Pravastatin Sodium (Pravastatin Sodium)

Trade Name : PRAVASTATIN SODIUM

Proficient Rx LP

TABLET

Strength 40 mg/1

PRAVASTATIN SODIUM HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pravastatin Sodium (Pravastatin Sodium) which is also known as PRAVASTATIN SODIUM and Manufactured by Proficient Rx LP. It is available in strength of 40 mg/1 per ml. Read more

Pravastatin Sodium (Pravastatin Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Dosage and Administration
  • u00a0 u00a0 Patients with Renal Impairment u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 7/2016
  • Contraindications
  • u00a0 u00a0 Pregnancy , Lactation u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 7/2016
  • Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
  • Pravastatin is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
  • Limitations of use:
  • No data
  • Pravastatin sodium tablets, USP are supplied as:
  • 10 mg tablets:
  • 20 mg tablets:
  • 40 mg tablets:
  • 80 mg tablets:
  • u2022
  • (3)
  • No data
  • (4.1n- 6.2n- 11)
  • (4.2n- 5.2)
  • (4.3n- 8.1n- 8.3)
  • (4.4n- 8.2)
  • No data
  • (5.1n- 8.5)
  • Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month-long placebo-controlled trials, 1.7% of pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant.
  • In short-term clinical trials, the most commonly reported adverse reactions (u22652% and > placebo) regardless of causality were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache.
  • To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or .
  • (6.1)
  • For the concurrent therapy of either cyclosporine, fibrates, niacin (nicotinic acid), or erythromycin, the risk of myopathy increases [see and ].
  • (2.6n- 7.1)
  • (2.7n- 7.2)
  • No data
  • To date, there has been limited experience with overdosage of pravastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.
  • Pravastatin is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.
  • Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-u03b2,u03b4,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1u03b1(u03b2S*,u03b4S*),2u03b1,6u03b1,8u03b2(R*),8au03b1]]-.
  • Structural formula:
  • Pravastatin sodium 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 are available for oral administration as 10 mg, 20 mg, 40 mg, and 80u00a0mg 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.
  • No data
  • No data
  • No data
  • No data
  • No data
  • Muscle Pain
  • Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing pravastatin sodium tablets [see ].
  • Liver Enzymes
  • It is recommended that liver enzyme tests be performed before the initiation of pravastatin sodium tablets, and thereafter when clinically indicated. All patients treated with pravastatin sodium tablets should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see ].
  • Embryofetal Toxicity
  • Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy [see ] n
  • Lactation
  • Advise women not to breastfeed during treatment with Pravastatin sodium tablets [see ] n
  • Manufactured For:
  • Accord Healthcare, Inc.,
  • 1009, Slater Road,
  • Suite 210-B,
  • Durham, NC 27703,
  • USA.
  • Manufactured By:
  • Plot No. : 457, 458,
  • Village u2013 Matoda,
  • Bavla Road, Ta.- Sanand,
  • Dist.- Ahmedabad u2013 382 210.
  • INDIA.
  • 10 0983 0 669002
  • Issued July 2016
  • Repackaged By;
  • Proficient RX LP
  • Thousand Oaks CA 91320
  • NDC 71205-121-30
  • Pravastatin Sodium Tablets USP
  • 40 mg : 30 Tablets Label

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

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Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

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