国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Sandoz Inc
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application Authorized Generic
AMLODIPINE AND VALSARTAN- AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED SANDOZ INC ---------- 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._ • • 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: • • Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions . DOSAGE AND ADMINISTRATION GENERAL CONSIDERATIONS: • • HYPE RTE NSIO N: • • • • 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 • • • 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 完全なドキュメントを読む