Side effects of diltiazem

Contents

Atrial fibrillation medications

If this approach does not work for you, or your AF episodes happen more frequently, we may tell you to start taking the medication daily.

There are a few antiarrhythmics which can be used for the ‘pill-in-the-pocket’ approach or used regularly. Which medication you use will depend on any underlying heart disease, such as coronary heart disease, heart failure and hypertension. It will also depend on the side effects and how effective the drug may be.

Flecainide

Flecainide is a sodium channel-blocking drug, which slows the conduction (carrying the electrical impulses) within the heart. Its main purpose is to act on the atria and also slow conduction through the AV-node.

It is very effective in treating episodes of AF and is often better tolerated than some of the other anti-arrhythmic medications. Its effect is more obvious with faster heart rates, which makes it very useful to control fast episodes of AF.

This drug is only given to people who have a normal functioning heart.

Dose

When you start taking flecainide, you will start on a low dose (50mg twice a day), with possibly going up to 200mg twice a day. this will depend on your symptoms and your ECG.

If you are prescribed flecainide, you may also have to take a beta block or calcium channel blocker. This is to protect the lower chambers of the heart (ventricles) from contracting too quickly.

Monitoring

Once you start taking flecainide you will need to have regular ECGs. Flecainide slows the conduction in the heart and this change will be shown on your ECG. But we will want to make sure that the conduction has not slowed down too much. You will normally have an ECG about one week after starting flecainide and then after each increase in dosage.

Side effects

The most common side effect of flecainide is visual disturbances. This is usually reported as blurred vision. Less common side effects include gastrointestinal symptoms (such as nausea) and dizziness.

Flecainide can also cause arrhythmias, so this is why it is only given to patients that have a normal functioning heart.

Sotalol

Sotalol is a mixture of a beta-blocker and an anti-arrhythmic. In low doses, it acts like a beta blocker. With higher doses, it acts like an anti-arrhythmic by blocking potassium channels and slowing conduction in the heart.

You will start on a low dose (40mg twice a day) and can go up to 160mg twice a day. This will depend on your symptoms and your ECG.

When you start taking sotalol you will need to have regular ECGs. This is because higher doses of sotalol slow down conduction in the heart, which will be reflected in your ECG. We need to check that the conduction has not slowed down too much.

It is especially important that we check this when your heart is in sinus rhythm.

Sotalol can also be pro-arrhythmic, which causes arrhythmias. If we see certain changes on your ECG you may tell you to reduce or stop your sotalol.

You will usually have an ECG about one week after starting sotalol and after each dose increase.

The most common side effect with sotalol is bradycardia (when the heart beats at a slow rate, usually less than 60 beats per minute).

Other side effects, which are associated with beta blockers, include:

  • fatigue or tiredness
  • cold extremities (cold hands and feet)
  • exacerbation of asthma
  • light-headedness.

Amiodarone

This drug works in a similar way to sotalol by blocking potassium channels and slowing conduction within the heart.

Amiodarone is very effective at maintaining sinus (normal) rhythm. We would suggest this drug for patients with structural heart disease or who have tried other AF medications without success.

Even though it is a powerful and effective drug, it does have side effects so we may suggest you take it for a short period of time.

You will start this medication either with a tablet or by intravenous injection over 24 hours. This will depend on the severity of your symptoms.

Because of the structure of amiodarone, it takes a long time (weeks to months) for levels of the drug to build up in the body. We will start with getting you to take 200mg three times a day for one week. This will then be reduced to twice a day for one week, and then one a day afterwards.

Although generally well tolerated, amiodarone can cause some side effects.

Skin

Amiodarone can make the skin have a greyish/blue look when it comes into contact with sunlight. Your skin may also be more sensitive to getting sunburnt, so it is important to wear plenty of sunblock and protective clothing. As amiodarone remains in the body for a long time, you may need to continue using sunblock for a few months after you stop taking the drug.

