Amlodipine and valsartan

The usual dose is 5/160 to 10mg/320 mg daily. The majority of the effect is seen within 2 weeks.

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Exforge is a fixed combination of amlodipine and valsartan.

Exforge contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is:

Its empirical formula is C20H25ClN2O5•C6H6O3S and its molecular weight is 567.1.

Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4yl]methyl]-L-valine; its structural formula is:

Its empirical formula is C24H29N5O3 and its molecular weight is 435.5.

Exforge tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.

The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Additionally the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc, and titanium dioxide.

Amlodipine and valsartan combination is used when a single medicine to lower your blood pressure is not enough. It is also used as the first medicine to treat your condition if your doctor feels that you need to take more than one blood pressure medicine.

amlodipine and valsartan comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

In addition to the use of amlodipine and valsartan, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that amlodipine and valsartan will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take amlodipine and valsartan with or without food.

Dosing

The dose of amlodipine and valsartan will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of amlodipine and valsartan. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—One tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than amlodipine 10 milligrams (mg) and valsartan 320 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of amlodipine and valsartan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

General Considerations

Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose.
Amlodipine and Valsartan tablets may be administered with or without food.
Amlodipine and Valsartan tablets may be administered with other antihypertensive agents.

Add-on Therapy

A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone or with valsartan (or another angiotensin II receptor blocker) alone may be switched to combination therapy with Amlodipine and Valsartan tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Amlodipine and Valsartan tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to Amlodipine and Valsartan tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg.

Replacement Therapy

For convenience, patients receiving Amlodipine and Valsartan from separate tablets may instead wish to receive tablets of Amlodipine and Valsartan tablets containing the same component doses.

Initial Therapy

A patient may be initiated on Amlodipine and Valsartan tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is Amlodipine and Valsartan tablets 5/160 mg once daily in patients who are not volume-depleted.

Fetal Toxicity

Pregnancy Category D  

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Amlodipine and Valsartan tablets as soon as possible [see Use in Specific Populations (8.1)].

Hypotension

Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Amlodipine and Valsartan tablets in placebo-controlled studies. In patients with an activated renin-angiotensin system, such as volume-and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur in patients receiving angiotensin receptor blockers. Volume depletion should be corrected prior to administration of Amlodipine and Valsartan tablets. Treatment with Amlodipine and Valsartan tablets should start under close medical supervision.

Initiate therapy cautiously in patients with heart failure or recent myocardial infarction and in patients undergoing surgery or dialysis. Patients with heart failure or post-myocardial infarction patients given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients. In the Valsartan in Acute Myocardial Infarction Trial (VALIANT), hypotension in post-myocardial infarction patients led to permanent discontinuation of therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated patients.

Since the vasodilation induced by amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering amlodipine, particularly in patients with severe aortic stenosis.

If excessive hypotension occurs with Amlodipine and Valsartan tablets, the patient should be placed in a supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Risk of Myocardial Infarction or Increased Angina

Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.

Impaired Hepatic Function

Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the reninangiotensin system (e.g. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on Amlodipine and Valsartan tablets. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Amlodipine and Valsartan tablets [see Drug Interactions (7)].

Hyperkalemia

Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically.

Some patients with heart failure have developed increases in potassium with valsartan therapy. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of Amlodipine and Valsartan tablets may be required [see Adverse Reactions (6.1)].

Amlodipine and Valsartan tablets was studied in 2 placebo-controlled and 4 active-controlled trials in hypertensive patients. In a double-blind, placebo-controlled study, a total of 1012 patients with mild-to-moderate hypertension received treatments of 3 combinations of Amlodipine and Valsartan (5/80, 5/160, 5/320 mg) or amlodipine alone (5 mg), valsartan alone (80, 160, or 320 mg) or placebo. All doses with the exception of the 5/320 mg dose were initiated at the randomized dose. The high dose was titrated to that dose after a week at a dose of 5/160 mg. At week 8, the combination treatments were statistically significantly superior to their monotherapy components in reduction of diastolic and systolic blood pressures.

Table 1: Effect of Amlodipine and Valsartan Tablets on Sitting Diastolic Blood Pressure

*Mean Change and Placebo-Subtracted Mean Change from Baseline (mmHg) at Week 8 in Sitting Diastolic Blood Pressure. Mean baseline diastolic BP was 99.3 mmHg.

