Page 60 - C:\Users\MY PC\Desktop\FlipBook

62

Prescribing Information

Valzomix® (Amlodipine and Valsartan)

INDICATIONS AND USAGE: Treatment of hypertension: In patients not adequately controlled
on monotherapy, and as initial therapy in patients likely to need multiple drugs to achieve their
blood pressure goals. DOSAGE AND ADMINISTRATION: When used as initial therapy, initiate with
5/80 mg, the maximum dose is 10/320 mg once-daily. Majority of effect attained within 2 weeks.
It may be administered with other antihypertensive agents. May be used as add-on therapy for
patients not controlled on monotherapy. Patients who experience dose-limiting adverse reactions
on monotherapy may be switched to this combination, containing a lower dose of the components.
It may also be substituted for titrated components. DOSAGE FORMS AND STRENGT:Tablets
(Amlodipine/Valsartan): 5/80, 5/160, 10/160 mg. CONTRAINDICATIONS: Known hypersensitivity
to any component; co-administration with Aliskiren in patients with diabetes. WARNINGS AND
PRECAUTIONS: : Correct volume depletion prior to initiation, be cautious in patients with increased
angina and/or myocardial infarction, and in susceptible patients monitor renal function and potassium.
ADVERSE REACTIONS:The adverse experiences that occurred in clinical trials (≥2% of patients) at a
higher incidence than placebo included peripheral edema, nasopharyngitis, upper respiratory tract
infection and dizziness. DRUG INTERACTIONS:Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may
lead to increased risk of renal impairment and loss of anti-hypertensive effect. Dual inhibition of the
renin-angiotensin system, increases the risk of renal impairment, hypotension, and hyperkalemia.
Co-administration with Lithium increases serum lithium level and Lithium toxicity. If Simvastatin is
co-administered with Amlodipine, do not exceed doses greater than 20 mg daily of Simvastatin.
USE IN SPECIAL POPULATIONS:Lactation: Breastfeeding is not recommended. Geriatric Patients: Not
recommended for initial therapy. Hepatic Impairment: Not recommended for initial therapy.

FDA label, Reference ID: 4447778.
See FDA approved labeling for more information.