Thyroid

The thyroid gland produces a hormone which controls the body’s metabolism. Amiodarone can affect this gland making it both overactive or underactive. An overactive thyroid happens to about two per cent of patients and an underactive thyroid happens to about six per cent of patients. Your doctor will take regular blood tests to check if either of these has developed.

If you experience symptoms of extreme tiredness or restlessness, contact your GP to discuss this further. Your doctor will arrange for you to have blood tests if you have not already had them. Both underactive and overactive thyroids can be treated with medications. If you develop an overactive thyroid, we may tell you to stop taking amiodarone.

Eyes

Small deposits can form on the cornea of the eye (the clear surface that covers the pupil, iris and white of the eye). These deposits are not harmful, but you may notice the effects when looking at bright lights at night time, such as when you are driving.

Around one in ten people taking amiodarone will notice a bluish halo around their vision but this is not harmful.

Lungs

Amiodarone can cause problems with thickening (fibrosis) of the lungs, which may be irreversible. The risk of this occurring increases if you have been on the medication for a long time. If you experience shortness of breath, see your GP as soon as you can.

Liver

Amiodarone can cause problems with the function of the liver in rare cases. Your doctor will perform regular blood tests to check that your liver function is normal. If you experience jaundice (yellowing of the skin) or new nausea and vomiting, see your GP as soon as possible.

Other side effects

When you first start taking amiodarone, you may experience some nausea and vomiting. This should settle within a few days, but if you continue to have problems, contact your GP. You may also get some taste disturbances, like a metallic taste in your mouth. This is not uncommon for people taking amiodarone, but if you are concerned, see your GP.

When you start taking amiodarone, you will have a blood test to check your liver and thyroid function. You will also have a chest X-ray if you have not had one recently. Your GP will then recheck your liver and thyroid function every six months.

Amiodarone can interact with many medications and herbal medicines. So it is very important that your GP and pharmacist are aware of all the medicines you are taking (including herbal products).

We may recommend reducing your statin dose and digoxin intake. If you are taking warfarin, amiodarone will cause your INR to increase, so we will reduce your warfarin dose.

If you notice any of the following you should contact your GP as soon as possible:

  • Any difficulties breathing, or if you develop an unexplained cough.
  • Extreme tiredness or restlessness.
  • Jaundice (any yellowing of your skin or the whites of your eyes). These could be signs of a problem developing in your liver.
  • A severe skin rash. This could be a sign of an allergic reaction.

Dronedarone

Dronedarone has a similar structure to amiodarone but is not considered to be as effective as amiodarone. The advantage of dronedarone is that it seems to be better tolerated and has fewer side effects.

We would only recommend someone to take this drug if other antiarrhythmics are unsuitable for them or if they cannot tolerate them. It is also only used by patient who paroxysmal or persistent AF to help maintain sinus rhythm.

The dose of dronedarone is 400mg twice a day and you will need to take it with food.

There are some reports of this drug causing liver damage, so when you first start taking it you have a blood test to check your liver function. This will happen every month for the first six months of your treatment, then at nine months. You will then have another at 12 months and then at certain intervals after that.

You will also have a blood test seven to ten days after starting the drug to check your kidney function. You will also have an ECG at least every six months. If your ECG shows that you have remained in persistent AF, this indicates that the medication is not working as it should and you will need to stop taking it.

The most common side effects that people experience are:

  • gastrointestinal disturbances, such as nausea, vomiting, diarrhoea or abdominal discomfort
  • skin rashes
  • bradycardia
  • changes in your ECG (although this is rare).

Side effects should stop within the first two weeks of starting dronedarone. But for some patients, we will tell them to stop taking because of the side effects.

You should contact your GP if you experience any of the following:

  • Any difficulties breathing
  • Swollen ankles
  • New onset abdominal pain
  • Jaundice (any yellowing of your skin or the whites of your eyes)

These could be signs of a problem developing in your liver.

Dronedarone can interact with many medications and herbal medicines. So you must make your GP and pharmacist aware of all the medicines you are taking (including herbal products).

We may tell you to reduce your statin, verapamil/diltiazem or digoxin dose as dronedarone interacts with them. It can also increase the circulating levels of these drugs in the body.

