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PRAVASTATIN SODIUM 20 mg Tablet, 90-count

by Accord Healthcare Inc. · 90 TABLET in 1 BOTTLE (16729-009-15)

NDC 16729-0009-15

🏷️ FDA NDC (as labeled) 16729-009-15 billing pads the product segment with a zero

This package

Contains90-count Cost per ea$0.0587 NADAC Per package$5.28 / 90 tablets Pack sizes3 compare ↓

Also priced by: Part D plans $0.1412/unit — full pricing hub ↓

Also comes in: 500 tablets 16729-0009-16 1000 tablets 16729-0009-17

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Pravastatin Sodium (different manufacturers) — 5 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0350-2025

Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0341-2025

Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0349-2025

Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0325-2025

Class II · Jun 28, 2024 — Failed Dissolution Specifications: results below specifications (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0612-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Past resolved recalls for this product (4)

Class II · Feb 7, 2023 · Terminated — CGMP Deviations: recalling drug products following an FDA inspection. (Accord Healthcare, Inc.) · FDA recall D-0421-2023

Class II · Feb 7, 2023 · Terminated — CGMP Deviations: recalling drug products following an FDA inspection. (Accord Healthcare, Inc.) · FDA recall D-0422-2023

Class II · Feb 7, 2023 · Terminated — CGMP Deviations: recalling drug products following an FDA inspection. (Accord Healthcare, Inc.) · FDA recall D-0423-2023

Class II · Feb 7, 2023 · Terminated — CGMP Deviations: recalling drug products following an FDA inspection. (Accord Healthcare, Inc.) · FDA recall D-0424-2023

🆔 Identity & classification

FDA NDC (as labeled) 16729-009-15

Product NDC 16729-009

11-digit billing NDC 16729000915

NCPDP billing unit EA — each (per item)

RxCUI 904458, 904467, 904475, 904481

UNII 3M8608UQ61

Application # ANDA207068

SPL Set ID 6c011348-a236-47d3-bbef-3e0b956dd080

Established class (EPC) HMG-CoA Reductase Inhibitor

Mechanism of action Hydroxymethylglutaryl-CoA Reductase Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2017-02-16

Route ORAL

Dosage form TABLET

Substance PRAVASTATIN SODIUM

GPI-14 39400065100330

GPI class Pravastatin Sodium

GCN Seq No 016367

GCN 48672

HICL code 006227

Ingredient (HICL) Pravastatin Sodium

HIC1 code M

Therapeutic class — broad (HIC1) Blood

HIC2 code M4

Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids

HIC3 code M4D

Therapeutic class — specific (HIC3) Antihyperlipidemic-Hmgcoa Reductase Inhib(Statins)

AHFS code 24:06.08.00

AHFS class Hmg-Coa Reductase Inhibitors

FDB label name PRAVASTATIN SODIUM 20 MG TAB

FDB brand name Pravastatin Sodium

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 16729-009-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 16729-0009-15. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the HMG-CoA Reductase Inhibitor class.

Pharmacologic class HMG-CoA Reductase Inhibitor

Drug family (ATC) HMG CoA reductase inhibitors

How it works Hydroxymethylglutaryl-CoA Reductase Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAccord Healthcare Inc.

Application holderACCORD HEALTHCARE INC

FDA applicationANDA207068 (ANDA)

Labeler code16729

First marketedFeb 2017

Product typeHuman Prescription Drug

Portfolio143 products on file

🔎 All NDCs from Accord Healthcare Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PRAVASTATIN SODIUM 20 MG TAB Ingredient Pravastatin Sodium

📖 What it is MedlinePlus · NLM

Pravastatin is used to reduce the risk of heart attack and stroke decrease the amount of cholesterol (a fat-like substance that can build up and clog blood vessels causing heart attack or stroke or other health conditions) Pravastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing how much cholesterol your body makes. This lowers the amount of cholesterol that can build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Pravastatin works in two main ways. First, it lowers your LDL (bad cholesterol) and triglycerides while nudging your HDL (good cholesterol) higher. Second — and this is the big one...
What exactly is pravastatin supposed to do for me?
Good news — pravastatin is flexible. You can take it at any time of day, morning or evening, and with or without food. The cholesterol-lowering effect is similar either way. The on...
Does it matter what time of day I take it, or whether I take it with food?

