The incidence of hypokalaemia was 0. No consistent effects of eplerenone on heart rate, QRS duration, or PR or QT interval were observed in normal subjects evaluated for electrocardiographic changes during pharmacokinetic studies. Most of the subjects The primary endpoint, death from CV causes or hospitalization for heart failure occurred in The effect of eplerenone on the primary endpoint outcomes was consistent across all pre-specified subgroups. The secondary endpoint of all cause mortality was met by Death from CV causes was reported in Eplerenone has not been studied in pediatric subjects with heart failure.
Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Diltiazem if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets.
Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Diltiazem , use it as soon as possible. Adverse Reactions Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities usually have been excluded. In domestic placebo-controlled angina trials, the incidence of adverse reactions reported during diltiazem therapy was not greater than that reported during placebo therapy.
The following represent occurrences observed in clinical studies of angina patients. In many cases, the relationship to diltiazem has not been established.
The most common occurrences from these studies, as well as their frequency of presentation, are edema 2. Cardiac Conduction , bradycardia, bundle branch block, congestive heart failure, ECG abnormality, flushing, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.
Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tremor.
Acute Hepatic Injury , thirst, vomiting, weight increase. Petechiae, photosensitivity, pruritus, urticaria. Amblyopia, CPK elevation, dry mouth, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties, tinnitus.
The following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride tablets: There have been observed cases of a generalized rash, some characterized as leukocytoclastic vasculitis. In addition, events such as myocardial infarction have been observed, which are not readily distinguishable from the natural history of the disease in these patients. A definitive cause and effect relationship between these events and diltiazem hydrochloride tablets therapy cannot yet be established.
Exfoliative dermatitis proven by rechallenge has also been reported. The toxic dose in man is not known. Due to extensive metabolism, blood levels after a standard dose of diltiazem can vary over fold, limiting the usefulness of blood levels in overdose cases.
Of cases with known outcome, most patients recovered and in cases with a fatal outcome, the majority involved multiple drug ingestion.
Events observed following diltiazem overdose included bradycardia, hypotension, heart block, and cardiac failure. Bradycardia frequently responded favorably to atropine, as did heart block, although cardiac pacing was also frequently utilized to treat heart block.
Fluids and vasopressors were used to maintain blood pressure, and in cases of cardiac failure, inotropic agents were administered. The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent.
In a few reported cases, overdose with calcium channel blockers associated with hypotension and bradycardia that was initially refractory to atropine became more responsive to atropine after the patients received intravenous calcium.
In some cases intravenous calcium has been administered 1 g calcium chloride or 3 g calcium gluconate over 5 minutes and repeated every 10 to 20 minutes as necessary. Use Cardizem with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it. Cardizem may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects.
To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Cardizem may cause you to become sunburned more easily. Rar se constata greata, varsaturi, inrosirea fetei si eritem alergic. La unii pacienti se pot constata agravarea simptomelor anginoase si o scadere accentuata a tensiunii arteriale.
Foarte rar, se poate produce colaps, insotit uneori de sincope si aritmii bradicardice. Exceptional, s-au raportat cazuri de dermatita exfoliativa. Pentru a evita dezvoltarea tolerantei la Olicard retard sau a unei tolerante incrucisate la alti nitrati organici, se vor evita tratamentele de durata cu doze mari. A moderate less than 2-fold increase of diltiazem plasma concentration in cases of co-administration with a stronger CYP3A4 inhibitor has been documented.
Diltiazem is also a CYP3A4 isoform inhibitor. Co-administration with other CYP3A4 substrates may result in an increase in plasma concentration of either co-administered drug. Co-administration of diltiazem with a CYP3A4 inducer may result in a decrease of diltiazem plasma concentrations.
Diltiazem significantly increases plasma concentrations of midazolam and triazolam and prolongs their half-life. Special care should be taken when prescribing short-acting benzodiazepines metabolized by the CYP3A4 pathway in patients using diltiazem. The patient should be monitored when initiating methylprednisolone treatment. An adjustment in the dose of methylprednisolone may be necessary.
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