You should also avoid grapefruit whilst taking dronedarone.

Getting further supplies of dronedarone

You may find that your GP is unable to continue to provide you with further supplies of dronedarone tablets. This is due to funding restrictions by the Clinical Commissioning Groups (CCGs).

Your GP may prescribe dronedarone for you if they have an agreement from the hospital, known as a shared care document. This details the responsibilities of both the GP and the hospital.

If you are having difficulties obtaining a regular supply of your tablets, please contact Sally Manning, senior arrhythmia pharmacist.

Cardizem CD

SIDE EFFECTS

Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.

The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving CARDIZEM CD up to 360 mg with rates in placebo patients shown for comparison.

CARDIZEM CD Capsule Placebo-Controlled Angina and Hypertension Trials Combined

Cardiovascular: Angina, arrhythmia, AV block (second- or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.

Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.

Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see WARNINGS, Acute Hepatic Injury), thirst, vomiting, weight increase.

Dermatological: Petechiae, photosensitivity, pruritus, urticaria.

Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.

The following postmarketing events have been reported infrequently in patients receiving CARDIZEM: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and CARDIZEM therapy is yet to be established.

Read the entire FDA prescribing information for Cardizem CD (Diltiazem HCl)

Cartia XT (Oral)

Generic Name: diltiazem (Oral route)

dil-TYE-a-zem

Medically reviewed by Drugs.com. Last updated on Nov 11, 2018.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Commonly used brand name(s)

In the U.S.

  • Cardizem
  • Cardizem CD
  • Cardizem LA
  • Cartia XT
  • Dilacor XR
  • Dilt-CD
  • Diltia XT
  • Dilt-XR
  • Diltzac
  • Matzim LA
  • Taztia XT
  • Tiazac

Available Dosage Forms:

  • Capsule, Extended Release
  • Tablet
  • Capsule, Extended Release, 24 HR
  • Tablet, Extended Release
  • Capsule, Extended Release, 12 HR
  • Tablet, Extended Release, 24 HR

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Benzothiazepine

Uses for Cartia XT

Diltiazem is used alone or together with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Diltiazem is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, diltiazem relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

This medicine is available only with your doctor’s prescription.

Before using Cartia XT

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diltiazem in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diltiazem in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving diltiazem.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Cisapride
  • Colchicine
  • Eliglustat
  • Flibanserin
  • Lomitapide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acalabrutinib
  • Acebutolol
  • Afatinib
  • Alfentanil
  • Alprenolol
  • Aprepitant
  • Atazanavir
  • Atenolol
  • Atorvastatin
  • Benzhydrocodone
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bosutinib
  • Brexpiprazole
  • Bucindolol
  • Buprenorphine
  • Carbamazepine
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Ceritinib
  • Cilostazol
  • Clarithromycin
  • Clonidine
  • Clopidogrel
  • Cobimetinib
  • Codeine
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dantrolene
  • Deflazacort
  • Digoxin
  • Dihydrocodeine
  • Dilevalol
  • Domperidone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Droperidol
  • Encorafenib
  • Eplerenone
  • Erythromycin
  • Esmolol
  • Fentanyl
  • Fingolimod
  • Fosaprepitant
  • Fosnetupitant
  • Hydrocodone
  • Ibrutinib
  • Ifosfamide
  • Ivabradine
  • Ivacaftor
  • Ivosidenib
  • Labetalol
  • Lacosamide
  • Levobunolol
  • Lovastatin
  • Lurasidone
  • Meperidine
  • Mepindolol
  • Methadone
  • Metipranolol
  • Metoprolol
  • Morphine
  • Morphine Sulfate Liposome
  • Nadolol
  • Naloxegol
  • Nebivolol
  • Neratinib
  • Netupitant
  • Nilotinib
  • Olaparib
  • Oxprenolol
  • Oxycodone
  • Penbutolol
  • Pentazocine
  • Pindolol
  • Piperaquine
  • Pixantrone
  • Propranolol
  • Ranolazine
  • Simeprevir
  • Simvastatin
  • Sonidegib
  • Sotalol
  • St John’s Wort
  • Sufentanil
  • Tacrolimus
  • Talinolol
  • Tertatolol
  • Tezacaftor
  • Timolol
  • Tolvaptan
  • Tramadol
  • Venetoclax
  • Vincristine
  • Vincristine Sulfate Liposome

