Rx Product Guide

   
   
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Diltiazem Hydrochloride (dill-TIE-uh-zem HIGH-droe-KLOR-ide)
Trade Name(s):   Cardizem
  ·Tablets 30 mg
  ·Tablets 60 mg
  ·Tablets 90 mg
  ·Tablets 120 mg
  ·Powder for injection 25 mg
  ·Injection 5 mg/mL
  Cardizem CD
  ·Capsules, extended-release 120 mg
  ·Capsules, extended-release 180 mg
  ·Capsules, extended-release 240 mg
  ·Capsules, extended-release 300 mg
  ·Capsules, extended-release 360 mg
  Cardizem LA
  ·Tablets, extended-release 120 mg
  ·Tablets, extended-release 180 mg
  ·Tablets, extended-release 240 mg
  ·Tablets, extended-release 300 mg
  ·Tablets, extended-release 360 mg
  ·Tablets, extended-release 420 mg
  Cartia XT
  ·Capsules, extended-release 120?mg
  ·Capsules, extended-release 180 mg
  ·Capsules, extended-release 240 mg
  ·Capsules, extended-release 300 mg
  Dilacor XR
  ·Capsules, extended-release 120 mg
  ·Capsules, extended-release 180 mg
  ·Capsules, extended-release 240 mg
  Dilt-XR
  ·Capsules, extended-release 120 mg
  ·Capsules, extended-release 180 mg
  ·Capsules, extended-release 240 mg
  Diltia XT
  ·Capsules, extended-release 180 mg
  Diltiazem Hydrochloride Extended Release
  ·Capsules, extended-release 60 mg
  ·Capsules, extended-release 90 mg
  Diltzac
  ·Capsules, extended-release 120 mg
  ·Capsules, extended-release 180 mg
  ·Capsules, extended-release 240 mg
  ·Capsules, extended-release 300 mg
  ·Capsules, extended-release 360 mg
  Taztia XT
  ·Capsules, extended-release 120 mg
  ·Capsules, extended-release 180 mg
  ·Capsules, extended-release 240 mg
  Tiazac
  ·Capsules, extended-release 120 mg
  ·Capsules, extended-release 180 mg
  ·Capsules, extended-release 240 mg
  ·Capsules, extended-release 300 mg
  ·Capsules, extended-release 360 mg
  ·Capsules, extended-release 420 mg
Apo-Diltiaz
Apo-Diltiaz CD
Apo-Diltiaz Injectable
Apo-Diltiaz SR
Gen-Diltiazem
Gen-Diltiazem CD
Novo-Diltiazem
Novo-Diltiazem CD
Nu-Diltiaz
Nu-Diltiaz-CD
ratio-Diltiazem CD
Sandoz Diltiazem CD
Tiazac XC

Indicates Canadian Trade Name.


Class: Calcium channel blocking agent

Action: Inhibits movement of calcium ions across cell membrane in systemic and coronary vascular smooth muscle; slows calcium ion movement across cell membranes in both cardiac muscle and cardiac pacemaker cells, decreasing sinoatrial and atrioventricular (AV) conduction.

Absorption:
IV IV - T max is 2 to 3 h.
Extended release (ER) Extended release (ER) - T max is 10 to 14 h.
Immediate release (IR) Immediate release (IR) - T max is 2 to 4 h.
Distribution:
Vd approximately 305 L. 70% to 80% protein bound (approximately 40% to a l -acid glycoprotein and approximately 30% to albumin). Excreted in breast milk.
Metabolism:
Metabolized in the liver (including via CYP-450) to several metabolites; desacetyl diltiazem is 25% to 50% as potent as diltiazem. Undergoes first-pass metabolism after oral administration.
Excretion:
The t ½ is approximately 3.4 h (IV), 4 ? to 9 ? h (ER), and 3 to 4.5 h (IR). 2% to 4% excreted unchanged in urine (oral). Systemic Cl approximately 65 ? L/h (IV).
Peak:
2 to 5 min (IV).
Special Populations:
Hepatic Function Impairment - Bioavailability is increased, and t ½ is prolonged.
Indications:
Oral Treatment of angina pectoris caused by coronary artery spasm; chronic stable angina (classic effort-associated angina); essential hypertension (extended- and sustained-release forms only).
Parenteral Treatment of atrial fibrillation or flutter; paroxysmal supraventricular tachycardia.
Contraindications: Sick sinus syndrome; second- or third-degree AV block; except with functioning pacemaker; hypotension with systolic pressure less than 90 mm Hg; acute MI; pulmonary congestion; hypersensitivity to the drug; ventricular tachycardia (IV); atrial fibrillation or atrial flutter associated with an accessory bypass tract (IV); IV diltiazem and IV beta-blockers administered together (within a few hours).

