPK LDH SGOT and SGPT have been noted and a single incident ot significantly ele vated transaminases and alkaline phosphatase was seen in a patient with a history ot gall bladder disease after about eleven months ot niledipme therapy The relationship to PROCARDIA therapy is uncertain These laboratory abnormalities have rarely been associated with clinical symptoms Cholestasis possibly due to PROCARDIA therapy has been reported twice m the extensive world while this patient's experience ( i n solicited comments received,"My daily routine consisted of sitting in my chair trying to stay alive." PROCARDIA M as soon as it became available.

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