sacubitril and valsartan 97 mg; 103 mg Tablet, 60-count — NDC 13668-636-60 (Billing 13668-0636-60)
This is a package of 60 tablets of sacubitril and valsartan 97 mg; 103 mg Tablet from Torrent Pharmaceuticals Limited, marketed since Jul 2025 and currently FDA-listed, this package's marketing is listed to end Dec 2026; retail pharmacies pay about $0.5921 per tablet (NADAC). It is the main listing for this product, which comes in 4 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 074410
- GCN: 39048
- GPI-14 (Medi-Span): 40992002600340
- HICL (First Databank): 042256
- AHFS class code: 24:32.12.00
- RxCUI (RxNorm): 1656340
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Angiotensin II receptor blockers (ARBs), other combinations class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Sacubitril and valsartan works on two fronts at once. One part (sacubitril) helps your body's own protective heart hormones stick around longer, which helps your kidneys get rid of...
- What exactly is this medication supposed to do for my heart failure?
- That's a really important question. A few combinations need to be avoided or watched carefully. You should never take this with an ACE inhibitor like lisinopril or enalapril at the...
- Can I take it with my other medications? I'm also on ibuprofen sometimes for pain.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.592 | $35.53 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $2.39 | $143.68 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $1.45 | $87.14 / 60 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 13668-0636-05 13668-636-05 | 500 TABLET in 1 BOTTLE | — | — | 2025-07-16 | Dec 31, 2026 | Active |
| 13668-0636-33 13668-636-33 | 180 TABLET in 1 BOTTLE | $0.5921 / ea | $106.58 | 2025-07-16 | Dec 31, 2026 | Active |
| 13668-0636-60 You're viewing this Main listing | 60 TABLET in 1 BOTTLE | $0.5921 / ea | $35.53 | 2025-07-16 | Dec 31, 2026 | Active |
| 13668-0636-74 13668-636-74 | 100 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK | — | — | 2025-07-16 | Dec 31, 2026 | Active |
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.5921 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 97% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 13668-0636-33?
What NDC number is used to bill for this package of sacubitril and valsartan 97 mg; 103 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sacubitril and Valsartan 97 mg/1; 103 mg 00904-7581-04 | Major | 1 tablet | $0.592 | AB | Availability likely | — |
| sacubitril and valsartan 97 mg/1; 103 mgthis 13668-0636-60 | Torrent | 60 tablets | $0.592 | AB | Availability likely | — |
| Sacubitril and valsartan 97 mg/1; 103 mg 31722-0675-18 | Camber | 180 tablets | $0.592 | AB | Availability likely | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 33342-0572-09 | Macleods | 60 tablets | $0.592 | AB | Availability likely | — |
| Sacubitril and Valsartan Sacubitril and Valsartan 97 mg/1; 103 mg 43598-0645-18 | Dr. | 180 tablets | $0.592 | AB | Availability likely | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 50268-0608-13 | AvPAK | 1 tablet | $0.592 | AB | Availability likely | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 60687-0977-57 | American | 1 tablet | $0.592 | AB | Availability likely | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 69238-2733-01 | Amneal | 60 tablets | $0.592 | AB | Availability likely | — |
| sacubitril and valsartan 97 mg/1; 103 mg 70748-0197-07 | Lupin | 60 tablets | $0.592 | AB | Availability likely | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 70954-0977-20 | ANI | 60 tablets | $0.592 | AB | Availability likely | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 72205-0282-18 | Novadoz | 180 tablets | $0.592 | AB | Availability likely | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 82293-0029-10 | Novugen | 60 tablets | $0.592 | AB | Availability likely | — |
| Entresto 97 mg/1; 103 mg 00078-0696-20 | Novartis | 60 tablets | $11.589 | AB | Availability likely | +1857% |
| sacubitril and valsartan 97 mg/1; 103 mg 13668-0747-05 | Torrent | 500 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 42385-0932-18 | Laurus | 180 tablets | — | AB | FDA listed | — |
| sacubitril and valsartan 97 mg/1; 103 mg 46708-0558-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
| sacubitril and valsartan 97 mg/1; 103 mg 51407-0937-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| sacubitril and valsartan 97 mg/1; 103 mg 62332-0558-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 67877-0709-51 | Ascend | 180 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 67877-0950-33 | Ascend | 10 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 70069-0855-60 | Somerset | 60 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 70377-0033-11 | Biocon | 30 tablets | — | AB | FDA listed | — |
| sacubitril and valsartan 97 mg/1; 103 mg 70710-1274-04 | Zydus | 100 tablets | — | AB | FDA listed | — |
| sacubitril and valsartan 97 mg/1; 103 mg 70771-1923-04 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Entresto 97 mg/1; 103 mg 71610-0807-37 | Aphena | 3120 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 71610-0955-19 | Aphena | 3060 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 71610-0984-37 | Aphena | 3120 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 72865-0312-10 | XLCare | 1000 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 73190-0007-10 | AvKARE | 1000 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 73190-0019-18 | AvKARE | 180 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 82293-0040-10 | Novugen | 60 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 72603-0882-01 | NorthStar | 60 tablets | — | AB | FDA listed | — |
| Sacubitril and Valsartan 97 mg/1; 103 mg 60290-0087-01 | Umedica | 60 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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UNII 7773C1ROEU
Low-substituted hydroxypropyl cellulose is a plant-derived thickener and binder made from cellulose. In medicines, it helps bind tablet ingredients together, controls how quickly the medicine dissolves, and improves texture in liquids and semi-solid formulations.
