AMLODIPINE BESYLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)

Available from:

New Horizon Rx Group, LLC

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%. Amlodipine besylate tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Chronic Stable Angina Amlodipine besylate tablets, USP are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets, USP may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina) Amlodipine besylate tablets, USP are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets, USP may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets, USP are indicated to reduce the risk of hospitalization due t

Product summary:

Amlodipine Besylate Tablets, USP 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat, beveled edged tablets debossed “IP 6” on obverse and plain on reverse. Amlodipine Besylate Tablets, USP 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are supplied as white, round, flat, beveled edged tablets debossed “IP 7” on obverse and plain on reverse Amlodipine Besylate Tablets, USP, 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white, round, flat, beveled edged tablets debossed “IP 8” on obverse and plain on reverse. NDC 58517-120-30 bottles of 30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP. Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Manufactured For: New Horizon Rx Group, LLC Kenner, LA 70062 Rev. 11/13 PATIENT PACKAGE INSERT SUMMARY OF INFORMATION ABOUT AMLODIPINE BESYLATE TABLETS Read this information carefully before you start taking amlodipine besylate 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, ask your doctor. Your doctor will know if amlodipine besylate is right for you. What is amlodipine besylate? Amlodipine besylate is 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 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 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? Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. Tell your doctor if you: How should I take amlodipine besylate? What should I avoid while taking amlodipine besylate? What are the possible side effects of amlodipine besylate? Amlodipine besylate may cause the following side effects. Most side effects are mild or moderate: It is rare, but when you first start taking amlodipine besylate 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 (between 59° to 86°F). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate in a dry place. General advice about amlodipine besylate Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine besylate the way your doctor told you to. Do not give amlodipine besylate 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 the Amneal website at www.amneal.com or call 1-877-835-5472. 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: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Manufactured For: New Horizon Rx Group, LLC Kenner, LA 70062 Rev. 11/13

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE TABLET
NEW HORIZON RX GROUP, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE BESYLATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE BESYLATE.
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Amlodipine besylate tablets, USP is a calcium channel blocker and may
be used alone or in combination with other
antihypertensive and antianginal agents for the treatment of:
Hypertension (1.1)
Coronary Artery Disease (1.2)
Chronic Stable Angina
Vasospastic Angina (Prinzmetal’s or Variant Angina)
DOSAGE AND ADMINISTRATION
Adult recommended starting dose: 5 mg once daily with maximum dose 10
mg once daily. (2.1)
Small, fragile, or elderly patients, or patients with hepatic
insufficiency may be started on 2.5 mg once daily. (2.1)
Pediatric starting dose: 2.5 mg to 5 mg once daily. (2.2)
IMPORTANT LIMITATION: Doses in excess of 5 mg daily have not been
studied in pediatric patients. (2.2)
DOSAGE FORMS AND STRENGTHS
2.5 mg, 5 mg, and10 mg Tablets (3)
CONTRAINDICATIONS
Known sensitivity to amlodipine (4)
WARNINGS AND PRECAUTIONS
Symptomatic hypotension is possible, particularly in patients with
severe aortic stenosis. However, because of the
gradual onset of action, acute hypotension is unlikely. (5.1)
Worsening angina and acute myocardial infarction can develop after
starting or increasing the dose of amlodipine
besylate tablets, particularly in patients with severe obstructive
coronary artery disease. (5.2)
Titrate slowly when administering calcium channel blockers to patients
with severe hepatic impairment. (5.4)
ADVERSE REACTIONS
Most common adverse reactions are headache and edema which occurred in
a dose related manner. Other adverse
experiences not dose related but reported with an incidence >1% are
headache, fatigue, nausea, abdominal pain, and
somnolence. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMNE