Recommended Topic Related To:

Dilacor XR

"Dec. 18, 2012 -- People who can't get their high blood pressure down with drugs may be helped by a new procedure that deactivates overactive nerves in the kidneys, a small study shows.

The procedure is already available in Europe and "...

Dilacor XR

SIDE EFFECTS

Serious adverse reactions to diltiazem hydrochloride have been rare in studies with other formulations, as well as with Dilacor XR®. It should be recognized, however, that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.

Hypertension

The most common adverse events (frequency ≥ 1%) in placebo-controlled, clinical hypertension studies with Dilacor XR using daily doses up to 540 mg, are listed in the table below with placebo-treated patients included for comparison.

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND, PLACEBO-CONTROLLED HYPERTENSION TRIALS

Adverse Events (COSTART Term) Dilacor XR®*
n=303
# pts (%)
Placebo
n=87
# pts (%)
rhinitis 29 (9.6) 7 (8.0)
headache 27 (8.9) 12 (13.8)
pharyngitis 17 (5.6) 4 (4.6)
constipation 11 (3.6) 2 (2.3)
cough increase 9 (3.0) 2 (2.3)
flu syndrome 7 (2.3) 1 (1.1)
edema, peripheral 7 (2.3) 0 (0.0)
myalgia 7 (2.3) 0 (0.0)
diarrhea 6 (2.0) 0 (0.0)
vomiting 6 (2.0) 0 (0.0)
sinusitis 6 (2.0) 1 (1.1)
asthenia 5 (1.7) 0 (0.0)
pain, back 5 (1.7) 2 (2.3)
nausea 5 (1.7) 1 (1.1)
dyspepsia 4 (1.3) 0 (0.0)
vasodilatation 4 (1.3) 0 (0.0)
injury, accident 4 (1.3) 0 (0.0)
pain, abdominal 3 (1.0) 0 (0.0)
arthrosis 3 (1.0) 0 (0.0)
insomnia 3 (1.0) 0 (0.0)
dyspnea 3 (1.0) 0 (0.0)
rash 3 (1.0) 1 (1.1)
tinnitus 3 (1.0) 0 (0.0)
*Adverse events occurring in 1% or more of patients receiving Dilacor XR.

Angina

The most common adverse events (frequency ≥ 1%) in a placebo-controlled, short-term (2 week) clinical angina study with Dilacor XR are listed in the table below with placebo-treated patients included for comparison. In this trial, following a placebo phase, patients were randomly assigned to once daily doses of either 120, 240, or 480 mg of Dilacor XR.

MOST COMMON ADVERSE EVENTS IN A DOUBLE-BLIND, PLACEBO-CONTROLLED SHORT-TERM, ANGINA TRIALS

Adverse Events (COSTART Term) Dilacor XR®*
n=139
# pts (%)
Placebo
n=50
# pts (%)
asthenia 5 (3.6) 2 (4.0)
headache 4 (2.9) 3 (6.0)
pain, back 4 (2.9) 1 (2.0)
rhinitis 4 (2.9) 1 (2.0)
constipation 3 (2.2) 1 (2.0)
nausea 3 (2.2) 0 (0.0)
edema, peripheral 3 (2.2) 1 (2.0)
dizziness 3 (2.2) 0 (0.0)
cough, increased 3 (2.2) 0 (0.0)
bradycardia 2 (1.4) 0 (0.0)
fibrillation, atrial 2 (1.4) 0 (0.0)
arthralgia 2 (1.4) 0 (0.0)
dream, abnormal 2 (1.4) 0 (0.0)
dyspnea 2 (1.4) 0 (0.0)
pharyngitis 2 (1.4) 1 (2.0)
*Adverse events occurring in 1% or more of patients receiving Dilacor XR.

Infrequent Adverse Events

The following additional events (COSTART Terms), listed by body system, were reported infrequently (less than 1%) in all subjects, hypertensive (n=425) or angina (n=318) patients who received Dilacor XR, or with other formulations of diltiazem.

Hypertension

Cardiovascular: First-degree AV block, arrhythmia, postural hypotension, tachycardia, pallor, palpitations, phlebitis, ECG abnormality, ST elevation.

Nervous System: Vertigo, hypertonia, paresthesia, dizziness, somnolence.

Digestive System: Dry mouth, anorexia, tooth disorder, eructation.

Skin and Appendages: Sweating, urticaria, skin hypertrophy (nevus).

