Dosing & Uses
Dosage Forms & Strengths
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
- Mild or moderate (CrCl >30 mL/min): Dose adjustment not necessary
- Severe (CrCl <30 mL/min): Not studied
- 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
Serious - Use Alternative
Significant - Monitor Closely
Increased BUN (6-17%)
Peripheral edema (5-8%)
Increased potassium (3%)
Upper respiratory infection (3%)
Abdominal pain (3%)
- Jaundice and hepatic enzyme elevations
- Hypersensitivity: Angioedema (rare)
- Digestive: Elevated liver enzymes, hepatitis (rare)
- Renal: Impaired renal function, renal failure
- Clinical laboratory tests: Hyperkalemia
- Dermatologic: Alopecia, bullous dermatitis
- Blood and lymphatic: Thrombocytopenia (rare)
- Vascular: Vasculitis
Black Box Warnings
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death
Hypersensitivity to valsartan, amlodipine or other ingredients
Pregnancy (2nd & 3rd trimesters): significant risk of fetal & neonatal morbidity & mortality
Concomitant administration with aliskiren in patients with diabetes mellitus
Use during the 2nd or 3rd trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Black Box Warnings)
Excessive hypotension may occur (rare); caution if volume/salt depleted, initiate cautiously in patients with heart failure, recent MI, or those undergoing surgery or dialysis
Worsening angina and acute MI may occur after starting or increasing amlodipine dose, particularly with severe obstructive CAD
Peripheral edema may occur within 2-3 weeks of starting therapy (amlodipine)
Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy
Patients whose renal function may depend in part on the activity of the renin angiotensin system (e.g. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion)
May cause hyperkalemia
Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy; closely monitor blood pressure
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
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.
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.