Prescription Drug Information: PRAVASTATIN SODIUM (Page 7 of 7)

15 REFERENCES

  1. Fredrickson DS, Levy RI, Lees RS. Fat transport in lipoproteins — An integrated approach to mechanisms and disorders. N Engl J Med. 1967;276: 34-44, 94-103, 148-156, 215-225, 273-281.
  2. Manson JM, Freyssinges C, Ducrocq MB, Stephenson WP. Postmarketing surveillance of lovastatin and simvastatin exposure during pregnancy. Reprod Toxicol. 1996;10(6):439-446.
  3. Shepherd J, Cobbe SM, Ford I, et al, for the West of Scotland Coronary Prevention Study Group (WOS). Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 1995;333:1301-1307.
  4. The Long-term Intervention with Pravastatin in Ischemic Disease Group (LIPID). Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998;339:1349-1357.
  5. Sacks FM, Pfeffer MA, Moye LA, et al, for the Cholesterol and Recurrent Events Trial Investigators (CARE). The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med. 1996;335:1001-1009.
  6. Pitt B, Mancini GBJ, Ellis SG, et al, for the PLAC I Investigators. Pravastatin limitation of atherosclerosis in the coronary arteries (PLAC I): Reduction in atherosclerosis progression and clinical events. J Am Coll Cardiol. 1995;26:1133-1139.
  7. Jukema JW, Bruschke AVG, van Boven AJ, et al, for the Regression Growth Evaluation Statin Study Group (REGRESS). Effects of lipid lowering by pravastatin on progression and regression of coronary artery disease in symptomatic man with normal to moderately elevated serum cholesterol levels. Circ. 1995;91:2528-2540.
  8. Crouse JR, Byington RP, Bond MG, et al. Pravastatin, lipids, and atherosclerosis in the carotid arteries: Design features of a clinical trial with carotid atherosclerosis outcome (PLAC II). Control Clin Trials. 1992;13:495-506.
  9. Salonen R, Nyyssonen K, Porkkala E, et al. Kuopio Atherosclerosis Prevention Study (KAPS). A population-based primary preventive trial of the effect of LDL lowering on atherosclerotic progression in carotid and femoral arteries. Circ. 1995;92:1758-1764.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied
Pravastatin Sodium Tablets, USP are supplied as:

20 mg tablets: White to off-white, rounded, rectangular-shaped, biconvex tablets debossed with “B 20” on one side and plain on other side. They are suppliedin bottles of 1000’s Count (NDC: 63629-8909-1). Bottles contain a desiccant canister.

16.2 Storage
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.

17 PATIENT COUNSELING INFORMATION

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 [see Warnings and Precautions (5.1) ].

Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of Pravastatin Sodium, and thereafter when clinically indicated. All patients treated with Pravastatin Sodium 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 Warnings and Precautions (5.3) ].

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 Contraindications (4.3), Use in Specific Populations (8.1,8.3)].

Lactation

Advise women not to breastfeed during treatment with Pravastatin Sodium [see Contraindications (4.4), Use in Specific Populations (8.2)].

Manufactured by:

Appco Pharma LLC
Piscataway, NJ 08854

Manufactured for:

Biocon Pharma Inc.,
485 US Highway 1 S
Suite B305, IselinNJ 08830-3009

USA

Revised: 10/2020

Pravastatin Sodium 20 mg tab#1000

Label
(click image for full-size original)
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8909(NDC:70377-046)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE (white to off -White) Score no score
Shape RECTANGLE (Rounded, Rectangle) Size 8mm
Flavor Imprint Code B;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-8909-1 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209869 02/01/2021
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-8909), RELABEL (63629-8909)

Revised: 11/2021 Bryant Ranch Prepack

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