Pravachol
Description
PRAVACHOL is a prescription medicine that is added to diet, when diet and exercise are not enough. PRAVACHOL helps lower cholesterol in the blood. It lowers LDL bad cholesterol and raises HDL good cholesterol.
In addition, in patients with high cholesterol who do not have heart disease, PRAVACHOL is proven to help prevent heart attack, reduce the risk of dying from a heart attack, and reduce the risk of undergoing heart bypass surgery or angioplasty (a procedure used to open a narrowing in the coronary artery without surgery).
In patients with heart disease, PRAVACHOL is proven to help prevent heart attack and stroke, reduce the risk of dying from a heart attack, reduce the risk of undergoing heart bypass surgery and angioplasty, and slow the progression of hardening of the arteries.
Recommendations
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking.
Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. Try to take this medicine at the same time each day.
STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted.
IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
FOLLOW THE DIETARY PLAN provided by your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine.
BEFORE HAVING ANY KIND OF SURGERY, tell your doctor that you are taking this medicine.
BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.
FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately.
Bill Winkley, CA, 40:
I would like to thank you again for your greatest business. I am infinitely pleased with Pharmacy, and actually look forward to meeting other men with high blood pressure so that I can refer them to you. I have given Pharmacy the most profound acclaim to the reference site in which I found you. I will indeed be returning to Pharmacy for future business!
Debra, LA, 45:
Hello, Thanks for your messages welcoming me and confirming my order and removing the worries I usually have when ordering online - it took me all evening to decide where I was going to buy Pravachol online (first time). Your professional and friendly website and competitive prices made it an easy decision after all.
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 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 noncardiovascular
causes.
Secondary Prevention of Cardiovascular Events
In patients with clinically evident coronary heart disease, PRAVACHOL 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
(Fredrickson Type IIa and IIb).
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 life-style 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 190 mg/dL or
2. LDL-C remains 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 - 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 patients response to therapy.
Precautions
FOLLOW THE DIETARY PLAN provided by your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine.
BEFORE HAVING ANY KIND OF SURGERY, tell your doctor that you are taking this medicine.
BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.
FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately.
Bill Winkley, CA, 40:
I would like to thank you again for your greatest business. I am infinitely pleased with Pharmacy, and actually look forward to meeting other men with high blood pressure so that I can refer them to you. I have given Pharmacy the most profound acclaim to the reference site in which I found you. I will indeed be returning to Pharmacy for future business!
Debra, LA, 45:
Hello, Thanks for your messages welcoming me and confirming my order and removing the worries I usually have when ordering online - it took me all evening to decide where I was going to buy Pravachol online (first time). Your professional and friendly website and competitive prices made it an easy decision after all.
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 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 noncardiovascular
causes.
Secondary Prevention of Cardiovascular Events
In patients with clinically evident coronary heart disease, PRAVACHOL 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
(Fredrickson Type IIa and IIb).
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 life-style 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 190 mg/dL or
2. LDL-C remains 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 - 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 patients response to therapy.
PRAVACHOL (pravastatin sodium) may elevate creatine phosphokinase and transaminase levels
(see ADVERSE REACTIONS). This should be considered in the differential diagnosis of
chest pain in a patient on therapy with pravastatin.
Homozygous Familial Hypercholesterolemia
Pravastatin has not been evaluated in patients with rare homozygous familial hypercholesterolemia.
In this group of patients, it has been reported that HMG-CoA reductase inhibitors
are less effective because the patients lack functional LDL receptors.
Renal Insufficiency
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 3a-hydroxy isomeric metabolite (SQ 31,906). A small
increase was seen in mean AUC values and half-life (t??2) for the inactive enzymatic ring
hydroxylation metabolite (SQ 31,945). Given this small sample size, the dosage administered,
and the degree of individual variability, patients with renal impairment who are receiving
pravastatin should be closely monitored.
Information for Patients
Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness,
particularly if accompanied by malaise or fever.
Ingredients
PRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the HMGCoA
reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive
inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (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-b,d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium
salt, [1S-[1a(bS*,dS*),2a,6a,8b(R*),8aa]]-.
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.