Table 2: Effect of Amlodipine and Valsartan Tablets on Sitting Systolic Blood Pressure

*Mean Change and Placebo-Subtracted Mean Change from Baseline (mmHg) at Week 8 in Sitting Systolic Blood Pressure. Mean baseline systolic BP was 152.8 mmHg.

In a double-blind, placebo controlled study, a total of 1246 patients with mild to moderate hypertension received treatments of 2 combinations of Amlodipine and Valsartan (10/160, 10/320 mg), or amlodipine alone (10 mg), valsartan alone (160 or 320 mg) or placebo. With the exception of the 10/320 mg dose, treatment was initiated at the randomized dose. The high dose was initiated at a dose of 5/160 mg and titrated to the randomized dose after 1 week. At week 8, the combination treatments were statistically significantly superior to their monotherapy components in reduction of diastolic and systolic blood pressures.

Table 3: Effect of Amlodipine and Valsartan Tablets on Sitting Diastolic Blood Pressure

*Mean Change and Placebo-Subtracted Mean Change from Baseline (mmHg) at Week 8 in Sitting Diastolic Blood Pressure. Mean baseline diastolic BP was 99.1 mmHg.

Table 4: Effect of Amlodipine and Valsartan Tablets on Sitting Systolic Blood Pressure

*Mean Change and Placebo-Subtracted Mean Change from Baseline (mmHg) at Week 8 in Sitting Systolic Blood Pressure. Mean baseline systolic BP was 156.7 mmHg. 

In a double-blind, active-controlled study, a total of 947 patients with mild to moderate hypertension who were not adequately controlled on valsartan 160 mg received treatments of 2 combinations of Amlodipine and Valsartan (10/160, 5/160 mg) or valsartan alone (160 mg). At week 8, the combination treatments were statistically significantly superior to the monotherapy component in reduction of diastolic and systolic blood pressures.

Table 5: Effect of Amlodipine and Valsartan Tablets on Sitting Diastolic/Systolic Blood Pressure

*Mean Change from Baseline at Week 8 in Sitting Diastolic/Systolic Blood Pressure. Mean baseline BP was 149.5/96.5 (systolic/diastolic) mmHg.

**Treatment Difference = difference in mean BP reduction between Amlodipine and Valsartan tablets and the control group (Valsartan 160 mg).

In a double-blind, active-controlled study, a total of 944 patients with mild to moderate hypertension who were not adequately controlled on amlodipine 10 mg received a combination of Amlodipine and Valsartan (10/160 mg) or amlodipine alone (10 mg). At week 8, the combination treatment was statistically significantly superior to the monotherapy component in reduction of diastolic and systolic blood pressures.

Table 6: Effect of Amlodipine and Valsartan Tablets on Sitting Diastolic/Systolic Blood Pressure

*Mean Change from Baseline at Week 8 in Sitting Diastolic/Systolic Blood Pressure. Mean baseline BP was 147.0/95.1 (systolic/diastolic) mmHg.

**Treatment Difference = difference in mean BP reduction between Amlodipine and Valsartan tablets and the control group (Amlodipine 10 mg).

Amlodipine and Valsartan tablets was also evaluated for safety in a 6-week, double-blind, active-controlled trial of 130 hypertensive patients with severe hypertension (mean baseline BP of 171/113 mmHg). Adverse events were similar in patients with severe hypertension and mild/moderate hypertension treated with Amlodipine and Valsartan tablets.

A wide age range of the adult population, including the elderly was studied (range 19 to 92 years, mean 54.7 years). Women comprised almost half of the studied population (47.3%). Of the patients in the studied Amlodipine and Valsartan tablets group, 87.6% were Caucasian. Black and Asian patients each represented approximately 4% of the population in the studied Amlodipine and Valsartan tablets group.

Two additional double-blind, active-controlled studies were conducted in which Amlodipine and Valsartan tablets was administered as initial therapy. In 1 study, a total of 572 black patients with moderate to severe hypertension were randomized to receive either combination amlodipine/valsartan or amlodipine monotherapy for 12 weeks. The initial dose of amlodipine/valsartan was 5/160 mg for 2 weeks with forced titration to 10/160 mg for 2 weeks, followed by optional titration to 10/320 mg for 4 weeks and optional addition of HCTZ 12.5 mg for 4 weeks. The initial dose of amlodipine was 5 mg for 2 weeks with forced titration to 10 mg for 2 weeks, followed by optional titration to 10 mg for 4 weeks and optional addition of HCTZ 12.5 mg for 4 weeks. At the primary endpoint of 8 weeks, the treatment difference between amlodipine/valsartan and amlodipine was 6.7/2.8 mmHg.

