AMLODIPINE BESYLATE TABLETS
Read this information carefully before you start taking
amlodipine besylate tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about
amlodipine besylate tablets, ask your doctor. Your doctor will know if
amlodipine besylate tablets are right for you.
What are amlodipine besylate tablets?
Amlodipine besylate tablets are a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions.
High Blood Pressure (hypertension)
High blood pressure comes from blood pushing too hard against your blood vessels.
Amlodipinebesylate tablets relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.
Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back.
Amlodipine besylate tablets can relieve this pain.
Who should not use amlodipine besylate tablets?
Do not use
amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in
amlodipine besylate tablets), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients.
What should I tell my doctor before taking amlodipine besylate tablets?
Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. Tell your doctor if you:
- ever had heart disease
- ever had liver problems
- are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.
- are breast-feeding. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.
How should I take amlodipine besylate tablets?
- Take amlodipine besylate tablets once a day, with or without food.
- It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine besylate tablets at a time.
- If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time.
- Other medicines: You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don’t stop taking it while you are taking amlodipine besylate tablets.
- While you are taking amlodipine besylate tablets, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor.
- If you took too much amlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.
What should I avoid while taking amlodipine besylate tablets?
- Do not breast-feed. It is not known if amlodipine besylate will pass through your milk.
- Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.
What are the possible side effects of amlodipine besylate tablets?
Amlodipine besylate tablets may cause the following side effects. Most side effects are mild or moderate:
- swelling of your legs or ankles
- tiredness, extreme sleepiness
- stomach pain, nausea
- dizziness
- flushing (hot or warm feeling in your face)
- arrhythmia (irregular heartbeat)
- heart palpitations (very fast heartbeat)
It is rare, but when you first start taking
amlodipine besylate tablets or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room.
Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of
amlodipine besylate tablets. For a complete list, ask your doctor or pharmacist.
How do I store amlodipine besylate tablets?
Keep
amlodipine besylate tablets away from children. Store
amlodipine besylate tablets at room temperature (between 59° and 86° F). Keep
amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep
amlodipine besylate tablets in a dry place.
General advice about amlodipine besylate tablets
Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use
amlodipine besylate tablets the way your doctor told you to. Do not give
amlodipine besylate tablets to other people, even if they have the same symptoms you have. It may harm them.
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INDICATIONS AND USAGE
Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
- Hypertension
- Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- Coronary Artery Disease
- Chronic Stable Angina
- Vasospastic Angina (Prinzmetal’s or Variant Angina)
- Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%
DOSAGE AND ADMINISTRATION
- Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily.
- Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily.
- Pediatric starting dose: 2.5 mg to 5 mg once daily.
Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients.
DOSAGE FORMS AND STRENGTHS
- 2.5 mg, 5 mg, and 10 mg Tablets
CONTRAINDICATIONS
- Known sensitivity to amlodipine
WARNINGS AND PRECAUTIONS
- Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely.
- Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate, particularly in patients with severe obstructive coronary artery disease.
- Titrate slowly in patients with severe hepatic impairment.
ADVERSE REACTIONS
Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence > 1% are fatigue, nausea, abdominal pain, and somnolence.
To report SUSPECTED ADVERSE REACTIONS, contact Ranbaxy Pharmaceuticals Inc. at 1-888-RANBAXY (726-2299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
- Do not exceed doses greater than 20 mg daily of simvastatin.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Use only if the potential benefit justifies the risk.
- Nursing: Discontinue when administering amlodipine besylate.
- Pediatric: Effect on patients less than 6 years old is not known.
- Geriatric: Start dosing at the low end of the dose range.