Prescription Drug Information: Pravastatin Sodium (Page 7 of 7)

14.6 Pediatric Clinical Study

A double-blind, placebo-controlled study in 214 patients (100 boys and 114 girls) with heterozygous familial hypercholesterolemia (HeFH), aged 8 to 18 years was conducted for 2 years. The children (aged 8 to 13 years) were randomized to placebo (N=63) or 20 mg of pravastatin daily (N=65) and the adolescents (aged 14 to 18 years) were randomized to placebo (N=45) or 40 mg of pravastatin daily (N=41). Inclusion in the study required an LDL-C level >95th percentile for age and sex and one parent with either a clinical or molecular diagnosis of familial hypercholesterolemia. The mean baseline LDL-C value was 239 mg/dL and 237 mg/dL in the pravastatin (range: 151 to 405 mg/dL) and placebo (range: 154 to 375 mg/dL) groups, respectively.

Pravastatin significantly decreased plasma levels of LDL-C, Total-C, and ApoB in both children and adolescents (see Table 10). The effect of pravastatin treatment in the 2 age groups was similar.

Table 10: Lipid-Lowering Effects of Pravastatin in Pediatric Patients with Heterozygous Familial Hypercholesterolemia: Least-Squares Mean % Change from Baseline at Month 24 (Last Observation Carried Forward: Intent-to-Treat)a
Pravastatin 20 mg (Aged 8-13 years) N=65 Pravastatin 40 mg (Aged 14-18 years) N=41 Combined Pravastatin (Aged 8-18 years) N=106 Combined Placebo (Aged 8-18 years) N=108 95% CI of the Difference Between Combined Pravastatin and Placebo
a The above least-squares mean values were calculated based on log-transformed lipid values.b Significant at p≤0.0001 when compared with placebo.

LDL-C

−26.04b

−21.07b

−24.07b

−1.52

(−26.74, −18.86)

TC

−20.75b

−13.08b

−17.72b

−0.65

(−20.40, −13.83)

HDL-C

1.04

13.71

5.97

3.13

(−1.71, 7.43)

TG

−9.58

−0.30

−5.88

−3.27

(−13.95, 10.01)

ApoB (N)

−23.16b (61)

−18.08b (39)

−21.11b (100)

−0.97(106)

(−24.29, −16.18)

The mean achieved LDL-C was 186 mg/dL (range: 67 to 363 mg/dL) in the pravastatin group compared to 236 mg/dL (range: 105 to 438 mg/dL) in the placebo group.

The safety and efficacy of pravastatin doses above 40 mg daily have not been studied in children. The long-term efficacy of pravastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.

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

Product: 50090-1533

NDC: 50090-1533-0 30 TABLET in a BOTTLE

NDC: 50090-1533-1 90 TABLET in a BOTTLE

Product: 50090-1594

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 for:

Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

May 2021

Pravastatin Sodium

Label ImageLabel Image

Pravastatin Sodium

Label ImageLabel Image
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1533(NDC:68462-197)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color GREEN Score no score
Shape RECTANGLE (Rounded rectangular) Size 10mm
Flavor Imprint Code G5;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1533-0 30 TABLET in 1 BOTTLE None
2 NDC:50090-1533-1 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077987 05/11/2007
PRAVASTATIN SODIUM pravastatin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1594(NDC:68462-195)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM (PRAVASTATIN) PRAVASTATIN SODIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6mm
Flavor Imprint Code G5;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1594-0 90 TABLET in 1 BOTTLE None
2 NDC:50090-1594-1 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077987 05/11/2007 06/30/2019
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1533), REPACK (50090-1533), RELABEL (50090-1594), REPACK (50090-1594)

Revised: 08/2022 A-S Medication Solutions

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.