📖 Read our full Pravastatin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Pravastatin Sodium — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Pravastatin Sodium (74 interactions) — ranked by severity →

Nutrient depletion considerations

Pravastatin Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

COENZYME Q10 Insufficient Evidence

🧪 Full Pravastatin Sodium nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color pink / yellow / green

ShapeOval

ImprintPB;4

Size17 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

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.
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.
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.
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.
UNII 3A3U0GI71G
Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
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.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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	$0.059	$5.28 / 90 tablets
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	$0.1412	$12.71 / 90 tablets

NADAC price history (per ea) — tap or hover for the price & month

▲ Up 3% over the last 15 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Pravastatin Sodium 20 mg 68180-0486-02	Lupin	500 tablets	$0.058	AB	Discontinued	save 2%
Pravastatin Sodium 20 mgthis 16729-0009-15	Accord	90 tablets	$0.059	AB	FDA listed	—
Pravastatin Sodium 20 mg 00093-7201-10	Teva	1000 tablets	$0.062	AB	Availability likely	+6%
Pravastatin Sodium 20 mg 00904-5892-61	Major	100 tablets	$0.062	AB	Availability likely	+6%
Pravastatin Sodium 20 mg 16714-0559-01	NorthStar	90 tablets	$0.062	AB	Availability likely	+6%
Pravastatin Sodium 20 mg 50268-0666-15	AvPAK	50 tablets	$0.062	AB	Availability likely	+6%
Pravastatin Sodium 20 mg 51079-0458-20	Mylan	100 tablets	$0.062	AB	Discontinued	+6%
Pravastatin Sodium 20 mg 60687-0178-01	American	100 tablets	$0.062	AB	Discontinued	+6%
Pravastatin Sodium 20 mg 60687-0897-01	American	100 tablets	$0.062	AB	Availability likely	+6%
Pravastatin Sodium 20 mg 68462-0196-05	Glenmark	500 tablets	$0.062	AB	Availability likely	+6%
Pravastatin Sodium 20 mg 69097-0789-05	CIPLA	90 tablets	$0.062	AB	Availability likely	+6%
Pravastatin Sodium 20 mg 82009-0006-10	Quallent	1000 tablets	$0.062	AB	Availability likely	+6%
Pravastatin sodium 20 mg 84386-0032-90	Aurobindo	90 tablets	$0.062	AB	Availability likely	+6%
Pravastatin Sodium 20 mg 00615-8540-05	NCS	15 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 00615-8619-05	NCS	15 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 35356-0919-30	Lake	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 43063-0807-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 48433-0148-20	Safecor	100 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-0973-00	A-S	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-0975-00	A-S	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-2025-00	A-S	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-6898-00	A-S	90 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-7551-00	A-S	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-7552-00	A-S	90 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-7709-00	A-S	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-7710-00	A-S	90 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 50090-7813-00	A-S	90 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 50090-7892-00	A-S	30 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 50090-7893-00	A-S	90 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 50090-7947-00	A-S	30 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 50090-7948-00	A-S	90 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 51407-0888-10	Golden	1000 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 51655-0343-52	Northwind	30 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 55111-0230-01	Dr.Reddy's	100 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 55154-7275-00	Cardinal	10 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 60505-0169-01	Apotex	100 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 62135-0848-90	Chartwell	90 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 63629-8906-01	Bryant	90 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 63629-8909-01	Bryant	1000 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 63629-9163-01	Bryant	30 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 65862-0633-05	Aurobindo	500 tablets	—	—	FDA listed	—
Pravastatin Sodium 20 mg 67046-1519-03	Coupler	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 68071-3361-03	NuCare	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 68071-3788-09	NuCare	90 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 68071-3895-09	NuCare	90 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 68788-4049-03	Preferred	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 68788-7779-03	Preferred	90 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 68788-8421-03	Preferred	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 68788-8871-03	Preferred	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 69292-0102-10	Amici	1000 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 70377-0046-11	Biocon	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 70518-1938-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 70518-2887-01	REMEDYREPACK	90 tablets	—	AB	Discontinued	—
Pravastatin sodium 20 mg 70518-4408-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 71205-0149-30	Proficient	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 71335-0296-01	Bryant	30 tablets	—	AB	Discontinued	—
Pravastatin Sodium 20 mg 71335-0947-01	Bryant	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 71335-1022-01	Bryant	30 tablets	—	AB	Discontinued	—
Pravastatin Sodium 20 mg 71335-2908-01	Bryant	1000 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 71335-9692-01	Bryant	30 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 72189-0060-90	DIRECT	90 tablets	—	AB	FDA listed	—
Pravastatin Sodium 20 mg 72789-0143-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Pravastatin sodium 20 mg 82868-0091-30	Northwind	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2017

