Cardizem La
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Questions & Answers
Side Effects & Adverse Reactions
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- Cardiac Conduction. Diltiazem prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (13 of 3290 patients or 0.40%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem (see ADVERSE REACTIONS).
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- Congestive Heart Failure. Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction 24% ± 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt). Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. Experience with the use of diltiazem in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.
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- Hypotension. Decreases in blood pressure associated with diltiazem therapy may occasionally result in symptomatic hypotension.
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- Acute Hepatic Injury. Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem is uncertain in some cases, but probable in some (see PRECAUTIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CARDIZEM LA is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
CARDIZEM LA is indicated for the management of chronic stable angina.
History
There is currently no drug history available for this drug.
Other Information
CARDIZEM® LA (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is:
Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.99. CARDIZEM LA Tablets, for oral administration are formulated as a once-a-day extended-release tablet containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride.
Also contains: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ethyl acrylate and methyl methacrylate copolymer dispersion, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, microcrystalline wax, polydextrose, polyethylene glycol, polysorbate, povidone, pregelatinized starch, simethicone, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide.
Sources
Cardizem La Manufacturers
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Abbvie Inc.
![Cardizem La (Diltiazem Hydrochloride) Tablet, Extended Release [Abbvie Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cardizem La | Abbvie Inc.
CARDIZEM LA Tablets are an extended-release formulation intended for once-a-day administration.
Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM LA Tablets once-a-day at the nearest equivalent total daily dose. Higher doses of CARDIZEM LA Tablets once-a-day dosage may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but the safety and efficacy of doses as high as 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
The tablet should be swallowed whole and not chewed or crushed.
Hypertension.Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The dosage range studied in clinical trials was 120 to 540 mg once daily. The dosage may be titrated to a maximum of 540 mg daily.
CARDIZEM LA Tablets should be taken about the same time once each day either in the morning or at bedtime. The time of dosing should be considered when making dose adjustments based on trough effects.
Angina.Dosage for the treatment of angina should be individualized based on response. The initial dose of 180 mg once daily may be increased at intervals of 7 to 14 days if adequate response is not obtained. CARDIZEM LA doses above 360 mg appear to confer no additional benefit.
CARDIZEM LA can be given once daily, either in the evening or in the morning.
Concomitant Use with Other Cardiovascular Agents • Sublingual NTG. May be taken as required to abort acute anginal attacks during Diltiazem Hydrochloride Extended-Release therapy. • Prophylactic Nitrate Therapy. Diltiazem Hydrochloride Extended-Release Tablets may be safely coadministered with short-and long-acting nitrates. • Beta-blockers (see WARNINGS and PRECAUTIONS). • Antihypertensives. CARDIZEM LA has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of Diltiazem Hydrochloride Extended-Release Tablets or the concomitant antihypertensives may need to be adjusted when adding one to the other. -
Valeant Pharmaceuticals North America Llc
Cardizem La | Cardinal Health
adults and children 12 years and over
1 suppository once daily. Remove foil. Insert suppository well into rectum touching the bowel wall. Retain about 15 to 20 minutes.
children 6 years to under 12 years
1/2 suppository once daily
children under 6 years
ask a doctor
In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with petroleum jelly
![Cardizem La (Diltiazem Hydrochloride) Tablet, Extended Release [Valeant Pharmaceuticals North America Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4d00384f-322b-4f52-85ad-a0b30e9e2ae5&name=image-01.jpg)
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