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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 X7XJ6RM9Q2
A plant-derived cellulose processed into tiny crystals. It acts as a binder and filler to give the tablet or capsule structure and helps the medicine break apart properly in your stomach.
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UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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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 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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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.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue sacubitril and valsartan tablets as soon as possible ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue sacubitril and valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1 ) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2 )
1.1Adult Heart Failure Sacubitril and valsartan tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. LVEF is a variable measure, so use clinical judgment in deciding whom to treat [see Clinical Studies ( 14.1 )] .
1.2Pediatric Heart Failure Sacubitril and valsartan tablets are indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. The target maintenance dose is 97 mg/103mg orally twice daily. (2.2) Adjust adult doses every 2 to 4 weeks to the target maintenance dose, as tolerated by the patient.
( 2.2 ) For pediatric patients, see the Full Prescribing Information for recommended dosage, titrations, preparation and administration instructions. (2.3, 2.4) Reduce starting dose to half the usually recommended starting dosage for: o patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents. ( 2.6 ) o patients with severe renal impairment.( 2.7 ) o patients with moderate hepatic impairment.
( 2.8 )
2.1General Considerations Sacubitril and valsartan tablets are contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. If switching from an ACE inhibitor to sacubitril and valsartan tablets allow a washout period of 36 hours between administration of the two drugs [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] .
2.2Adult Heart Failure The recommended starting dose of sacubitril and valsartan tablet is 49/51 mg orally twice-daily. Double the dose of sacubitril and valsartan tablets after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
2.3Pediatric Heart Failure For the recommended dosage for pediatric patients aged 1 year and older, refer to Table 1 if using the tablets. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.
Table 1: Recommended Dose and Titration for Pediatric Patients Using Tablets Weight (kg) Titration Step Dose (twice daily) Starting Second Final Less than 40 kg † 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg At least 40 kg, less than 50 kg 24 mg/26 mg 49 mg/51 mg 72 mg/78 mg ‡ At least 50 kg 49 mg/51 mg 72 mg/78 mg ‡ 97 mg/103 mg † Use of the oral suspension is recommended in these patients. Recommended mg/kg doses are of the combined amount of both sacubitril and valsartan [see Dosage and Administration (2.4)] . ‡ Doses of 72 mg/78 mg can be achieved using three 24 mg/26 mg tablets [see Dosage Forms and Strengths (3)] .
2.4Preparation of Oral Suspension Using Tablets Sacubitril and valsartan oral suspension can be substituted at the recommended tablet dosage in patients unable to swallow tablets. Sacubitril and valsartan 800 mg/200 mL oral suspension can be prepared in a concentration of 4 mg/mL (sacubitril/valsartan 1.96/2.04 mg/mL). Use sacubitril and valsartan 49/51 mg tablets in the preparation of the suspension.
To make an 800 mg/200 mL (4 mg/mL) oral suspension, transfer eight tablets of sacubitril and valsartan 49/51 mg film-coated tablets into a mortar. Crush the tablets into a fine powder using a pestle. Add 60 mL of Ora-Plus ® into the mortar and triturate gently with pestle for 10 minutes, to form a uniform suspension.