On the market since

Feb 2017

📍

2026

Currently FDA-listed

9 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Pravastatin Sodium — the program that covers self-administered drugs. 14 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Pravastatin Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$31.8M

Claims incl. refills

2.1M

Beneficiaries

1.7M

Spend / beneficiary

$18.70

Spend / claim

$15.06

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
16729-0009-15 You're viewing this	90 TABLET in 1 BOTTLE (16729-009-15)	$0.0587 / ea	$5.28	2017-02-16	Active
16729-0009-16	500 TABLET in 1 BOTTLE (16729-009-16)	$0.0587 / ea	$29.36	2017-02-16	Active
16729-0009-17	1000 TABLET in 1 BOTTLE (16729-009-17)	$0.0587 / ea	$58.72	2017-02-16	Active

You're viewing the smallest of 3 pack sizes for this product.

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0587 NADAC).

Pack size FAQ

What quantity is in NDC 16729-0009-15?

NDC 16729-0009-15 is a 90-count package — 90 tablet in 1 bottle.

What is the difference between NDC 16729-0009-15 and NDC 16729-0009-16?

Both are PRAVASTATIN SODIUM 20 mg Tablet — the drug itself is identical. NDC 16729-0009-15 is the 90-count package, while NDC 16729-0009-16 is the 500 tablets package.

What NDC number is used to bill for this package of PRAVASTATIN SODIUM 20 mg Tablet?

Bill NDC 16729-0009-15 — the 11-digit billing format is 16729000915. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Pravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.

As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.

Hypertriglyceridemia. Pravastatin is an HMG-CoA reductase inhibitor (statin) indicated (1) : To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.

Hypertriglyceridemia.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Take orally once daily at any time of the day, with or without food (2.1) . For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pravastatin sodium tablets 80 mg daily, prescribe alternative LDL- C-lowering treatment (2.1) . Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating pravastatin sodium tablets, and adjust the dosage if necessary (2.1) .

Adults: recommended starting dosage is pravastatin sodium tablets 40 mg to 80 mg once daily. (2.2) Pediatric Patients (2.3): aged 8 to 13 years, the recommended dosage is 20 mg once daily. aged 14 to 18 years, the recommended starting dosage is 40 mg once daily. Severe renal impairment: recommended starting dosage is pravastatin sodium 10 mg once daily.

Recommended maximum pravastatin sodium tablets dosage is 40mg once daily. (2.4) See full prescribing information for dosage modifications due to drug interactions (2.5, 7) .

2.1Important Dosage and Administration Information Take pravastatin sodium tablets orally once daily as a single dose at any time of the day, with or without food. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pravastatin sodium tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating pravastatin sodium tablets, and adjust the dosage if necessary.

2.2Recommended Dosage in Adult Patients The recommended starting dosage is pravastatin sodium tablets 40 mg to 80 mg once daily.