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfuzosin
  • Buspirone
  • Cimetidine
  • Colestipol
  • Dalfopristin
  • Digitoxin
  • Dutasteride
  • Efavirenz
  • Enflurane
  • Fosphenytoin
  • Guggul
  • Indinavir
  • Lithium
  • Methylprednisolone
  • Midazolam
  • Moricizine
  • Nevirapine
  • Phenytoin
  • Quinupristin
  • Rifampin
  • Sirolimus
  • Suvorexant
  • Triazolam

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bowel blockage, severe or
  • Congestive heart failure—Use with caution. May make these conditions worse.
  • Heart attack or
  • Heart block (type of abnormal heart rhythm, can use if have a pacemaker that works properly) or
  • Hypotension (low blood pressure), severe or
  • Lung problem (eg, pulmonary congestion) or
  • Sick sinus syndrome (type of abnormal heart rhythm, can use if have a pacemaker that works properly)—Should not be used in patients with these conditions.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of diltiazem

This section provides information on the proper use of a number of products that contain diltiazem. It may not be specific to Cartia XT. Please read with care.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the extended-release tablet, extended-release capsule, or tablet whole. Do not open, crush, or chew it. It is best to take the extended-release capsule on an empty stomach.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For chest pain:
    • For oral dosage form (extended-release capsules):
      • Adults—At first, 120 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (extended-release tablets):
      • Adults—At first, 180 milligrams (mg) once a day, either in the morning or evening. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—At first, 30 milligrams (mg) four times a day before meals and at bedtime. Your doctor may increase your dose if needed.
      • Children—Use and dose must be determined by your doctor.
  • For high blood pressure:
    • For oral dosage form (extended-release capsules):
      • Adults—At first, 180 to 240 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (extended-release tablets):
      • Adults—At first, 180 to 240 milligrams (mg) once a day, either in the morning or at bedtime. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Cartia XT

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Hypotension (low blood pressure) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision, confusion, severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness. .

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loose skin, chills, cough, diarrhea, itching, joint or muscle pain, red skin lesions, often with a purple center, skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter ) medicines and herbal or vitamin supplements.

Cartia XT side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Body aches or pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • hoarseness
  • runny nose
  • tender or swollen glands in the neck
  • trouble swallowing
  • voice changes

Less common

  • Chest pain or discomfort
  • chills
  • diarrhea
  • difficult or labored breathing
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • shivering
  • slow or irregular heartbeat
  • sweating
  • swelling of the hands, ankles, feet, or lower legs
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • no heartbeat
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sores, ulcers, or white spots in the mouth or on the lips

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Sneezing
  • stuffy nose

Less common

  • Acid or sour stomach
  • belching
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • degenerative disease of the joint
  • difficulty with moving
  • hearing loss
  • heartburn
  • indigestion
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • pain or tenderness around the eyes and cheekbones
  • rash
  • stomach discomfort, upset, or pain
  • swollen joints

Incidence not known

  • Hair loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 2019 Truven Health Analytics, Inc. All Rights Reserved.

Medical Disclaimer

More about Cartia XT (diltiazem)

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Pricing & Coupons
  • En Español
  • 12 Reviews
  • Drug class: calcium channel blocking agents

Consumer resources

  • Cartia XT

Other brands: Cardizem, Cardizem CD, Tiazac, Dilt-XR, … +6 more

Professional resources

  • Cartia XT (FDA)
  • … +1 more

Related treatment guides

  • Angina Pectoris Prophylaxis
  • Heart Failure
  • High Blood Pressure

This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Cardizem; Cardizem CD; Cardizem LA; Cartia XT; Dilt-XR; dilTIAZem CD ; Matzim LA; Taztia XT; Tiadylt ER; Tiazac

Brand Names: Canada

What is this drug used for?