Add 140 mL of Ora-Sweet ® SF into mortar and triturate with pestle for another 10 minutes, to form a uniform suspension. Transfer the entire contents from the mortar into a clean 200 mL amber colored PET or glass bottle. Place a press-in bottle adapter and close the bottle with a child resistant cap.
The oral suspension can be stored for up to 15 days. Do not store above 25°C (77°F) and do not refrigerate. Shake before each use. *Ora-Sweet SF ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc.
2.6Dose Adjustment for Patients Not Taking an ACE inhibitor or ARB or Previously Taking Low Doses of These Agents In patients not currently taking an ACE inhibitor or an angiotensin II receptor blocker (ARB) and for patients previously taking low doses of these agents, start sacubitril and valsartan tablets at half the usually recommended starting dose. After initiation, increase the dose every 2 to 4 weeks in adults and every 2 weeks in pediatri… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sacubitril and valsartan film-coated tablets are supplied as unscored, round shaped (24/26 mg) and oval shaped (49/51 mg and 97/103 mg) tablets in following strengths: Sacubitril and Valsartan Tablets 24/26 mg, (sacubitril 24 mg and valsartan 26 mg) are violet white colored, round shaped, biconvex, film coated tablet with beveled edges, unscored, debossed with "U4" on one side and plain on the other side. Sacubitril and Valsartan Tablets 49/51 mg, (sacubitril 49 mg and valsartan 51 mg) are pale yellow colored, oval shaped, biconvex, film coated tablet with beveled edges, unscored, debossed with “U5” on one side and plain on other side.
Sacubitril and Valsartan Tablets 97/103 mg, (sacubitril 97 mg and valsartan 103 mg) are light pink colored, oval shaped, biconvex, film coated tablet with beveled edges, unscored, debossed with “U7” on one side and plain on other side. or Sacubitril and Valsartan Tablets 49/51 mg, (sacubitril 49 mg and valsartan 51 mg) are white to off white, oval shaped, biconvex, film coated tablet with beveled edges, unscored, debossed with "U5" on one side and plain on other side. Sacubitril and Valsartan Tablets 97/103 mg, (sacubitril 97 mg and valsartan 103 mg) are white to off white, oval shaped, biconvex, film coated tablet with beveled edges, unscored, debossed with "U7" on one side and plain on other side.
Film-coated tablets: 24/26 mg; 49/51 mg; 97/103 mg (3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sacubitril and valsartan tablets are contraindicated: in patients with hypersensitivity to any component in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions ( 5.2 )] with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions ( 7.1 )] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions ( 7.1 )] Hypersensitivity to any component.
(4 ) History of angioedema related to previous ACEi or ARB therapy. ( 4 ) Concomitant use with ACE inhibitors. ( 4 , 7.1 ) Concomitant use with aliskiren in patients with diabetes.
( 4 , 7.1 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Observe for signs and symptoms of angioedema and hypotension. ( 5.2 , 5.3 ) Monitor renal function and potassium in susceptible patients. ( 5.4 , 5.5 )
5.1Fetal Toxicity Sacubitril and valsartan can cause fetal harm when administered to a pregnant woman. 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. When pregnancy is detected, consider alternative drug treatment and discontinue sacubitril and valsartan tablets.
However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus [see Use in Specific Populations ( 8.1 )].
5.2Angioedema Sacubitril and valsartan may cause angioedema [see Adverse Reactions ( 6.1 )] . If angioedema occurs, discontinue sacubitril and valsartan tablets immediately, provide appropriate therapy, and monitor for airway compromise. Sacubitril and valsartan must not be re-administered.
In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1,000 (0.3 mL to 0.5 mL) and take measures necessary to ensure maintenance of a patent airway.
Sacubitril and valsartan has been associated with a higher rate of angioedema in Black than in non-Black patients. Patients with a prior history of angioedema may be at increased risk of angioedema with sacubitril and valsartan [see Adverse Reactions ( 6.1 )] . Sacubitril and valsartan must not be used in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy [see Contraindications ( 4 )] .
Sacubitril and valsartan should not be used in patients with hereditary angioedema.
5.3Hypotension Sacubitril and valsartan lowers blood pressure and may cause symptomatic hypotension [see Adverse Reactions ( 6.1 )] . Patients with an activated renin-angiotensin system, such as volume-and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. Correct volume or salt depletion prior to administration of sacubitril and valsartan or start at a lower dose.
