Amlodipine Besylate (Page 5 of 5)
16. HOW SUPPLIED/STORAGE AND HANDLING
2.5 mg Tablets
Amlodipine besylate-2.5 mg Tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one side and 237 on the other and supplied as follows:
NDC 31722-237-90 Bottle of 90
NDC 31722-237-10 Bottle of 1000
5 mg Tablets
Amlodipine besylate-5 mg Tablets (amlodipine besylate, USP equivalent to 5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one side and 238 on the other and supplied as follows:
NDC 31722-238-90 Bottle of 90
NDC 31722-238-10 Bottle of 1000
10 mg Tablets
Amlodipine besylate-10 mg Tablets (amlodipine besylate, USP equivalent to 10 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one side and 239 on the other and supplied as follows:
NDC 31722-239-90 Bottle of 90
NDC 31722-239-10 Bottle of 1000
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Rev: 10/15
SUMMARY OF INFORMATION ABOUT AMLODIPINE BESYLATE TABLETS, USP
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. Amlodipine besylate 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
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), 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 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 many 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 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:
- headache
- 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. 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 (store between 20° to 25°C (68° to 77°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.
You can ask your pharmacist or doctor for information about amlodipine besylate tablets, or you can visit Camber Pharmaceuticals website at www.camberpharma.com or call 1-866-495-8330.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
Manufactured by:
InvaGen Pharmaceuticals, Inc.
Hauppauge, NY 11788
Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
Rev: 10/15
Barcode: 239-10-2015
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Amlodipine Besylate Tablets, USP 5mg
NDC: 10544-113-30
Amlodipine Besylate Tablets, USP 10mg
NDC: 10544-112-30
| AMLODIPINE BESYLATE amlodipine besylate tablet | ||||||||||||||||||
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| AMLODIPINE BESYLATE amlodipine besylate tablet | ||||||||||||||||||
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| Labeler — Blenheim Pharmacal, Inc. (171434587) |
| Registrant — Blenheim Pharmacal, Inc. (171434587) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Blenheim Pharmcal, Inc, | 171434587 | repack (10544-113), repack (10544-112) | |
Revised: 10/2015 Blenheim Pharmacal, Inc.
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