AMLODIPINE BESYLATE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Hikma Pharmaceuticals USA Inc.

INN (Jina la Kimataifa):

AMLODIPINE BESYLATE

Tungo:

AMLODIPINE 2.5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic

Bidhaa muhtasari:

2.5 mg Tablets Amlodipine besylate tablets, USP – 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are white, diamond, shaped tablets engraved with "W59" on one side and supplied as follows: Bottles of 30 with Child-resistance closure, NDC 0143-9959-30 Bottles of 90 with Child-resistance closure, NDC 0143-9959-09 Bottles of 100 with Child-resistance closure, NDC 0143-9959-01 5 mg Tablets Amlodipine besylate tablets, USP – 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white, octagon shaped tablets engraved with "W60" on one side and supplied as follows: Bottles of 30 with Child-resistance closure, NDC 0143-9960-30 Bottles of 90 with Child-resistance closure, NDC 0143-9960-09 Bottles of 100 with Child-resistance closure, NDC 0143-9960-01 10 mg Tablets Amlodipine besylate tablets, USP – 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white, round tablets engraved with "W61" on one side and supplied as follows: Bottles of 30 with Child-resistance closure, NDC 0143-9961-30 Bottles of 90 with Child-resistance closure, NDC 0143-9961-90 Bottles of 100 with Child-resistance closure, NDC 0143-9961-01 Storage This package is child-resistant. Store bottles at 20° to 25°C (68° to 77°F) [ See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. . Distributed by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 USA Manufactured by: HIKMA Pharmaceuticals LLC P.O. Box 182400 Amman 11118 Jordan Revised November 2019

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
West-Ward Pharmaceuticals Corp
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Medication Guide
Amlodipine Besylate Tablets, USP
Read this information carefully before you start taking Amlodipine
Besylate Tablets, USP 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, USP ask your doctor.
Your doctor will know if Amlodipine Besylate Tablets, USP is right for
you.
What are Amlodipine Besylate Tablets, USP?
Amlodipine Besylate Tablets, USP 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, USP 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,
USP can relieve this pain.
Who should not use Amlodipine Besylate Tablets, USP?
Do not use Amlodipine Besylate Tablets, USP if you are allergic to
amlodipine (the active ingredient in
Amlodipine Besylate Tablets, USP), 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, USP?
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

Tabia za bidhaa

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
HIKMA PHARMACEUTICALS USA INC.
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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 TABLETS, USP
INITIAL U.S. APPROVAL: 1987
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 (1.1)
o 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 (1.2)
o Chronic Stable Angina
o Vasospastic Angina (Prinzmetal’s or Variant Angina)
o 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. (2.1)
o 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
• Tablets: 2.5 mg, 5 mg, and 10 mg (3)
CONTRAINDICATIONS
Known sensitivity to amlodipine (4)
WARNINGS AND PRECAUTIONS
• Symptomatic hypotension is possible, particularly in patients with
severe aortic stenosis. However, 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 in patients with severe hepatic impairment. (5.3)
ADVERSE REACTIONS
Most common advers