Valsartan 40 mg Tablet, 1,000-count
Other active recalls for Valsartan (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Angiotensin 2 Receptor Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Valsartan is used in adults and in children 1 year of age and older alone or in combination with other medications to treat high blood pressure. It is also used in adults to treat heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. High blood press...
Read the full MedlinePlus article ↗- Valsartan is mainly used to treat high blood pressure, which helps lower your risk of stroke and heart attack. It's also used in adults with heart failure to reduce the chance of b...
- Yes — valsartan tablets can be taken with or without food, so whatever works best for your routine is fine. If you're taking the oral solution, take it as directed by your prescrib...
- Can I take valsartan with or without food?
- Most people do well on valsartan. The most common issues are headache, dizziness, and fatigue. If you feel faint or lightheaded — especially when standing up — that can be a sign y...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Valsartan — tap one for details:
Valsartan may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII LQA7B6G8JG
A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2655 | $265.50 / 1000 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Valsartan 40 mg 00378-5807-93 | Mylan | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 33342-0062-07 | Macleods | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 43547-0367-03 | Solco | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 50268-0746-15 | AvPAK | 1 tablet | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 60687-0612-21 | American | 1 tablet | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 65162-0837-03 | Amneal | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 72578-0131-06 | Viona | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 72819-0181-03 | Archis | 30 tablets | $0.097 | AB | Discontinued | — |
| Diovan 40 mg 00078-0423-15 | Novartis | 30 tablets | $7.816 | AB | Availability likely | — |
| Valsartan 40 mg 29300-0232-10 | Unichem | 1000 tablets | — | — | FDA listed | — |
| Valsartan 40 mg 31722-0151-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 31722-0745-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 42291-0856-30 | AvKARE | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 42385-0989-05 | Laurus | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mgthis 46708-0044-91 | Alembic | 1000 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 50228-0135-10 | ScieGen | 1000 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 51660-0140-03 | Ohm | 10 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 53746-0837-05 | Amneal | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 55111-0731-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| valsartan 40 mg 59746-0360-58 | Jubilant | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 62332-0044-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 65862-0570-10 | Aurobindo | 10 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 67877-0415-05 | Ascend | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 70771-1882-03 | Zydus | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 71335-1337-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 71335-2151-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 71335-2308-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 72789-0553-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 76483-0026-00 | SQUARE | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 68180-0276-01 | Lupin | 100 tablets | — | — | Discontinued | — |
| Valsartan 40 mg 53401-0033-81 | Aphena | 1080 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0044-10 | 100 TABLET in 1 CARTON (46708-044-10) | 2015-01-06 | Active |
| 46708-0044-30 | 30 TABLET in 1 BOTTLE (46708-044-30) | 2015-01-06 | Active |
| 46708-0044-71 | 500 TABLET in 1 BOTTLE (46708-044-71) | 2015-01-06 | Active |
| 46708-0044-90 | 90 TABLET in 1 BOTTLE (46708-044-90) | 2015-01-06 | Active |
| 46708-0044-91 You're viewing this | 1000 TABLET in 1 BOTTLE (46708-044-91) | 2015-01-06 | Active |
You're viewing the largest of 5 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 46708-0044-91?
What is the difference between NDC 46708-0044-91 and NDC 46708-0044-30?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue valsartan tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue valsartan tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. (5.1)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Valsartan tablets is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension , to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Treatment of heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure (1.2)
1.1Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs.
There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.
The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Valsartan tablets, USP may be used alone or in combination with other antihypertensive agents.
1.2Heart Failure Valsartan tablets are indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, valsartan tablets significantly reduced hospitalizations for heart failure. There is no evidence that valsartan tablets provides added benefits when it is used with an adequate dose of an ACE inhibitor [see Clinical Studies (14.2)].
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Indication Starting Dose Dose Range Target Maintenance Dose* Adult Hypertension (2.1) 80 or 160 mg once daily 80 to 320 mg once daily --- Pediatric Hypertension (6-16 years) (2.2) 1.3 mg/kg once daily (up to 40 mg total) 1.3 to 2.7 mg/kg once daily (up to 40-160 mg total) --- Heart Failure (2.3) 40 mg twice daily 40 to 160 mg twice daily 160 mg twice daily * as tolerated by patient
2.1Adult Hypertension The recommended starting dose of valsartan tablets is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day.
