Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Norvasc

Descriptions


Amlodipine is used alone or together with other medicines to lower hypertension (high blood pressure) in adults and children. 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. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Amlodipine is also used to relieve chronic stable angina (chest pain) in adults.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. This relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.

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

This product is available in the following dosage forms:

  • Suspension
  • 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 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.

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 this medicine.

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 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
  • Digoxin
  • Domperidone
  • Droperidol
  • Epirubicin
  • Fosnetupitant
  • Lacosamide
  • Netupitant
  • Piperaquine
  • 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.

  • Indinavir
  • 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:

  • 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

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.

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.

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 (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

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 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

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

  1. Swelling of the ankles or feet

Less common

  1. Difficult or labored breathing
  2. dizziness
  3. fast, irregular, pounding, or racing heartbeat or pulse
  4. feeling of warmth
  5. redness of the face, neck, arms, and occasionally, upper chest
  6. tightness in the chest

Rare

  1. Black, tarry stools
  2. bleeding gums
  3. blistering, peeling, or loosening of the skin
  4. blood in the urine or stools
  5. blurred vision
  6. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  7. chest pain or discomfort
  8. chills
  9. cold and clammy skin
  10. cold sweats
  11. confusion
  12. cough
  13. dark yellow urine
  14. diarrhea
  15. dilated neck veins
  16. dizziness or lightheadedness when getting up from a lying or sitting position
  17. extra heartbeats
  18. extreme fatigue
  19. fainting
  20. fever
  21. itching of the skin
  22. joint or muscle pain
  23. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  24. numbness and tingling of the face, fingers, or toes
  25. pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
  26. painful or difficult urination
  27. pale, bluish-colored, or cold hands or feet
  28. pinpoint red or purple spots on the skin
  29. red, irritated eyes
  30. redness of the face, neck, arms, and occasionally, upper chest
  31. redness, soreness or itching skin
  32. shakiness in the legs, arms, hands, or feet
  33. slow or irregular heartbeat
  34. sore throat
  35. sores, ulcers, or white spots on the lips or in the mouth
  36. sores, welting, or blisters
  37. sudden sweating
  38. sweating
  39. swelling of the face, fingers, feet, or lower legs
  40. swollen glands
  41. trembling or shaking of the hands or feet
  42. unsteadiness or awkwardness
  43. unusual bleeding or bruising
  44. unusual tiredness or weakness
  45. weak or absent pulses in the legs
  46. weakness in the arms, hands, legs, or feet
  47. weight gain
  48. yellow eyes or skin

Incidence not known

  1. Abdominal or stomach pain
  2. clay-colored stools
  3. difficulty with speaking
  4. drooling
  5. headache
  6. loss of appetite
  7. loss of balance control
  8. muscle trembling, jerking, or stiffness
  9. nausea
  10. rash
  11. shuffling walk
  12. twisting movements of the body
  13. uncontrolled movements, especially of the face, neck, and back
  14. unpleasant breath odor
  15. vomiting of blood
  16. 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

  1. Acid or sour stomach
  2. belching
  3. feeling of warmth
  4. heartburn
  5. indigestion
  6. lack or loss of strength
  7. muscle cramps
  8. redness of the face, neck, arms, and occasionally, upper chest
  9. sleepiness or unusual drowsiness
  10. stomach discomfort, upset, or pain

Rare

  1. Abnormal dreams
  2. anxiety
  3. back pain
  4. bad unusual or unpleasant (after) taste
  5. bleeding gums
  6. blistering, crusting, irritation, itching, or reddening of the skin
  7. bloating
  8. bloody nose
  9. burning feeling in the chest or stomach
  10. burning while urinating
  11. burning, dry, or itching eyes
  12. change in color of the treated skin
  13. change in sense of smell
  14. change in taste
  15. changes in vision
  16. constipation
  17. continuing ringing or buzzing or other unexplained noise in the ears
  18. cracked, dry, or scaly skin
  19. decreased sexual performance or desire
  20. depression
  21. difficulty with moving
  22. difficulty with swallowing
  23. discharge, excessive tearing
  24. double vision
  25. dry mouth
  26. dryness of the skin
  27. excess air or gas in the stomach or intestines
  28. excessive muscle tone
  29. eye pain
  30. feeling of constant movement of self or surroundings
  31. feeling of unreality
  32. feeling unusually cold
  33. flushed, dry skin
  34. fruit-like breath odor
  35. full feeling
  36. general feeling of discomfort or illness
  37. hair loss or thinning of the hair
  38. headache, severe and throbbing
  39. hearing loss
  40. increased appetite
  41. increased hunger
  42. increased sweating
  43. increased thirst
  44. increased urge to urinate during the night
  45. increased urination
  46. irritability
  47. irritation in the mouth
  48. lack of feeling or emotion
  49. loose stools
  50. loss of memory
  51. muscle pains or stiffness
  52. muscle tension or tightness
  53. muscle weakness
  54. nervousness
  55. pain
  56. pains in the stomach, side, or abdomen, possibly radiating to the back
  57. passing gas
  58. problems with memory
  59. redness and swelling of the gums
  60. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  61. restlessness
  62. runny nose
  63. seeing double
  64. sensation of spinning
  65. sense of detachment from self or body
  66. shakiness and unsteady walk
  67. shivering
  68. sneezing
  69. stuffy nose
  70. sweating
  71. swollen joints
  72. tenderness in the stomach area
  73. thirst
  74. trouble in holding or releasing urine
  75. trouble sleeping
  76. twitching
  77. uncaring
  78. unexplained weight loss
  79. unsteadiness, trembling, or other problems with muscle control or coordination
  80. waking to urinate at night
  81. weight loss

Incidence not known

  1. 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.