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Pravastatin Sodium 10 mg Tablet, 90-count — NDC 50090-1594-00 package photo

Pravastatin Sodium 10 mg Tablet, 90-count

by A-S Medication Solutions · 90 TABLET in 1 BOTTLE (50090-1594-0)
NDC 50090-1594-00
🏷️ FDA NDC (as labeled) 50090-1594-0 billing pads the package segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.1412/unit — full pricing hub ↓
Also comes in: 30 tablets 50090-1594-01
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

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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 50090-1594-0
Product NDC 50090-1594
11-digit billing NDC 50090159400
NCPDP billing unit EA — each (per item)
RxCUI 904458, 904475
UNII 3M8608UQ61
Application # ANDA077987
SPL Set ID bdf02140-3647-498e-ba0a-f4ca920b4e90
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 2007-05-11
Route ORAL
Dosage form TABLET
Substance PRAVASTATIN SODIUM
GPI-14 39400065100320
GPI class Pravastatin Sodium
GCN Seq No 016366
GCN 48671
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 10 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 50090-1594-0 — a 5-4-1 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 package segment → 50090-1594-00. 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

LabelerA-S Medication Solutions
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA077987 (ANDA)
Labeler code50090
First marketedMay 2007
Product typeHuman Prescription Drug
Portfolio2,774 products on file
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 10 MG TAB Ingredient Pravastatin Sodium
📗 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 →
1
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.

🧪 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 Green / Yellow
ShapeRound
ImprintG5;10
Size6 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 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 6HG8UB2MUY
    Meglumine is a sugar-alcohol compound used as a solubilizer and pH buffer in medicines. It helps dissolve drugs that don't mix well in water and maintains stable acidity levels in the formulation.
  • 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.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

9 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1412 $12.71 / 90 tablets
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pravastatin Sodium 10 mg 00093-0771-10 Teva 1000 tablets $0.057 AB Availability likely —
Pravastatin Sodium 10 mg 00904-5891-61 Major 100 tablets $0.057 AB Availability likely —
Pravastatin Sodium 10 mg 16714-0558-01 NorthStar 90 tablets $0.057 AB Availability likely —
Pravastatin Sodium 10 mg 50268-0665-15 AvPAK 50 tablets $0.057 AB Availability likely —
Pravastatin Sodium 10 mg 60687-0886-01 American 100 tablets $0.057 AB Availability likely —
Pravastatin Sodium 10 mg 68462-0195-05 Glenmark 500 tablets $0.057 AB Availability likely —
Pravastatin Sodium 10 mg 69097-0788-05 CIPLA 90 tablets $0.057 AB Availability likely —
Pravastatin sodium 10 mg 84386-0031-90 Aurobindo 90 tablets $0.057 AB Availability likely —
Pravastatin Sodium 10 mg 16729-0008-15 Accord 90 tablets $0.058 AB FDA listed —
Pravastatin Sodium 10 mg 68180-0485-02 Lupin 500 tablets $0.071 AB Discontinued —
Pravastatin Sodium 10 mg 00615-8539-39 NCS 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 00615-8618-39 NCS 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mgthis 50090-1594-00 A-S 90 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 50090-3853-00 A-S 90 tablets — AB FDA listed —
Pravastatin sodium 10 mg 51407-0887-10 Golden 1000 tablets — AB FDA listed —
Pravastatin sodium 10 mg 55111-0229-01 Dr.Reddy's 100 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 55154-3350-00 Cardinal 10 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 60505-0168-01 Apotex 100 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 62135-0847-90 Chartwell 90 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 63629-8833-01 Bryant 90 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 63629-8904-01 Bryant 90 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 63629-8905-01 Bryant 1000 tablets — AB Discontinued —
Pravastatin Sodium 10 mg 63629-9162-01 Bryant 30 tablets — AB FDA listed —
Pravastatin sodium 10 mg 65862-0632-05 Aurobindo 500 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 67046-1518-03 Coupler 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 67046-1621-03 Coupler 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 68071-5001-03 NuCare 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 68071-5007-03 NuCare 30 tablets — AB FDA listed —
Pravastatin sodium 10 mg 68788-4059-03 Preferred 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 68788-8425-03 Preferred 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 69292-0101-10 Amici 1000 tablets — AB FDA listed —
Pravastatin sodium 10 mg 70377-0045-11 Biocon 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 70518-0549-00 REMEDYREPACK 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 71335-1243-01 Bryant 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 71335-2298-01 Bryant 1000 tablets — AB FDA listed —
Pravastatin sodium 10 mg 71335-2848-01 Bryant 90 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 72162-1706-03 Bryant 30 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 72162-1951-00 Bryant 1000 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 72189-0059-90 DIRECT 90 tablets — AB FDA listed —
Pravastatin Sodium 10 mg 82868-0104-30 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