If hypotension occurs, consider dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia). If hypotension persists despite such measures, reduce the dosage or temporarily discontinue sacubitril and valsartan tablets. Permanent discontinuation of therapy is usually not required.
5.4Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), decreases in renal function may be anticipated in susceptible individuals treated with sacubitril and valsartan [see Adverse Reactions ( 6.1 )]. In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death.
Closely monitor serum creatinine, and down-titrate or interrupt sacubitril and valsartan in patients who develop a clinically significant decrease in renal function [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )]. As with all drugs that affect the RAAS, sacubitril and valsartan may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions ( 5.2 )] Hypotension [see Warnings and Precautions ( 5.3 )] Impaired Renal Function [see Warnings and Precautions ( 5.4 )] Hyperkalemia [see Warnings and Precautions ( 5.5 )] Adverse reactions occurring greater than or equal to 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc., at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 6,622 heart failure patients were treated with sacubitril and valsartan in the PARADIGM-HF (vs. enalapril) and PARAGON-HF (vs. valsartan) clinical trials. Of these, 5,085 were exposed for at least 1 year.
Adult Heart Failure In PARADIGM-HF, patients were required to complete sequential enalapril and sacubitril and valsartan run-in periods of (median) 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing sacubitril and valsartan and enalapril. During the enalapril run-in period, 1,102 patients (10.5%) were permanently discontinued from the study, 5.6% because of an adverse event, most commonly renal dysfunction (1.7%), hyperkalemia (1.7%) and hypotension (1.4%). During the sacubitril and valsartan run-in period, an additional 10.4% of patients permanently discontinued treatment, 5.9% because of an adverse event, most commonly renal dysfunction (1.8%), hypotension (1.7%) and hyperkalemia (1.3%).
Because of this run-in design, the adverse reaction rates described below are lower than expected in practice. In the double-blind period, safety was evaluated in 4,203 patients treated with sacubitril and valsartan and 4,229 treated with enalapril. In PARADIGM-HF, patients randomized to sacubitril and valsartan received treatment for up to 4.3 years, with a median duration of exposure of 24 months; 3,271 patients were treated for more than one year.
Discontinuation of therapy because of an adverse event during the double-blind period occurred in 450 (10.7%) of sacubitril and valsartan-treated patients and 516 (12.2%) of patients receiving enalapril. Adverse reactions occurring at an incidence of greater than or equal to 5% in patients who were treated with sacubitril and valsartan in the double-blind period of PARADIGM-HF are shown in Table 3. In PARADIGM-HF, the incidence of angioedema was 0.1% in both the enalapril and sacubitril and valsartan run-in periods.
In the double-blind period, the incidence of angioedema was higher in patients treated with sacubitril and valsartan than enalapril (0.5% and 0.2%, respectively). The incidence of angioedema in Black patients was 2.4% with sacubitril and valsartan and 0.5% with enalapril [see Warnings and Precautions ( 5.2 )]. Orthostasis was reported in 2.1% of patients treated with sacubitril and valsartan compared to 1.1% of patients treated with enalapril during the double-blind period of PARADIGM-HF.
Falls were reported in 1.9% of patients treated with sacubitril and valsartan compared to 1.3% of patients treated with enalapril. Table 3: Adverse Reactions Reported in greater than or equal to 5% of Patients Treated with Sacubitril and valsartan in the Double-Blind Period of PARADIGM-HF Sacubitril and valsartan (n = 4,203) % Enalapril (n = 4,229) % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5 In PARAGON-HF, no new adverse reactions were identified. Pediatric Heart Failure The adverse reactions observed in pediatric patients 1 year to less than 18 years old who received treatment with sacubitril and valsartan were… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Avoid concomitant use with aliskiren in patients with estimated glomerular filtration rate (eGFR) less than 60. ( 7.1 ) Potassium-sparing diuretics: May lead to increased serum potassium. ( 7.2 ) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): May lead to increased risk of renal impairment. ( 7.3 ) Lithium: Increased risk of lithium toxicity. ( 7.4 )
7.1Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of sacubitril and valsartan with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications ( 4 )] . Avoid use of sacubitril and valsartan with an ARB, because sacubitril and valsartan contains the angiotensin II receptor blocker valsartan . The concomitant use of sacubitril and valsartan with aliskiren is contraindicated in patients with diabetes [see Contraindications ( 4 )] .