2.3Recommended Dosage in Pediatric Patients 8 Years of Age and Older with HeFH In pediatric patients aged 8 to 13 years, the recommended dosage is pravastatin sodium tablets 20 mg once daily. In pediatric patients aged 14 to 18 years, the recommended starting dosage is pravastatin sodium tablets 40 mg once daily.

2.4Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment, the recommended starting dosage is pravastatin sodium 10 mg once daily. The maximum recommended dosage of pravastatin sodium tablets in patients with severe renal impairment is 40 mg once daily [see Clinical Pharmacology (12.3) ]. The recommended dosage of pravastatin sodium tablets for patients with mild or moderate renal impairment is the same as patients with normal renal function.

2.5Dosage and Administration Modifications Due to Drug Interactions In patients taking a bile acid sequestrant, administer pravastatin sodium tablets at least 1 hour before or 4 hours after the bile acid sequestrant [see Drug Interactions (7.2) ]. Concomitant use of pravastatin sodium tablets with the following drugs requires dosage modifications of pravastatin sodium tablets [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ]: Cyclosporine In patients taking cyclosporine, the recommended starting dosage is pravastatin sodium 10 mg once daily.

The maximum recommended dosage of pravastatin sodium tablets in patients taking cyclosporine is 20 mg once daily. Clarithromycin and Erythromycin The maximum recommended dosage is pravastatin sodium tablets 40 mg once daily.

💊 Dosage Forms and Strengths 113 words ▾

3 DOSAGE FORMS AND STRENGTHS Pravastatin sodium tablets, USP are supplied as: 10 mg tablets: Pink coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘1’ on other side. 20 mg tablets: Yellow coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘2’ on other side. 40 mg tablets: Light Green coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘8’ on other side.

80 mg tablets: Yellow coloured, mottled, oval shaped, uncoated tablets, debossed ‘PB’ on one side and ‘4’ on other side. Tablets: 10 mg, 20 mg, 40 mg, and 80 mg of pravastatin sodium. (3)

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . Hypersensitivity to any pravastatin or any excipients in pravastatin sodium tablets. Hypersensitivity to pravastatin or any excipient in pravastatin sodium tablets. (4) Acute liver failure or decompensated cirrhosis (4 , 5.3)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher pravastatin dosage. Discontinue pravastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue pravastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.

Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing pravastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. (5.1 , 7.1 , 8.5 , 8.6) Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported.

Discontinue pravastatin if IMNM is suspected (5.2) . Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred.

Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue (5.3) .

5.1Myopathy and Rhabdomyolysis Pravastatin may cause myopathy and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including pravastatin. Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CK) to greater than 10 times the upper limit of normal (ULN), occurred < 0.1%; in pravastatin-treated patients in clinical trials.

Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher pravastatin dosage [see Drug Interactions (7.1) ]. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Pravastatin is not recommended in patients taking gemfibrozil [see Drug Interactions (7) ]. There are pravastatin dosage restrictions for patients taking cyclosporin and select macrolide antibiotics [see Dosage and Administration (2.5) ].

The following drugs when used concomitantly with pravastatin may also increase the risk of myopathy and rhabdomyolysis: niacin, fibrates, and colchicine [see Drug Interactions (7) ]. Discontinue pravastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Muscle symptoms and CK increases may resolve if pravastatin is discontinued.

Temporarily discontinue pravastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis, e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the pravastatin dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

5.2Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents.

Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue pravastatin if IMNM is suspected.

5.3 Hepatic Dysfun…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] In short-term clinical trials, the most commonly reported adverse reactions (≥2% and greater than placebo) were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction 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. In pravastatin placebo-controlled clinical trials, 1,313 patients (age range 20 to 76 years, 32% women, 93.5% White, 5% Black, 0.9% Hispanic, 0.4% Asian, 0.2% Other) with a median treatment duration of 14 weeks, 3.3% of patients on pravastatin and 1.2% patients on placebo discontinued due to adverse reactions (regardless of causality).

