Valsartan/amlodipine

Name: Valsartan/amlodipine

Dosing & Uses

Dosage Forms & Strengths

amlodipine/valsartan

tablet

  • 5mg/160mg
  • 5mg/320mg
  • 10mg/160mg
  • 10mg/320mg

Hypertension

Initiate with 5 mg/160 mg PO qDay OR

Substitute for individually titrated components

May increase dose after at least 2 weeks, not to exceed 10 mg/day amlodipine and 320 mg/day valsartan

May be adminsitered concomitantly with other antihypertensive agents

Dosage modifications

Renal impairment

  • Mild or moderate (CrCl >30 mL/min): Dose adjustment not necessary
  • Severe (CrCl <30 mL/min): Not studied

Hepatic impairment

  • Not recommended for initial therapy; amlodipine 2.5 mg is not an available strength with available dosage forms for this drug combination
  • Amlodipine: Exposure is increased with hepatic insufficiency, consider decreasing dose
  • Valsartan: Exposure increased with mild-to-moderate hepatic insufficiency does not require dosage adjustment; unknown for severe hepatic impairment

Safety and efficacy not established

Not recommended for initial therapy; amlodipine 2.5 mg is not an available strength with available dosage forms for this drug combination

Base initial dose on 2.5 mg of amlodipine PO qDay

No overall difference in the efficacy or safety of valsartan has been observed, but greater sensitivity of some older individuals cannot be ruled out

Pregnancy & Lactation

Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters). During the second and third trimesters of pregnancy, these drugs have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.

Lactation: discontinue drug or do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Patient Handout

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