In the other study of similar design, a total of 646 patients with moderate to severe hypertension (MSSBP of ≥160 mmHg and <200 mmHg) were randomized to receive either combination amlodipine/valsartan or amlodipine monotherapy for 8 weeks. The initial dose of amlodipine/valsartan was 5/160 mg for 2 weeks with forced titration to 10/160 mg for 2 weeks, followed by the optional addition of HCTZ 12.5 mg for 4 weeks. The initial dose of amlodipine was 5 mg for 2 weeks with forced titration to 10 mg for 2 weeks, followed by the optional addition of HCTZ 12.5 mg for 4 weeks. At the primary endpoint of 4 weeks, the treatment difference between amlodipine/valsartan and amlodipine was 6.6/3.9 mmHg.

There are no trials of the Amlodipine and Valsartan tablets combination tablet demonstrating reductions in cardiovascular risk in patients with hypertension, but the amlodipine component and several ARBs, which are the same pharmacological class as the valsartan component, have demonstrated such benefits.

Information for Patients
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Amlodipine and Valsartan tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Manufactured by:
Alembic Pharmaceuticals Limited
(Formulation Division),
Panelav 389350, Gujarat, India
Manufactured for:
Alembic Pharmaceuticals, Inc.
750 Route 202, Bridgewater, NJ 08807
USA
Revision: 04/2017

FDA-APPROVED PATIENT LABELING
PATIENT INFORMATION
Amlodipine (am-LOE-di-peen) and
Valsartan (val-SAR-tan) Tablets, USP

Read the Patient Information that comes with Amlodipine and Valsartan tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Amlodipine and Valsartan tablets, ask your doctor or pharmacist.

What is Amlodipine and Valsartan tablets?
Amlodipine and Valsartan tablets contain 2 prescription medicines:

1. amlodipine, a calcium channel blocker
2. valsartan, an angiotensin receptor blocker (ARB).
Amlodipine and Valsartan tablets may be used to lower high blood pressure (hypertension) in adults
• when 1 medicine to lower your high blood pressure is not enough
• as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than 1 medicine.
Amlodipine and Valsartan tablets have not been studied in children under 18 years of age.

What should I tell my doctor before taking Amlodipine and Valsartan tablets?
Tell your doctor about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. See “What is the most important information I should know about Amlodipine and Valsartan tablets?”
• are breastfeeding or plan to breastfeed. Amlodipine and Valsartan may pass into your milk. Do not breastfeed while you are taking Amlodipine and Valsartan tablets.
• have heart problems
• have liver problems
• have kidney problems
• are vomiting or having a lot of diarrhea
• have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue, throat, and may cause difficulty breathing.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines and Amlodipine and Valsartan tablets could affect each other, causing serious side effects.

Especially tell your doctor if you take:
• simvastatin or other cholesterol-lowering medicine
• other medicines for high blood pressure or a heart problem
• water pills (diuretics)
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically.
• a salt substitute. Your doctor may check the amount of potassium in your blood periodically.
• nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)
• medicines used to prevent and treat fungal skin infections (such as ketoconazole, itraconazole)
• medicines used to treat bacterial infections (such as clarithromycin, telithromycin)
• certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporine) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.
lithium, a medicine used in some types of depression.

Know the medicine you take. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine. Talk to your doctor or pharmacist before you start taking any new medicine. Your doctor or pharmacist will know what medicines are safe to take together.

How should I take Amlodipine and Valsartan tablets?
• Take Amlodipine and Valsartan tablets exactly as your doctor tells you.
• Take Amlodipine and Valsartan tablets once each day.
• Amlodipine and Valsartan tablets can be taken with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
• If you take too much Amlodipine and Valsartan tablets, call your doctor or Poison Control Center, or go to the emergency room.
• Tell all your doctors or dentist you are taking Amlodipine and Valsartan tablets if you:
o are going to have surgery
o go for kidney dialysis

What should I avoid while taking Amlodipine and Valsartan tablets?
You should not take Amlodipine and Valsartan tablets during pregnancy. See “What is the most important information I should know about Amlodipine and Valsartan tablets?”