🏛️
2007
On the market since
May 2007
📍
2026
Currently FDA-listed
19 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 NDCDescription Marketing startStatus
50090-1594-00 You're viewing this 90 TABLET in 1 BOTTLE (50090-1594-0) 2015-01-05 Active
50090-1594-01 30 TABLET in 1 BOTTLE (50090-1594-1) 2015-01-05 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 50090-1594-00?
NDC 50090-1594-00 is a 90-count package — 90 tablet in 1 bottle.
What is the difference between NDC 50090-1594-00 and NDC 50090-1594-01?
Both are Pravastatin Sodium 10 mg Tablet — the drug itself is identical. NDC 50090-1594-00 is the 90-count package, while NDC 50090-1594-01 is the 30 tablets package.
What NDC number is used to bill for this package of Pravastatin Sodium 10 mg Tablet?
Bill NDC 50090-1594-00 — the 11-digit billing format is 50090159400. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50090-1594-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50090-1594-00, written without dashes as 50090159400. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50090-1594-00, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (1594) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (50090-1594-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
A-S Medication Solutions is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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: 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). 2.

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. 3. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.

4. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). 5.

As an adjunct to diet for the treatment of adults with: • Primary dysbetalipoproteinemia. • Hypertriglyceridemia. Pravastatin sodium tablets are 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. • 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.

⏱️ Dosage and Administration ~3 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, 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 40 mg once daily. ( 2.4 ) • See full prescribing information for dosage modifications due to drug interactions ( 2.5 , 7 ).

Important 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. Recommended 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.

Important 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.

Recommended Dosage in Pediatric Patients 8 Years of Age and Older with HeFH • In pediatric patients aged 8 to 13 years, the…

💊 Dosage Forms and Strengths 121 words ▾

3 DOSAGE FORMS AND STRENGTHS Pravastatin Sodium Tablets, USP are supplied as: • 10 mg of pravastatin sodium:Yellow colored, circular shaped, flat faced tablets with “G5” debossed on one side and “10” debossed on the other side. • 20 mg of pravastatin sodium:Yellow, rounded-rectangular, biconvex tablets with “G5” debossed on one side and “20” debossed on the other side. • 40 mg of pravastatin sodium:Green, rounded-rectangular, biconvex tablets with “G5” debossed on one side and “40” debossed on the other side. • 80 mgof pravastatin sodium : Yellow, oval, biconvex tablets with “G5” debossed on one side and “80” debossed on the other side. • Tablets: 10 mg, 20 mg, 40 mg, 80 mg of pravastatin sodium, USP.

( 3 )

⛔ Contraindications 55 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 sodium dosage. Discontinue pravastatin sodium if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue pravastatin sodium 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 sodium 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 sodium 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 sodium 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 sodium. 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 sodium-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 sodium dosage [see Drug Interactions ( 7.1 )]. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Pravastatin sodium is not recommended in patients taking gemfibrozil [see Drug Interactions ( 7 )]. There are pravastatin sodium dosage restrictions for patients taking cyclosporin and select macrolide antibiotics [see Dosage and Administration ( 2.5 )].

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

Temporarily discontinue pravastatin sodium 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 sodium 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 necessar…

🤒 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 Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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 sodium placebo-controlled clinical trials, 1313 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 sodium 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 sodium-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 g-GT Increased 1.2 2 Adverse Reactions (regardless of causality) The safety and tolerability of pravastatin sodium at a dose of 80 mg in 2 controlled trials with a mean exposure of 8.6 months was similar to that of pravastatin sodium 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 sodium 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 sodium 40 mg and 10,719 patients treated with placebo.