Avoid use with aliskiren in patients with renal impairment (eGFR less than 60 mL/min/1.73 m 2 ).
7.2Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions ( 5.5 )] .
7.3Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) 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, concomitant use of NSAIDs, including COX-2 inhibitors, with sacubitril and valsartan may result in worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically.
7.4Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with sacubitril and valsartan.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended. ( 8.2 ) Severe Hepatic Impairment: Use not recommended. ( 2. 8, 8.6 )
8.1Pregnancy Risk Summary Sacubitril and valsartan can cause fetal harm when administered to a pregnant woman. 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 (see Clinical Considerations) . 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.
In animal reproduction studies, sacubitril and valsartan treatment during organogenesis resulted in increased embryo-fetal lethality in rats and rabbits and teratogenicity in rabbits (see Data) . When pregnancy is detected, consider alternative drug treatment and discontinue sacubitril and valsartan tablets. However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions 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.
Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates with histories of in utero exposure to sacubitril and valsartan for hypotension, oliguria, and hyperkalemia.
In neonates with a history of in utero exposure to sacubitril and valsartan, 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 renal function. Data Animal Data Sacubitril and valsartan treatment during organogenesis resulted in increased embryo-fetal lethality in rats at doses greater than or equal to 49 mg sacubitril/51 mg valsartan/kg/day (less than or equal to 0.06 [LBQ657, the active metabolite] and 0.72 [valsartan]-fold the maximum recommended human dose [MRHD] of 97/103 mg twice-daily on the basis of the area under the plasma drug concentration-time curve [AUC]) and rabbits at doses greater than or equal to 5 mg sacubitril/5 mg valsartan/kg/day (2-fold and 0.03-fold the MRHD on the basis of valsartan and LBQ657 AUC, respectively).
Sacubitril and valsartan is teratogenic based on a low incidence of fetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at a sacubitril and valsartan dose of greater than or equal to 5 mg sacubitril/5 mg valsartan/kg/day. The adverse embryo-fetal effects of sacubitril and valsartan are attributed to the angiotensin receptor antagonist activity. Pre- and postnatal development studies in rats at sacubitril doses up to 750 mg/kg/day (2.2-fold the MRHD on the basis of LBQ657 AUC) and valsartan at doses up to 600 mg/kg/day (0.86-fold the MRHD on the basis of AUC) indicate that treatment with sacubitril an… [Excerpted — this section continues on DailyMed.]
🆘 Overdosage ▾
10 OVERDOSAGE Limited data are available with regard to overdosage in human subjects with sacubitril and valsartan. In healthy volunteers, a single dose of sacubitril and valsartan 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of sacubitril and valsartan.
Symptomatic treatment should be provided. Sacubitril and valsartan is unlikely to be removed by hemodialysis because of high protein binding.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sacubitril and valsartan tablets contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. Sacubitril and valsartan inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT 1 ) receptor via valsartan. The cardiovascular and renal effects of sacubitril and valsartan in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan.
Valsartan inhibits the effects of angiotensin II by selectively blocking the AT 1 receptor, and also inhibits angiotensin II-dependent aldosterone release.
12.2Pharmacodynamics The pharmacodynamic effects of sacubitril and valsartan were evaluated after single and multiple dose administrations in healthy subjects and in patients with heart failure, and are consistent with simultaneous neprilysin inhibition and renin-angiotensin system blockade. In a 7-day valsartan-controlled study in patients with reduced ejection fraction (HFrEF), administration of sacubitril and valsartan resulted in a significant non-sustained increase in natriuresis, increased urine cGMP, and decreased plasma MR-proANP and NT-proBNP compared to valsartan.
In a 21-day study in HFrEF patients, sacubitril and valsartan significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1. Sacubitril and valsartan also blocked the AT 1 -receptor as evidenced by increased plasma renin activity and plasma renin concentrations. In PARADIGM-HF, sacubitril and valsartan decreased plasma NT-proBNP (not a neprilysin substrate) and increased plasma BNP (a neprilysin substrate) and urine cGMP compared with enalapril.
