What is amlodipine?

am-LOE-di-peen

Commonly used brand name(s)

In the U.S.

Norvasc

Available Dosage Forms:

Tablet
Tablet, Disintegrating

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Dihydropyridine

Uses For amlodipine

Amlodipine is used alone or together with other medicines to treat angina (chest pain) and 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.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

amlodipine is available only with your doctor's prescription.

Before Using amlodipine

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 amlodipine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amlodipine 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 amlodipine to treat high blood pressure in children younger than 6 years 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 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 amlodipine.

Pregnancy

Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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 amlodipine, 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 amlodipine 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.

Amiodarone
Atazanavir
Carbamazepine
Ceritinib
Clarithromycin
Clopidogrel
Conivaptan
Dabrafenib
Dantrolene
Dasabuvir
Domperidone
Droperidol
Eliglustat
Eslicarbazepine Acetate
Fentanyl
Idelalisib
Lacosamide
Mitotane
Nilotinib
Ombitasvir
Paritaprevir
Piperaquine
Primidone
Ritonavir
Siltuximab
Simvastatin
St John's Wort
Tacrolimus
Tegafur
Telaprevir

Using amlodipine 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.

Acebutolol
Aceclofenac
Acemetacin
Alprenolol
Amtolmetin Guacil
Aspirin
Atenolol
Avanafil
Betaxolol
Bevantolol
Bisoprolol
Bromfenac
Bucindolol
Bufexamac
Carteolol
Carvedilol
Celecoxib
Celiprolol
Choline Salicylate
Clonixin
Dalfopristin
Dexibuprofen
Dexketoprofen
Diclofenac
Diflunisal
Dilevalol
Diltiazem
Dipyrone
Esmolol
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Floctafenine
Fluconazole
Flufenamic Acid
Flurbiprofen
Ibuprofen
Ibuprofen Lysine
Indinavir
Indomethacin
Itraconazole
Ketoconazole
Ketoprofen
Ketorolac
Labetalol
Levobunolol
Lornoxicam
Loxoprofen
Lumiracoxib
Meclofenamate
Mefenamic Acid
Meloxicam
Mepindolol
Metipranolol
Metoprolol
Morniflumate
Nabumetone
Nadolol
Naproxen
Nebivolol
Nepafenac
Niflumic Acid
Nimesulide
Oxaprozin
Oxprenolol
Oxyphenbutazone
Parecoxib
Penbutolol
Phenylbutazone
Piketoprofen
Pindolol
Piroxicam
Pranoprofen
Proglumetacin
Propranolol
Propyphenazone
Proquazone
Quinupristin
Rifapentine
Rofecoxib
Salicylic Acid
Salsalate
Sodium Salicylate
Sotalol
Sulindac
Talinolol
Tenoxicam
Tertatolol
Tiaprofenic Acid
Timolol
Tolfenamic Acid
Tolmetin
Valdecoxib

Interactions with Food/Tobacco/Alcohol

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.

Proper Use of amlodipine

Take amlodipine exactly as directed even if you feel well and do not notice any chest pain. 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. Do not miss any doses.

For patients taking amlodipine for high blood pressure:

In addition to the use of the medicine, treatment for your high blood pressure may include weight control and a change in the types of food 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 amlodipine 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 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 take amlodipine with or without food.

Take amlodipine at the same time each day.

Dosing

The dose of amlodipine 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 amlodipine. 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 (tablets):
- For angina (chest pain):
  - Adults—5 to 10 milligrams (mg) once a day.
  - Children—Use and dose must be determined by your doctor.
- For high blood pressure:
  - Adults—At first, 2.5 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg once a day.
  - Children 6 to 17 years of age—2.5 to 5 mg once a 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 amlodipine, 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 amlodipine 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 amlodipine

It is very important that your doctor check your progress at regular visits to make sure amlodipine is working properly. Blood tests may be needed to check for unwanted effects. a

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.

If you have been using amlodipine 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.

Chest pain resulting from exercise or physical exertion is usually reduced or prevented by amlodipine. This may tempt you to be too active. Make sure you discuss with your doctor a safe amount of exercise for your medical problem.

