Valsartan-Amlodipine-Hydrochlorothiazide

Valsartan-Amlodipine-Hydrochlorothiazide is a combination of prescription medications used for the treatment of hypertension. 

• Valsartan-Amlodipine-Hydrochlorothiazide is available under the following different brand names: Exforge HCT

Adult dosage

Tablet

• 5 mg/160 mg/12.5 mg
• 5 mg/160 mg/25 mg
• 10 mg/160 mg/12.5 mg
• 10 mg/160 mg/25 mg
• 10 mg/320 mg/25 mg

Hypertension

Adult dosage

• 5-10 mg amlodipine/160-320 mg valsartan/12.5-25 mg hydrochlorothiazide every day; may titrate dose after 2 weeks
• May increase dose after 2 weeks if needed
• Not to exceed 10 mg/320 mg/25 mg orally once-daily

Geriatric dosage

• Initiate with 2.5 mg orally every day; may titrate dose after 2 weeks
• May increase dose after 2 weeks if needed
• Not to exceed 10 mg/320 mg /25 mg orally once-daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Valsartan-Amlodipine-Hydrochlorothiazide include:

• diarrhea,
• liver problems,
• muscle or bone pain,
• cough,
• nausea,
• changes in liver function tests,
• tiredness, and
• changes in certain other blood tests.

Serious side effects of Valsartan-Amlodipine-Hydrochlorothiazide include:

• jaundice
• bleeding or bruising
• dark or “tea-colored” urine
• loss of appetite
• light-colored stools (bowel movements)
• pain, aching, or tenderness on the right side of the stomach area (abdomen)
• tiredness or weakness in the stomach area (abdomen)

Rare side effects of Valsartan-Amlodipine-Hydrochlorothiazide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Valsartan-Amlodipine-Hydrochlorothiazide has severe interactions with the following drugs:
  • aliskiren
  • dantrolene
• Valsartan-Amlodipine-Hydrochlorothiazide has serious interactions with at least 40 other drugs.
• Valsartan-Amlodipine-Hydrochlorothiazide has moderate interactions with at least 355 other drugs.
• Valsartan-Amlodipine-Hydrochlorothiazide has minor interactions with at least 188 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to valsartan, amlodipine, sulfonamide drugs, or other ingredients
• Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality
• Anuria
• Coadministration with aliskiren in patients with diabetes

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Valsartan-Amlodipine-Hydrochlorothiazide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Valsartan-Amlodipine-Hydrochlorothiazide?”

Cautions

• Avoid severe hepatic impairment or renal impairment (i.e., CrCl less than 30 mL/min)
• 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
• 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); correct volume depletion prior to initiation
• 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; monitor renal function and potassium in susceptible patients
• Acute transient myopia and acute angle-closure glaucoma have been reported, particularly with a history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
• Hydrochlorothiazide may exacerbate systemic lupus erythematosus
• Instruct patients to protect skin from the sun and undergo regular skin cancer screening
• Hydrochlorothiazide may alter glucose tolerance and raise cholesterol and triglycerides
• Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
• Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium; monitor calcium levels in patients with hypercalcemia receiving therapy

Pregnancy and Lactation

• Angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death; most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents; published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan
• When pregnancy is detected discontinue Diovan HCT as soon as possible
• Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly
• Valsartan
  • Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death
  • Perform serial ultrasound examinations to assess the intra-amniotic environment; fetal testing may be appropriate, based on the week of gestation; however, oligohydramnios may not appear until after the fetus has sustained an irreversible injury; if oligohydramnios is observed, consider alternative drug treatment
  • Closely observe neonates with histories of in utero exposure to the drug for hypotension, oliguria, and hyperkalemia; in neonates with a history of in utero exposure to this drug combination, if oliguria or hypotension occurs, support blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing the renal function
• Hydrochlorothiazide
  • Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma; hydrochlorothiazide can cause placental hypoperfusion; accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in the umbilical vein plasma
  • Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia; since they do not prevent or alter the course of EPH (Edema, proteinuria, hypertension) gestosis (pre-eclampsia), these drugs should not be used to treat hypertension in pregnant women; use of hydrochlorothiazide for other indications (e.g., heart disease) in pregnancy should be avoided
• Lactation
  • There is limited information regarding the presence of drugs in human milk, effects on the breastfed infant, or on milk production; valsartan is present in rat milk; hydrochlorothiazide is present in human breast milk
  • Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with this drug combination