In PARAMOUNT, a randomized, double-blind, 36-week study in patients with heart failure with LVEF greater than or equal to 45% comparing 97/103 mg of sacubitril and valsartan (n=149) to 160 mg of valsartan (n =152) twice-daily, sacubitril and valsartan decreased NT-proBNP by 17% while valsartan increased NT-proBNP by 8% at Week 12 (p = 0.005). In PARAGON-HF, sacubitril and valsartan decreased NT-proBNP by 24% (Week 16) and 19% (Week 48) compared to 6% and 3% reductions on valsartan, respectively. In PANORAMA-HF, a reduction in NT-proBNP was observed at Weeks 4 and 12 for sacubitril and valsartan (40% and 50%) compared to baseline.
The NT-proBNP levels continued to decrease over the duration of the study with a reduction of 65% for sacubitril and valsartan at Week 52 compared to baseline. QT Prolongation: In a thorough QTc clinical study in healthy male subjects, single doses of sacubitril and valsartan tablets 194 mg sacubitril/206 mg valsartan and 583 mg sacubitril/617 mg valsartan had no effect on cardiac repolarization. Amyloid-β: Neprilysin is one of multiple enzymes involved in the clearance of amyloid-β (Aβ) from the brain and cerebrospinal fluid (CSF).
Administration of sacubitril and valsartan tablets 194 mg sacubitril/206 mg valsartan once-daily for 2 weeks to healthy subjects was associated with an increase in CSF Aβ 1-38 compared to placebo; there were no changes in concentrations of CSF Aβ 1-40 or CSF Aβ 1-42 . The clinical relevance of this finding is unknown [see Nonclinical Toxicology ( 13 )] . Blood Pressure: Addition of a 50 mg single dose of sildenafil to sacubitril and valsartan at steady state (194 mg sacubitril/206 mg valsartan once daily for 5 days) in patients with hypertension was associated with additional blood pressure (BP) reduction (approximately 5/4 mmHg, systolic/diastolic BP) compared to administration of sacubitril and valsartan alone.
Co-administration of sacubitril and valsartan did not significantly alter the BP effect of intravenous nitroglycerin.
12.3Pharmacokinetics Absorption Following oral administrati… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sacubitril and valsartan tablets are unscored, round shaped (24/26 mg) and oval shaped (49/51 mg and 97/103 mg), biconvex, film-coated tablets with beveled edges. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below. Sacubitril and valsartan Tablets Sacubitril/Valsartan mg/mg Color Debossment NDC 13668-XXX-XX Bottle of 60 Bottle of 180 Bottle of 500 Carton of 100 (10x10) unit- dose tablets 24/26 Violet white U4 634-60 634-33 634-05 634-74 49/51 Pale yellow U5 635-60 635-33 635-05 635-74 97/103 Light pink U7 636-60 636-33 636-05 636-74 or Sacubitril and valsartan Tablets Sacubitril/Valsartan mg/mg Color Debossment NDC 13668-XXX-XX Bottle of 60 Bottle of 180 Bottle of 500 Carton of 100 (10x10) unit- dose tablets 24/26 Violet white U4 634-60 634-33 634-05 634-74 49/51 White to off white U5 746-60 746-33 746-05 746-74 97/103 White to off white U7 747-60 747-33 747-05 747-74 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Protect from moisture.
📋 Description ▾
11 DESCRIPTION Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan contain anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, Sacubitril and valsartan dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan.
The Sacubitril and valsartan is chemically described as Trisodium (4-{[(1 S ,3 R )-1-([1,1'-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-( N -pentanoyl- N -{[(2'-(1 H -tetrazol-1-id-5-yl)[1,1'-biphenyl]-4-yl]methyl}-L-valinate). Its empirical formula is C 48 H 55 N 6 O 8 Na 3 . Its molecular mass is 912.96 g/mol and its schematic structural formula is: Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan.
The tablet inactive ingredients are crospovidone, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and talc. The film-coat inactive ingredients are hypromellose, macrogol/PEG, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet contains iron oxide black and iron oxide red.
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🔬 Clinical Studies ▾
14 CLINICAL STUDIES Dosing in clinical trials was based on the total amount of both components of sacubitril and valsartan tablets, i.e., 24/26 mg, 49/51 mg, and 97/103 mg were referred to as 50 mg, 100 mg, and 200 mg, respectively.