  • It is used to treat high blood pressure.
  • It is used to treat a type of long-term chest pain (stable angina) in some people.
  • It is used to treat certain types of abnormal heartbeats.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take this drug?

  • If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have certain types of abnormal heartbeats. There are many types of abnormal heartbeats with which this drug must not be used. Ask your doctor or pharmacist if you are not sure.
  • If you have any of these health problems: Fluid in the lungs, low blood pressure, or recent heart attack.
  • If you are taking any of these drugs: Ivabradine or rifampin.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Check blood pressure and heart rate as the doctor has told you.
  • You may need to have an ECG checked before starting this drug and while taking it. Talk with your doctor.
  • If you are taking this drug and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • You may need to avoid drinking alcohol with some products. Talk with your doctor or pharmacist to see if you need to avoid drinking alcohol with this drug.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Very bad dizziness or passing out.
  • Slow heartbeat.
  • An abnormal heartbeat that is new or worse.
  • Heart failure has gotten worse in some people taking this drug. If you have heart failure, talk with your doctor. Call your doctor right away if you have shortness of breath, a big weight gain, or swelling in the arms or legs.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

All oral products:

  • Headache.
  • Feeling dizzy, tired, or weak.

Injection:

  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All oral products:

  • Swallow whole. Do not chew, break, or crush.
  • Take this drug at the same time of day.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.

Long-acting capsules (24 hour):

  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this drug.
  • Some products may be opened and sprinkled on a spoonful of applesauce. Some products must be swallowed whole. Check with your pharmacist to see if you can open this product.

Injection:

  • It is given into a vein for a period of time.

What do I do if I miss a dose?

All oral products:

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Injection:

  • Call your doctor to find out what to do.

How do I store and/or throw out this drug?

All oral products:

  • Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.

Injection:

  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.

All products:

  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Last Reviewed Date

Copyright

Question

Asked by CRP

How To Stop Taking Cardizem 120 Mg/once A Day

How do I stop taking Cardizem? I’ve only been taking it for about three weeks now for coronary artery spasms. I take 120mg once a day. I will check with my doctor before stopping, but I’d like to know the plan ahead of time. Thank you!

Answer

CRP,

Thanks for your question. I’m glad you mentioned your plan to check with your doctor before stopping medication. Patients should never change the dose or stop taking a medication without their physician’s knowledge and guidance.

A lot will depend on your need for treatment of the coronary artery spasms, as well as the reason you wish to stop the medication. If your physician feels that further treatment is needed, he might suggest another medication in its place. If he agrees with stopping the Cardizem without replacing it, he might taper the dose over time, observing you for symptoms of coronary spasm. Since this is not a large dose, stopping it all at once may be a possibility. It all depends on your situation (history, other medication, blood pressure, and more). Be sure to discuss your reasons for stopping it, so that alternatives can be chosen to accommodate these issues.

Best wishes.

Martin Cane, M.D.

Cardizem

Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities usually have been excluded.

In domestic placebo-controlled angina trials, the incidence of adverse reactions reported during CARDIZEM therapy was not greater than that reported during placebo therapy.

Cardiovascular

Angina, arrhythmia, AV block (first-degree), AV block (second-or third-degree – see WARNINGS, Cardiac Conduction), bradycardia, bundle branch block, congestive heart failure, ECG abnormality, flushing, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.

Nervous System

Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tremor.

Gastrointestinal

Anorexia, constipation, diarrhea, dysgeusia, dyspepsia, mild elevations of alkaline phosphatase, SGOT, SGPT, and LDH (see WARNINGS, Acute Hepatic Injury), thirst, vomiting, weight increase.

Dermatological

Petechiae, photosensitivity, pruritus, urticaria.

Other

Amblyopia, CPK elevation, dry mouth, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties, tinnitus.