Respiratory System: Epistaxis, bronchitis, respiratory disorder.

Urogenital System: Cystitis, kidney calculus, impotence, dysmenorrhea, vaginitis, prostate disease.

Metabolic and Nutritional Disorders: Gout, edema.

Musculoskeletal System: Arthralgia, bursitis, bone pain.

Hemic and Lymphatic System: Lymphadenopathy.

Body as a Whole: Pain, unevaluable reaction, neck pain, neck rigidity, fever, chest pain, malaise.

Special Senses: Amblyopia (blurred vision), ear pain.

Angina

Cardiovascular: Palpitations, AV block, sinus bradycardia, bigeminal extrasystole, angina pectoris, hypertension, hypotension, myocardial infarct, myocardial ischemia, syncope, vasodilatation, ventricular extrasystole.

Nervous System: Abnormal thinking, neuropathy, paresthesia.

Digestive System: Diarrhea, dyspepsia, vomiting, colitis, flatulence, GI hemorrhage, stomach ulcers.

Skin and Appendages: Contact dermatitis, pruritus, sweating.

Respiratory System: Respiratory distress.

Urogenital System: Kidney failure, pyelonephritis, urinary tract infection.

Metabolic and Nutritional Disorders: Weight increase.

Musculoskeletal System: Myalgia.

Body as a Whole: Chest pain, accidental injury, infection.

Special Senses: Eye hemorrhage, ophthalmitis, otitis media, taste perversion, tinnitus.

There have been post-marketing reports of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of diltiazem hydrochloride.

Read the Dilacor XR (diltiazem hydrochloride capsule, extended release) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with any agents known to affect cardiac contractility and/or conduction. (See WARNINGS.) Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride. (See WARNINGS.) As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem hydrochloride undergoes biotransformation by cytochrome P-450 mixed function oxidase. Co-administration of diltiazem hydrochloride with other agents which follow the same route of biotransformation may result in the competitive inhibition of metabolism. Especially in patients with renal and/or hepatic impairment, dosages of similarly metabolized drugs, particularly those of low therapeutic ratio such as cyclosporine, may require adjustment when starting or stopping concomitantly administered diltiazem hydrochloride to maintain optimum therapeutic blood levels. Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated plasma levels of carbamazepine, resulting in toxicity in some cases.

Beta-Blockers: Controlled and uncontrolled domestic studies suggest that concomitant use of diltiazem hydrochloride and beta-blockers is usually well-tolerated, but available data are not sufficient to predict the effects of concomitant treatment in patients with left ventricular dysfunction or cardiac conduction abnormalities. Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and the bioavailability of propranolol was increased approximately 50%. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted. (See WARNINGS.)

Cimetidine: A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and area-under-the-curve (53%) after a 1 week course of cimetidine at 1,200 mg per day and diltiazem 60 mg per day. Ranitidine produced smaller, nonsignificant increases. The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of diltiazem. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. An adjustment in the diltiazem dose may be warranted.

Clonidine: Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Monitor heart rate in patients receiving concomitant diltiazem and clonidine.

Digitalis: Administration of diltiazem hydrochloride with digoxin in 24 healthy male subjects increased plasma digoxin concentrations approximately 20%. Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease. Since there have been conflicting results regarding the effects of digoxin levels, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing diltiazem hydrochloride therapy to avoid possible over- or under-digitalization. (See WARNINGS.)

Anesthetics: The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium channel blockers should be titrated carefully.

Statins: Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of diltiazem. When possible, use a non-CYP3A4-metabolized statin with diltiazem; otherwise, dose adjustments for both diltiazem and the statin should be considered along with close monitoring for signs and symptoms of any statin related adverse events.

In a healthy volunteer cross-over study (N=10), co-administration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg twice daily diltiazem SR resulted in a 5-fold higher mean simvastatin AUC compared with simvastatin alone. High average steady-state exposures of diltiazem would result in a greater increase in simvastatin exposure. A daily dose of 480 mg of diltiazem would be expected to result in an 8-fold higher mean simvastatin AUC compared with simvastatin alone. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.

In a ten-subject randomized, open label, 4-way cross-over study, co-administration of diltiazem (120 mg twice daily diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3-to 4- fold higher mean lovastatin AUC and Cmax values compared with lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration.

Read the Dilacor XR Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

A A A

Dilacor XR - User Reviews

Dilacor XR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Dilacor XR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Hypertension

Get tips on handling your hypertension.