AMLODIPINE AND VALSARTAN tablet film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Trigen Laboratories, LLC

INN (Kansainvälinen yleisnimi):

AMLODIPINE BESYLATE

Koostumus:

AMLODIPINE 5 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AMLODIPINE AND VALSARTAN - AMLODIPINE AND VALSARTAN TABLET, FILM
COATED
TRIGEN LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
AMLODIPINE AND VALSARTAN TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE AND VALSARTAN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE AND
VALSARTAN TABLETS.
AMLODIPINE AND VALSARTAN TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 2007
WARNING: FETAL TOXICITY_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE
BOXED WARNING._
When pregnancy is detected, discontinue amlodipine and valsartan
tablets as soon as possible. (5.1)
Drugs that act directly on the renin-angiotensin system can cause
injury and death to the developing fetus. (5.1)
INDICATIONS AND USAGE
Amlodipine and valsartan tablets are the combination tablet of
amlodipine, a dihydropyridine calcium channel blocker (DHP
CCB), and valsartan, an angiotensin II receptor blocker (ARB).
Amlodipine and valsartan tablets are indicated for the
treatment of hypertension, to lower blood pressure: (1)
In patients not adequately controlled on monotherapy (1)
As initial therapy in patients likely to need multiple drugs to
achieve their blood pressure goals (1).
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions. (1)
DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS: (2)
Majority of effect attained within 2 weeks (2.1)
May be administered with other antihypertensive agents (2.1)
HYPERTENSION (2)
May be used as add-on therapy for patients not controlled on
monotherapy (2.2)
Patients who experience dose-limiting adverse reactions on monotherapy
may be switched to amlodipine and valsartan
tablets containing a lower dose of that component (2.2)
May be substituted for titrated components (2.3)
When used as initial therapy: Initiate with 5/160 mg, then titrate
upwards as necessary to a maximum of 10/320 mg
once daily (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets (amlodipine/valsartan mg): 5/160, 10/