After taking a dose of amlodipine you may get a headache that lasts for a short time. This should become less noticeable after you have taken amlodipine 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 amlodipine 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 over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

amlodipine 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

Swelling of the ankles or feet

Less common

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
shortness of breath
tightness in the chest
wheezing

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
dark yellow urine
cough
diarrhea
dilated neck veins
dizziness or lightheadedness when getting up from a lying or sitting position
extra heartbeats
extreme fatigue
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

Abdominal or stomach pain
clay-colored stools
diarrhea
headache
loss of appetite
nausea
rash
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
heartburn
indigestion
lack or loss of strength
muscle cramps
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
hyperventilation
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 or stiffness
muscle tension or tightness
muscle 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
sleeplessness
sneezing
stuffy nose
sweating
swollen joints
tenderness in the stomach area
thirst
trouble in holding or releasing urine
trouble sleeping
twitching
unable to sleep
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.

How to use amlodipine?

Usual Adult Dose for Hypertension

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day

Small or fragile patients may be started on 2.5 mg orally once a day.

Usual Adult Dose for Angina Pectoris

Chronic stable or vasospastic angina, or angiographically documented coronary artery disease in patients without heart failure or an ejection fraction less than 40%: 5 to 10 mg orally once a day

Most patients with chronic stable or vasospastic angina require 10 mg for adequate effect. In clinical studies, most patients with coronary artery disease required 10 mg.

Usual Adult Dose for Coronary Artery Disease

Usual Geriatric Dose for Hypertension

Initial dose: 2.5 mg orally once a day
Maintenance dose: 2.5 to 10 mg orally once a day

Usual Geriatric Dose for Angina Pectoris

Chronic stable or vasospastic angina: 5 to 10 mg orally once a day
The lower dose is recommended in the elderly; however, most patients require 10 mg for adequate effect.

Usual Pediatric Dose for Hypertension

6 to 17 years: 2.5 mg to 5 mg orally once a day
Doses in excess of 5 mg daily have not been studied in pediatric patients.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Hypertension: Patients with hepatic insufficiency may be started on 2.5 mg orally once a day.

Chronic stable or vasospastic angina: 5 to 10 mg orally once a day
The lower dose is recommended in patients with hepatic insufficiency; however, most patients require 10 mg for adequate effect.

Slow titration is recommended when administering amlodipine to patients with severe hepatic dysfunction.

Dose Adjustments

Dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

Precautions

Worsening angina and acute myocardial infarction can develop after initiating or increasing the dosage of amlodipine, especially in patients with severe obstructive coronary artery disease.

Caution is recommended in patients with aortic stenosis, heart failure, and/or hepatic dysfunction.

Monitoring for symptoms of hypotension and edema is recommended when amlodipine is coadministered with CYP450 3A4 inhibitors. Blood pressure should be closely monitored when amlodipine is coadministered with CYP450 3A4 inducers.

Safety and effectiveness have not been established in pediatric patients less than 6 years of age.

Dialysis

Amlodipine is only slightly removed by hemodialysis, if at all, since it is highly protein bound.

Other Comments

When amlodipine is added to other antihypertensive therapy, a 2.5 mg starting dose is often used.

Amlodipine may be administered with or without food.

What are the side effects of amlodipine?

Norvasc Side Effects

Common Side Effects of Norvasc

The most common side effect of Norvasc is edema, or swelling of the hands, feet, ankles, or lower legs. You are more likely to experience edema with higher doses of Norvasc. Other common side effects of Norvascinclude:

Headache
Abdominal pain
Nausea
Dizziness
Drowsiness and fatigue
Flushing (feeling of warmth)

Severe Side Effects of Norvasc

Taking Norvasc can result in several serious side effects. Seek medical help immediately if you experience:

More frequent or severe chest pain
Palpitations (rapid, strong, or irregular heartbeats)
Fainting

Rare Side Effects of Norvasc

In clinical trials, Norvasc has been associated with numerous rare side effects, which affect less than one percent of people. These include, but are not limited to:

Muscle cramps
Diarrhea, vomiting, and weight changes
Abnormal vision
Depression and anxiety
Itchiness and rashes
Difficulty breathing

Contact your doctor if you experience any severe side effects.