Description
Isradipine is used alone or together with other medicines (such as hydrochlorothiazide) to treat high blood pressure (hypertension). 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 .
Isradipine 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, isradipine relaxes 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 .
This product is available in the following dosage forms:
- Capsule
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 isradipine in the pediatric population. Safety and efficacy have not been established .
Geriatric
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of isradipine in the elderly. However, elderly patients are more likely to have liver or kidney problems which may require an adjustment of dose in patients receiving isradipine .
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.
- Mefloquine
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.
- Acecainide
- Acetophenazine
- Ajmaline
- Amiodarone
- Amitriptyline
- Amoxapine
- Aprindine
- Arsenic Trioxide
- Astemizole
- Azimilide
- Bretylium
- Carbamazepine
- Ceritinib
- Chloral Hydrate
- Chloroquine
- Chlorpromazine
- Clonidine
- Clopidogrel
- Dantrolene
- Darunavir
- Desipramine
- Dibenzepin
- Digoxin
- Disopyramide
- Dofetilide
- Dolasetron
- Doxepin
- Dronedarone
- Droperidol
- Encainide
- Enflurane
- Epirubicin
- Erythromycin
- Ethopropazine
- Flecainide
- Fluconazole
- Fluoxetine
- Fluphenazine
- Foscarnet
- Gemifloxacin
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.
- Amprenavir
- Dalfopristin
- Indinavir
- Magnesium
- Quinupristin
- Rifampin
- Rifapentine
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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 or
- Congestive heart failure—Use with caution. May make these conditions worse .
- Kidney disease or
- Liver disease—Use with caution. The effects of isradipine may be increased because of the slower removal of the medicine from the body .
Proper Use
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. 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 whole with a full glass of water. Do not break, crush, or chew it .
If you are taking the extended-release tablets, part of the tablet may pass into your stools after your body has absorbed the medicine. This is normal and is nothing to worry about .
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 high blood pressure:
- For oral dosage form (capsules):
- Adults—At first, 2.5 milligrams (mg) twice a day. Your doctor may increase your dose if needed.
- Children—Use and dose must be determined by your doctor .
- For oral dosage form (extended-release tablets):
- Adults—At first, 5 milligrams (mg) once a day. Your doctor may increase your dose if needed.
- Children—Use and dose must be determined by your doctor .
- For oral dosage form (capsules):
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
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .
Low blood pressure (hypotension) 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 .
This medicine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of face, arms, hands, lower legs, or feet; tingling of hands or feet; or unusual weight gain or loss .
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
- Bloating or swelling of face, arms, hands, lower legs, or feet
- tingling of hands or feet
- unusual weight gain or loss
Less common
- Chest pain
- difficult or labored breathing
- dizziness
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- full or bloated feeling
- nausea
- pressure in the stomach
- redness of the face, neck, arms and occasionally, upper chest
- shortness of breath
- swelling of abdominal or stomach area
- tightness in chest
- unusual tiredness or weakness
- vomiting
- wheezing
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of Overdose
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- flushing
- 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:
More common
- Headache
Less common
- Diarrhea
- difficulty having a bowel movement (stool)
- rash
- stomach soreness or discomfort
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.
CON-XXXXXXXX
