AMLODIPINE BESYLATE- 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:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine besylate tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets may be used alone or in combination with other antianginal agents. Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. There are no adequate and well controlled studies in pregnant women. Amlodipine should be used dur

Product summary:

Amlodipine Besylate Tablets, USP are available containing 2.5 mg, 5 mg or 10 mg of amlodipine base. The 2.5 mg tablets are  blue, round, unscored tablets debossed with M on one side of the tablet and A8 on the other side. They are available as follows: NDC 0615-6582-39 blistercards of 30 tablets NDC 0615-6582-31 blistercards of 31 tablets NDC 0615-6582-30 boxes of 30 tablets for unit-dose dispensing The 5 mg tablets are  blue, round, unscored tablets debossed with M on one side of the tablet and A9 on the other side. They are available as follows: NDC 0615-6577-05 blistercards of 15 tablets NDC 0615-6577-39 blistercards of 30 tablets NDC 0615-6577-31 blistercards of 31 tablets The 10 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and A10 on the other side. They are available as follows: NDC 0615-6578-05 blistercards of 15 tablets NDC 0615-6578-39 blistercards of 30 tablets NDC 0615-6578-31 blistercards of 31 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Viagra® is a registered trademark of Pfizer Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMLODIPINE BESYLATE TABLETS.
AMLODIPINE BESYLATE TABLETS, USP FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Amlodipine 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)
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)
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, and 10 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,
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,