Interactions:
Anesthetics Depression of cardiac contractility, conductivity, and automaticity as well as vascular dilation associated with anesthetics may be potentiated.
Benzodiazepines (eg, midazolam, triazolam), carbamazepine, cyclosporine, digitalis, encainide, lovastatin Plasma levels of these agents may be elevated by diltiazem, increasing the pharmacologic and toxic effects.
Beta-blockers May have additive negative inotropic and chronotropic effects.
Cimetidine, ranitidine Diltiazem levels may be increased.
Other antihypertensive agents May have additive effects.
Rifampin Coadministration lowered diltiazem plasma concentrations to undetectable levels.
INCOMPATIBILITIES:
Do not mix with furosemide.
Lab Test Interferences: None well documented.

Adverse Reactions:

cardiovascular:
Bradycardia (4%); first-degree AV block (3%); angina, arrhythmia, AV block (second- or third-degree), bundle branch block, CHF, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles (less than 2%); peripheral edema, asystole, MI (postmarketing).

cns:
Dizziness (6%); headache, fatigue (5%); asthenia (3%); abnormal dreams, amnesia, depression, gait abnormalities, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tremor (less than 2%); lightheadedness; weakness; shakiness; extrapyramidal symptoms (postmarketing).

dermatologic:
Rash (1%); petechiae, photosensitivity, pruritus, ecchymosis (less than 2%); alopecia, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis, exfoliative dermatitis, purpura, generalized rash (postmarketing).

eent:
Amblyopia, epistaxis, eye irritation, nasal congestion, rhinitis, tinnitus (less than 2%); retinopathy (postmarketing).

gi:
Nausea (1%); anorexia, constipation, diarrhea, dry mouth, dysgeusia, thirst, vomiting (less than 2%); abdominal discomfort; cramps; dyspepsia; gingival hyperplasia (postmarketing).

gu:
Albuminuria, crystalluria, hyperuricemia, impotence, nocturia, polyuria, sexual difficulties, gynecomastia (less than 2%).

hematologic-lymphatic:
Hemolytic anemia, increased bleeding time, leukopenia, thrombocytopenia (postmarketing).

labtestabs:
Mild elevations of ALT, AST, LDH, and alkaline phosphatase, CPK increase (less than 2%).

metabolic-nutritional:
Hyperglycemia, weight gain (less than 2%).

musculoskeletal:
Muscle cramps, neck rigidity, osteoarticular pain (less than 2%); joint pain.

respiratory:
Cough (2%); dyspnea (less than 2%).

miscellaneous:
Lower limb edema (7%); edema (5%); flushing (1%); allergic reactions, pain (less than 2%); angioedema (postmarketing).
Precautions:
Monitoring: Monitor and record BP and pulse frequently during treatment. Hold medication and notify health care provider if hypotension and/or bradycardia develop. Ensure that a defibrillator and emergency resuscitation equipment are readily available. Continuously monitor ECG during administration.
Pregnancy: Category C .
Lactation: Excreted in breast milk.
Children: Safety and efficacy not established.
Elderly: Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Renal function impairment: Use with caution. Dosage may need to be decreased.
Hepatic function impairment: Use with caution. Dosage may need to be decreased.
Acute hepatic injury Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed. These elevations were usually transient and often resolved with continued treatment.
Cardiac conduction Prolongs AV node refractory periods without prolonging sinus node recovery time, except in patients with sick sinus syndrome. This may rarely cause abnormally slow heart rates, particularly in patients with sick sinus syndrome, or second- or third-degree AV block.
CHF Use with caution.
Orthostatic hypotension Implement safety precautions if orthostatic hypotension occurs.
Withdrawal syndrome Abrupt withdrawal may cause increased frequency and duration of angina. Dosage is tapered gradually.
Overdosage: Signs & symptoms Bradycardia, hypotension, high-degree AV block, heart failure.

Patient/Family Education:
  • Advise patient or caregiver that IV diltiazem will be prepared and administered by health care professionals in a medical setting.
  • Advise patient that dose of medication may be adjusted to obtain max benefit.
  • Advise patient taking immediate-release tablets to take 3 or 4 times daily as prescribed. Advise patient to take each dose without regard to meals but to take with food if stomach upset occurs.
  • Advise patient taking extended-release products to take once daily as prescribed, without regard to meals. Advise patient to take with food if stomach upset occurs.
  • Caution patient to swallow extended-release products whole and not to crush or chew.
  • Advise patient to try to take each dose at about the same time each day.
  • Inform patient that drug controls, but does not cure, hypertension or angina and to continue taking as prescribed even when BP is not elevated or angina symptoms are not present.
  • Caution patient not to change the dose or stop taking unless advised by health care provider.
  • Instruct patient to continue taking other BP or angina medications as prescribed by health care provider.
  • Instruct patient being treated for angina to notify health care provider if frequency or severity of chest pain or need for sublingual nitroglycerin appears to be increasing.
  • Instruct patient in BP and pulse measurement skills.
  • Advise patient to monitor and record BP and pulse at home and to inform health care provider if abnormal measurements are noted. Also advise patient to take record of BP and pulse to each follow-up visit.
  • Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing.
  • Advise patient to notify health care provider if any of the following occur: frequent episodes of dizziness when arising; slow heart beat; persistent fatigue; any other unusual or unexplained symptom or sign.
  • Emphasize to hypertensive patient importance of other modalities on BP: weight control, regular exercise, smoking cessation, moderate intake of alcohol and salt.


   
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