14.1Adult Heart Failure PARADIGM-HF PARADIGM-HF was a multinational, randomized, double-blind trial comparing sacubitril and valsartan tablets and enalapril in 8,442 adult patients with symptomatic chronic heart failure (NYHA class II to IV) and systolic dysfunction (left ventricular ejection fraction ≤ 40%). Patients had to have been on an ACE inhibitor or ARB for at least four weeks and on maximally tolerated doses of beta-blockers. Patients with a systolic blood pressure of less than 100 mmHg at screening were excluded.
The primary objective of PARADIGM-HF was to determine whether sacubitril and valsartan tablets, a combination of sacubitril and an RAS inhibitor (valsartan), was superior to an RAS inhibitor (enalapril) alone in reducing the risk of the combined endpoint of cardiovascular (CV) death or hospitalization for heart failure (HF). After discontinuing their existing ACE inhibitor or ARB therapy, patients entered sequential single-blind run-in periods during which they received enalapril 10 mg twice-daily, followed by sacubitril and valsartan tablets 100 mg twice-daily, increasing to 200 mg twice-daily.
Patients who successfully completed the sequential run-in periods were randomized to receive either sacubitril and valsartan tablets 200 mg (N = 4,209) twice-daily or enalapril 10 mg (N = 4,233) twice-daily. The primary endpoint was the first event in the composite of CV death or hospitalization for HF. The median follow-up duration was 27 months and patients were treated for up to 4.3 years.
The population was 66% Caucasian, 18% Asian, and 5% Black; the mean age was 64 years and 78% were male. At randomization, 70% of patients were NYHA Class II, 24% were NYHA Class III, and 0.7% were NYHA Class IV. The mean left ventricular ejection fraction was 29%.
The underlying cause of heart failure was coronary artery disease in 60% of patients; 71% had a history of hypertension, 43% had a history of myocardial infarction, 37% had an eGFR less than 60 mL/min/1.73m 2 , and 35% had diabetes mellitus. Most patients were taking beta-blockers (94%), mineralocorticoid antagonists (58%), and diuretics (82%). Few patients had an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) (15%).
PARADIGM-HF demonstrated that sacubitril and valsartan tablets, a combination of sacubitril and an RAS inhibitor (valsartan), was superior to a RAS inhibitor (enalapril), in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis (hazard ratio [HR] 0.80; 95% confidence interval [CI], 0.73, 0.87, p < 0.0001). The treatment effect reflected a reduction in both cardiovascular death and heart failure hospitalization; see Table 4 and Figure 3.
Sudden death accounted for 45% of cardiovascular deaths, followed by pump failure, which accounted for 26%. Sacubitril and valsartan also improved overall survival (HR 0.84; 95% CI [0.76, 0.93], p = 0.0009) (Table 4). This finding was driven entirely by a lower incidence of cardiovascular mortality on sacubitril and valsartan tablets.
Table 4: Treatment Effect for the Primary Composite Endpoint, Its Components, and All-cause Mortality in PARADIGM-HF Sacubitril and valsartan N = 4,187 n (%) Enalapril N = 4,212 n (%) Hazard Ratio (95% CI) p -value Primary composite endpoint of cardiovascular death or heart failure hospitalization Cardiovascular death as first event Heart failure hospitalization as first event 914 (21.8) 377 (9.0) 537 (12.8) 1,117 (26.5) 459 (10.9) 658 (15.6) 0.80 (0.73, 0.87) < 0.0001 Number of patients with events: * Cardiovascular death** Heart failure hospitalizations 558 (13.3) 537 (12.8) 693 (16.5) 658 (15.6) 0.80 (0.71, 0.89) 0.79 (0.… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Carcinogenicity studies conducted in mice and rats with sacubitril and valsartan did not identify any carcinogenic potential for sacubitril and valsartan. The LBQ657 C max at the high dose (HD) of 1,200 mg/kg/day in male and female mice was, respectively, 14 and 16 times that in humans at the MRHD. The LBQ657 C max in male and female rats at the HD of 400 mg/kg/day was, respectively, 1.7 and 3.5 times that at the MRHD.
The doses of valsartan studied (high dose of 160 and 200 mg/kg/day in mice and rats, respectively) were about 4 and 10 times, respectively, the MRHD on a mg/m 2 basis. Mutagenicity and clastogenicity studies conducted with sacubitril and valsartan tablets, sacubitril, and valsartan did not reveal any effects at either the gene or chromosome level. Impairment of Fertility Sacubitril and valsartan did not show any effects on fertility in rats up to a dose of 73 mg sacubitril/77 mg valsartan/kg/day (≤ 1.0-fold and ≤ 0.18-fold the MRHD on the basis of the AUCs of valsartan and LBQ657, respectively).
