Dilacor XR (Oral)

Diltiazem is used by itself or with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). High blood pressure puts extra strain on the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure may also raise the risk of heart attacks. Controlling blood pressure may help reduce the chances of these problems.

Diltiazem is a calcium channel blocker. It works by influencing how calcium moves into the cells of the heart and blood vessels. This relaxes the blood vessels, lowers blood pressure, and increases the amount of blood and oxygen that reach the heart while reducing its workload.

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

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

Dizziness, lightheadedness, or fainting may happen, especially when you get up suddenly from lying down or sitting. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to help prevent the dizziness from coming back. If you faint, call your doctor right away.

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 signs of a serious liver problem.

Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks compared to the benefits. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There are no suitable studies on how age affects the use of diltiazem in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems for older adults that would limit the use of diltiazem. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and possible dose adjustments for patients taking diltiazem.

Breast Feeding

Research in women indicates that this medication poses minimal risk to infants when used while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if an interaction could occur. In such cases, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is crucial that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are selected based on their potential significance and are not 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 adjust some of the other medicines you take.

• Cisapride
• Eliglustat
• Flibanserin
• Lomitapide

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the medicines.

• Abametapir
• Acalabrutinib
• Acebutolol
• Alfentanil
• Alprazolam
• Amiodarone
• Apixaban
• Aprepitant
• Atazanavir
• Atenolol
• Atorvastatin
• Avapritinib
• Benzhydrocodone
• Betaxolol
• Bisoprolol
• Bosutinib
• Brexpiprazole
• Brigatinib
• Buprenorphine
• Carbamazepine
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Cilostazol
• Clarithromycin
• Clonidine
• Clopidogrel
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Colchicine
• Conivaptan
• Crizotinib
• Cyclosporine
• Dantrolene
• Daridorexant
• Darunavir
• Deflazacort
• Digoxin
• Dihydrocodeine
• Domperidone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Droperidol
• Elacestrant
• Elexacaftor
• Encorafenib
• Entrectinib
• Epirubicin
• Eplerenone
• Erythromycin
• Esmolol
• Everolimus
• Fedratinib
• Fentanyl
• Fexinidazole
• Finerenone
• Fingolimod
• Fosaprepitant
• Fosnetupitant
• Gepirone
• Hydrocodone
• Ibrutinib
• Ifosfamide
• Infigratinib
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Labetalol
• Lacosamide
• Larotrectinib
• Lemborexant
• Levobunolol
• Lovastatin
• Lumateperone
• Lurasidone
• Lurbinectedin
• Mavacamten
• Melphalan
• Meperidine
• Methadone
• Metipranolol
• Metoprolol
• Mitapivat
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Nadolol
• Naloxegol
• Nebivolol
• Netupitant
• Nilotinib
• Olaparib
• Omaveloxolone
• Oxprenolol
• Oxycodone
• Pacritinib
• Palovarotene
• Pemigatinib
• Penbutolol
• Pentazocine
• Pexidartinib
• Phenobarbital
• Pindolol
• Piperaquine
• Pixantrone
• Ponesimod
• Pralsetinib
• Primidone
• Propranolol
• Ranolazine
• Rimegepant
• Rivaroxaban
• Selpercatinib
• Selumetinib
• Simeprevir
• Simvastatin
• Siponimod
• Sirolimus Protein-Bound
• Sonidegib
• Sotalol
• Sparsentan
• St John's Wort
• Sufentanil
• Tacrolimus
• Tazemetostat
• Tezacaftor
• Timolol
• Tolvaptan
• Tramadol
• Ubrogepant
• Venetoclax
• Venlafaxine
• Voclosporin
• Zanubrutinib
• Zolpidem

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or frequency for one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are selected based on their potential significance and are not all-inclusive.

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical problems, especially:

• Severe bowel blockage
• Congestive heart failure—Use with caution. It may worsen these conditions.

• Heart attack or
• Heart block (a type of abnormal heart rhythm; it can be used if you have a working pacemaker) or
• Severe hypotension (low blood pressure) or
• Lung problems (e.g., pulmonary congestion) or
• Sick sinus syndrome (a type of abnormal heart rhythm; it can be used if you have a working pacemaker)—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Check with your doctor right away 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, discomfort, or tightness
• 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
• 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 happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to help prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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

• 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.

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

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.

You may swallow whole, crush, or chew the 30 milligrams (mg), 60 mg, 90 mg, or 120 mg tablet. Do not split the 30 mg tablet.

Swallow the extended-release tablet or extended-release capsule 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 as 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 as needed. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—At first, 30 milligrams (mg) 4 times a day before meals and at bedtime. Your doctor may adjust your dose as 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 as 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 as 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.