Patients were exposed to pravastatin sodium for a mean of 4 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 sodium 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…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • See full prescribing information for details regarding concomitant use of pravastatin sodium 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 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 Sodium Pravastatin sodium is a substrate of the transport protein OATP1B1. Pravastatin sodium 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 sodium 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 Sodium Gemfibrozil Clinical Impact: There is an increased risk of myopathy/rhabdomyolysis when pravastatin Sodium is administered with gemfibrozil Intervention: Avoid concomitant use of gemfibrozil with pravastatin sodium. Cyclosporine Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine with pravastatin sodium. Intervention: Initiate with a dosage of pravastatin sodium 10 mg once daily.

Do not exceed pravastatin sodium 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 sodium. Other macrolides (e.g., azithromycin) have the potential to increase pravastatin sodium exposures and increase the risk of myopathy and rhabdomyolysis when used concomintantly.

Intervention: For patients taking erythromycin or clarithromycin, do not exceed 40 mg pravastatin sodium 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 sodium. Intervention: Consider if the benefit of using niacin concomitantly with pravastatin sodium 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 sodium.

Intervention: Consider if the benefit of using fibrates concomitantly with pravastatin sodium 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 sodium.

Intervention: Consider if the benefit of using colchicine concomitantly with pravastatin sodium 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 Sodium Table 4 presents drug interactions that may decrease the efficacy of pravastatin sodium and instructions for preventing or managing them. Table 4: Drug Interactions that Decrease the Efficacy of Pravastatin Sodium Bile Acid Sequestrants Clinical Impact: Concomitant cholestyramine or colestipol administration decreased the mean exposure of pravastatin approximately 51% an…

👥 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 ( 8.2 )

8.1Pregnancy Risk Summary Discontinue pravastatin sodium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. pravastatin sodium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin sodium 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 sodium 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 1152 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, 20, 100, 500, and 1000 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 area (mg/m 2 ).…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Discontinue pravastatin sodium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. pravastatin sodium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin sodium 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 sodium 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 1152 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, 20, 100, 500, and 1000 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 area (mg/m 2 ).

In other studies, no teratogenic effects were observed when pravastatin was dosed orally during organogenesis in rabbits (gestation days 6 through 18) up to 50 mg/k…

🧒 Pediatric Use 111 words ▾

8.4Pediatric Use The safety and effectiveness of pravastatin sodium 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 sodium 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 sodium 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 170 words ▾

8.5Geriatric Use In clinical studies, 4,797 (36.4%) pravastatin sodium-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 (C max ), time to maximum plasma concentration (T max ), and half-life (t ½ ) 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 sodium-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 sodium for the increased risk of myopathy [see Warnings and Precautions ( 5.1 ) ].

🆘 Overdosage 17 words ▾

10 OVERDOSAGE No specific antidotes for pravastatin sodium 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 sodium is usually achieved by 4 weeks and is maintained after that.

12.3Pharmacokinetics Absorption Pravastatin sodium 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 Cmax 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 sodium tablets. 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-hydroxyisomer of pravastatin (SQ 31,906) and (b) enzymatic ring hydroxylation to SQ 31,945.

The 3α-hydroxyisomeric 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 (t ½ ) 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…

🧬 Mechanism of Action 24 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 37 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-1533 NDC: 50090-1533-0 30 TABLET in a BOTTLE NDC: 50090-1533-1 90 TABLET in a BOTTLE Product: 50090-1594 NDC: 50090-1594-0 90 TABLET in a BOTTLE NDC: 50090-1594-1 30 TABLET in a BOTTLE

📋 Description 175 words ▾

11 DESCRIPTION Pravastatin Sodium Tablets, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthaleneheptanoic 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, USP is an odorless, white to off-white, fine or crystalline powder.

It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin Sodium Tablets, USP for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.48 mg, 18.97 mg, 37.94 mg and 75.88 mg of pravastatin, respectively.

Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no.

10 aluminum lake and FD&C blue no. 1 aluminum lake. 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 ) ] . Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com July 2022 Description: Glenmark logo

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50090-1587-00 · A-S 50090-1595-00 · A-S →
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.