Diltiazem Hydrochloride Extended Release

Diltiazem Hydrochloride Extended Release

Diltiazem Hydrochloride Extended Release Recall

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Questions & Answers

Side Effects & Adverse Reactions

1.
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).
2.
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 hydrochloride in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.
3.
Hypotension: Decreases in blood pressure associated with diltiazem therapy may occasionally result in symptomatic hypotension.
4.
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

Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.

Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.

History

There is currently no drug history available for this drug.

Other Information

Diltiazem Hydrochloride Extended-Release Capsules, USP 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 chemical structure is:

2268b074-figure-01

Diltiazem hydrochloride, USP 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 450.98. Diltiazem hydrochloride, USP is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride.

Each diltiazem extended-release capsule, for oral administration, contains the following inactive ingredients:

120 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

180 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

240 mg — ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

300 mg— ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

This drug product conforms to USP Drug release test #11.

Diltiazem Hydrochloride Extended Release Manufacturers


  • Cardinal Health
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Capsule, Coated, Extended Release [Cardinal Health]
  • Watson Laboratories Inc.
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Tablet, Extended Release [Watson Laboratories Inc.]
  • Par Pharmaceutical, Inc.
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Capsule, Coated, Extended Release [Par Pharmaceutical, Inc.]
  • American Health Packaging
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Capsule, Coated, Extended Release [American Health Packaging]
  • American Health Packaging
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Capsule, Coated, Extended Release [American Health Packaging]
  • Lake Erie Medical Dba Quality Care Products Llc
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Capsule, Coated, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • State Of Florida Doh Central Pharmacy
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Capsule, Coated, Extended Release [State Of Florida Doh Central Pharmacy]
  • Cardinal Health
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Capsule, Coated, Extended Release [Cardinal Health]
  • Oceanside Pharmaceuticals
    Diltiazem Hydrochloride Extended Release (Diltiazem Hydrochloride) Capsule, Extended Release [Oceanside Pharmaceuticals]

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