The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: hepatic transaminase elevations, nausea, anxiety/depression, and dizziness. Adverse reactions (regardless of causality) reported in ≥2% of pravastatin-treated patients in placebo-controlled trials of up to 8 months duration are identified in Table 1: Table 1: Adverse Reactions in ≥ 2% of Patients Treated with Pravastatin (Any Dose) and at an Incidence Greater Than Placebo in Short-Term Placebo-Controlled Trials % Placebo N=411 % Any Dose N=902 Nausea/Vomiting 7.1

7.4Diarrhea 5.6

6.7Headache 4.6

6.3Upper Respiratory Infection 5.8

5.9Angina Pectoris 3.4

4.5Rash 1.4

4.5CPK Increased 3.6

4.1Dizziness 3.4

3.5ALT Increased 1.2

2.9Chest Pain 1.9

2.7Cough 1.7

2.5Myalgia 1.2

2.3Influenza 0.7 2.0 g-GT Increased 1.2

2.0Adverse Reactions (regardless of causality) The safety and tolerability of pravastatin at a dose of 80 mg in 2 controlled trials with a mean exposure of 8.6 months was similar to that of pravastatin at lower doses except that 4 out of 464 patients taking 80 mg of pravastatin had a single elevation of CK >10 times ULN compared to 0 out of 115 patients taking 40 mg of pravastatin. In pravastatin placebo-controlled clinical trials, 21,483 patients (age range 24 to 75 years, 10.3% women, 52.3% White, 0.8% Black, 0.5% Hispanic, 0.1% Asian, 0.1% Other, 46.1% not recorded) had a median treatment duration of 261 weeks.

Adverse reactions (regardless of causality) were pooled from 7 double-blind, placebo-controlled trials (West of Scotland Coronary Prevention Study [WOS]; Cholesterol and Recurrent Events study [CARE]; Long-term Intervention with Pravastatin in Ischemic Disease study [LIPID]; Pravastatin Limitation of Atherosclerosis in the Coronary Arteries study [PLAC I]; Pravastatin, Lipids and Atherosclerosis in the Carotids study [PLAC II]; Regression Growth Evaluation Statin Study [REGRESS]; and Kuopio Atherosclerosis Prevention Study [KAPS]) involving a total of 10,764 patients treated with pravastatin 40 mg and 10,719 patients treated with placebo.

Patients were exposed to pravastatin for a mean of 4.0 to 5.1 years in WOS, CARE, and LIPID and 1.9 to 2.9 years in PLAC I, PLAC II, KAPS, and REGRESS. Adverse reactions (regardless of causality) occurring in ≥5% of patients treated with pravastatin in these studies are identified in Table 2: Table 2: Adverse Reactions in ≥ 5% of Patients Treated with Pravastatin 40 mg and at an Incidence Greater than Placebo in Long-Term Placebo-Controlled Trials Placebo (N=10,719) % of patients Pra…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of pravastatin sodium tablets with other drugs that increase the risk of myopathy and rhabdomyolysis. (2.5, 7.1) Bile Acid Sequestrants: in patients taking a bile acid sequestrant, administer pravastatin sodium tablets at least 1 hour before or at least 4 hours after the bile acid sequestrant (7.2)

7.1Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Pravastatin Pravastatin is a substrate of the transport protein OATP1B1. Pravastatin plasma levels can be significantly increased with concomitant administration of inhibitors of OATP1B1. Table 3 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with pravastatin and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

Table 3:Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Pravastatin Gemfibrozil Clinical Impact: There is an increased risk of myopathy/rhabdomyolysis when pravastatin is administered with gemfibrozil Intervention: Avoid concomitant use of gemfibrozil with pravastatin. Cyclosporine Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine with pravastatin. Intervention: Initiate with a dosage of pravastatin sodium 10 mg once daily.

Do not exceed pravastatin 20 mg once daily [see Dosage and Administration (2.5) ]. Select Macrolide Antibiotics Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of clarithromycin or erythromycin with pravastatin. Other macrolides (e.g., azithromycin) have the potential to increase pravastatin exposures and increase the risk of myopathy and rhabdomyolysis when used concomitantly.