The following postmarketing events have been reported infrequently in patients receiving CARDIZEM: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia. There have been observed cases of a generalized rash, some characterized as leukocytoclastic vasculitis. In addition, events such as myocardial infarction have been observed, which are not readily distinguishable from the natural history of the disease in these patients. A definitive cause and effect relationship between these events and CARDIZEM therapy cannot yet be established. Exfoliative dermatitis (proven by rechallenge) has also been reported.

Read the entire FDA prescribing information for Cardizem (Diltiazem Hydrochloride)

General Information

The Diltiazem Hydrochloride extended-release capsules, taken in 120 to 240 mg a day doses, are principally used to reduce high blood pressure (hypertension).

According to the American Heart Association, high blood pressure in adults defined as a blood pressure greater than or equal to 140 mm Hg systolic pressure or greater than or equal to 90 mm Hg diastolic pressure. High blood pressure has been directly linked to increases in the risk of various heart and brain conditions such as coronary heart disease and stroke.

While high blood pressure can occur in anyone, high risk groups include blacks, middle-aged and elderly adults, obese people, heavy drinkers, and women taking oral contraceptives.

Clinical Results

Clinical studies compared the Diltiazem HCL extended release capsules with the Diltiazem HCL tablets. The two forms of the drug were shown to have similar trends in half-life, despite the difference in absorption rate. It was found that 95% of the extended-release capsule is absorbed throughout the dosing interval. The capsules take effect within two to three hours and active effects are detected for 10 to 14 hours.

Side Effects

Common side effects include headache, drowsiness, swelling of feet and ankles, constipation, nausea, sudden weight gain, and fatigue.

More serious, but less common side effects include, irregular or slow heartbeat, shortness of breath, and fatigue caused by heart failure.

There may be some drug interactions between Diltiazem HCL and aspirin, beta-blockers, digitalis preparations, carbamazepine, cyclosporine, digoxin, lithium, oral diabetes agents, phenytoin, rifampin, cimetidine, fluvoxamine, or ranitidine.

Warning

Suddenly discontinuing use of this drug may cause serious health problems. Any discontinuance of the drug should be in gradual dosage reductions.

Mechanism of Action

Diltiazem interferes with the movement of calcium into heart muscle cells and the smooth muscle cells in the walls of the arteries. This action relaxes blood vessels (causing them to widen), which lowers blood pressure, increases the blood supply to the heart, and decreases the hearts overall workload. “from www.DiscoveryHealth.com”

Literature References

For a brief overview of the drug Diltiazem HCL, visit Yahoo! Health

Visit the to find out more about the risks involved with high blood pressure.

Additional Information

Diltiazem Hydrochloride is also available in tablet form to relieve and control angina (chest pain associated with heart disease) and in injection form to correct cardiac arrhythmia (heartbeat irregularities).

Cardizem LA

CLINICAL PHARMACOLOGY

Mechanism Of Action

The therapeutic effects of diltiazem are believed to be related to its ability to inhibit the cellular influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle.

Hypertension

Diltiazem produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance. The magnitude of blood pressure reduction is related to the degree of hypertension; thus hypertensive individuals experience an antihypertensive effect, whereas there is only a modest fall in blood pressure in normotensives.

Angina

Diltiazem has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. This is accomplished via reductions in heart rate and systemic blood pressure at submaximal and maximal workloads. Diltiazem has been shown to be a potent dilator of coronary arteries, both epicardial and subendocardial. Spontaneous and ergonovine-induced coronary artery spasm are inhibited by diltiazem.

In animal models, diltiazem interferes with the slow inward (depolarizing) current in excitable tissue. Diltiazem causes excitation-contraction uncoupling in various myocardial. Diltiazem produces relaxation of coronary vascular smooth muscle and dilation of both large and small coronary arteries at drug levels which cause little or no negative inotropic effect. The resultant increases in coronary blood flow (epicardial and subendocardial) occur in ischemic and nonischemic models and are accompanied by dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance.

Pharmacodynamics

Like other calcium channel antagonists, diltiazem decreases sinoatrial and atrioventricular conduction in isolated tissues and has a negative inotropic effect in isolated preparations. In the intact animal, prolongation of the AH interval can be seen at higher doses.