What are the possible side effects of Amlodipine and Valsartan tablets?
Amlodipine and Valsartan tablets may cause serious side effects including:

• harm to an unborn baby causing injury and even death. See “What is the most important information I should know about Amlodipine and Valsartan tablets?”
• low blood pressure (hypotension). Low blood pressure is most likely to happen if you:
o take water pills
o are on a low-salt diet
o get dialysis treatments
o have heart problems
o get sick with vomiting or diarrhea
o drink alcohol

Lie down if you feel faint or dizzy. Call your doctor right away.
• more heart attacks and chest pain (angina) in people that already have severe heart problems. This may happen when you start Amlodipine and Valsartan tablets or when there is an increase in your dose of Amlodipine and Valsartan tablets. Get emergency help if you get worse chest pain or chest pain that does not go away.
• kidney problems. Kidney problems may become worse in people that already have kidney disease. Some people will have changes in blood tests for kidney function and may need a lower dose of Amlodipine and Valsartan tablets. Call your doctor if you have swelling in your feet, ankles, or hands or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing Amlodipine and Valsartan tablets.
• laboratory blood test changes in people with heart failure. Some people with heart failure who take valsartan, 1 of the medicines in Amlodipine and Valsartan tablets, have changes in blood tests including increased potassium and decreased kidney function.
The most common side effects of Amlodipine and Valsartan tablets include:
• swelling (edema) of the hands, ankles, or feet
• nasal congestion, sore throat, and discomfort when swallowing
• upper respiratory tract infection (head or chest cold)
• dizziness
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Amlodipine and Valsartan tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Amlodipine and Valsartan tablets?
• Store Amlodipine and Valsartan tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture.

• Keep Amlodipine and Valsartan tablets dry (protect it from moisture).

Keep Amlodipine and Valsartan tablets and all medicines out of the reach of children.
General Information about Amlodipine and Valsartan tablets

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use Amlodipine and Valsartan tablets for a condition for which it was not prescribed. Do not give Amlodipine and Valsartan tablets to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Amlodipine and Valsartan tablets. If you would like more information about Amlodipine and Valsartan tablets, talk with your doctor. You can ask your doctor or pharmacist for information about Amlodipine and Valsartan tablets that is written for health professionals.

For more information about Amlodipine and Valsartan tablets call Alembic Pharmaceuticals Limited at 1-866 210 9797.

What are the ingredients in Amlodipine and Valsartan tablets?
Active ingredients: Amlodipine besylate and valsartan

The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Additionally the 5/160 mg and 5/320 mg strengths contain iron oxide red. The film coating contains hypromellose, iron oxide yellow, polyethylene glycol, talc and titanium dioxide.

What is high blood pressure (hypertension)?
Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Amlodipine and Valsartan tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure lower your chance of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.
*Norvasc® is a registered trademark of Pfizer, Inc.
**Viagra® is a registered trademark of Pfizer, Inc.
Manufactured by:
Alembic Pharmaceuticals Limited
(Formulation Division),
Panelav 389350, Gujarat, India
Manufactured for:
Alembic Pharmaceuticals, Inc.
750 Route 202, Bridgewater, NJ 08807
USA
Revised. 04/2017

Amlodipine and Valsartan Tablets, USP 10 mg/160 mg (30 Tablets in 1 Bottle)

Each tablet contains 13.9 mg of amlodipine besylate USP equivalent to 10 mg of amlodipine and 160 mg of valsartan USP
62332-206-30

Amlodipine and Valsartan Tablets, USP  5 mg/320 mg (30 Tablets in 1 Bottle)

Each tablet contains 6.9 mg of amlodipine besylate USP equivalent to 5 mg of amlodipine and 320 mg of valsartan USP

62332-207-30

• Amlodipine Besylate and Valsartan
• Amlodipine/Valsartan
• Valsartan and Amlodipine

• Exforge®

Initial therapy: Amlodipine 5 mg-Valsartan 160 mg orally once a day

Add-on/Replacement therapy: Amlodipine 5 to 10 mg-Valsartan 160 to 320 mg orally once a day

Comments:
-May increase dose after 1 to 2 weeks of therapy.
-A patient who experiences dose-limiting adverse reactions on either component alone may be switched to this drug containing a lower dose of that component in combination with the other. If blood pressure remains uncontrolled after 3 to 4 weeks, may titrate up to a maximum of amlodipine 10 mg-valsartan 320 mg orally once a day.

Monitoring: Monitor renal function and serum electrolytes periodically.

Patient advice:
-Advise patients to immediately report any signs or symptoms of angioedema (breathing difficulty or swelling of face, eyes, lips, or tongue) and to stop taking this drug until consulting a physician.
-Females of childbearing age should be informed of the consequences of exposure to this drug during pregnancy; ask these patients to report pregnancies as soon as possible.