A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Pravachol Indications, Dosage, Storage, Stability - Pravastatin Sodium
Pravachol Indications, Dosage, Storage, Stability - Pravastatin Sodium
INDICATIONS AND USAGE
Therapy with PRAVACHOL (pravastatin sodium) should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.
Primary Prevention of Coronary Events
In hypercholesterolemic patients without clinically evident coronary heart disease, PRAVACHOL (pravastatin sodium) is indicated to:
• Reduce the risk of myocardial infarction
• Reduce the risk of undergoing myocardial revascularization procedures
• Reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.
Secondary Prevention of Cardiovascular Events
In patients with clinically evident coronary heart disease, PRAVACHOL (pravastatin sodium) is indicated to:
• Reduce the risk of total mortality by reducing coronary death
• Reduce the risk of myocardial infarction
• Reduce the risk of undergoing myocardial revascularization procedures
• Reduce the risk of stroke and stroke/transient ischemic attack (TIA)
• Slow the progression of coronary atherosclerosis.
Hyperlipidemia
PRAVACHOL is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, Apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb)8.
PRAVACHOL is indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV).
PRAVACHOL is indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
PRAVACHOL is indicated as an adjunct to diet and lifestyle modification for treatment of HeFH in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
1. LDL-C remains ³ 190 mg/dL or
2. LDL-C remains ³ 160 mg/dL and:
• there is a positive family history of premature cardiovascular disease or
• two or more other CVD risk factors are present in the patient
Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate (see NCEP Guidelines below).
Prior to initiating therapy with pravastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure Total-C, HDL-C, and TG. For patients with triglycerides (TG) <400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation:
LDL-C = Total -C - HDL-C – 1/5 TG
For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In many hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases, HMG-CoA reductase inhibitors are not indicated.
Lipid determinations should be performed at intervals of no less than four weeks and dosage adjusted according to the patient’s response to therapy.
The National Cholesterol Education Program’s Treatment Guidelines are summarized below:
|
NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
|
|
Risk Category
|
LDL Goal (mg/dl)
|
LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)
|
LDL Level at Which to Consider Drug Therapy (mg/dL)
|
CHDa or CHD risk equivalents(10-year risk > 20%) |
< 100 |
³ 100 |
³ 130
(100-129: drug optional)b |
2+ Risk factors (10-year risk £ 20 %) |
< 130 |
³ 130 |
10-year risk 10%-20%: ³ 130 |
10-year risk < 10%: ³ 160 |
0 -1 Risk factorc |
< 160 |
³ 160 |
³ 190
(160-189: LDL-lowering
drug optional) |
a CHD, coronary heart disease. |
b Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgement also may call for deferring drug therapy in this subcategory. |
c Almost all people with 0-1 risk factor have 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. |
After the LDL-C goal has been achieved, if the TG is still ³ 200 mg/dL, non-HDL-C (Total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.
At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is ³ 130 mg/dL (see NCEP Guidelines, above).
Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy.
As with other lipid-lowering therapy, PRAVACHOL (pravastatin sodium) is not indicated when hypercholesterolemia is due to hyperalphalipoproteinemia (elevated HDL-C).
The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below:
|
Category
|
Total-C (mg/dL)
|
LDL-C (mg/dL)
|
Acceptable |
<170 |
<110 |
Borderline |
170-199 |
110-129 |
High |
³ 200 |
³ 130 |
DOSAGE AND ADMINISTRATION
The patient should be placed on a standard cholesterol-lowering diet before receiving PRAVACHOL (pravastatin sodium) and should continue on this diet during treatment with PRAVACHOL (see NCEP Treatment Guidelines for details on dietary therapy).
PRAVACHOL can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.
Adult Patients
The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with a history of significant renal or hepatic dysfunction, a starting dose of 10 mg daily is recommended.
Pediatric Patients
Children (Ages 8 to 13 Years, Inclusive)
The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.
Adolescents (Ages 14 to 18 Years)
The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age. Doses greater than 40 mg have not been studied in this patient population.
Children and adolescents treated with pravastatin should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C (see INDICATIONS AND USAGE, Hyperlipidemia, NCEP Treatment Guidelines).
In patients taking immunosuppressive drugs such as cyclosporine (see WARNINGS: Skeletal Muscle) concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin once-a-day at bedtime and titration to higher doses should be done with caution. Most patients treated with this combination received a maximum pravastatin dose of 20 mg/day.
Concomitant Therapy
The lipid-lowering effects of PRAVACHOL on total and LDL cholesterol are enhanced when combined with a bile-acid-binding resin. When administering a bile-acid-binding resin (e.g., cholestyramine, colestipol) and pravastatin, PRAVACHOL should be given either 1 hour or more before or at least 4 hours following the resin. (See also ADVERSE REACTIONS: Concomitant Therapy.)
HOW SUPPLIED
PRAVACHOL® (pravastatin sodium) Tablets are supplied as:
10 mg tablets
Pink to peach, rounded, rectangular-shaped, biconvex with a P embossed on one side and PRAVACHOL 10 engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5154-05). Bottles contain a desiccant canister.
20 mg tablets
Yellow, rounded, rectangular-shaped, biconvex with a P embossed on one side and PRAVACHOL 20 engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5178-05) and bottles of 1000 (NDC 0003-5178-75). Bottles contain a desiccant canister.
40 mg tablets
Green, rounded, rectangular-shaped, biconvex with a P embossed on one side and PRAVACHOL 40 engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5194-10). Bottles contain a desiccant canister.
80 mg tablets
Yellow, oval-shaped, biconvex with BMS embossed on one side and 80 engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5195-10) and bottles of 500 (NDC 0003-5195-12). Bottles contain a desiccant canister.
Unimatic® unit-dose packs containing 100 tablets are also available for the 20 mg (NDC 0003-5178-06) potency.
STORAGE
Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.
REFERENCE
8 Fredrickson DS, et al. Fat Transport in Lipoproteins-An Integrated Approach to Mechanisms and Disorders. N Engl J Med 1967; 276:34-42, 94-102, 148-156, 215-224, 273-281.
US Patent Nos.: 4,346,227; 5,030,447; 5,180,589; 5,622,985
Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA, 5154DIM-21, 515432DIM-12, Revised March 2003 J4-538U, 1109268A9 1092990B2
top
