AMLODIPINE AND VALSARTAN- amlodipine besylate and valsartan tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)

Pieejams no:

Sandoz Inc

SNN (starptautisko nepatentēto nosaukumu):

AMLODIPINE BESYLATE

Kompozīcija:

AMLODIPINE 5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Amlodipine and valsartan tablets may be used in patients whose blood pressure is not adequately controlled on either monotherapy. Amlodipine and valsartan tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of amlodipine and valsartan tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of amlodipine and valsartan tablets. Patients with stage 2 hypertension (moderate or severe) are at a relatively higher risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination co

Produktu pārskats:

Amlodipine and valsartan tablets are available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. All strengths are packaged in bottles of 30 tablets. 5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. 10/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. 5/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. 10/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from moisture.

Autorizācija statuss:

New Drug Application Authorized Generic

Produkta apraksts

AMLODIPINE AND VALSARTAN- AMLODIPINE BESYLATE AND VALSARTAN TABLET,
FILM COATED
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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._
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INDICATIONS AND USAGE
Amlodipine and valsartan tablets are a 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:
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Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions .
DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS:
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HYPE RTE NSIO N:
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DOSAGE FORMS AND STRENGTHS
Tablets (amlodipine/valsartan mg): 5/160, 10/160, 5/320, 10/320 (3)
CONTRAINDICATIONS
Known hypersensitivity to any component;
Do not coadminister aliskiren with amlodipine and valsartan tablets in
patients with diabetes (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
In placebo-controlled clinical trials, discontinuation due to side
effects occurred in 1.8% of patients in the amlodipine and
valsartan tablet-treated patients and 2.1% in the placebo-treated
group. The most common reasons for discontinuation of
therapy with amlodipine and valsartan tablets were peripheral edema
and vertigo. The adverse experiences that occurred
in clinical trials (≥2% of patients) at a higher incidence than
placebo included peripheral edema, nasopharyngitis, upper
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
FET