Page 61 - C:\Users\MY PC\Desktop\FlipBook

63

Prescribing Information

Valzomix- HCT® (Amlodipine and Valsartan and Hydrochlorothiazide)

INDICATIONS AND USAGE: Treatment of hypertension. Limitations of use is for initial treatment of
hypertension. DOSAGE AND ADMINISTRATION:Once-daily. The maximum dose is 10/320/25 mg.
It may be used as add-on/switch therapy for patients not adequately controlled on any two of the
Calcium Channel Blockers, Angiotensin Receptor Blockers, and Diuretics. May be substituted for its
individually titrated components. DOSAGE FORMS AND STRENGTHS: Tablets (Amlodipine/Valsartan/
Hydrochlorothiazide) 5/160/12.5, 10/160/12.5 mg. CONTRAINDICATIONS:Anuria; hypersensitivity
to sulfonamide-derived drugs, Known hypersensitivity to any component; co-administration with
Aliskiren in patients with diabetes. WARNINGS AND PRECAUTIONS: Hypovolemia, increased
angina and/or myocardial infarction, in susceptible patients monitor renal function and potassium,
observe for signs of fluid or electrolyte imbalance. In systemic lupus erythematosus, exacerbation or
activation of disease can occur. Be cautious in acute angle-closure glaucoma. ADVERSE REACTIONS:
Most common adverse events (≥ 2% incidence) are dizziness, peripheral edema and headache.
DRUG INTERACTIONS: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) use 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. Cholestyramine and
Colestipol can reduce absorption of Thiazides. Co-administration with Lithium increases in serum
lithium level and Lithium toxicity. If Simvastatin is co-administered with Amlodipine, do not exceed
doses greater than 20 mg daily of Simvastatin. Dosage adjustment of Antidiabetic drugs may be
required. 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. 2/2021 revision.
See FDA approved labeling for more information.