Description
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.
This product is available in the following dosage forms:
- Solution
- 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
- Avacopan
- Carbamazepine
- Ceritinib
- Clarithromycin
- Clonidine
- Clopidogrel
- Conivaptan
- Cyclosporine
- Dantrolene
- Darunavir
- Digoxin
- Domperidone
- Droperidol
- Epirubicin
- Erythromycin
- Fedratinib
- Fexinidazole
- Fosnetupitant
- Itraconazole
- Lacosamide
- Mavacamten
- Melphalan
- Netupitant
- Omaveloxolone
- Phenobarbital
- Piperaquine
- Ponesimod
- Primidone
- Rifampin
- Ritonavir
- Simvastatin
- Tacrolimus
- Tazemetostat
- Tegafur
- Telaprevir
- Warfarin
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
- Aprepitant
- Boceprevir
- Cimetidine
- Ciprofloxacin
- Clofazimine
- Cobicistat
- Crizotinib
- Diltiazem
- Dronedarone
- Duvelisib
- Fluconazole
- Fluvoxamine
- Fosamprenavir
- Idelalisib
- Indinavir
- Ketoconazole
- Letermovir
- Lonafarnib
- Mifepristone
- Nefazodone
- Nelfinavir
- Nilotinib
- Posaconazole
- Ribociclib
- Rifapentine
- Saquinavir
- Schisandra sphenanthera
- Telithromycin
- Troleandomycin
- Tucatinib
- Verapamil
- Voriconazole
- Voxelotor
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.
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.
- For angina (chest pain):
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 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
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.
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