(Posted: 3/2/99 )
Note: The following summaries include only those safety-related sections that have been modified, and therefore do not contain all the information needed for safe and effective prescribing. Contact the manufacturer for the complete labeling/package insert.
NB: Comparison made to 1999 Physicians' Desk Reference (PDR), if drug's labeling included in the PDR.
Complied with the help of:
Julie Johnson, PharmD Student
McWhorter School of Pharmacy
Samford University
Birmingham, AL
(clomipramine HCl) |
(dolasetron mesylate) |
(cerivastatin Na) |
(alprostadil) |
(amiodarone HCl) |
(dorzolamide HCl/ timolol maleate) |
(isosorbide dinitrate) |
(nicotine transdermal) |
(terbinafine HCl) |
(fluvastatin Na) |
& LOESTRIN FE (norethindrone acetate/ ethinyl estradiol/ + ferrous fumarate in FE) |
(cefepime HCl) |
(atovaquone) |
(norethindrone/ ethinyl estradiol) |
(isosorbide mononitrate) |
(nitroglycerin) |
(norethindrone/ ethinyl estradiol) |
(lansoprazole) |
(succinylcholine chloride) |
(isosorbide dinitrate) |
(iodixanol) |
(bupropion HCl) |
(olanzapine) |
"While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, fluvoxamine, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. Fluvoxamine has also been shown to inhibit P450 1A2, an isoform also involved in TCA metabolism. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary). Conconmitant use of agents in the tricyclic antidepressant["s" deleted] class (which includes Anafranil) with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these drugs is withdrawn from co-therapy, an increased does of tricyclic antidepressant agent may be required. It is desirable to monitor TCA plasma levels whenever ["a TCA" deleted] an agent of the tricyclic antidepressant class (including Anafranil) is going to be co-administered with another drug known to be an inhibitor of P45 2D6 (and/or P450 1A2)."
"Cross hypersensitivity reactions have been reported in patients who received other selective 5-HT3 receptor antagonists. These reactions have not been seen with dolasetron mesylate."
"Furthermore, severe hypotension, bradycardia and syncope have been reported immediately or closely following IV administration."
Vascular (Extracardiac): Subsection revised (new text in italics) -
Local pain or burning on IV administration;rarely - peripheral ischemia, thrombophlebitis/phlebitis."
"A 59-year-old man with metastatic melanoma and no known pre-existing cardiac conditions developed severe hypotension and dizziness 40 minutes after receiving a 15 minute intravenous infusion of 1000 mg (13 mg/kg) of dolasetron mesylate."
"Rare cases of rhabdomyolysis (some with acute renal failure secondary to myoglobinuria) have been reported with cerivastatin and other ["HMG CoA reductase inhibitors" deleted] drugs in this class."
"Although specific interaction studies were not performed, in clinical studies, cerivastatin sodium was used concomitantly with angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, calcium-channel blockers, diuretics, and nonsteroidal anti-inflammatory drugs (NSAIDs) without evidence of clinically significant adverse interactions."
"The following events have been reported since market introduction. While these events were temporally associated with the use of Baycol, a causal relationship to the use of Baycol cannot be readily determined due to the spontaneous nature of reporting of medical events, and the lack of controls: hepatitis, myositis, rhabdomyolysis, some with associated renal failure (most cases involved concomitant gemfibrozil), urticaria, angioedema, visual disturbance, blurred vision."
"Follow these instructions exactly to prepare and inject a sterile dose of CAVERJECT. A dose may be administered manually as described in the 'Inject Your Dose of Caverject' section below, or with the use of an autoinjector (PenInject 2.25 AutoInjector)which is available separately. If you choose to use the PenInject 2.25 Autoinjector, see the pamphlet provided with it for instructions on loading, using, and maintaining this device."
"The applicability of these results to other populations (e.g., those without recent myocardial infarctions) or to Cordarone-treated patients is uncertain. While definitive controlled trials with Codarone are in progress, pooled analysis of small controlled studies in patients with structural heart disease (including post-myocardial infarction) have not shown excess mortality in the Cordarone-treated population."
Replaced with the following text -
"Cordarone therapy was evaluated in two multi-centered, randomized, double-blind, placebo-controlled trials involving 1202 (Canadian Amiodarone Myocardial Infarction Arrhythmia Trial; CAMIAT) and 1486 (European Myocardial Infarction Amiodarone Trial; EMIAT) post-MI patients followed for up to 2 years. Patients in CAMIAT qualified with ventricular arrhythmias, and those randomized to amiodarone received weight- and response-adjusted doses of 200 to 400 mg/day. Patients in EMIAT qualified with ejection fraction <40%, and those randomized to amiodarone received fixed doses of 200 mg/day. Both studies had weeks-long loading dose schedules. Intent-to-treat all-cause mortality results were as follows:"
Placebo |
Amiodarone |
Relative Risk |
||||
N |
Deaths |
N |
Deaths |
95% CI |
||
EMIAT |
743 |
102 |
743 |
103 |
0.99 |
0.76-1.31 |
CAMIAT |
596 |
68 |
606 |
57 |
0.88 |
0.58-1.16 |