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diltiazem hydrochloride |
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diltiazem hydrochloride Adizem (UK), Angitil (UK), Apo-Diltiaz (CA), Apo-Diltiazem (CA), Calcicard (UK), Cardizem, Cardizem CD, Cardizem LA, Cartia XT, Dilcardia (UK), Dilacor-XR, Diltia XT, Dilt-XR, Dilzem (UK), Disogram (UK), Gen-Diltiazem (CA), Novo-Diltazem (CA), Nu-Diltiaz (CA), Optil (UK), Slozem (UK), Syn-Diltiazem, Taztia XT, Tiazac, Tildiem (UK), Viazem (UK), Zemtard Pharmacologic class: Calcium channel blocker Therapeutic class: Antianginal, antiarrhythmic (class IV), antihypertensive Pregnancy risk category C ActionInhibits calcium from entering myocardial and vascular smooth-muscle cells, thereby depressing myocardial and smooth-muscle contraction and decreasing impulse formation and conduction velocity. As a result, systolic and diastolic pressures decrease. AvailabilityCapsules (extended-release, sustained-release): 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mg Injection: 5 mg/ml in 10-ml vials, 25-mg ready-to-use syringes, 100-mg Monovial Tablets: 30 mg, 60 mg, 90 mg, 120 mg ⊘Indications and dosages ➣ Angina pectoris and vasospastic (Prinzmetal's) angina; hypertension; supraventricular tachyarrhythmias; atrial flutter or fibrillation Adults: 30 to 90 mg P.O. three to four times daily (tablets), or 60 to 120 mg P.O. b.i.d. (sustained-release), or 180 to 240 mg P.O. once daily (extended-release), adjusted after 14 days as needed, up to a total daily dosage of 360 mg. Or 0.25 mg/kg by I.V. bolus over 2 minutes; if response is inadequate after 15 minutes, may give 0.35 mg/kg over 2 minutes; may follow with continuous I.V. infusion at 10 mg/hour (at a range of 5 to 15 mg/hour) for up to 24 hours. Dosage adjustment• Severe hepatic or renal impairment Off-label uses• Unstable angina, coronary artery bypass graft surgery Contraindications• Hypersensitivity to drug PrecautionsUse cautiously in: Administration• When giving I.V., dilute in dextrose 5% in water or normal saline solution.
Adverse reactionsCNS: headache, abnormal dreams, anxiety, confusion, dizziness, drowsiness, nervousness, psychiatric disturbances, asthenia, paresthesia, syncope, tremor CV: peripheral edema, bradycardia, chest pain, hypotension, palpitations, tachycardia, arrhythmias, heart failure EENT: blurred vision, tinnitus, epistaxis GI: nausea, vomiting, diarrhea, constipation, dyspepsia, dry mouth GU: urinary frequency, dysuria, nocturia, polyuria, gynecomastia, sexual dysfunction Hematologic: anemia, leukopenia, thrombocytopenia Metabolic: hyperglycemia Musculoskeletal: joint stiffness, muscle cramps Respiratory: cough, dyspnea Skin: rash, dermatitis, flushing, diaphoresis, photosensitivity, pruritus, urticaria, erythema multiforme Other: unpleasant taste, gingival hyperplasia, weight gain, decreased appetite, Stevens-Johnson syndrome InteractionsDrug-drug. Beta-adrenergic blockers, digoxin, disopyramide, phenytoin: bradycardia, conduction defects, heart failure Carbamazepine, cyclosporine, quinidine: decreased diltiazem metabolism, increased risk of toxicity Cimetidine, ranitidine: increased blood level and effects of diltiazem Fentanyl, nitrates, other antihypertensives, quinidine: additive hypotension HMG-CoA reductase inhibitors, imipramine, sirolimus, tacrolimus: increased blood levels of these drugs Lithium: decreased lithium blood level, reduced antimanic control Nonsteroidal anti-inflammatory drugs: decreased antihypertensive effect of diltiazem Theophylline: increased theophylline effects Drug-diagnostic tests. Hepatic enzymes: increased levels Drug-food. Grapefruit juice: increased blood level and effects of diltiazem Drug-behaviors. Acute alcohol ingestion: additive hypotension Patient monitoring• Check blood pressure and ECG before starting therapy, and monitor closely during dosage adjustment period. Withhold dose if systolic pressure is below 90 mm Hg. Patient teaching• Advise patient to change position slowly to minimize light-headedness and dizziness. How to thank TFD for its existence? Tell a friend about us, add a link to this page, add the site to iGoogle, or visit webmaster's page for free fun content. |
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At that time, Andrx entered into a settlement with the direct purchaser class of plaintiffs (other than those who have sued separately or opted out of the class) who, among other things, purchased Cardizem CD from Aventis during the period of July 1998, when Andrx first received FDA approval of its product, through June 1999, when Andrx commenced the sale of Cartia XT, its generic version of Cardizem CD. As a result of preliminary testing to date, Biovail has given notice to Andrx that its Cartia XT product may be infringing the agreed upon dissolution specifications contained in the Stipulation and Agreement, and that Biovail will be vigilant in asserting its rights under that Agreement. Currently we have filed 11 ANDAs with the FDA, of which two are already on the market; Dilacor XR and Cardizem CD generics, which we've trademarked and sell under the names Diltia XT and Cartia XT. |
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