Pronunciation:

am-LOE-di-peen

Brand Names:

• Katerzia
• Norliqva
• Norvasc

Dosage Forms:

• Solution
• Suspension
• Tablet

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Calcium Channel Blocker

Chemical—

Dihydropyridine

Uses of This Medicine:

Amlodipine is used alone or together with other medicines to treat 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.

Amlodipine is also used to relieve chronic stable angina (chest pain) or vasospastic angina (Prinzmetal's or variant angina). This medicine is also used to lower the risk of hospitalization for angina and heart surgery (eg, coronary revascularization) in patients with recently documented coronary artery disease (CAD) by angiography and without certain heart problems (eg, heart failure or an ejection fraction less than 40%).

Amlodipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. This relaxes the blood vessels and lowers blood pressure, 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 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 amlodipine to lower blood pressure in children younger than 6 years of age or to relieve chest pain in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine 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 this medicine.

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 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.

• Abametapir
• Atazanavir
• Ceritinib
• Clarithromycin
• Clopidogrel
• Conivaptan
• Cyclosporine
• Dantrolene
• Darunavir
• Digoxin
• Domperidone
• Droperidol
• Epirubicin
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Itraconazole
• Lacosamide
• Mavacamten
• Melphalan
• Netupitant
• Omaveloxolone
• Phenobarbital
• Piperaquine
• Primidone
• Rifampin
• Ritonavir
• Simvastatin
• Tacrolimus
• Tegafur
• Telaprevir

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.

• Aprepitant
• Boceprevir
• Ciprofloxacin
• Cobicistat
• Crizotinib
• Diltiazem
• Dronedarone
• Fluconazole
• Fluvoxamine
• Idelalisib
• Indinavir
• Ketoconazole
• Letermovir
• Lopinavir
• Nefazodone
• Nelfinavir
• Nilotinib
• Posaconazole
• Rifapentine
• Saquinavir
• Telithromycin
• Verapamil
• Voriconazole

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:

• Angina (chest pain) or
• Heart attack, acute or
• Heart or blood vessel disease (eg, coronary artery disease) or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Aortic stenosis (heart valve problem), severe or
• Heart or blood vessel disease—Use with caution. May cause side effects to become 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:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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. Therefore, 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, strokes, or kidney disease.

Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.

You may take this medicine with or without food. Take it at the same time each day.

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 forms (solution, suspension, or tablets):
  • For angina (chest pain):
    • Adults—5 to 10 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For high blood pressure:
    • Adults—At first, 5 milligrams (mg) once a day. Some patients may be started on 2.5 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg per day.
    • Children 6 to 17 years of age—2.5 to 5 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 5 mg per day.
    • Children younger than 6 years of age—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.

Do not take this medicine if it has been more than 12 hours since you missed your last dose.

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 or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause worsening of angina (chest pain) or a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, or sweating.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up suddenly from a lying or sitting position. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, call your doctor right away.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

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

If you have been using this medicine regularly for several weeks, do not suddenly stop using it. Stopping suddenly may cause your chest pain or high blood pressure to come back or get worse. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

After taking a dose of this medicine you may get a headache that lasts for a short time. This should become less noticeable after you have taken this medicine for a while. If this effect continues, or if the headaches are severe, check with your doctor.

In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with this medicine is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. 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 tenderness, swelling, or bleeding of your gums.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

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

Swelling of the ankles or feet

Less common

Chest tightness

difficult or labored breathing

dizziness

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

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

Rare

Black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

blurred vision

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

chest pain or discomfort

chills

cold and clammy skin

cold sweats

confusion

cough

dark yellow urine

diarrhea

dilated neck veins

dizziness or lightheadedness when getting up from a lying or sitting position

extra heartbeats

fainting

fever

itching of the skin

joint or muscle pain

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

numbness and tingling of the face, fingers, or toes

pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion

painful or difficult urination

pale, bluish-colored, or cold hands or feet

pinpoint red or purple spots on the skin

red, irritated eyes

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

redness, soreness or itching skin

shakiness in the legs, arms, hands, or feet

slow or irregular heartbeat

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sores, welting, or blisters

sudden sweating

sweating

swelling of the face, fingers, feet, or lower legs

swollen glands

trembling or shaking of the hands or feet

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

weak or absent pulses in the legs

weakness in the arms, hands, legs, or feet

weight gain

yellow eyes or skin

Incidence not known

Clay-colored stools

difficulty with speaking

drooling

headache

loss of appetite

loss of balance control

muscle trembling, jerking, or stiffness

nausea

rash

shuffling walk

stomach pain

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

unpleasant breath odor

vomiting of blood

yellow eyes or skin

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

feeling of warmth

heartburn

indigestion

lack or loss of strength

muscle cramps

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

sleepiness or unusual drowsiness

stomach discomfort, upset, or pain

Rare

Abnormal dreams

anxiety

back pain

bad unusual or unpleasant (after) taste

bleeding gums

blistering, crusting, irritation, itching, or reddening of the skin

bloating

bloody nose

burning feeling in the chest or stomach

burning while urinating

burning, dry, or itching eyes

change in color of the treated skin

change in sense of smell

change in taste

changes in vision

constipation

continuing ringing or buzzing or other unexplained noise in the ears

cracked, dry, or scaly skin

decreased sexual performance or desire

depression

difficulty with moving

difficulty with swallowing

discharge, excessive tearing

double vision

dry mouth

dryness of the skin

excess air or gas in the stomach or intestines

excessive muscle tone

eye pain

feeling of constant movement of self or surroundings

feeling of unreality

feeling unusually cold

flushed, dry skin

fruit-like breath odor

full feeling

general feeling of discomfort or illness

hair loss or thinning of the hair

headache, severe and throbbing

hearing loss

increased appetite

increased hunger

increased sweating

increased thirst

increased urge to urinate during the night

increased urination

irritability

irritation in the mouth

lack of feeling or emotion

loose stools

loss of memory

muscle pains, stiffness, tension, tightness, or weakness

nervousness

pain

pains in the stomach, side, or abdomen, possibly radiating to the back

passing gas

problems with memory

redness and swelling of the gums

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

restlessness

runny nose

seeing double

sensation of spinning

sense of detachment from self or body

shakiness and unsteady walk

shivering

sneezing

stuffy nose

sweating

swollen joints

tenderness in the stomach area

thirst

trouble in holding or releasing urine

trouble sleeping

twitching

uncaring

unexplained weight loss

unsteadiness, trembling, or other problems with muscle control or coordination

waking to urinate at night

weight loss

Incidence not known

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

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.