In man, diltiazem prevents spontaneous and ergonovine-provoked coronary artery spasm. It causes a decrease in peripheral vascular resistance and a modest fall in blood pressure in normotensive individuals and, in exercise tolerance studies in patients with ischemic heart disease, reduces the heart rate-blood pressure product for any given work load. Studies to date, primarily in patients with good ventricular function, have not revealed evidence of a negative inotropic effect; cardiac output, ejection fraction, and left ventricular end diastolic pressure have not been affected. Such data have no predictive value with respect to effects in patients with poor ventricular function, and increased heart failure has been reported in patients with preexisting impairment of ventricular function. There are as yet few data on the interaction of diltiazem and beta-blockers in patients with poor ventricular function. Resting heart rate is usually slightly reduced by diltiazem. Diltiazem decreases vascular resistance, increases cardiac output (by increasing stroke volume), and produces a slight decrease or no change in heart rate.

During dynamic exercise, increases in diastolic pressure are inhibited, while maximum achievable systolic pressure is usually reduced. Chronic therapy with diltiazem produces no change or an increase in plasma catecholamines. No increased activity of the renin-angiotensin-aldosterone axis has been observed. Diltiazem reduces the renal and peripheral effects of angiotensin II. Hypertensive animal models respond to diltiazem with reductions in blood pressure and increased urinary output and natriuresis without a change in urinary sodium/potassium ratio.

Intravenous diltiazem hydrochloride 20 mg prolongs AH conduction time and AV node functional and effective refractory periods by approximately 20%. In a study involving single oral doses of diltiazem hydrochloride 300 mg in six normal volunteers, the average maximum PR prolongation was 14% with no instances of greater than first-degree AV block. Diltiazem associated prolongation of the AH interval is not more pronounced in patients with first-degree heart block. In patients with sick sinus syndrome, diltiazem significantly prolongs sinus cycle length (up to 50% in some cases).

Chronic oral administration of diltiazem hydrochloride to patients in doses of up to 540 mg/day has resulted in small increases in PR interval, and on occasion produces abnormal prolongation .

Pharmacokinetics

Diltiazem is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect, giving an absolute bioavailability (compared to intravenous administration) of about 40%. Diltiazem undergoes extensive metabolism in which only 2% to 4% of the unchanged drug appears in the urine. Drugs that induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition.

Total radioactivity measurement following short IV administration in healthy volunteers suggests the presence of other unidentified metabolites, which attain higher concentrations than those of diltiazem and are more slowly eliminated; half-life of total radioactivity is about 20 hours compared to 2 to 5 hours for diltiazem.

In vitro binding studies show diltiazem is 70% to 80% bound to plasma proteins. Competitive in vitro ligand binding studies have also shown diltiazem hydrochloride binding is not altered by therapeutic concentrations of digoxin, hydrochlorothiazide, phenylbutazone, propranolol, salicylic acid, or warfarin. The plasma elimination half-life following single or multiple drug administration is approximately 3.0 to 4.5 hours. Desacetyl diltiazem is also present in the plasma at levels of 10% to 20% of the parent drug and is 25% to 50% as potent as a coronary vasodilator as diltiazem. Minimum therapeutic plasma diltiazem concentrations appear to be in the range of 50 to 200 ng/mL. There is a departure from linearity when dose strengths are increased; the half-life is slightly increased with dose. A study that compared patients with normal hepatic function to patients with cirrhosis found an increase in half-life and a 69% increase in bioavailability in the hepatically impaired patients. A single study in nine patients with severely impaired renal function showed no difference in the pharmacokinetic profile of diltiazem compared to patients with normal renal function.

CARDIZEM LA Tablets. A single 360 mg dose of CARDIZEM LA results in detectable plasma levels within 3 to 4 hours and peak plasma levels between 11 and 18 hours; absorption occurs throughout the dosing interval. The apparent elimination half-life for CARDIZEM LA Tablets after single or multiple dosing is 6 to 9 hours. When CARDIZEM LA Tablets were coadministered with a high fat content breakfast, diltiazem peak and systemic exposures were not affected indicating that the tablet can be administered without regard to food. As the dose of CARDIZEM LA Tablets is increased from 120 to 240 mg, area-under-the-curve increases 2.5-fold.