13.2Animal Toxicology and/or Pharmacology The effects of sacubitril and valsartan on amyloid-β concentrations in CSF and brain tissue were assessed in young (2 to 4 years old) cynomolgus monkeys treated with sacubitril and valsartan (24 mg sacubitril/26 mg valsartan/kg/day) for 2 weeks. In this study, sacubitril and valsartan affected CSF Aβ clearance, increasing CSF Aβ 1 to 40, 1 to 42, and 1 to 38 levels in CSF; there was no corresponding increase in Aβ levels in the brain. In addition, in a toxicology study in cynomolgus monkeys treated with sacubitril and valsartan tablets at 146 mg sacubitril/154 mg valsartan/kg/day for 39-weeks, there was no amyloid-β accumulation in the brain.
📄 Patient Package Insert ▾
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Torrent Pharmaceuticals Ltd. This Patient Information has been approved by the U.S. Food and Drug Administration.
8111019 Revised: June 2026 Patient Information Sacubitril and Valsartan (sak ue' bi tril and val sar' tan) Tablets, for oral use What is the most important information I should know about sacubitril and valsartan tablets? Sacubitril and valsartan tablets can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant.
Tell your doctor right away if you become pregnant during treatment with sacubitril and valsartan tablets. What is sacubitril and valsartan tablets? Sacubitril and valsartan tablets are prescription medicine used to treat: • adults with long-lasting (chronic) heart failure to help reduce the risk of death and hospitalization.
Sacubitril and valsartan tablets works better when the heart cannot pump a normal amount of blood to the body. • certain children 1 year of age and older who have symptomatic heart failure. It is not known if sacubitril and valsartan tablets are safe and effective in children under 1 year of age. Do not take sacubitril and valsartan tablets if you: • are allergic to any of the ingredients in sacubitril and valsartan tablets.
See the end of this Patient Information leaflet for a complete list of ingredients in sacubitril and valsartan tablets. • have had an allergic reaction, including swelling of your face, lips, tongue, throat, or trouble breathing while taking a type of medicine called an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB). • take an ACE inhibitor medicine. Do not take sacubitril and valsartan tablets for at least 36 hours before or after you take an ACE inhibitor medicine . Talk with your doctor or pharmacist before taking sacubitril and valsartan tablets if you are not sure if you take an ACE inhibitor medicine. • have diabetes and take a medicine that contains aliskiren.
Before taking sacubitril and valsartan tablets, tell your doctor about all of your medical conditions, including if you: have a history of hereditary angioedema have kidney or liver problems have diabetes are pregnant or plan to become pregnant. See "What is the most important information I should know about sacubitril and valsartan tablets?" are breastfeeding or plan to breastfeed. It is not known if sacubitril and valsartan passes into your breast milk.
You should not breastfeed during treatment with sacubitril and valsartan tablets. You and your doctor should decide if you will take sacubitril and valsartan tablets or breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking sacubitril and valsartan tablets with certain other medicines may affect each other. Taking sacubitril and valsartan tablets with other medicines can cause serious side effects. Especially tell your doctor if you take: • potassium supplements or a salt substitute • nonsteroidal anti-inflammatory drugs (NSAIDs) • lithium • other medicines for high blood pressure or heart problems, such as an ACE inhibitor, ARB, or aliskiren Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.
How should I take sacubitril and valsartan tablets? • Take sacubitril and valsartan tablets exactly as your doctor tells you to take it. • Take sacubitril and valsartan tablets 2 times each day. Your doctor may change your dose of sacubitril and valsartan tablets during treatment. • If you or your child cannot swallow tablets, or if tablets are not available in the prescribed strength, you or your child may take sacubitril and valsartan tablets prepared as a liquid (oral) suspension. • If you or your child switches between taking sacubitril and valsartan tablets and the liquid suspension prepared fr… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Sacubitril and Valsartan Tablets 24 mg/26 mg Sacubitril and Valsartan Tablets 49 mg/51 mg Sacubitril and Valsartan Tablets 97 mg/103 mg 24-26mg 49-51mg 49-51-old 97-103mg 97-103-old