The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.
No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of valsartan tablets in patients with hepatic or severe renal impairment. Valsartan tablets may be administered with other antihypertensive agents.
Valsartan tablets may be administered with or without food.
2.2Pediatric Hypertension 6 to 16 years of age For children who can swallow tablets, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total). The dosage should be adjusted according to blood pressure response. Doses higher than 2.7 mg/kg (up to 160 mg) once daily have not been studied in pediatric patients 6 to 16 years old.
For children who cannot swallow tablets, or children for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths of valsartan tablets , the use of a suspension is recommended. Follow the suspension preparation instructions below (see Preparation of Suspension ) to administer valsartan as a suspension. When the suspension is replaced by a tablet, the dose of valsartan may have to be increased.
The exposure to valsartan with the suspension is 1.6 times greater than with the tablet. No data are available in pediatric patients either undergoing dialysis orwith a glomerular filtration rate <30 mL/min/1.73 m 2 [see Pediatric Use (8.4)] . valsartan tablets are not recommended for patients <6 years old [see Adverse Reactions (6.1), Clinical Trials (14.1)]. Preparation of Suspension (for 160 mL of a 4 mg/mL suspension) Add 80 mL of Ora-Plus®* oral suspending vehicle to an amber glass bottle containing 8 tablets of Valsartan 80 mg, and shake for a minimum of 2 minutes.
Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 80 mL of Ora-Sweet SF®* oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients.
The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30°C/86°F) or up to 75 days at refrigerated conditions (2 to 8°C/35 to 46°F) in the glass bottle with a child-resistant screw-cap closure. Shake the bottle well (at least 10 seconds) prior to dispensing the suspension. *Ora-Sweet SF® and Ora-Plus® are registered trademarks of Paddock Laboratories, Inc.
2.3Heart Failure The recommended starting dose of valsartan tablets is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 40 mg are yellow colored, oval shaped, biconvex, film coated tablets debossed with L128 and breakline on one side and 40 on the other side. 80 mg are pink colored, oval shaped, biconvex, film coated tablets debossed with L129 on one side and 80 on the other side. 160 mg are yellow colored, oval shaped, biconvex, film coated tablets debossed with L130 on one side and 160 on the other side.
320 mg are purple colored, oval shaped, biconvex, film coated tablets debossed with L127 on one side and 320 on the other side. Tablets (mg): 40 (scored), 80, 160, 320
⛔ Contraindications ▾
4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes [see Drug Interactions(7)] Known hypersensitivity to any component; Do not coadminister aliskiren with valsartan tablets in patients with diabetes (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Observe for signs and symptoms of hypotension (5.2) Monitor renal function and potassium in susceptible patients (5.3, 5.4)
5.1Fetal 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 valsartan tablets as soon as possible. [see Use in Specific Populations (8.1)].
5.2Hypotension Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with valsartan tablets alone. 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. This condition should be corrected prior to administration of valsartan tablets , or the treatment should start under close medical supervision.
Caution should be observed when initiating therapy in patients with heart failure. Patients with heart failure given valsartan tablets 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.
If excessive hypotension occurs, the patient should be placed in the 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.
5.3Impaired Renal 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 renin-angiotensin 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 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 valsartan tablets [see Drug Interactions (7)].
5.4Hyperkalemia Some patients with heart failure have developed increases in potassium. 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 valsartan tablets may be required [see Adverse Reactions (6.1)].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain (6.1) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia (6.1) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088, or http://www.fda.gov/medwatch
6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Valsartan has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The overall incidence of adverse reactions with valsartan was similar to placebo. The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2% of placebo patients.
The most common reasons for discontinuation of therapy with valsartan were headache and dizziness. The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with valsartan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs.
1%), and abdominal pain (2% vs. 1%). Headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia occurred at a more than 1% rate but at about the same incidence in placebo and valsartan patients.
In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p <0.001). Dose-related orthostatic effects were seen in less than 1% of patients.
An increase in the incidence of dizziness was observed in patients treated with valsartan 320 mg (8%) compared to 10 to 160 mg (2% to 4%). Valsartan has been used concomitantly with hydrochlorothiazide without evidence of clinically important adverse interactions. Other adverse reactions that occurred in controlled clinical trials of patients treated with valsartan (>0.2% of valsartan patients) are listed below.
It cannot be determined whether these events were causally related to valsartan . Body as a Whole : Allergic reaction and asthenia Cardiovascular: Palpitations Dermatologic: Pruritus and rash Digestive: Constipation, dry mouth, dyspepsia, and flatulence Musculoskeletal: Back pain, muscle cramps, and myalgia Neurologic and Psychiatric: Anxiety, insomnia, paresthesia, and somnolence Respiratory: Dyspnea Special Senses: Vertigo Urogenital: Impotence Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.
Pediatric Hypertension Valsartan has been evaluated for safety in over 400 pediatric patients aged 6 to 17 years and more than 160 pediatric patients aged 6 months to 5 years. No relevant differences were identified between the adverse experience profile for pediatric patients aged 6 to 16 years and that previously reported for adult patients. Headache and hyperkalemia were the most common adverse events suspected to be study drug-related in older children (6 to 17 years old) and younger children (6 months to 5 years old), respe…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No clinically significant pharmacokinetic interactions were observed when valsartan tablets was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone. Coadministration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin.
CYP 450 Interactions: In vitro metabolism studies indicate that CYP 450 mediated drug interactions between valsartan and coadministered drugs are unlikely because of the low extent of metabolism [see Clinical Pharmacology (12.3)]. Transporters: The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Co-administration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium sparing diuretics (e.g. spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable. Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure.
These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including valsartan may be attenuated by NSAIDs including selective COX-2 inhibitors.
Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.
Closely monitor blood pressure, renal function and electrolytes in patients on valsartan tablets and other agents that affect the RAS. Do not coadminister aliskiren with valsartan tablets in patients with diabetes. Avoid use of aliskiren with valsartan tablets in patients with renal impairment (GFR <60 mL/min).
Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including valsartan tablets. Monitor serum lithium levels during concomitant use. Potassium sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine (7 NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect (7) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7) Lithium: Increases in serum lithium concentrations and lithium toxicity
7.1Clinical Laboratory Test Findings In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of valsartan tablets. Creatinine:…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Nursing or drug should be discontinued (8.3); Pediatrics : Efficacy and safety data support use in 6 to 16 year old patients(8.4); use is not recommended in patients <6 years old (6.1, 8.4)
8.1Pregnancy 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 valsartan as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. 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.
Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment.
If oligohydramnios is observed, discontinue valsartan, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Closely observe infants with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)].
8.3Nursing Mothers It is not known whether valsartan is excreted in human milk. Valsartan was excreted in the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from valsartan, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
8.4Pediatric Use The antihypertensive effects of valsartan have been evaluated in two randomized, double-blind clinical studies in pediatric patients from 1 to 5 and 6 to 16 years of age [see Clinical Studies (14.1)] . The pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see Pharmacokinetics, Special Populations, Pediatric (12.3)] . Valsartan was generally well tolerated in children 6 to 16 years and the adverse experience profile was similar to that described for adults.
In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. Valsartan is not recommended for pediatric patients under 6 years of age due to safety findings for which a relationship to treatment could not be excluded [see Adverse Reactions, Pediatric Hypertension (6.1)] . No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73m 2 .
There is limited clinical experience with valsartan in pediatric patients with mild to moderate hepatic impairment [see Warnings and Precautions (5.3)]. Daily oral dosing of neonatal/juvenile rats with valsartan at doses as low as 1 mg/kg/day (about 10% of the maximum recommended pediatric dose on a mg/m 2 basis) from postnatal day 7 to postnatal day 70 produced persistent, irreversible kidney damage. These kidney effects in neonatal rats represent expected exaggerated ph…
🤰 Pregnancy ▾
8.1Pregnancy 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 valsartan as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. 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.
Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment.