Intervention: For patients taking erythromycin or clarithromycin, do not exceed 40 mg pravastatin once daily [see Dosage and Administration (2.5) ]. Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of niacin with pravastatin. Intervention: Consider if the benefit of using niacin concomitantly with pravastatin outweighs the increased risk of myopathy and rhabdomyolysis.

If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Fibrates (other than Gemfibrozil) Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with pravastatin.

Intervention: Consider if the benefit of using fibrates concomitantly with pravastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with pravastatin.

Intervention: Consider if the benefit of using colchicine concomitantly with pravastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug.

7.2Drug Interactions that Decrease the Efficacy of Pravastatin Table 4 presents drug interactions that may decrease the efficacy of pravastatin and instructions for preventing or managing them. Table 4: Drug Interactions that Decrease the Efficacy of Pravastatin Bile Acid Sequestrants Clinical Impact: Concomitant cholestyramine or colestipol administration decreased the mean exposure of pravastatin approximately 51% and 47%, respectively [see Clinical Pharmacology (12.3) ]. Intervention: In patients taking a bile acid sequestrant, administer pravastatin at least…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm (8.1) Lactation: Breastfeeding not recommended during treatment with pravastatin sodium tablets (8.2)

8.1Pregnancy Risk Summary Discontinue pravastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pravastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] .

In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

Published data from prospective and retrospective observational cohort studies with pravastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) . In animal reproduction studies, no evidence of fetal malformations was seen in pregnant rats or rabbits orally administered pravastatin during the period of organogenesis at doses that resulted in 10 times and 120 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg/day, based on body surface area (mg/m 2 ).

An imbalance in some fetal skeletal variations, increased offspring mortality, and developmental delays occurred when pregnant rats were exposed to 10 times to 12 times the MRHD during organogenesis to parturition (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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.

Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential cofounders -including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.

There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for cofounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.

Animal Data Embryofetal and neonatal mortality was observed in rats given pravastatin during the period of organogenesis or during organogenesis continuing through weaning. In pregnant rats given oral gavage doses of 4 mg/kg/day, 20 mg/kg/day, 100 mg/kg/day, 500 mg/kg/day, and 1,000 mg/kg/day from gestation days 7 through 17 (organogenesis) increased mortality of offspring and increased cervical rib skeletal anomalies were observed at ≥100 mg/kg/day systemic exposure, 10 times the human exposure at 80 mg/day MRHD based on body surface a…

🤰 Pregnancy ~3 min read ▾

In other studies, no teratogenic effects were observed when pravastatin was dosed orally during organogenesis in rabbits (gestation days 6 through 18…

🧒 Pediatric Use 108 words ▾

8.4Pediatric use The safety and effectiveness of pravastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH. Use of pravastatin for this indication is based on a double-blind, placebo-controlled clinical study in 214 pediatric patients (100 males and 114 females) 8 years of age and older with HeFH. Doses greater than 40 mg daily have not been studied in this population.

The safety and effectiveness of pravastatin have not been established in pediatric patients younger than 10 years of age with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH).

🧓 Geriatric Use 157 words ▾

8.5Geriatric Use In clinical studies, 4,797 (36.4%) pravastatin-treated patients were aged 65 and older and 110 (0.8%) were aged 75 and older. No significant differences in efficacy or safety were observed between geriatric patients and younger patients. Mean pravastatin AUCs are 25% to 50% higher in elderly subjects than in healthy young subjects, but mean maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and half-life (t½) values are similar in both age groups and substantial accumulation of pravastatin would not be expected in the elderly [see Clinical Pharmacology (12.3) ].

Advanced age (≥65 years) is a risk factor for pravastatin-associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving pravastatin for the increased risk of myopathy [see Warnings and Precautions (5.1) ].

🆘 Overdosage 16 words ▾

10 OVERDOSAGE No specific antidotes for pravastatin are known. Contact Poison Control (1-800-222-1222) for latest recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pravastatin is a reversible inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol.

12.2Pharmacodynamics Inhibition of HMG-CoA reductase by pravastatin accelerates the expression of LDL-receptors, followed by the uptake of LDL-C from blood to the liver, leading to a decrease in plasma LDL-C and total cholesterol. Sustained inhibition of cholesterol synthesis in the liver also decreases levels of very-low-density lipoproteins. The maximum LDL-C reduction of pravastatin is usually achieved by 4 weeks and is maintained after that.

12.3Pharmacokinetics Absorption Pravastatin sodium tablet is administered orally in the active form. Peak plasma pravastatin concentrations occurred 1 to 1.5 hours upon oral administration. Based on urinary recovery of total radiolabeled drug, the average oral absorption of pravastatin is 34% and absolute bioavailability is 17%.

While the presence of food in the gastrointestinal tract reduces area under the concentration-time curve (AUC) and C max by 31% and 49%, respectively, the lipid-lowering effects of the drug are similar whether taken with or 1 hour prior to meals. Pravastatin plasma concentrations, including AUC, C max , and steady-state minimum (C min ), are directly proportional to administered dose. Systemic bioavailability of pravastatin administered following a bedtime dose was decreased 60% compared to that following an AM dose.

Despite this decrease in systemic bioavailability, the efficacy of pravastatin administered once daily in the evening, although not statistically significant, was marginally more effective than that after a morning dose. The coefficient of variation (CV), based on between-subject variability, was 50% to 60% for AUC. The geometric means of pravastatin C max and AUC following a 20 mg dose in the fasted state were 26.5 ng/mL and 59.8 ng*hr/mL, respectively.

Steady-state AUCs, C max , and C min plasma concentrations showed no evidence of pravastatin accumulation following once or twice daily administration of pravastatin Distribution Approximately 50% of the circulating drug is bound to plasma proteins. Elimination Metabolism The major biotransformation pathways for pravastatin are: (a) isomerization to 6-epi pravastatin and the 3α-hydroxy isomer of pravastatin (SQ 31,906) and (b) enzymatic ring hydroxylation to SQ 31,945. The 3α-hydroxy isomeric metabolite (SQ 31,906) has 1/10 to 1/40 the HMG-CoA reductase inhibitory activity of the parent compound.

Pravastatin undergoes extensive first-pass extraction in the liver (extraction ratio 0.66). Excretion Approximately 20% of a radiolabeled oral dose is excreted in urine and 70% in the feces. After intravenous administration of radiolabeled pravastatin to normal volunteers, approximately 47% of total body clearance was via renal excretion and 53% by non-renal routes (i.e., biliary excretion and biotransformation).

Following single dose oral administration of 14 C-pravastatin, the radioactive elimination t ½ for pravastatin is 1.8 hours in humans and the elimination half-life (t½) for total radioactivity (pravastatin plus metabolites) is 77 hours. Specific Populations Renal Impairment A single 20 mg oral dose of pravastatin was administered to 24 patients with varying degrees of renal impairment (as determined by creatinine clearance). No effect was observed on the pharmacokinetics of pravastatin or its 3α-hydroxy isomeric metabolite (SQ 31,906).

Compared to healthy subjects with normal renal function, patients with severe renal impairment had 69% and 37% higher mean AUC and C max values, respectively, and a 0.61 hour shorter t ½ for the inactive enzymatic ring hydroxylation metabolite (SQ 31,945) [see Use in Specific Populations (8.6) ] . Hepatic Impairment In a study comparing the kinetics of pravastatin in patients with biopsy confirmed cirrhosis (N=7) and normal subjects (N=7), the mean AUC varied 18-fold…

🧬 Mechanism of Action 89 words ▾

12.1Mechanism of Action Pravastatin is a reversible inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Pravastatin sodium tablets, USP are supplied as: 10 mg tablets: Pink coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘1’ on other side. They are supplied in bottles containing desiccant canister as follows. NDC Number Size 16729-008-15 Bottle of 90 tablets with a child-resistant closure 16729-008-16 Bottle of 500 tablets 16729-008-17 Bottle of 1000 tablets 20 mg tablets: Yellow coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘2’ on other side.

They are supplied in bottles containing desiccant canister as follows. NDC Number Size 16729-009-15 Bottle of 90 tablets with a child-resistant closure 16729-009-16 Bottle of 500 tablets 16729-009-17 Bottle of 1000 tablets 40 mg tablets: Light Green coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘8’ on other side. They are supplied in bottles containing desiccant canister as follows.

NDC Number Size 16729-010-15 Bottle of 90 tablets with a child-resistant closure 16729-010-16 Bottle of 500 tablets 16729-010-17 Bottle of 1000 tablets 80 mg tablets: Yellow coloured, mottled, oval shaped, uncoated tablets, debossed ‘PB’ on one side and ‘4’ on other side. They are supplied in bottles containing desiccant canister as follows. NDC Number Size 16729-011-15 Bottle of 90 tablets with a child-resistant closure 16729-011-16 Bottle of 500 tablets 16729-011-17 Bottle of 1000 tablets Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep tightly closed (protect from moisture). Protect from light.

📋 Description 140 words ▾

11 DESCRIPTION Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl- coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-,monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula: Pravastatin sodium is white to yellowish white, hygroscopic powder.

It is freely soluble in water and methanol, soluble in anhydrous ethanol, practically insoluble in chloroform and acetonitrile. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose and povidone.

The 10 mg tablet also contains ferric oxide red, the 20 mg and 80 mg tablets also contain ferric oxide yellow, and the 40 mg tablet also contains D & C yellow No. 10 aluminum lake & FD & C blue No. l aluminum lake. Pravastatin Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Myopathy and Rhabdomyolysis Advise patients that pravastatin sodium tablets may cause myopathy and rhabdomyolysis. Inform patients that the risk is increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] .

Hepatic Dysfunction Inform patients that pravastatin sodium tablets may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3) ] . Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with pravastatin sodium tablets.

Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.4) ] . Pregnancy Advise pregnant patients and patients who may become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if pravastatin sodium tablets should be discontinued [see Use in Specific Populations (8.1) ] .

Lactation Advise patients that breastfeeding is not recommended during treatment with pravastatin sodium tablets [see Use in Specific Populations (8.2) ] .

Glossary — plain-language definitions of medical terms used in this label:

case series: A report describing what happened to a small group of patients, with no comparison group.

immunosuppressive: Describes something that lowers the activity of the immune system.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

acute kidney injury: A sudden drop in kidney function over hours or days, which is often reversible if the cause is treated.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

autoimmune: Describes a condition in which the body's defense system mistakenly attacks its own healthy cells or tissues.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

CK: A protein measured in a blood test that rises when muscle is being damaged.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatine kinase: A protein measured in a blood test that rises when muscle is being damaged.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

excipient: An inactive ingredient added to a medicine to bind, preserve, flavor, or shape it.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

HbA1c: A blood test showing average blood sugar over the past two to three months; also called A1C or glycated hemoglobin.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperbilirubinemia: A higher-than-normal level of bilirubin in the blood, which can cause yellowing of the skin or eyes.

hypercholesterolemia: A higher-than-normal level of cholesterol, a type of fat, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypertriglyceridemia: A higher-than-normal level of triglycerides, a type of fat, in the blood.

hypothyroidism: A condition where the thyroid gland makes too little thyroid hormone, which can slow the body down.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

myopathy: A disease of the muscles that can make them weak, painful, or tender.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reversible inhibitor: A substance that blocks an enzyme or receptor temporarily, with the effect fading as it leaves the body.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

Tmax: The time after a dose when a medicine reaches its highest level in the blood.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

transient ischemic attack: A brief, stroke-like episode from a temporary drop in blood flow to the brain, with symptoms that go away.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

ULN: The highest value considered normal for a lab test; results above it are flagged as elevated.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 16729-0008-15 · Accord 16729-0010-15 · Accord →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

PRAVASTATIN SODIUM 20 mg Tablet, 90-count

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