BENICAR olmesartan medoxomil tablet film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)

Dostupno od:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International ime):

OLMESARTAN MEDOXOMIL

Sastav:

OLMESARTAN MEDOXOMIL 20 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

New Drug Application

Svojstava lijeka

BENICAR - OLMESARTAN MEDOXOMIL TABLET, FILM COATED
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENICAR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BENICAR.
BENICAR (OLMESARTAN MEDOXOMIL) TABLETS
INITIAL U.S. APPROVAL: 2002
WARNING: AVOID USE IN PREGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
When pregnancy is detected, discontinue Benicar as soon as possible.
Drugs that act directly on the renin-angiotensin
system can cause injury and even death to the developing fetus (5.1).
RECENT MAJOR CHANGES
Dosage and Administration, Use in pediatric hypertension (6 to 16
years of age) (2.2) 2/2010
INDICATIONS AND USAGE
Benicar is an angiotensin II receptor blocker (ARB) indicated for the
treatment of hypertension, alone or with other
antihypertensive agents (1).
DOSAGE AND ADMINISTRATION
INDIC ATIO N
STARTING DOSE
DOSE RANGE
Adult Hypertension (2.1)
20 mg once daily
20 - 40 mg once daily
Pediatric Hypertension (6 - 16 years) (2.2)
20 to <35 kg 10 mg once daily
≥35 kg 20 mg once daily
20 to <35 kg 10 - 20 mg once daily
≥35 kg 20 - 40 mg once daily
Benicar may be administered with or without food.
If blood pressure is not controlled by Benicar alone, a diuretic may
be added. Benicar may be administered with other
antihypertensive agents.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 20 mg, and 40 mg (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Avoid fetal (in utero) exposure (5.1).
Observe for signs and symptoms of hypotension in volume- or
salt-depleted patients with treatment initiation (5.2).
Monitor for worsening renal function in patients with renal impairment
(5.3).
ADVERSE REACTIONS
The most common adverse reaction in adults was dizziness (3%) (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DAIICHI SANKYO, INC. AT
1-877-437-7763 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
Nursing mothers: C