Description
Ivabradine is used to treat adults who have chronic heart failure to reduce their risk of hospitalization for worsening heart failure. It is also used to treat heart failure in children 6 months of age and older who have stable heart failure, with symptoms, caused by an enlarged heart (dilated cardiomyopathy).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Tablet
Before Using
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 ivabradine in children younger than 6 months of age. 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 ivabradine in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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.
- Bepridil
- Boceprevir
- Ceritinib
- Cisapride
- Clarithromycin
- Cobicistat
- Conivaptan
- Darunavir
- Dronedarone
- Fluconazole
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Lefamulin
- Lonafarnib
- Mesoridazine
- Mifepristone
- Nefazodone
- Nelfinavir
- Nirmatrelvir
- Paritaprevir
- Pimozide
- Piperaquine
- Posaconazole
- Ribociclib
- Ritonavir
- Saquinavir
- Sparfloxacin
- Telaprevir
- Telithromycin
- Terfenadine
- Thioridazine
- Troleandomycin
- Tucatinib
- Voriconazole
- Ziprasidone
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.
- Adagrasib
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Azithromycin
- Bedaquiline
- Buprenorphine
- Buserelin
- Carbamazepine
- Chloroquine
- Chlorpromazine
- Citalopram
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desflurane
- Desipramine
- Deslorelin
- Deutetrabenazine
- Dexmedetomidine
- Diltiazem
Other Interactions
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:
- Atrial fibrillation or
- Heart rhythm problems (eg, heart block, sinus arrest)—Use with caution. May make these conditions worse.
- Bradycardia (slow heartbeat) or
- Heart failure, decompensated or
- Heart rhythm problem (eg, AV block, sinoatrial block, sick sinus syndrome), without a pacemaker or
- Hypotension (very low blood pressure) or
- Liver disease, severe or
- Pacemaker dependence—Should not be used in patients with these conditions.
Proper Use
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food.
If you cannot swallow the tablet, you may use the oral liquid. To use:
- Empty the contents of the ampule into a medication cup. Keep the ampule in its unopened foil pouch until you are ready to use it.
- Measure the liquid with a marked oral syringe to get your dose.
- Place the tip of the oral syringe into your or your child’s mouth and towards the cheek. Then slowly push down on the plunger until the oral syringe is empty.
- Do not save or reuse any leftover oral liquid in the cup or oral syringe.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
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 heart failure:
- For oral dosage form (solution):
- Adults—At first, 5 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 7.5 mg 2 times a day.
- Children 6 months of age and older weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, 0.05 milligram per kilogram (mg/kg) of body weight. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 7.5 mg 2 times a day.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults—At first, 5 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 7.5 mg 2 times a day.
- Children weighing 40 kilograms (kg) or more—At first, 2.5 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 7.5 mg 2 times a day.
- Children weighing less than 40 kg—Use and dose must be determined by your doctor.
- For oral dosage form (solution):
Missed Dose
If you miss a dose of this medicine, 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.
Throw away any unused oral liquid.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
Do not use this medicine if you are also using clarithromycin (Biaxin®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nefazodone (Serzone®), nelfinavir (Viracept®), or telithromycin (Ketek®). Using these medicines together may cause serious unwanted effects.
This medicine may increase your risk for heart rhythm problems, including atrial fibrillation and bradycardia. Check with your doctor right away if you have fast, slow, or irregular heartbeat, dizziness, fainting, or trouble breathing while using this medicine.
This medicine may cause temporary visual brightness, usually caused by sudden changes in light (luminous phenomena or phosphenes). This may happen within the first 2 months of treatment with this medicine. Use caution when driving or using machines where sudden changes in light can happen, especially when driving at night.
Do not take other medicines unless thy have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
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
- Blurred vision
- chest pain or discomfort
- fast or irregular heartbeat
- headache
- lightheadedness, dizziness, or fainting
- nervousness
- pounding in the ears
- slow or irregular heartbeat
- unusual tiredness
Incidence not known
- Confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- hives or welts, itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- sweating
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:
Less common
- Seeing flashes of light
Incidence not known
- Double vision
- feeling of constant movement of self or surroundings
- flushing or redness of the skin
- seeing double
- sensation of spinning
- trouble seeing
- unusually warm skin
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.
DRG-20138533