If oligohydramnios is observed, discontinue valsartan, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Closely observe infants with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)].
🧒 Pediatric Use ▾
8.4Pediatric Use The antihypertensive effects of valsartan have been evaluated in two randomized, double-blind clinical studies in pediatric patients from 1 to 5 and 6 to 16 years of age [see Clinical Studies (14.1)] . The pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see Pharmacokinetics, Special Populations, Pediatric (12.3)] . Valsartan was generally well tolerated in children 6 to 16 years and the adverse experience profile was similar to that described for adults.
In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. Valsartan is not recommended for pediatric patients under 6 years of age due to safety findings for which a relationship to treatment could not be excluded [see Adverse Reactions, Pediatric Hypertension (6.1)] . No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73m 2 .
There is limited clinical experience with valsartan in pediatric patients with mild to moderate hepatic impairment [see Warnings and Precautions (5.3)]. Daily oral dosing of neonatal/juvenile rats with valsartan at doses as low as 1 mg/kg/day (about 10% of the maximum recommended pediatric dose on a mg/m 2 basis) from postnatal day 7 to postnatal day 70 produced persistent, irreversible kidney damage. These kidney effects in neonatal rats represent expected exaggerated pharmacological effects that are observed if rats are treated during the first 13 days of life.
Since this period coincides with up to 44 weeks after conception in humans, it is not considered to point toward an increased safety concern in 6 to 16 year old children. Neonates with a history of in utero exposure to v alsartan : If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
🧓 Geriatric Use ▾
8.5Geriatric Use In the controlled clinical trials of valsartan, 1,214 (36.2%) of hypertensive patients treated with valsartan were ≥65 years and 265 (7.9%) were ≥75 years. No overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. Of the 2,511 patients with heart failure randomized to valsartan in the Valsartan Heart Failure Trial, 45% (1,141) were 65 years of age or older.
There were no notable differences in efficacy or safety between older and younger patients in either trial.
🆘 Overdosage ▾
10 OVERDOSAGE Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported.
If symptomatic hypotension should occur, supportive treatment should be instituted. Valsartan tablets is not removed from the plasma by hemodialysis. Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the maximum recommended human dose on a mg/m 2 basis).
(Calculations assume an oral dose of 320 mg/day and a 60-kg patient.)
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland.
Its action is therefore independent of the pathways for angiotensin II synthesis. There is also an AT 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT 1 receptor than for the AT 2 receptor.
The increased plasma levels of angiotensin II following AT 1 receptor blockade with valsartan may stimulate the unblocked AT 2 receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT 1 receptor about one-200th that of valsartan itself. Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension.
ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known.
Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.
12.2Pharmacodynamics Valsartan inhibits the pressor effect of angiotensin II infusions. An oral dose of 80 mg inhibits the pressor effect by about 80% at peak with approximately 30% inhibition persisting for 24 hours. No information on the effect of larger doses is available.
Removal of the negative feedback of angiotensin II causes a 2- to 3-fold rise in plasma renin and consequent rise in angiotensin II plasma concentration in hypertensive patients. Minimal decreases in plasma aldosterone were observed after administration of valsartan; very little effect on serum potassium was observed. In multiple-dose studies in hypertensive patients with stable renal insufficiency and patients with renovascular hypertension, valsartan had no clinically significant effects on glomerular filtration rate, filtration fraction, creatinine clearance, or renal plasma flow.
In multiple-dose studies in hypertensive patients, valsartan had no notable effects on total cholesterol, fasting triglycerides, fasting serum glucose, or uric acid.
12.3Pharmacokinetics Valsartan peak plasma concentration is reached 2 to 4 hours after dosing. Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours. Absolute bioavailability for valsartan is about 25% (range 10% to 35%).
The bioavailability of the suspension [see Dosage and Administration; Pediatric Hypertension (2.2)] is 1.6 times greater than with the tablet. With the tablet, food decreases the exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (C max ) by about 50%. AUC and C max values of valsartan increase approximately linearly with increasing dose over the clinical dosing range.
Valsartan does not accumulate appreciably in plasma following repeated administration. Metabolism and Elimination: Valsartan, when administered as an oral solution, is primarily recovered…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland.
