Pronunciation:

fe-LOE-di-peen

Brand Names:

• Plendil

Dosage Forms:

• Tablet, Extended Release

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Calcium Channel Blocker

Chemical—

Dihydropyridine

Uses of This Medicine:

Felodipine is used alone or together with other medicines 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.

Felodipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. Felodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart, which reduces the workload.

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

Before Using This Medicine:

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.

Children—

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

Older adults—

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

Breast-feeding—

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.

Other 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.

• Itraconazole
• Ketoconazole
• Levoketoconazole

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
• Atazanavir
• Carbamazepine
• Ceritinib
• Clarithromycin
• Clopidogrel
• Cobicistat
• Conivaptan
• Cyclosporine
• Dabrafenib
• Dantrolene
• Darunavir
• Digoxin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Duvelisib
• Epirubicin
• Erythromycin
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Idelalisib
• Ivosidenib
• Lacosamide
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Melphalan
• Mibefradil
• Morphine
• Morphine Sulfate Liposome
• Netupitant
• Nilotinib
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Phenobarbital
• Pirtobrutinib
• Pixantrone
• Primidone
• Repotrectinib
• Ritlecitinib
• St John's Wort
• Tacrolimus
• Trofinetide

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
• Nelfinavir
• Oxcarbazepine
• Quinupristin
• 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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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:

• Heart failure—Use with caution. May make this condition worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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 might 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. Do not crush, break, or chew it.

You may take this medicine without food or with a light meal.

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 oral dosage form (extended-release tablets):
  • For high blood pressure:
    • Adults—At first, 5 milligrams (mg) once a day. 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 This Medicine:

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 the face, arms, hands, lower legs, or feet; tingling of the hands or feet; or unusual weight gain or weight loss.

Redness, swelling, or bleeding of the gums may occur while taking this medicine. Brushing and flossing your teeth carefully and regularly, and massaging your gums may help prevent this. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any redness, swelling, or bleeding of your gums.

Side Effects of This Medicine:

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

rapid weight gain

tingling of hands or feet

unusual weight gain or loss

Less common

Body aches or pain

chills

cough

difficulty in breathing

ear congestion

fever

headache

loss of voice

nasal congestion

runny nose

sneezing

sore throat

unusual tiredness or weakness

Incidence not known

Blurred vision

chest pain, tightness, or heaviness

confusion

congestion

cough producing mucus

diarrhea

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

fast, slow, or irregular heartbeat

general feeling of discomfort or illness

hoarseness

joint pain

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

muscle aches and pains

nausea

pain or discomfort in arms, jaw, back, or neck

pale skin

shivering

shortness of breath

sweating

swelling or puffiness of face

tender or swollen glands in neck

trouble in swallowing

trouble sleeping

troubled breathing with exertion

unusual bleeding or bruising

voice changes

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Feeling of warmth

redness of the face, neck, arms and occasionally, upper chest

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

Acid or sour stomach

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

constipation

heartburn

indigestion

lack or loss of strength

skin rash

stomach discomfort, upset, or pain

Rare

Bleeding gums

irritation in mouth

redness and swelling of gums

Incidence not known

Bloated or full feeling

bloody nose

burning while urinating

decreased interest in sexual intercourse

difficult or painful urination

difficulty in moving

discouragement

disturbed color perception

double vision

dry mouth

excess air or gas in stomach or intestines

feeling sad or empty

fear or nervousness

frequent strong or increased urge to urinate

halos around lights

hives or welts

inability to have or keep an erection

increased need to urinate

increased volume of pale or dilute urine

irritability

itching

loss in sexual ability, desire, drive, or performance

loss of interest or pleasure

muscle cramps or stiffness

night blindness

overbright appearance of lights

pain or tenderness around eyes and cheekbones

passing gas

passing urine more often

redness of skin

sleepiness or unusual drowsiness

sleeplessness

sores, welting, or blisters

swelling of the breasts or breast soreness in both females and males

swollen joints

tiredness

trouble concentrating

tunnel vision

unable to sleep

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.