Drug Interactions

Impact Of Diltiazem On Other Co-Administered Drugs

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 blockers should be titrated carefully.

Benzodiazepines: Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3-to 4-fold and the Cmax by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5-to 2.5fold) during coadministration with diltiazem. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g., prolonged sedation) of both midazolam and triazolam.

Beta-blockers: Controlled and uncontrolled domestic studies suggest that concomitant use of diltiazem 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 concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted .

Buspirone: In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5-fold and Cmax 4.1-fold compared to placebo. The elimination half-life and Tmax of buspirone were not significantly affected by diltiazem. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.

Carbamazepine: Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase), resulting in toxicity in some cases.

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.

Cyclosporine: A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted, or discontinued. The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.

Digitalis: Administration of diltiazem 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. Monitor digoxin levels when initiating, adjusting, and discontinuing diltiazem therapy to avoid possible over-or under-digitalization .

Quinidine: Diltiazem increases the AUC (0-∞) of quinidine by 51%, elimination half-life by 36%, and decreases its oral clearance by 33%. Monitor for quinidine adverse effects and adjust the dose adjusted.

Statins: Diltiazem 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 together 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 BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8-to 9-fold mean increase in simvastatin AUC can be expected. If co-administration 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 BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3-to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.

Impact Of Other Co-Administered Drugs On Diltiazem Include, But Not Limited To:

Rifampin

Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered.

Cimetidine and Ranitidine

A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and AUC (53%) after a 1-week course of cimetidine at 1200 mg per day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, non-significant increases. The effect may be mediated by cimetidine’s known inhibition of hepatic cytochrome P450, 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.

Clinical Studies

In a randomized, double-blind, parallel-group, dose-response study involving 478 patients with essential hypertension, evening doses of CARDIZEM LA 120, 240, 360, and 540 mg were compared to placebo and to 360 mg administered in the morning. The mean reductions in diastolic blood pressure by ABPM at roughly 24 hours after the morning (4 AM to 8 AM) or evening (6 PM to 10 PM) administration (i.e., the time corresponding to expected trough serum concentrations) are shown in the table below:

Mean Change in Trough Diastolic Pressure by ABPM

Evening Dosing Morning Dosing
120 mg 240 mg 360 mg 540 mg 360 mg
-2.0 -4.4 -4.4 -8.1 -6.4

A second randomized, double-blind, parallel-group, dose-response study (N=258) evaluated CARDIZEM LA following morning doses of placebo or 120, 180, 300, or 540 mg. Diastolic blood pressure measured by supine office cuff sphygmomanometer at trough (7 AM to 9 AM) decreased in an apparently linear manner over the dosage range studied. Group mean changes for placebo, 120 mg, 180 mg, 300 mg and 540 mg were -2.6, -1.9, -5.4, -6.1, and -8.6 mm Hg, respectively.

Whether the time of administration impacts the clinical benefits of antihypertensive treatment is not known.

Postural hypotension is infrequently noted upon suddenly assuming an upright position. No reflex tachycardia is associated with the chronic antihypertensive effects.

The effects of CARDIZEM LA on angina were evaluated in a randomized, double-blind, parallel-group, dose-response trial of 311 patients with chronic stable angina. Evening doses of 180, 360, and 420 mg were compared to placebo and to 360 mg administered in the morning. All doses of CARDIZEM LA administered at night increased exercise tolerance when compared with placebo after 21 hours. The mean effect, placebo-subtracted, was 20 to 28 seconds for all three doses, and no dose-response was demonstrated. CARDIZEM LA, 360 mg, given in the morning, also improved exercise tolerance when measured 25 hours later. As expected, the effect was smaller than the effects measured only 21 hours following nighttime administration. CARDIZEM LA had a larger effect to increase exercise tolerance at peak serum concentrations than at trough.

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