Its action is therefore independent of the pathways for angiotensin II synthesis. There is also an AT 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT 1 receptor than for the AT 2 receptor.
The increased plasma levels of angiotensin II following AT 1 receptor blockade with valsartan may stimulate the unblocked AT 2 receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT 1 receptor about one-200th that of valsartan itself. Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension.
ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known.
Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Valsartan is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below. Valsartan tablets USP, 40 mg: Yellow colored, oval shaped, biconvex, film coated tablets, debossed with L128 and breakline on one side and 40 on the other side.
NDC46708-044-30 bottle of 30 tablets NDC 46708-044-90 bottle of 90 tablets NDC 46708-044-71 bottle of 500 tablets NDC 46708-044-91 bottle of 1000 tablets NDC 46708-044-10 cartons of 100 (10X10 unit-dose blisters) Valsartan tablets USP, 80 mg: Pink colored, oval shaped, biconvex, film coated tablets, debossed with L129 on one side and 80 on the other side. NDC 46708-045-30 bottle of 30 tablets NDC 46708-045-90 bottle of 90 tablets NDC 46708-045- 71 bottle of 500 tablets NDC 46708-045-91 bottle of 1000 tablets NDC 46708-045-10 cartons of 100 (10X10 unit-dose blisters) Valsartan tablets USP, 160 mg: Yellow colored, oval shaped, biconvex, film coated tablets, debossed with L130 on one side and 160 on the other side.
NDC 46708-046-30 bottle of 30 tablets NDC 46708-046-90 bottle of 90 tablets NDC 46708-046- 71 bottle of 500 tablets NDC 46708-046-91 bottle of 1000 tablets NDC 46708-046-10 cartons of 100 (10X10 unit-dose blisters) Valsartan tablets USP, 320 mg: Purple colored, oval shaped, biconvex, film coated tablets, debossed with L127 on one side and 320 on the other side. NDC 46708-047-30 bottle of 30 tablets NDC 46708-047-90 bottle of 90 tablets NDC 46708-047- 71 bottle of 500 tablets NDC 46708-047- 91 bottle of 1000 tablets Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].
Protect from moisture. Dispense in tight container (USP).
📋 Description ▾
11 DESCRIPTION Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2'-(1 H -tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is Valsartan is a white to practically white fine powder.
It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol.
Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red. Structure
💬 Information for Patients ▾
17 PATIENT INFORMATION Information for Patients Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to 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.
Valsartan Tablets, USP Read the Patient Information that comes with valsartan tablets before you take 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 valsartan tablets, ask your doctor or pharmacist. What is the most important information I should know about valsartan tablets? Valsartan tablets can cause harm or death to an unborn baby.
Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking valsartan tablets, tell your doctor right away. What is valsartan tablet?
Valsartan tablets are prescription medicine called an angiotensin receptor blocker (ARB). It is used in adults to: lower high blood pressure (hypertension) in adults and children, 6 to 16 years of age. treat heart failure in adults. In these patients, valsartan tablets may lower the need for hospitalization that happens from heart failure.
Valsartan tablets are not for children under 6 years of age or children with certain kidney problems. High Blood Pressure (Hypertension). Blood pressure is the force in your blood vessels when your heart beats and when your heart rests.
You have high blood pressure when the force is too much. Valsartan tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.Medicines that lower your 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 the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure and vision problems. Heart Failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body.
Just walking or moving can make you short of breath, so you may have to rest a lot. What should I tell my doctor before taking valsartan tablets? Tell your doctor about all your medical conditions including whether you: have any allergies.
See the end of this leaflet for a complete list of ingredients in valsartan tablets. have a heart condition have liver problems have kidney problems are pregnant or planning to become pregnant. See “ What is the most important information I should know about valsartan tablets ?” are breast-feeding. It is not known if valsartan passes into your breast milk.
You and your doctor should decide if you will take valsartan tablets or breast-feed, but not both. Talk with your doctor about the best way to feed your baby if you take valsartan tablets. have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue and/or throat, and may cause difficulty breathing.
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take: other medicines for high blood pressure or a heart problem water pills (also called “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) certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drug…